{
"NDC": [
{
"NDCCode": "71993-301-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (71993-301-30) ",
"NDC11Code": "71993-0301-30",
"ProductNDC": "71993-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital And Acetaminophen",
"NonProprietaryName": "Butalbital And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203484",
"LabelerName": "Atland Pharmaceuticals, LLC",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN",
"StrengthNumber": "25; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Barbiturates [CS],Barbiturate [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200130",
"SamplePackage": "N"
},
{
"NDCCode": "71993-301-10",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (71993-301-10) ",
"NDC11Code": "71993-0301-10",
"ProductNDC": "71993-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital And Acetaminophen",
"NonProprietaryName": "Butalbital And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203484",
"LabelerName": "Atland Pharmaceuticals, LLC",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN",
"StrengthNumber": "25; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Barbiturates [CS],Barbiturate [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200130",
"SamplePackage": "N"
},
{
"NDCCode": "71993-265-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (71993-265-30) ",
"NDC11Code": "71993-0265-30",
"ProductNDC": "71993-265",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quazepam",
"NonProprietaryName": "Quazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180320",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018708",
"LabelerName": "Atland Pharmaceuticals, LLC",
"SubstanceName": "QUAZEPAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180320",
"SamplePackage": "N",
"IndicationAndUsage": "Quazepam Tablets are indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. The effectiveness of Quazepam Tablets has been established in placebo-controlled clinical studies of 5 nights duration in acute and chronic insomnia. The sustained effectiveness of Quazepam Tablets has been established in chronic insomnia in a sleep lab (polysomnographic) study of 28 nights duration. Because insomnia is often transient and intermittent, the prolonged administration of Quazepam Tablets is generally not necessary or recommended. Since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered.",
"Description": "Quazepam Tablets contain quazepam, a trifluoroethyl benzodiazepine hypnotic agent, having the chemical name 7-chloro-5- (o-fluoro-phenyl)-1,3-dihydro-1-(2,2,2- trifluoroethyl)-2H-1,4-benzodiazepine-2-thione and the following structural. Quazepam has the empirical formula C 17H 11ClF 4N 2S, and a molecular weight of 386.8. It is a white crystalline compound, soluble in ethanol and insoluble in water. Each Quazepam Tablet contains 15 mg of quazepam. The inactive ingredients for Quazepam Tablets include cellulose, corn starch, FD&C Yellow No. 6, lactose, magnesium stearate, silicon dioxide, and sodium lauryl sulfate."
},
{
"NDCCode": "71993-300-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (71993-300-30) ",
"NDC11Code": "71993-0300-30",
"ProductNDC": "71993-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen, Caffeine And Dihydrocodeine Bitartrate",
"NonProprietaryName": "Acetaminophen, Caffeine And Dihydrocodeine Bitartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204209",
"LabelerName": "Atland Pharmaceuticals, LLC",
"SubstanceName": "ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE",
"StrengthNumber": "325; 30; 16",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200130",
"SamplePackage": "N"
},
{
"NDCCode": "71993-309-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (71993-309-30) ",
"NDC11Code": "71993-0309-30",
"ProductNDC": "71993-309",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolmetin Sodium",
"NonProprietaryName": "Tolmetin Sodium",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073393",
"LabelerName": "Atland Pharmaceuticals, LLC",
"SubstanceName": "TOLMETIN SODIUM",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240405",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE:Carefully consider the potential benefits and risks of tolmetin sodium capsules, USP and other treatment options before deciding to use tolmetin sodium capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Tolmetin sodium capsules are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. Tolmetin sodium capsules are indicated in the treatment of acute flares and the long-term management of the chronic disease. Tolmetin sodium capsules are also indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of tolmetin sodium capsules have not been established in pediatric patients under 2 years of age (see PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION).",
"Description": "DESCRIPTION:Each capsule for oral administration contains 492 mg of tolmetin sodium, USP as the dihydrate in an amount equivalent to 400 mg of tolmetin. Each capsule contains 36 mg (1.568 mEq) of sodium and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The empty gelatin capsule shells contain FD&C Blue No. 1, gelatin, and titanium dioxide. In addition, the imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol, and shellac glaze. The pKa of tolmetin is 3.5 and tolmetin sodium is freely soluble in water, soluble in methanol and slightly soluble in alcohol. Tolmetin sodium is a nonselective nonsteroidal anti-inflammatory agent. The structural formula is. (C 15H 14NNaO 3 2H 2O). M.W. 315.30. Sodium 1-methyl-5 p-toluoylpyrrole-2-acetate dihydrate."
},
{
"NDCCode": "71993-312-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (71993-312-30) ",
"NDC11Code": "71993-0312-30",
"ProductNDC": "71993-312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolmetin Sodium",
"NonProprietaryName": "Tolmetin Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074473",
"LabelerName": "Atland Pharmaceuticals, LLC",
"SubstanceName": "TOLMETIN SODIUM",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250225",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Carefully consider the potential benefits and risks of tolmetin sodium tablets, USP and other treatment options before deciding to use tolmetin sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Tolmetin sodium tablets are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. Tolmetin sodium tablets are indicated in the treatment of acute flares and the long-term management of the chronic disease. Tolmetin sodium tablets are also indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of tolmetin sodium tablets have not been established in pediatric patients under 2 years of age (see PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION).",
"Description": "DESCRIPTION: Each tablet for oral administration contains 738 mg of tolmetin sodium, USP as the dihydrate in an amount equivalent to 600 mg of tolmetin. Each tablet contains 54 mg (2.35 mEq) of sodium and the following inactive ingredients: black iron oxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch (maize), sodium lauryl sulfate, titanium dioxide, triacetin and yellow iron oxide. The pKa of tolmetin is 3.5 and tolmetin sodium is freely soluble in water, soluble in methanol and slightly soluble in alcohol. Tolmetin sodium is a nonselective nonsteroidal anti-inflammatory agent. The structural formula is. (C15H14NNaO3 2H2O). M.W. 315.30. Sodium 1-methyl-5 p-toluoylpyrrole-2-acetate dihydrate."
