RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (25 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "85786-602-24",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (85786-602-24)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "85786-0602-24",
      "ProductNDC": "85786-602",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dr. Simi Nighttime Cold And Flu",
      "NonProprietaryName": "Acetaminophen 325 Mg, Dextromethorphan Hbr 15 Mg, Doxylamine Succinate 6.25 Mg",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260330",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Farmacias De Similares TX LLC",
      "SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN",
      "StrengthNumber": "15; 6.25; 325",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-04-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260330",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves common cold/flu symptoms: ■ cough due to minor throat & bronchial irritation ■ sore throat ■ headache ■ minor aches & pains ■ fever ■ runny nose & sneezing."
    },
    {
      "NDCCode": "85786-104-24",
      "PackageDescription": "24 TABLET, FILM COATED in 1 BOTTLE (85786-104-24) ",
      "NDC11Code": "85786-0104-24",
      "ProductNDC": "85786-104",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dr Simi All Day Pain Relief",
      "NonProprietaryName": "Naproxen Sodium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250817",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091353",
      "LabelerName": "Farmacias De Similares TX LLC",
      "SubstanceName": "NAPROXEN SODIUM",
      "StrengthNumber": "220",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250818",
      "SamplePackage": "N",
      "IndicationAndUsage": "Do not take more than directed. . The smallest effective dose should be used. Drink a full glass of water with each dose."
    },
    {
      "NDCCode": "85786-108-24",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (85786-108-24)  / 24 TABLET in 1 BOTTLE, PLASTIC",
      "NDC11Code": "85786-0108-24",
      "ProductNDC": "85786-108",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dr. Simi Pain Reliever Pm",
      "NonProprietaryName": "Acetaminophen, Diphenhydramine Hcl",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260410",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Farmacias De Similares TX LLC",
      "SubstanceName": "DIPHENHYDRAMINE HCL; ACETAMINOPHEN",
      "StrengthNumber": "25; 500",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260410",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness."
    },
    {
      "NDCCode": "85786-202-24",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (85786-202-24)  / 12 TABLET in 1 BLISTER PACK",
      "NDC11Code": "85786-0202-24",
      "ProductNDC": "85786-202",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dr. Simi Allergy Relief",
      "NonProprietaryName": "Diphenhydramine Hcl",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260420",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Farmacias De Similares TX LLC",
      "SubstanceName": "DIPHENHYDRAMINE HCL",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260420",
      "SamplePackage": "N",
      "IndicationAndUsage": "■ Temporarily relieves these symptoms due to hay fever, common cold or other respiratory allergies: ■ sneezing ■ runny nose ■ itchy, watery eyes ■ itching of the nose or throat ■ Temporarily relieves these symptoms due to the common cold: ■ runny nose ■ sneezing."
    },
    {
      "NDCCode": "85786-401-24",
      "PackageDescription": "24 CAPSULE, LIQUID FILLED in 1 CARTON (85786-401-24) ",
      "NDC11Code": "85786-0401-24",
      "ProductNDC": "85786-401",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Simethicone 180 Mg",
      "NonProprietaryName": "Simethicone 180 Mg",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M002",
      "LabelerName": "Farmacias De Similares TX LLC",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": "180",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-02-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Relieves - bloating - pressure -fullness commonly referred to as gas."
    },
    {
      "NDCCode": "85786-502-24",
      "PackageDescription": "24 CAPSULE, LIQUID FILLED in 1 CARTON (85786-502-24) ",
      "NDC11Code": "85786-0502-24",
      "ProductNDC": "85786-502",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Docusate Sodium 100mg",
      "NonProprietaryName": "Docusate Sodium 100mg",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M007",
      "LabelerName": "Farmacias De Similares TX LLC",
      "SubstanceName": "DOCUSATE SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2026-02-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Relieves occasional constipation (irregularity) . Generally produces bowel movement in 12 to 72 hours."
