{
"NDC": [
{
"NDCCode": "49483-373-20",
"PackageDescription": "200 TABLET in 1 BOTTLE (49483-373-20) ",
"NDC11Code": "49483-0373-20",
"ProductNDC": "49483-373",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tension Headache Relief",
"NonProprietaryName": "Acetaminophen, Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210616",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "TIME CAP LABS INC",
"SubstanceName": "ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "500; 65",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230808",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Temporarily relieves minor aches and pains due to: 1 headache, 2 muscular aches."
},
{
"NDCCode": "49483-373-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (49483-373-01) ",
"NDC11Code": "49483-0373-01",
"ProductNDC": "49483-373",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tension Headache Relief",
"NonProprietaryName": "Acetaminophen, Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210616",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "TIME CAP LABS INC",
"SubstanceName": "ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "500; 65",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210616",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Temporarily relieves minor aches and pains due to: 1 headache, 2 muscular aches."
},
{
"NDCCode": "49483-133-20",
"PackageDescription": "200 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-20) ",
"NDC11Code": "49483-0133-20",
"ProductNDC": "49483-133",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen Capsules 200 Mg",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20210727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079205",
"LabelerName": "TIME CAP LABORATORIES, INC.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220616",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves minor aches and pains due to :."
},
{
"NDCCode": "49483-133-23",
"PackageDescription": "1 BOTTLE in 1 CARTON (49483-133-23) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "49483-0133-23",
"ProductNDC": "49483-133",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen Capsules 200 Mg",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20210727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079205",
"LabelerName": "TIME CAP LABORATORIES, INC.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220616",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves minor aches and pains due to :."
},
{
"NDCCode": "49483-145-20",
"PackageDescription": "200 CAPSULE in 1 BOTTLE (49483-145-20) ",
"NDC11Code": "49483-0145-20",
"ProductNDC": "49483-145",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Psyllium Husk",
"ProprietaryNameSuffix": "Fiber Supplement",
"NonProprietaryName": "Psyllium Husk",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240405",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "TIME CAP LABS INC",
"SubstanceName": "PSYLLIUM HUSK",
"StrengthNumber": ".52",
"StrengthUnit": "g/1",
"Status": "Deprecated",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240405",
"SamplePackage": "N",
"IndicationAndUsage": "effective in treating occasional constipation and restoring regularity. This product generally produces bowel movement in 12 to 72 hours."
},
{
"NDCCode": "49483-272-20",
"PackageDescription": "200 TABLET in 1 BOTTLE (49483-272-20) ",
"NDC11Code": "49483-0272-20",
"ProductNDC": "49483-272",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucosa",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120416",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "TIME CAP LABORATORIES,INC",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2023-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230915",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus."
},
{
"NDCCode": "49483-280-20",
"PackageDescription": "200 TABLET in 1 BOTTLE (49483-280-20) ",
"NDC11Code": "49483-0280-20",
"ProductNDC": "49483-280",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucosa Dm",
"NonProprietaryName": "Guaifenesin Dextromethorphan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120417",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "TIME CAP LABORATORIES, INC.",
"SubstanceName": "GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "400; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230915",
"SamplePackage": "N",
"IndicationAndUsage": "Uses helps loosen phlegm (mucus) helps thin bronchial secretions to make coughs more productive temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold."
},
{
"NDCCode": "49483-341-20",
"PackageDescription": "200 TABLET, FILM COATED in 1 BOTTLE (49483-341-20) ",
"NDC11Code": "49483-0341-20",
"ProductNDC": "49483-341",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110718",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "TIME CAP LABS INC",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231025",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. temporarily relieves minor aches and pains due to: 1 the common cold, 2 headache, 3 backache, 4 minor pain of arthritis, 5 toothache, 6 muscular aches, 7 premenstrual and menstrual cramps."
},
{
"NDCCode": "49483-370-20",
"PackageDescription": "200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-370-20) ",
"NDC11Code": "49483-0370-20",
"ProductNDC": "49483-370",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Pain Relief",
"NonProprietaryName": "Acetaminophen, Aspirin And Caffeine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "TIME CAP LABS",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves minor aches and pains due to:."
},
{
"NDCCode": "49483-692-20",
"PackageDescription": "200 TABLET in 1 BOTTLE (49483-692-20) ",
"NDC11Code": "49483-0692-20",
"ProductNDC": "49483-692",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride Tablets,10 Mg",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078933",
"LabelerName": "TIME CAP LABORATORIES, INC.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240311",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat."
},
{
"NDCCode": "49483-720-20",
"PackageDescription": "200 TABLET in 1 BOTTLE (49483-720-20) ",
"NDC11Code": "49483-0720-20",
"ProductNDC": "49483-720",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Maximum Strength Acid Reducer",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217543",
"LabelerName": "TIME CAP LABORATORIES,INC",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230615",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. : 1 relieves heartburn associated with acid indigestion and sour stomach, 2 prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages."