},
{
"NDCCode": "71993-314-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (71993-314-30) ",
"NDC11Code": "71993-0314-30",
"ProductNDC": "71993-314",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranitidine",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211289",
"LabelerName": "Atland Pharmaceuticals, LLC",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260918",
"SamplePackage": "N",
"IndicationAndUsage": "Ranitidine Tablets are indicated in. : 1 Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of Ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo ā controlled comparative studies have been carried out for periods longer than 1 year., 3 The treatment of pathological hypersecretory conditions. (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 Short-term treatment of active, benign gastric ulcers. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year., 6 Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with Ranitidine Tablets USP, 150 mg twice daily., 7 Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Ranitidine Tablets USP, 150 mg 4 times daily., 8 Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.",
"Description": "Ranitidine Tablets USP are available for oral administration containing 150 mg or 300 mg of ranitidine. The active ingredient in Ranitidine Tablets USP, 150 mg and 300 mg is Ranitidine hydrochloride (HCl), USP, a histamine H 2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-Nā-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure. The empirical formula is C 13H 22N 4O 3S.HCl, representing a molecular weight of 350.87. Ranitidine HCl is white to pale yellow, crystalline, practically odorless powder, sensitive to light and moisture. Melts at about 140°C with decomposition. Ranitidine is available as 150 mg and 300 mg tablets for oral administration. Each Ranitidine Tablet USP, 150 mg contains 150 mg ranitidine (equivalent to 168 mg of ranitidine HCl) and the following inactive ingredients microcrystalline cellulose, croscarmellose sodium, magnesium stearate, Opadry ® 200 Orange 203A530006 (Polyvinyl alcohol, talc, titanium dioxide, glycerol monostearate, sodium lauryl sulphate, FD&C yellow 6 and iron oxide yellow), purified water. Each Ranitidine Tablet USP, 300 mg contains 300 mg ranitidine (equivalent to 336 mg of ranitidine HCl) and the following inactive ingredients microcrystalline cellulose, croscarmellose sodium, magnesium stearate, Opadry ® 200 Yellow 203A520014 (Polyvinyl alcohol, talc, titanium dioxide, glycerol monostearate, sodium lauryl sulphate, FD&C yellow 5 and FD&C Blue 1), purified water. Contains color additives including FD&C Yellow No.5 (tartrazine). Meets FDA approved specifications for nitrosamine impurities."
},
{
"NDCCode": "71993-315-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (71993-315-30) ",
"NDC11Code": "71993-0315-30",
"ProductNDC": "71993-315",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranitidine",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211289",
"LabelerName": "Atland Pharmaceuticals, LLC",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260919",
"SamplePackage": "N",
"IndicationAndUsage": "Ranitidine Tablets are indicated in. : 1 Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of Ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo ā controlled comparative studies have been carried out for periods longer than 1 year., 3 The treatment of pathological hypersecretory conditions. (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 Short-term treatment of active, benign gastric ulcers. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year., 6 Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with Ranitidine Tablets USP, 150 mg twice daily., 7 Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Ranitidine Tablets USP, 150 mg 4 times daily., 8 Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.",
"Description": "Ranitidine Tablets USP are available for oral administration containing 150 mg or 300 mg of ranitidine. The active ingredient in Ranitidine Tablets USP, 150 mg and 300 mg is Ranitidine hydrochloride (HCl), USP, a histamine H 2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-Nā-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure. The empirical formula is C 13H 22N 4O 3S.HCl, representing a molecular weight of 350.87. Ranitidine HCl is white to pale yellow, crystalline, practically odorless powder, sensitive to light and moisture. Melts at about 140°C with decomposition. Ranitidine is available as 150 mg and 300 mg tablets for oral administration. Each Ranitidine Tablet USP, 150 mg contains 150 mg ranitidine (equivalent to 168 mg of ranitidine HCl) and the following inactive ingredients microcrystalline cellulose, croscarmellose sodium, magnesium stearate, Opadry ® 200 Orange 203A530006 (Polyvinyl alcohol, talc, titanium dioxide, glycerol monostearate, sodium lauryl sulphate, FD&C yellow 6 and iron oxide yellow), purified water. Each Ranitidine Tablet USP, 300 mg contains 300 mg ranitidine (equivalent to 336 mg of ranitidine HCl) and the following inactive ingredients microcrystalline cellulose, croscarmellose sodium, magnesium stearate, Opadry ® 200 Yellow 203A520014 (Polyvinyl alcohol, talc, titanium dioxide, glycerol monostearate, sodium lauryl sulphate, FD&C yellow 5 and FD&C Blue 1), purified water. Contains color additives including FD&C Yellow No.5 (tartrazine). Meets FDA approved specifications for nitrosamine impurities."
},
{
"NDCCode": "16590-301-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (16590-301-30)",
"NDC11Code": "16590-0301-30",
"ProductNDC": "16590-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meclizine Hydrochloride",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19810603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087127",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC],Emesis Suppression [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.",
"Description": "Meclizine hydrochloride, an oral antiemetic, is a white, slightly yellowish, crystalline powder which has a slight odor and is tasteless. It has the following structural formula:. C25H27CIN22HCIH2O M.W. 481.89. The chemical name is 1-(p-chloro-alpha-phenylbenzyl)-4-(m-methyl-benzyl) - piperazine dihydrochloride monohydrate. Meclizine Hydrochloride Tablets are available in 12.5 mg, and *25 mg strengths for oral administration. *Contains FD&C Yellow #5 (see PRECAUTIONS). Each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, starch, and stearic acid. In addition, the 12.5 mg tablet contains FD&C Blue #1; and the 25 mg tablet contains D&C Yellow #10 and FD&C Yellow #5."
},
{
"NDCCode": "17089-301-18",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (17089-301-18) > 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17089-0301-18",
"ProductNDC": "17089-301",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna-digest",
"NonProprietaryName": "Angelica Archangelica Root - Anisum - Artemisia Abrotanum Flowering Top - Ascorbic Acid - Citrullus Colocynthis Fruit Pulp - Gentiana Lutea Root - Melatonin - Niacin - Pancrelipase Amylase - Pancrelipase Lipase - Pork Liver - Serotonin - Strychnos Nux-vomica Seed - Sus Scrofa Diencephalon - Sus Scrofa Duodenum - Sus Scrofa Gall Bladder - Sus Scrofa Pancreas - Sus Scrofa Pylorus - Thiamine Hydrochloride - Trypsin - Tryptophan -",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20181221",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "ARTEMISIA ABROTANUM FLOWERING TOP; PANCRELIPASE AMYLASE; ANGELICA ARCHANGELICA ROOT; ANISUM; ASCORBIC ACID; CITRULLUS COLOCYNTHIS FRUIT PULP; SUS SCROFA DIENCEPHALON; SUS SCROFA DUODENUM; SUS SCROFA GALLBLADDER; GENTIANA LUTEA ROOT; PORK LIVER; PANCRELIPASE LIPASE; MELATONIN; NIACIN; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; SUS SCROFA PYLORUS; SEROTONIN; THIAMINE HYDROCHLORIDE; TRYPTOPHAN; TRYPSIN",
"StrengthNumber": "1; 2; 1; 1; 2; 3; 6; 8; 8; 1; 8; 2; 4; 2; 3; 8; 8; 6; 4; 6; 2",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Pharm_Classes": "Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2019-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Take 15 minutes before meals."