    },
    {
      "NDCCode": "24236-602-24",
      "PackageDescription": "200 TABLET in 1 CANISTER (24236-602-24)",
      "NDC11Code": "24236-0602-24",
      "ProductNDC": "24236-602",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Trazodone Hydrochloride",
      "NonProprietaryName": "Trazodone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130327",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071524",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "TRAZODONE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "44567-602-24",
      "PackageDescription": "24 BAG in 1 CARTON (44567-602-24)  / 50 mL in 1 BAG",
      "NDC11Code": "44567-0602-24",
      "ProductNDC": "44567-602",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dexmedetomidine In Dextrose",
      "NonProprietaryName": "Dexmedetomidine",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20160419",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA206628",
      "LabelerName": "WG Critical Care, LLC",
      "SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
      "StrengthNumber": "4",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20181018",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection is a alpha2 adrenergic receptor agonist indicated for: 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection by continuous infusion not to exceed 24 hours. (1.1) , 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2) .",
      "Description": "Dexmedetomidine Injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine in 5% Dextrose Injection is a sterile ready-to-use, nonpyrogenic solution suitable for intravenous infusion. Dexmedetomidine Injection and Dexmedetomidine in Dextrose Injection contains the dexmedetomidine as active pharmaceutical ingredient in the form of the hydrochloride salt form. Dexmedetomidine hydrochloride is a central alpha-2 adrenergic agonist. Structurally it is the S-enantiomer of medetomidine and is chemically described as 4-[(S)-α,2,3-Trimethylbenzyl]imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.74 and the empirical formula is C13H16N2  HCl and the structural formula is. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7. Each mL contains 118 mcg of dexmedetomidine hydrochloride USP, equivalent to 100 mcg (0.1 mg) of dexmedetomidine, 1.6 mg of methylparaben NF and 0.2 mg of propylparaben NF, as preservatives and 9 mg of sodium chloride USP, as tonicity agent in water for injection. Dexmedetomidine in 5% Dextrose Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride USP, equivalent to 4 mcg of dexmedetomidine, and 50 mg dextrose monohydrate USP, as tonicity agent, in water for injection."
    },
    {
      "NDCCode": "65753-602-24",
      "PackageDescription": "50 POUCH in 1 CONTAINER (65753-602-24)  / 7 g in 1 POUCH",
      "NDC11Code": "65753-0602-24",
      "ProductNDC": "65753-602",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cortex Sunx 50 Thick",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230309",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "CoreTex Products Inc",
      "SubstanceName": "HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE",
      "StrengthNumber": "10; 5; 5; 3",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Active",
      "LastUpdate": "2026-04-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230309",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. higher SPF gives more sunburn protection. retains SPF after 80 minutes of activity in the water or sweating. provides high protection against sunburn."
    },
    {
      "NDCCode": "66915-602-24",
      "PackageDescription": "50 g in 1 JAR (66915-602-24)",
      "NDC11Code": "66915-0602-24",
      "ProductNDC": "66915-602",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sol Protect",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110801",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CoValence, Inc.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": ".0702",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "67209-602-03",
      "PackageDescription": "24 BOTTLE in 1 BOX (67209-602-03)  > 30 TABLET in 1 BOTTLE",
      "NDC11Code": "67209-0602-03",
      "ProductNDC": "67209-602",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluconazole",
      "NonProprietaryName": "Fluconazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110307",
      "MarketingCategoryName": "APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT",
      "ApplicationNumber": "ANDA078423",
      "LabelerName": "WellSpring Pharma Services Inc.",
      "SubstanceName": "FLUCONAZOLE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-07"
    },
    {
      "NDCCode": "10135-602-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (10135-602-90)",
      "NDC11Code": "10135-0602-90",
      "ProductNDC": "10135-602",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Felbamate",
      "NonProprietaryName": "Felbamate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201680",
      "LabelerName": "Marlex Pharmaceuticals Inc",
      "SubstanceName": "FELBAMATE",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings). Felbamate tablets, USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, felbamate tablets, USP can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.",
      "Description": "Felbamate, USP is an antiepileptic available as 400mg and 600mg tablets for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate, USP is a white to off-white crystalline powder with a characteristic odor. It is very slightly soluble in water, slightly soluble in ethanol, sparingly soluble in methanol, and freely soluble in dimethyl sulfoxide. The molecular weight is 238.24; felbamate’s molecular formula is C₁₁H₁₄N₂O₄; its structural formula is:. The inactive ingredients for felbamate tablets, USP 400 mg and 600 mg are croscarmellose sodium. FD&C Yellow No. 6, D&C Yellow No. 10 and FD&C Red No. 40 (600 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch."