},
{
"NDCCode": "45865-373-20",
"PackageDescription": "20 TABLET in 1 BOTTLE (45865-373-20)",
"NDC11Code": "45865-0373-20",
"ProductNDC": "45865-373",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078558",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.",
"Description": "Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (p – isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide."
},
{
"NDCCode": "50563-375-01",
"PackageDescription": "1 KIT in 1 KIT (50563-375-01) * 20 SOLUTION in 1 PACKET (50563-373-01) * 20 SOLUTION in 1 PACKET (50563-374-01) * 20 SOLUTION in 1 PACKET (50563-372-01) ",
"NDC11Code": "50563-0375-01",
"ProductNDC": "50563-375",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Body Prescriptions Antibacterial Hand Wipes Juicy Peach Peach Mint Strawberry Peach",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20201027",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ENCHANTE ACCESSORIES INC.",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201027",
"SamplePackage": "N"
},
{
"NDCCode": "52125-373-20",
"PackageDescription": "100 TABLET in 1 VIAL (52125-373-20)",
"NDC11Code": "52125-0373-20",
"ProductNDC": "52125-373",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078558",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "66267-373-20",
"PackageDescription": "20 TABLET, DELAYED RELEASE in 1 BOTTLE (66267-373-20) ",
"NDC11Code": "66267-0373-20",
"ProductNDC": "66267-373",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091432",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171121",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of naproxen delayed-release tablets and other treatment options before deciding to use naproxen delayed-release tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals ( see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Naproxen delayed-release tablets are indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis, 2 For the relief of the signs and symptoms of osteoarthritis, 3 For the relief of the signs and symptoms of ankylosing spondylitis, 4 For the relief of the signs and symptoms of juvenile arthritis.",
"Description": "Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. It has the following structural formula. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen delayed-release tablets USP are available as enteric coated, white tablets containing 375 mg of naproxen and 500 mg of naproxen, USP for oral administration. The inactive ingredients are croscarmellose sodium, povidone, colloidal silicon dioxide and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer dispersion, talc, titanium dioxide, triethyl citrate and purified water. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4."
},
{
"NDCCode": "67544-373-20",
"PackageDescription": "20 CAPSULE in 1 BOTTLE, PLASTIC (67544-373-20)",
"NDC11Code": "67544-0373-20",
"ProductNDC": "67544-373",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19880112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071428",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol, USP. Temazepam capsules, 15 mg and 30 mg, are for oral administration. Active ingredient: temazepam, USP. Inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate. The capsule shells and imprinting inks contain: gelatin, iron oxide black, shellac, propylene glycol, titanium dioxide, methylparaben, butylparaben, propylparaben, benzyl alcohol, sodium propionate and edetate calcium disodium. The 15 mg capsules also contain D&C Yellow #10 and FD&C Blue #1."
},
{
"NDCCode": "73069-373-51",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BOX (73069-373-51) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0373-51",
"ProductNDC": "73069-373",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-neuro 3",
"NonProprietaryName": "Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Vasodilation [PE],Vasodilator [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-373-52",
"PackageDescription": "3 VIAL, MULTI-DOSE in 1 BOX (73069-373-52) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0373-52",
"ProductNDC": "73069-373",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-neuro 3",
"NonProprietaryName": "Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Vasodilation [PE],Vasodilator [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-373-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-373-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0373-53",
"ProductNDC": "73069-373",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-neuro 3",
"NonProprietaryName": "Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Vasodilation [PE],Vasodilator [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-373-54",
"PackageDescription": "6 VIAL, MULTI-DOSE in 1 BOX (73069-373-54) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0373-54",
"ProductNDC": "73069-373",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-neuro 3",
"NonProprietaryName": "Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Vasodilation [PE],Vasodilator [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-373-55",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 BOX (73069-373-55) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0373-55",
"ProductNDC": "73069-373",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-neuro 3",
"NonProprietaryName": "Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Vasodilation [PE],Vasodilator [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-373-56",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-373-56) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0373-56",
"ProductNDC": "73069-373",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-neuro 3",
"NonProprietaryName": "Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Vasodilation [PE],Vasodilator [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-373-57",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-373-57) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0373-57",
"ProductNDC": "73069-373",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-neuro 3",
"NonProprietaryName": "Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Vasodilation [PE],Vasodilator [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-373-58",
"PackageDescription": "50 VIAL, MULTI-DOSE in 1 BOX (73069-373-58) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0373-58",
"ProductNDC": "73069-373",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-neuro 3",
"NonProprietaryName": "Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Vasodilation [PE],Vasodilator [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-373-59",
"PackageDescription": "100 VIAL, MULTI-DOSE in 1 BOX (73069-373-59) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0373-59",
"ProductNDC": "73069-373",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-neuro 3",
"NonProprietaryName": "Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Vasodilation [PE],Vasodilator [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "49483-221-06",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (49483-221-06) ",
"NDC11Code": "49483-0221-06",
"ProductNDC": "49483-221",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitro-time",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140619",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "TIME CAP LABORATORIES, INC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181009",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide."