},
{
"NDCCode": "21130-301-65",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (21130-301-65) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "21130-0301-65",
"ProductNDC": "21130-301",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Care Allergy Relief",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20200626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076011",
"LabelerName": "Safeway",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200626",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
},
{
"NDCCode": "21695-301-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (21695-301-30)",
"NDC11Code": "21695-0301-30",
"ProductNDC": "21695-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenazopyridine Hydrochloride",
"NonProprietaryName": "Phenazopyridine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled. The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See DOSAGE AND ADMINISTRATION section.).",
"Description": "Phenazopyridine Hydrochloride is light or dark red to dark violet, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. It has the following structural formula. Phenazopyridine HCl tablets contain the following inactive ingredients: carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch."
},
{
"NDCCode": "23359-301-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (23359-301-30)",
"NDC11Code": "23359-0301-30",
"ProductNDC": "23359-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bump Dha",
"NonProprietaryName": "Folate, Vitamin B2, Vitamin B6, Vitamin B12, Potassium Iodide, Zinc Biglycinate, Magnesium Oxide, Nadh, Dha, Carbonyl Iron",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170324",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": "LEVOMEFOLATE MAGNESIUM; LEUCOVORIN; FLAVIN ADENINE DINUCLEOTIDE; FLAVIN MONONUCLEOTIDE; PYRIDOXINE HYDROCHLORIDE; PYRIDOXAL PHOSPHATE ANHYDROUS; COBAMAMIDE; POTASSIUM IODIDE; ZINC GLYCINATE; MAGNESIUM OXIDE; NADH; OMEGA-3 FATTY ACIDS; IRON PENTACARBONYL",
"StrengthNumber": "1; 1; 1; 2; 20; 5; 500; 250; 15; 125; 25; 300; 15",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; 1/1; mg/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-04-24"
},
{
"NDCCode": "24658-301-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (24658-301-30)",
"NDC11Code": "24658-0301-30",
"ProductNDC": "24658-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111017",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078034",
"LabelerName": "Blu Pharmceuticals LLC",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-05-09"
},
{
"NDCCode": "29300-301-13",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (29300-301-13) ",
"NDC11Code": "29300-0301-13",
"ProductNDC": "29300-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prasugrel",
"NonProprietaryName": "Prasugrel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231016",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213315",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "PRASUGREL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231016",
"SamplePackage": "N",
"IndicationAndUsage": "Prasugrel is a P2Y12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows. Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) (1.1). Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI (1.1).",
"Description": "Prasugrel tablet, USP contains prasugrel USP, a thienopyridine class inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP receptor. Prasugrel is formulated as the hydrochloride salt, a racemate, which is chemically designated as 5-[(1RS)-2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride. Prasugrel hydrochloride, USP has the empirical formula C20H20FNO3SHCl representing a molecular weight of 409.90. The chemical structure of prasugrel hydrochloride, USP is. Prasugrel hydrochloride, USP is a white to light brown crystalline solid. It is freely soluble in methanol, sparingly soluble in ethanol and dichloromethane. Prasugrel tablets, USP are available for oral administration as 5 mg or 10 mg capsule shaped, biconvex, film-coated, non-scored tablets, debossed on each side. Each yellow to yellowish 5 mg tablet is manufactured with 5.49 mg prasugrel hydrochloride USP, equivalent to 5 mg prasugrel and each light brown to brown 10 mg tablet with 10.98 mg prasugrel hydrochloride USP, equivalent to 10 mg of prasugrel. Other ingredients include mannitol, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, sucrose stearate, and glyceryl behenate. The color coatings contain lactose, hypromellose, titanium dioxide, talc (only in Prasugrel 5 mg tablet), triacetin, iron oxide yellow, and iron oxide red (only in Prasugrel 10 mg tablet). FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "29336-301-02",
"PackageDescription": "30 PATCH in 1 CARTON (29336-301-02) > 1 d in 1 PATCH",
"NDC11Code": "29336-0301-02",
"ProductNDC": "29336-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minitran",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20070401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089771",
"LabelerName": "Graceway Pharmaceuticals, LLC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Transdermal nitroglycerin is indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute attack.",
"Description": "Nitroglycerin is a 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. and whose molecular weight is 227.09. The organic nitrates are vasodilators, active on both arteries and veins. The MINITRAN (nitroglycerin) Transdermal Delivery System is a unit designed to provide continuous controlled release of nitroglycerin through intact skin. The rate of release of nitroglycerin is linearly dependent upon the area of the applied system; each cm2 of applied system delivers approximately 0.03 mg of nitroglycerin per hour. Thus, the 3.3, 6.7, 13.3 and 20 cm2 system delivers approximately 0.1, 0.2, 0.4 and 0.6 mg of nitroglycerin per hour, respectively. The remainder of the nitroglycerin in each system serves as a reservoir and is not delivered in normal use. After 12 hours, for example, each system has delivered about 14% of its original content of nitroglycerin. The MINITRAN Transdermal Delivery System contains nitroglycerin as the active component. The remaining components of the system (acrylate copolymer adhesive, fatty acid esters, and polyethylene backing) are pharmacologically inactive. Each patch is packaged in foil/polymer film laminate. Prior to use, a protective peel strip is removed from the adhesive surface. Following use, the patch should be discarded in a manner that prevents accidental application or ingestion by children or others."
},
{
"NDCCode": "31720-301-08",
"PackageDescription": "1 BOTTLE in 1 BOX (31720-301-08) / 30 mL in 1 BOTTLE",
"NDC11Code": "31720-0301-08",
"ProductNDC": "31720-301",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acne Treatment Gel",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221205",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "S+",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221205",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of acne."
},
{
"NDCCode": "31722-301-32",
"PackageDescription": "1 CARTON in 1 KIT (31722-301-32) / 30 PACKET in 1 CARTON (31722-301-31) / 1 POWDER, FOR SUSPENSION in 1 PACKET (31722-301-25) ",
"NDC11Code": "31722-0301-32",
"ProductNDC": "31722-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eltrombopag",
"NonProprietaryName": "Eltrombopag Olamine",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20250513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216620",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250513",
"SamplePackage": "N",
"IndicationAndUsage": "Eltrombopag for oral suspension is a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag for oral suspension should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. ( 1.1) for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag for oral suspension should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. ( 1.2) for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. ( 1.3) Limitations of Use: Eltrombopag for oral suspension is not indicated for the treatment of patients with myelodysplastic syndrome (MDS). ( 1.4) Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. ( 1.4).",
"Description": "Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3ā-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2ā-hydroxy-3-biphenylcarboxylic acid, aminoethanol (1:2). It has the molecular formula C 25H 22N 4O 4.C 4H 14N 2O 2. The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula:. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 8.3, and very slightly soluble in methanol and dimethylformamide. Eltrombopag for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet contains eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of eltrombopag for oral suspension are mannitol, sucralose, and xanthan gum."