    },
    {
      "NDCCode": "29784-602-01",
      "PackageDescription": "1 POUCH in 1 BOX (29784-602-01)  / 4 PATCH in 1 POUCH / 1.03 g in 1 PATCH",
      "NDC11Code": "29784-0602-01",
      "ProductNDC": "29784-602",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Profoot Plantar Relief Strips",
      "NonProprietaryName": "Camphor (natural), Menthol, Methyl Salicylate",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20231018",
      "EndMarketingDate": "20270531",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Rooftop Consumer Health, Inc.",
      "SubstanceName": "CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE",
      "StrengthNumber": "12; 57; 63",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2024-10-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20231018",
      "EndMarketingDatePackage": "20270531",
      "SamplePackage": "N",
      "IndicationAndUsage": "For temporary relief of minor aches & pains of muscles & joints associated with:  arthritis  strains  bruises  sprains."
    },
    {
      "NDCCode": "33342-602-78",
      "PackageDescription": "5 kg in 1 CONTAINER (33342-602-78) ",
      "NDC11Code": "33342-0602-78",
      "ProductNDC": "33342-602",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Atomoxetine Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20240226",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "kg/5kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-12-28",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "26-FEB-24"
    },
    {
      "NDCCode": "44523-602-01",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (44523-602-01)  / 25 g in 1 BOTTLE, PLASTIC",
      "NDC11Code": "44523-0602-01",
      "ProductNDC": "44523-602",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Sulfacetamide And Sulfur",
      "NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110430",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "BioComp Pharma, Inc.",
      "SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
      "StrengthNumber": "100; 50",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-04-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20110430",
      "SamplePackage": "N",
      "IndicationAndUsage": "This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
      "Description": "Each mL contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
    },
    {
      "NDCCode": "52305-602-30",
      "PackageDescription": "250 mL in 1 BOTTLE, PUMP (52305-602-30) ",
      "NDC11Code": "52305-0602-30",
      "ProductNDC": "52305-602",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alaska Airlines",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200629",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Freshorize Ltd.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".13",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2025-10-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200629",
      "SamplePackage": "N",
      "IndicationAndUsage": "To decrease bacteria on the skin."
    },
    {
      "NDCCode": "55316-602-06",
      "PackageDescription": "454 g in 1 POUCH (55316-602-06) ",
      "NDC11Code": "55316-0602-06",
      "ProductNDC": "55316-602",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Epsom Salt",
      "NonProprietaryName": "Magnesium Sulfate",
      "DosageFormName": "GRANULE, FOR SOLUTION",
      "RouteName": "ORAL; TOPICAL",
      "StartMarketingDate": "20080227",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M007",
      "LabelerName": "DZA Brands, LLC",
      "SubstanceName": "MAGNESIUM SULFATE HEPTAHYDRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20080227",
      "SamplePackage": "N",
      "IndicationAndUsage": "for relief of occasional constipation (irregularity). this product generally produces bowel movement in 1/2 to 6 hours."
    },
    {
      "NDCCode": "55316-602-07",
      "PackageDescription": "1814 g in 1 POUCH (55316-602-07) ",
      "NDC11Code": "55316-0602-07",
      "ProductNDC": "55316-602",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Epsom Salt",
      "NonProprietaryName": "Magnesium Sulfate",
      "DosageFormName": "GRANULE, FOR SOLUTION",
      "RouteName": "ORAL; TOPICAL",
      "StartMarketingDate": "20080227",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M007",
      "LabelerName": "DZA Brands, LLC",
      "SubstanceName": "MAGNESIUM SULFATE HEPTAHYDRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20080227",
      "SamplePackage": "N",
      "IndicationAndUsage": "for relief of occasional constipation (irregularity). this product generally produces bowel movement in 1/2 to 6 hours."