},
{
"NDCCode": "49483-221-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (49483-221-10) ",
"NDC11Code": "49483-0221-10",
"ProductNDC": "49483-221",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitro-time",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140619",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "TIME CAP LABORATORIES, INC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181009",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide."
},
{
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"StartMarketingDate": "20140619",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "TIME CAP LABORATORIES, INC",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181009",
"SamplePackage": "N",
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"Description": "Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide."
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{
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"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (49483-222-10) ",
"NDC11Code": "49483-0222-10",
"ProductNDC": "49483-222",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitro-time",
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"StartMarketingDate": "20140619",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "TIME CAP LABORATORIES, INC",
"SubstanceName": "NITROGLYCERIN",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide."
},
{
"NDCCode": "49483-223-06",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (49483-223-06) ",
"NDC11Code": "49483-0223-06",
"ProductNDC": "49483-223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitro-time",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140619",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "TIME CAP LABORATORIES, INC",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
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"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide."
}
]
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
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<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses helps loosen phlegm (mucus) helps thin bronchial secretions to make coughs more productive temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49483-341-20</NDCCode>
<PackageDescription>200 TABLET, FILM COATED in 1 BOTTLE (49483-341-20) </PackageDescription>
<NDC11Code>49483-0341-20</NDC11Code>
<ProductNDC>49483-341</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110718</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>TIME CAP LABS INC</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. temporarily relieves minor aches and pains due to: 1 the common cold, 2 headache, 3 backache, 4 minor pain of arthritis, 5 toothache, 6 muscular aches, 7 premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49483-370-20</NDCCode>
<PackageDescription>200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-370-20) </PackageDescription>
<NDC11Code>49483-0370-20</NDC11Code>
<ProductNDC>49483-370</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Pain Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Aspirin And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>TIME CAP LABS</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves minor aches and pains due to:.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49483-692-20</NDCCode>
<PackageDescription>200 TABLET in 1 BOTTLE (49483-692-20) </PackageDescription>
<NDC11Code>49483-0692-20</NDC11Code>
<ProductNDC>49483-692</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride Tablets,10 Mg</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078933</ApplicationNumber>
<LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49483-720-20</NDCCode>
<PackageDescription>200 TABLET in 1 BOTTLE (49483-720-20) </PackageDescription>
<NDC11Code>49483-0720-20</NDC11Code>
<ProductNDC>49483-720</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Maximum Strength Acid Reducer</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217543</ApplicationNumber>
<LabelerName>TIME CAP LABORATORIES,INC</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. : 1 relieves heartburn associated with acid indigestion and sour stomach, 2 prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>45865-373-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (45865-373-20)</PackageDescription>
<NDC11Code>45865-0373-20</NDC11Code>
<ProductNDC>45865-373</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078558</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (p – isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50563-375-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (50563-375-01) * 20 SOLUTION in 1 PACKET (50563-373-01) * 20 SOLUTION in 1 PACKET (50563-374-01) * 20 SOLUTION in 1 PACKET (50563-372-01) </PackageDescription>
<NDC11Code>50563-0375-01</NDC11Code>
<ProductNDC>50563-375</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Body Prescriptions Antibacterial Hand Wipes Juicy Peach Peach Mint Strawberry Peach</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201027</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ENCHANTE ACCESSORIES INC.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52125-373-20</NDCCode>
<PackageDescription>100 TABLET in 1 VIAL (52125-373-20)</PackageDescription>
<NDC11Code>52125-0373-20</NDC11Code>
<ProductNDC>52125-373</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078558</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>66267-373-20</NDCCode>
<PackageDescription>20 TABLET, DELAYED RELEASE in 1 BOTTLE (66267-373-20) </PackageDescription>
<NDC11Code>66267-0373-20</NDC11Code>
<ProductNDC>66267-373</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091432</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of naproxen delayed-release tablets and other treatment options before deciding to use naproxen delayed-release tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals ( see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Naproxen delayed-release tablets are indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis, 2 For the relief of the signs and symptoms of osteoarthritis, 3 For the relief of the signs and symptoms of ankylosing spondylitis, 4 For the relief of the signs and symptoms of juvenile arthritis.</IndicationAndUsage>
<Description>Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. It has the following structural formula. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen delayed-release tablets USP are available as enteric coated, white tablets containing 375 mg of naproxen and 500 mg of naproxen, USP for oral administration. The inactive ingredients are croscarmellose sodium, povidone, colloidal silicon dioxide and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer dispersion, talc, titanium dioxide, triethyl citrate and purified water. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4.</Description>
</NDC>
<NDC>