},
{
"NDCCode": "37808-301-65",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (37808-301-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "37808-0301-65",
"ProductNDC": "37808-301",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acid Controller",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075400",
"LabelerName": "H E B",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151023",
"SamplePackage": "N",
"IndicationAndUsage": "relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages."
},
{
"NDCCode": "42254-301-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (42254-301-30)",
"NDC11Code": "42254-0301-30",
"ProductNDC": "42254-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xodol",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111010",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040556",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Xodol® is indicated for the relief of moderate to moderately severe pain.",
"Description": "Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. WARNING: May be habit-forming (see PRECAUTIONS, Information for Patients/Caregivers, and DRUG ABUSE AND DEPENDENCE). Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5Ī±-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Xodol® is available in the following strengths. Hydrocodone Bitartrate..........................5 mg. WARNING: May be habit-forming. Acetaminophen .................................... 300 mg. Hydrocodone Bitartrate..........................7.5 mg. WARNING: May be habit-forming. Acetaminophen .................................... 300 mg. Hydrocodone Bitartrate..........................10 mg. WARNING: May be habit-forming. Acetaminophen .................................... 300 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. This product complies with USP dissolution test 2."
},
{
"NDCCode": "42291-301-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (42291-301-30)",
"NDC11Code": "42291-0301-30",
"ProductNDC": "42291-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120504",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078428",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2016-01-22"
},
{
"NDCCode": "42961-301-20",
"PackageDescription": "4 BOTTLE, UNIT-DOSE in 1 BOX, UNIT-DOSE (42961-301-20) > 30 mL in 1 BOTTLE, UNIT-DOSE",
"NDC11Code": "42961-0301-20",
"ProductNDC": "42961-301",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Xpect Buffered Eyewash Sterile Isotonic",
"NonProprietaryName": "Water",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20111001",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Cintas Corporation",
"SubstanceName": "WATER",
"StrengthNumber": ".98",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2022-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20111001",
"SamplePackage": "N"
},
{
"NDCCode": "43353-301-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (43353-301-30) ",
"NDC11Code": "43353-0301-30",
"ProductNDC": "43353-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203508",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170404",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril Tablets, USP are indicated for the treatment of hypertension to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Programās Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Lisinopril may be administered alone or with other antihypertensive agents.",
"Description": "Lisinopril, USP is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, USP a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L- proline dihydrate. Its molecular formula is C21H31N3O5 2H2O and its structural formula is:. Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets ā lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate. 5 mg, 10 mg, 20 mg and 30 mg tablets ā lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, iron oxide red. 40 mg tablets - lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, iron oxide yellow."
},
{
"NDCCode": "43547-301-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (43547-301-03) ",
"NDC11Code": "43547-0301-03",
"ProductNDC": "43547-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220304",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206720",
"LabelerName": "Solco Healthcare US, LLC.",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220304",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Programās Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6 and its structural formula is:. Olmesartan medoxomil is a white or off-white crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets, USP, are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil (USP) and the following inactive ingredients: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, polyvinyl alcohol-part hydrolyzed, titanium dioxide, macrogol/polyethylene glycol 3350, talc, (5 mg only) FD&C Red #40 Aluminum Lake, (5 mg only) FD&C Yellow #6 Aluminum Lake, (5 mg only) FD&C Blue #1 Aluminum Lake. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "44827-301-02",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (44827-301-02) > 30 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "44827-0301-02",
"ProductNDC": "44827-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrine",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "19940301",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Valesco Pharmaceuticals LLC.",
"SubstanceName": "EPINEPHRINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "In general, the most common uses of epinephrine are to relieve respiratory distress due to bronchospasm, to provide rapid relief of hypersensitivity reactions to drugs and other allergens, and to prolong the action of infiltration anesthetics. Its cardiac effects may be of use in restoring cardiac rhythm in cardiac arrest due to various causes, but it is not used in cardiac failure or in hemorrhagic, traumatic, or cardiogenic shock. Epinephrine is used as a hemostatic agent. It is also used in treating mucosal congestion of hay fever, rhinitis and acute sinusitis; to relieve bronchial asthmatic paroxysms; in syncope due to complete heart block or carotid sinus hypersensitivity; for symptomatic relief of serum sickness, urticaria, angioneurotic edema; for resuscitation in cardiac arrest following anesthetic accidents; in simple (open angle) glaucoma; for relaxation of uterine musculature and to inhibit uterine contractions. Epinephrine injection can be utilized to prolong the action of local anesthetics (see CONTRAINDICATIONS).",
"Description": "Epinephrine Injection, USP is a sterile, nonpyrogenic solution intended for subcutaneous or intramuscular injection. When diluted, it may also be administered intracardially or intravenously. Each mL contains: Epinephrine 1 mg (as the Hydrochloride), Water for Injection q.s. Sodium Chloride added for isotonicity, Chlorobutanol 0.5% (a chloroform derivative) as a preservative and Sodium Metabisulfite not more than 0.15% as an antioxidant. Epinephrine is the active principle of the adrenal medulla, chemically described as (-)-3,4-Dihydroxy-Ī±-[(methylamino)methyl)]benzyl alcohol, and has the following structural formula."
},
{
"NDCCode": "47993-301-07",
"PackageDescription": "30 g in 1 BOTTLE (47993-301-07) ",
"NDC11Code": "47993-0301-07",
"ProductNDC": "47993-301",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer With Ve",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141008",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, DL-; ALCOHOL",
"StrengthNumber": "1.5; 62",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Directions. Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry."
},
{
"NDCCode": "49349-301-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (49349-301-02)",
"NDC11Code": "49349-0301-02",
"ProductNDC": "49349-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nabumetone",
"NonProprietaryName": "Nabumetone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076009",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "NABUMETONE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "49643-301-30",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49643-301-30) ",
"NDC11Code": "49643-0301-30",
"ProductNDC": "49643-301",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Acacia Pollen",
"NonProprietaryName": "Acacia Spp.",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "ACACIA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49852-301-30",
"PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (49852-301-30) ",
"NDC11Code": "49852-0301-30",
"ProductNDC": "49852-301",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Hand Cleanser",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Tri-Coastal Design Company Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140901",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "49973-301-30",
"PackageDescription": "15 BLISTER PACK in 1 BOX (49973-301-30) > 2 TABLET in 1 BLISTER PACK",
"NDC11Code": "49973-0301-30",
"ProductNDC": "49973-301",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Azo",
"NonProprietaryName": "Urinary Pain Relief",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120524",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "i-Health, Inc.",
"SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
"StrengthNumber": "95",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20120524",
"SamplePackage": "N"
}
]
}
ļ»æ<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>71993-301-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (71993-301-30) </PackageDescription>
<NDC11Code>71993-0301-30</NDC11Code>
<ProductNDC>71993-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital And Acetaminophen</ProprietaryName>
<NonProprietaryName>Butalbital And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203484</ApplicationNumber>
<LabelerName>Atland Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>25; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturates [CS],Barbiturate [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71993-301-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (71993-301-10) </PackageDescription>
<NDC11Code>71993-0301-10</NDC11Code>
<ProductNDC>71993-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital And Acetaminophen</ProprietaryName>
<NonProprietaryName>Butalbital And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203484</ApplicationNumber>
<LabelerName>Atland Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>25; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturates [CS],Barbiturate [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71993-265-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71993-265-30) </PackageDescription>
<NDC11Code>71993-0265-30</NDC11Code>
<ProductNDC>71993-265</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quazepam</ProprietaryName>
<NonProprietaryName>Quazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180320</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018708</ApplicationNumber>
<LabelerName>Atland Pharmaceuticals, LLC</LabelerName>
<SubstanceName>QUAZEPAM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quazepam Tablets are indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. The effectiveness of Quazepam Tablets has been established in placebo-controlled clinical studies of 5 nights duration in acute and chronic insomnia. The sustained effectiveness of Quazepam Tablets has been established in chronic insomnia in a sleep lab (polysomnographic) study of 28 nights duration. Because insomnia is often transient and intermittent, the prolonged administration of Quazepam Tablets is generally not necessary or recommended. Since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered.</IndicationAndUsage>
<Description>Quazepam Tablets contain quazepam, a trifluoroethyl benzodiazepine hypnotic agent, having the chemical name 7-chloro-5- (o-fluoro-phenyl)-1,3-dihydro-1-(2,2,2- trifluoroethyl)-2H-1,4-benzodiazepine-2-thione and the following structural. Quazepam has the empirical formula C 17H 11ClF 4N 2S, and a molecular weight of 386.8. It is a white crystalline compound, soluble in ethanol and insoluble in water. Each Quazepam Tablet contains 15 mg of quazepam. The inactive ingredients for Quazepam Tablets include cellulose, corn starch, FD&C Yellow No. 6, lactose, magnesium stearate, silicon dioxide, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>71993-300-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (71993-300-30) </PackageDescription>
<NDC11Code>71993-0300-30</NDC11Code>
<ProductNDC>71993-300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen, Caffeine And Dihydrocodeine Bitartrate</ProprietaryName>
<NonProprietaryName>Acetaminophen, Caffeine And Dihydrocodeine Bitartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204209</ApplicationNumber>
<LabelerName>Atland Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE</SubstanceName>
<StrengthNumber>325; 30; 16</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71993-309-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (71993-309-30) </PackageDescription>
<NDC11Code>71993-0309-30</NDC11Code>
<ProductNDC>71993-309</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolmetin Sodium</ProprietaryName>
<NonProprietaryName>Tolmetin Sodium</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073393</ApplicationNumber>
<LabelerName>Atland Pharmaceuticals, LLC</LabelerName>
<SubstanceName>TOLMETIN SODIUM</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE:Carefully consider the potential benefits and risks of tolmetin sodium capsules, USP and other treatment options before deciding to use tolmetin sodium capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Tolmetin sodium capsules are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. Tolmetin sodium capsules are indicated in the treatment of acute flares and the long-term management of the chronic disease. Tolmetin sodium capsules are also indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of tolmetin sodium capsules have not been established in pediatric patients under 2 years of age (see PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>DESCRIPTION:Each capsule for oral administration contains 492 mg of tolmetin sodium, USP as the dihydrate in an amount equivalent to 400 mg of tolmetin. Each capsule contains 36 mg (1.568 mEq) of sodium and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The empty gelatin capsule shells contain FD&C Blue No. 1, gelatin, and titanium dioxide. In addition, the imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol, and shellac glaze. The pKa of tolmetin is 3.5 and tolmetin sodium is freely soluble in water, soluble in methanol and slightly soluble in alcohol. Tolmetin sodium is a nonselective nonsteroidal anti-inflammatory agent. The structural formula is. (C 15H 14NNaO 3 2H 2O). M.W. 315.30. Sodium 1-methyl-5 p-toluoylpyrrole-2-acetate dihydrate.</Description>
</NDC>
<NDC>
<NDCCode>71993-312-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (71993-312-30) </PackageDescription>
<NDC11Code>71993-0312-30</NDC11Code>
<ProductNDC>71993-312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolmetin Sodium</ProprietaryName>
<NonProprietaryName>Tolmetin Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074473</ApplicationNumber>
<LabelerName>Atland Pharmaceuticals, LLC</LabelerName>
<SubstanceName>TOLMETIN SODIUM</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Carefully consider the potential benefits and risks of tolmetin sodium tablets, USP and other treatment options before deciding to use tolmetin sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Tolmetin sodium tablets are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. Tolmetin sodium tablets are indicated in the treatment of acute flares and the long-term management of the chronic disease. Tolmetin sodium tablets are also indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of tolmetin sodium tablets have not been established in pediatric patients under 2 years of age (see PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>DESCRIPTION: Each tablet for oral administration contains 738 mg of tolmetin sodium, USP as the dihydrate in an amount equivalent to 600 mg of tolmetin. Each tablet contains 54 mg (2.35 mEq) of sodium and the following inactive ingredients: black iron oxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch (maize), sodium lauryl sulfate, titanium dioxide, triacetin and yellow iron oxide. The pKa of tolmetin is 3.5 and tolmetin sodium is freely soluble in water, soluble in methanol and slightly soluble in alcohol. Tolmetin sodium is a nonselective nonsteroidal anti-inflammatory agent. The structural formula is. (C15H14NNaO3 2H2O). M.W. 315.30. Sodium 1-methyl-5 p-toluoylpyrrole-2-acetate dihydrate.</Description>