<NDCCode>67544-373-20</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE, PLASTIC (67544-373-20)</PackageDescription>
<NDC11Code>67544-0373-20</NDC11Code>
<ProductNDC>67544-373</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temazepam</ProprietaryName>
<NonProprietaryName>Temazepam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880112</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071428</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TEMAZEPAM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol, USP. Temazepam capsules, 15 mg and 30 mg, are for oral administration. Active ingredient: temazepam, USP. Inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate. The capsule shells and imprinting inks contain: gelatin, iron oxide black, shellac, propylene glycol, titanium dioxide, methylparaben, butylparaben, propylparaben, benzyl alcohol, sodium propionate and edetate calcium disodium. The 15 mg capsules also contain D&C Yellow #10 and FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>73069-373-51</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BOX (73069-373-51) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0373-51</NDC11Code>
<ProductNDC>73069-373</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-neuro 3</ProprietaryName>
<NonProprietaryName>Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Vasodilation [PE],Vasodilator [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-373-52</NDCCode>
<PackageDescription>3 VIAL, MULTI-DOSE in 1 BOX (73069-373-52) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0373-52</NDC11Code>
<ProductNDC>73069-373</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-neuro 3</ProprietaryName>
<NonProprietaryName>Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Vasodilation [PE],Vasodilator [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-373-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-373-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0373-53</NDC11Code>
<ProductNDC>73069-373</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-neuro 3</ProprietaryName>
<NonProprietaryName>Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Vasodilation [PE],Vasodilator [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-373-54</NDCCode>
<PackageDescription>6 VIAL, MULTI-DOSE in 1 BOX (73069-373-54) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0373-54</NDC11Code>
<ProductNDC>73069-373</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-neuro 3</ProprietaryName>
<NonProprietaryName>Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Vasodilation [PE],Vasodilator [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-373-55</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 BOX (73069-373-55) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0373-55</NDC11Code>
<ProductNDC>73069-373</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-neuro 3</ProprietaryName>
<NonProprietaryName>Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Vasodilation [PE],Vasodilator [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-373-56</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-373-56) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0373-56</NDC11Code>
<ProductNDC>73069-373</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-neuro 3</ProprietaryName>
<NonProprietaryName>Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Vasodilation [PE],Vasodilator [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-373-57</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-373-57) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0373-57</NDC11Code>
<ProductNDC>73069-373</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-neuro 3</ProprietaryName>
<NonProprietaryName>Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Vasodilation [PE],Vasodilator [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-373-58</NDCCode>
<PackageDescription>50 VIAL, MULTI-DOSE in 1 BOX (73069-373-58) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0373-58</NDC11Code>
<ProductNDC>73069-373</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-neuro 3</ProprietaryName>
<NonProprietaryName>Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Vasodilation [PE],Vasodilator [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-373-59</NDCCode>
<PackageDescription>100 VIAL, MULTI-DOSE in 1 BOX (73069-373-59) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0373-59</NDC11Code>
<ProductNDC>73069-373</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-neuro 3</ProprietaryName>
<NonProprietaryName>Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Vasodilation [PE],Vasodilator [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49483-221-06</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (49483-221-06) </PackageDescription>
<NDC11Code>49483-0221-06</NDC11Code>
<ProductNDC>49483-221</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitro-time</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140619</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>TIME CAP LABORATORIES, INC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>49483-221-10</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (49483-221-10) </PackageDescription>
<NDC11Code>49483-0221-10</NDC11Code>
<ProductNDC>49483-221</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitro-time</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140619</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>TIME CAP LABORATORIES, INC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>49483-222-06</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (49483-222-06) </PackageDescription>
<NDC11Code>49483-0222-06</NDC11Code>
<ProductNDC>49483-222</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitro-time</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140619</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>TIME CAP LABORATORIES, INC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>6.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>49483-222-10</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (49483-222-10) </PackageDescription>
<NDC11Code>49483-0222-10</NDC11Code>
<ProductNDC>49483-222</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitro-time</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140619</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>TIME CAP LABORATORIES, INC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>6.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>49483-223-06</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (49483-223-06) </PackageDescription>
<NDC11Code>49483-0223-06</NDC11Code>
<ProductNDC>49483-223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitro-time</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140619</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>TIME CAP LABORATORIES, INC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide.</Description>
</NDC>
</NDCList>