</NDC>
<NDC>
<NDCCode>71993-314-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71993-314-30) </PackageDescription>
<NDC11Code>71993-0314-30</NDC11Code>
<ProductNDC>71993-314</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranitidine</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260918</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211289</ApplicationNumber>
<LabelerName>Atland Pharmaceuticals, LLC</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranitidine Tablets are indicated in. : 1 Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of Ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo ā controlled comparative studies have been carried out for periods longer than 1 year., 3 The treatment of pathological hypersecretory conditions. (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 Short-term treatment of active, benign gastric ulcers. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year., 6 Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with Ranitidine Tablets USP, 150 mg twice daily., 7 Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Ranitidine Tablets USP, 150 mg 4 times daily., 8 Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.</IndicationAndUsage>
<Description>Ranitidine Tablets USP are available for oral administration containing 150 mg or 300 mg of ranitidine. The active ingredient in Ranitidine Tablets USP, 150 mg and 300 mg is Ranitidine hydrochloride (HCl), USP, a histamine H 2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-Nā-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure. The empirical formula is C 13H 22N 4O 3S.HCl, representing a molecular weight of 350.87. Ranitidine HCl is white to pale yellow, crystalline, practically odorless powder, sensitive to light and moisture. Melts at about 140°C with decomposition. Ranitidine is available as 150 mg and 300 mg tablets for oral administration. Each Ranitidine Tablet USP, 150 mg contains 150 mg ranitidine (equivalent to 168 mg of ranitidine HCl) and the following inactive ingredients microcrystalline cellulose, croscarmellose sodium, magnesium stearate, Opadry ® 200 Orange 203A530006 (Polyvinyl alcohol, talc, titanium dioxide, glycerol monostearate, sodium lauryl sulphate, FD&C yellow 6 and iron oxide yellow), purified water. Each Ranitidine Tablet USP, 300 mg contains 300 mg ranitidine (equivalent to 336 mg of ranitidine HCl) and the following inactive ingredients microcrystalline cellulose, croscarmellose sodium, magnesium stearate, Opadry ® 200 Yellow 203A520014 (Polyvinyl alcohol, talc, titanium dioxide, glycerol monostearate, sodium lauryl sulphate, FD&C yellow 5 and FD&C Blue 1), purified water. Contains color additives including FD&C Yellow No.5 (tartrazine). Meets FDA approved specifications for nitrosamine impurities.</Description>
</NDC>
<NDC>
<NDCCode>71993-315-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71993-315-30) </PackageDescription>
<NDC11Code>71993-0315-30</NDC11Code>
<ProductNDC>71993-315</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranitidine</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260918</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211289</ApplicationNumber>
<LabelerName>Atland Pharmaceuticals, LLC</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranitidine Tablets are indicated in. : 1 Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of Ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo ā controlled comparative studies have been carried out for periods longer than 1 year., 3 The treatment of pathological hypersecretory conditions. (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 Short-term treatment of active, benign gastric ulcers. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year., 6 Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with Ranitidine Tablets USP, 150 mg twice daily., 7 Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Ranitidine Tablets USP, 150 mg 4 times daily., 8 Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.</IndicationAndUsage>
<Description>Ranitidine Tablets USP are available for oral administration containing 150 mg or 300 mg of ranitidine. The active ingredient in Ranitidine Tablets USP, 150 mg and 300 mg is Ranitidine hydrochloride (HCl), USP, a histamine H 2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-Nā-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure. The empirical formula is C 13H 22N 4O 3S.HCl, representing a molecular weight of 350.87. Ranitidine HCl is white to pale yellow, crystalline, practically odorless powder, sensitive to light and moisture. Melts at about 140°C with decomposition. Ranitidine is available as 150 mg and 300 mg tablets for oral administration. Each Ranitidine Tablet USP, 150 mg contains 150 mg ranitidine (equivalent to 168 mg of ranitidine HCl) and the following inactive ingredients microcrystalline cellulose, croscarmellose sodium, magnesium stearate, Opadry ® 200 Orange 203A530006 (Polyvinyl alcohol, talc, titanium dioxide, glycerol monostearate, sodium lauryl sulphate, FD&C yellow 6 and iron oxide yellow), purified water. Each Ranitidine Tablet USP, 300 mg contains 300 mg ranitidine (equivalent to 336 mg of ranitidine HCl) and the following inactive ingredients microcrystalline cellulose, croscarmellose sodium, magnesium stearate, Opadry ® 200 Yellow 203A520014 (Polyvinyl alcohol, talc, titanium dioxide, glycerol monostearate, sodium lauryl sulphate, FD&C yellow 5 and FD&C Blue 1), purified water. Contains color additives including FD&C Yellow No.5 (tartrazine). Meets FDA approved specifications for nitrosamine impurities.</Description>
</NDC>
<NDC>
<NDCCode>16590-301-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (16590-301-30)</PackageDescription>
<NDC11Code>16590-0301-30</NDC11Code>
<ProductNDC>16590-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19810603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087127</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC],Emesis Suppression [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.</IndicationAndUsage>
<Description>Meclizine hydrochloride, an oral antiemetic, is a white, slightly yellowish, crystalline powder which has a slight odor and is tasteless. It has the following structural formula:. C25H27CIN22HCIH2O M.W. 481.89. The chemical name is 1-(p-chloro-alpha-phenylbenzyl)-4-(m-methyl-benzyl) - piperazine dihydrochloride monohydrate. Meclizine Hydrochloride Tablets are available in 12.5 mg, and *25 mg strengths for oral administration. *Contains FD&C Yellow #5 (see PRECAUTIONS). Each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, starch, and stearic acid. In addition, the 12.5 mg tablet contains FD&C Blue #1; and the 25 mg tablet contains D&C Yellow #10 and FD&C Yellow #5.</Description>
</NDC>
<NDC>
<NDCCode>17089-301-18</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BOX (17089-301-18) > 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>17089-0301-18</NDC11Code>
<ProductNDC>17089-301</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna-digest</ProprietaryName>
<NonProprietaryName>Angelica Archangelica Root - Anisum - Artemisia Abrotanum Flowering Top - Ascorbic Acid - Citrullus Colocynthis Fruit Pulp - Gentiana Lutea Root - Melatonin - Niacin - Pancrelipase Amylase - Pancrelipase Lipase - Pork Liver - Serotonin - Strychnos Nux-vomica Seed - Sus Scrofa Diencephalon - Sus Scrofa Duodenum - Sus Scrofa Gall Bladder - Sus Scrofa Pancreas - Sus Scrofa Pylorus - Thiamine Hydrochloride - Trypsin - Tryptophan -</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181221</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>ARTEMISIA ABROTANUM FLOWERING TOP; PANCRELIPASE AMYLASE; ANGELICA ARCHANGELICA ROOT; ANISUM; ASCORBIC ACID; CITRULLUS COLOCYNTHIS FRUIT PULP; SUS SCROFA DIENCEPHALON; SUS SCROFA DUODENUM; SUS SCROFA GALLBLADDER; GENTIANA LUTEA ROOT; PORK LIVER; PANCRELIPASE LIPASE; MELATONIN; NIACIN; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; SUS SCROFA PYLORUS; SEROTONIN; THIAMINE HYDROCHLORIDE; TRYPTOPHAN; TRYPSIN</SubstanceName>
<StrengthNumber>1; 2; 1; 1; 2; 3; 6; 8; 8; 1; 8; 2; 4; 2; 3; 8; 8; 6; 4; 6; 2</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Take 15 minutes before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21130-301-65</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (21130-301-65) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21130-0301-65</NDC11Code>
<ProductNDC>21130-301</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Signature Care Allergy Relief</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076011</ApplicationNumber>
<LabelerName>Safeway</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21695-301-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (21695-301-30)</PackageDescription>
<NDC11Code>21695-0301-30</NDC11Code>
<ProductNDC>21695-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenazopyridine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenazopyridine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled. The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See DOSAGE AND ADMINISTRATION section.).</IndicationAndUsage>
<Description>Phenazopyridine Hydrochloride is light or dark red to dark violet, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. It has the following structural formula. Phenazopyridine HCl tablets contain the following inactive ingredients: carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>23359-301-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (23359-301-30)</PackageDescription>
<NDC11Code>23359-0301-30</NDC11Code>
<ProductNDC>23359-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bump Dha</ProprietaryName>
<NonProprietaryName>Folate, Vitamin B2, Vitamin B6, Vitamin B12, Potassium Iodide, Zinc Biglycinate, Magnesium Oxide, Nadh, Dha, Carbonyl Iron</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170324</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>LEVOMEFOLATE MAGNESIUM; LEUCOVORIN; FLAVIN ADENINE DINUCLEOTIDE; FLAVIN MONONUCLEOTIDE; PYRIDOXINE HYDROCHLORIDE; PYRIDOXAL PHOSPHATE ANHYDROUS; COBAMAMIDE; POTASSIUM IODIDE; ZINC GLYCINATE; MAGNESIUM OXIDE; NADH; OMEGA-3 FATTY ACIDS; IRON PENTACARBONYL</SubstanceName>
<StrengthNumber>1; 1; 1; 2; 20; 5; 500; 250; 15; 125; 25; 300; 15</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; 1/1; mg/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-04-24</LastUpdate>
</NDC>
<NDC>
<NDCCode>24658-301-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (24658-301-30)</PackageDescription>
<NDC11Code>24658-0301-30</NDC11Code>
<ProductNDC>24658-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111017</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078034</ApplicationNumber>
<LabelerName>Blu Pharmceuticals LLC</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-09</LastUpdate>
</NDC>
<NDC>
<NDCCode>29300-301-13</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (29300-301-13) </PackageDescription>
<NDC11Code>29300-0301-13</NDC11Code>
<ProductNDC>29300-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prasugrel</ProprietaryName>
<NonProprietaryName>Prasugrel</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231016</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213315</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>PRASUGREL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prasugrel is a P2Y12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows. Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) (1.1). Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI (1.1).</IndicationAndUsage>
<Description>Prasugrel tablet, USP contains prasugrel USP, a thienopyridine class inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP receptor. Prasugrel is formulated as the hydrochloride salt, a racemate, which is chemically designated as 5-[(1RS)-2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride. Prasugrel hydrochloride, USP has the empirical formula C20H20FNO3SHCl representing a molecular weight of 409.90. The chemical structure of prasugrel hydrochloride, USP is. Prasugrel hydrochloride, USP is a white to light brown crystalline solid. It is freely soluble in methanol, sparingly soluble in ethanol and dichloromethane. Prasugrel tablets, USP are available for oral administration as 5 mg or 10 mg capsule shaped, biconvex, film-coated, non-scored tablets, debossed on each side. Each yellow to yellowish 5 mg tablet is manufactured with 5.49 mg prasugrel hydrochloride USP, equivalent to 5 mg prasugrel and each light brown to brown 10 mg tablet with 10.98 mg prasugrel hydrochloride USP, equivalent to 10 mg of prasugrel. Other ingredients include mannitol, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, sucrose stearate, and glyceryl behenate. The color coatings contain lactose, hypromellose, titanium dioxide, talc (only in Prasugrel 5 mg tablet), triacetin, iron oxide yellow, and iron oxide red (only in Prasugrel 10 mg tablet). FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>29336-301-02</NDCCode>
<PackageDescription>30 PATCH in 1 CARTON (29336-301-02) > 1 d in 1 PATCH</PackageDescription>
<NDC11Code>29336-0301-02</NDC11Code>
<ProductNDC>29336-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minitran</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20070401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089771</ApplicationNumber>
<LabelerName>Graceway Pharmaceuticals, LLC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Transdermal nitroglycerin is indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute attack.</IndicationAndUsage>
<Description>Nitroglycerin is a 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. and whose molecular weight is 227.09. The organic nitrates are vasodilators, active on both arteries and veins. The MINITRAN (nitroglycerin) Transdermal Delivery System is a unit designed to provide continuous controlled release of nitroglycerin through intact skin. The rate of release of nitroglycerin is linearly dependent upon the area of the applied system; each cm2 of applied system delivers approximately 0.03 mg of nitroglycerin per hour. Thus, the 3.3, 6.7, 13.3 and 20 cm2 system delivers approximately 0.1, 0.2, 0.4 and 0.6 mg of nitroglycerin per hour, respectively. The remainder of the nitroglycerin in each system serves as a reservoir and is not delivered in normal use. After 12 hours, for example, each system has delivered about 14% of its original content of nitroglycerin. The MINITRAN Transdermal Delivery System contains nitroglycerin as the active component. The remaining components of the system (acrylate copolymer adhesive, fatty acid esters, and polyethylene backing) are pharmacologically inactive. Each patch is packaged in foil/polymer film laminate. Prior to use, a protective peel strip is removed from the adhesive surface. Following use, the patch should be discarded in a manner that prevents accidental application or ingestion by children or others.</Description>
</NDC>
<NDC>
<NDCCode>31720-301-08</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (31720-301-08) / 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>31720-0301-08</NDC11Code>
<ProductNDC>31720-301</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acne Treatment Gel</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221205</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>S+</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>31722-301-32</NDCCode>
<PackageDescription>1 CARTON in 1 KIT (31722-301-32) / 30 PACKET in 1 CARTON (31722-301-31) / 1 POWDER, FOR SUSPENSION in 1 PACKET (31722-301-25) </PackageDescription>
<NDC11Code>31722-0301-32</NDC11Code>
<ProductNDC>31722-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eltrombopag</ProprietaryName>
<NonProprietaryName>Eltrombopag Olamine</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216620</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eltrombopag for oral suspension is a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag for oral suspension should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. ( 1.1) for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag for oral suspension should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. ( 1.2) for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. ( 1.3) Limitations of Use: Eltrombopag for oral suspension is not indicated for the treatment of patients with myelodysplastic syndrome (MDS). ( 1.4) Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. ( 1.4).</IndicationAndUsage>
<Description>Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3ā-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2ā-hydroxy-3-biphenylcarboxylic acid, aminoethanol (1:2). It has the molecular formula C 25H 22N 4O 4.C 4H 14N 2O 2. The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula:. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 8.3, and very slightly soluble in methanol and dimethylformamide. Eltrombopag for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet contains eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of eltrombopag for oral suspension are mannitol, sucralose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>37808-301-65</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (37808-301-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>37808-0301-65</NDC11Code>
<ProductNDC>37808-301</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acid Controller</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151023</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075400</ApplicationNumber>
<LabelerName>H E B</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42254-301-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42254-301-30)</PackageDescription>
<NDC11Code>42254-0301-30</NDC11Code>
<ProductNDC>42254-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xodol</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111010</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040556</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Xodol® is indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. WARNING: May be habit-forming (see PRECAUTIONS, Information for Patients/Caregivers, and DRUG ABUSE AND DEPENDENCE). Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5Ī±-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Xodol® is available in the following strengths. Hydrocodone Bitartrate..........................5 mg. WARNING: May be habit-forming. Acetaminophen .................................... 300 mg. Hydrocodone Bitartrate..........................7.5 mg. WARNING: May be habit-forming. Acetaminophen .................................... 300 mg. Hydrocodone Bitartrate..........................10 mg. WARNING: May be habit-forming. Acetaminophen .................................... 300 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. This product complies with USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>42291-301-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (42291-301-30)</PackageDescription>
<NDC11Code>42291-0301-30</NDC11Code>
<ProductNDC>42291-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120504</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078428</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>42961-301-20</NDCCode>
<PackageDescription>4 BOTTLE, UNIT-DOSE in 1 BOX, UNIT-DOSE (42961-301-20) > 30 mL in 1 BOTTLE, UNIT-DOSE</PackageDescription>
<NDC11Code>42961-0301-20</NDC11Code>
<ProductNDC>42961-301</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Xpect Buffered Eyewash Sterile Isotonic</ProprietaryName>
<NonProprietaryName>Water</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20111001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>Cintas Corporation</LabelerName>
<SubstanceName>WATER</SubstanceName>
<StrengthNumber>.98</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43353-301-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (43353-301-30) </PackageDescription>
<NDC11Code>43353-0301-30</NDC11Code>
<ProductNDC>43353-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203508</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril Tablets, USP are indicated for the treatment of hypertension to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Programās Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Lisinopril may be administered alone or with other antihypertensive agents.</IndicationAndUsage>
<Description>Lisinopril, USP is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, USP a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L- proline dihydrate. Its molecular formula is C21H31N3O5 2H2O and its structural formula is:. Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets ā lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate. 5 mg, 10 mg, 20 mg and 30 mg tablets ā lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, iron oxide red. 40 mg tablets - lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>43547-301-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (43547-301-03) </PackageDescription>
<NDC11Code>43547-0301-03</NDC11Code>
<ProductNDC>43547-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220304</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206720</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC.</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Programās Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6 and its structural formula is:. Olmesartan medoxomil is a white or off-white crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets, USP, are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil (USP) and the following inactive ingredients: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, polyvinyl alcohol-part hydrolyzed, titanium dioxide, macrogol/polyethylene glycol 3350, talc, (5 mg only) FD&C Red #40 Aluminum Lake, (5 mg only) FD&C Yellow #6 Aluminum Lake, (5 mg only) FD&C Blue #1 Aluminum Lake. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>44827-301-02</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (44827-301-02) > 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>44827-0301-02</NDC11Code>
<ProductNDC>44827-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinephrine</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19940301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Valesco Pharmaceuticals LLC.</LabelerName>
<SubstanceName>EPINEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>In general, the most common uses of epinephrine are to relieve respiratory distress due to bronchospasm, to provide rapid relief of hypersensitivity reactions to drugs and other allergens, and to prolong the action of infiltration anesthetics. Its cardiac effects may be of use in restoring cardiac rhythm in cardiac arrest due to various causes, but it is not used in cardiac failure or in hemorrhagic, traumatic, or cardiogenic shock. Epinephrine is used as a hemostatic agent. It is also used in treating mucosal congestion of hay fever, rhinitis and acute sinusitis; to relieve bronchial asthmatic paroxysms; in syncope due to complete heart block or carotid sinus hypersensitivity; for symptomatic relief of serum sickness, urticaria, angioneurotic edema; for resuscitation in cardiac arrest following anesthetic accidents; in simple (open angle) glaucoma; for relaxation of uterine musculature and to inhibit uterine contractions. Epinephrine injection can be utilized to prolong the action of local anesthetics (see CONTRAINDICATIONS).</IndicationAndUsage>
<Description>Epinephrine Injection, USP is a sterile, nonpyrogenic solution intended for subcutaneous or intramuscular injection. When diluted, it may also be administered intracardially or intravenously. Each mL contains: Epinephrine 1 mg (as the Hydrochloride), Water for Injection q.s. Sodium Chloride added for isotonicity, Chlorobutanol 0.5% (a chloroform derivative) as a preservative and Sodium Metabisulfite not more than 0.15% as an antioxidant. Epinephrine is the active principle of the adrenal medulla, chemically described as (-)-3,4-Dihydroxy-Ī±-[(methylamino)methyl)]benzyl alcohol, and has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>47993-301-07</NDCCode>
<PackageDescription>30 g in 1 BOTTLE (47993-301-07) </PackageDescription>
<NDC11Code>47993-0301-07</NDC11Code>
<ProductNDC>47993-301</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer With Ve</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141008</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; ALCOHOL</SubstanceName>
<StrengthNumber>1.5; 62</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions. Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49349-301-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (49349-301-02)</PackageDescription>
<NDC11Code>49349-0301-02</NDC11Code>
<ProductNDC>49349-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nabumetone</ProprietaryName>
<NonProprietaryName>Nabumetone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076009</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>NABUMETONE</SubstanceName>
<StrengthNumber>500</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>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>49643-301-30</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49643-301-30) </PackageDescription>
<NDC11Code>49643-0301-30</NDC11Code>
<ProductNDC>49643-301</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Acacia Pollen</ProprietaryName>
<NonProprietaryName>Acacia Spp.</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>ACACIA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>49852-301-30</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, PLASTIC (49852-301-30) </PackageDescription>
<NDC11Code>49852-0301-30</NDC11Code>
<ProductNDC>49852-301</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand Cleanser</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Tri-Coastal Design Company Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For handwashing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49973-301-30</NDCCode>
<PackageDescription>15 BLISTER PACK in 1 BOX (49973-301-30) > 2 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>49973-0301-30</NDC11Code>
<ProductNDC>49973-301</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Azo</ProprietaryName>
<NonProprietaryName>Urinary Pain Relief</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120524</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>i-Health, Inc.</LabelerName>
<SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>95</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>