    },
    {
      "NDCCode": "60687-602-01",
      "PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-602-01)  / 1 CAPSULE in 1 BLISTER PACK (60687-602-11) ",
      "NDC11Code": "60687-0602-01",
      "ProductNDC": "60687-602",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090858",
      "LabelerName": "American Health Packaging",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-10-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
      "Description": "The active ingredient in gabapentin capsules is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: anhydrous lactose, cornstarch, and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate, and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propyl glycol, strong ammonia solution, and titanium dioxide."
    },
    {
      "NDCCode": "60793-602-10",
      "PackageDescription": "10 SYRINGE in 1 PACKAGE (60793-602-10)  / 2 mL in 1 SYRINGE (60793-602-02) ",
      "NDC11Code": "60793-0602-10",
      "ProductNDC": "60793-602",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bicillin C-r 900/300",
      "NonProprietaryName": "Penicillin G Benzathine And Penicillin G Procaine",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "19530518",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050138",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE",
      "StrengthNumber": "900000; 300000",
      "StrengthUnit": "[iU]/2mL; [iU]/2mL",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], Penicillins [CS]",
      "Status": "Active",
      "LastUpdate": "2026-07-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19530518",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bicillin C-R 900/300 and other antibacterial drugs, Bicillin C-R 900/300 should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Bicillin C-R 900/300 is indicated in the treatment of infections as described below that are susceptible to serum levels characteristic of this particular dosage form. Therapy should be guided by bacteriological studies (including susceptibility testing) and by clinical response. Bicillin C-R 900/300 is indicated in the treatment of the following in pediatric patients. Moderately severe to severe infections of the upper-respiratory tract, scarlet fever, erysipelas, and skin and soft-tissue infections due to susceptible streptococci. NOTE: Streptococci in Groups A, C, G, H, L, and M are very susceptible to penicillin G. Other groups, including Group D (enterococci), are resistant. Penicillin G sodium or potassium is recommended for streptococcal infections with bacteremia. Moderately severe pneumonia and otitis media due to susceptible Streptococcus pneumoniae. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, peritonitis, and arthritis of pneumococcal etiology are better treated with penicillin G sodium or potassium during the acute stage. When high, sustained serum levels are required, penicillin G sodium or potassium, either IM or IV, should be used. This drug should not be used in the treatment of venereal diseases, including syphilis, gonorrhea, yaws, bejel, and pinta.",
      "Description": "Bicillin C-R 900/300 (penicillin G benzathine and penicillin G procaine injectable suspension) contains the equivalent of 900,000 units of penicillin G as the benzathine and 300,000 units of penicillin G as the procaine salts. It is available for deep intramuscular injection. Penicillin G benzathine is prepared by the reaction of dibenzylethylene diamine with two molecules of penicillin G. It is chemically designated as (2S ,5R,6R)-3,3-Dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid compound with N,N'-dibenzylethylenediamine (2:1), tetrahydrate. It occurs as a white, crystalline powder and is very slightly soluble in water and sparingly soluble in alcohol. Its chemical structure is as follows. Penicillin G procaine, (2S ,5R,6R)-3,3-Dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid compound with 2-(diethylamino)ethyl p-aminobenzoate (1:1) monohydrate, is an equimolar salt of procaine and penicillin G. It occurs as white crystals or a white, microcrystalline powder and is slightly soluble in water. Its chemical structure is as follows. Each 2 mL syringe contains the equivalent of 1,200,000 units of penicillin G as follows: penicillin G benzathine equivalent to 900,000 units of penicillin G and penicillin G procaine equivalent to 300,000 units of penicillin G in a stabilized aqueous suspension with sodium citrate buffer; and as w/v, approximately 0.5% lecithin, 0.55% carboxymethylcellulose, 0.55% povidone, 0.1% methylparaben, and 0.01% propylparaben. Bicillin C-R 900/300 injectable suspension is viscous and opaque. Read CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections prior to use."
    },
    {
      "NDCCode": "66336-602-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (66336-602-30)",
      "NDC11Code": "66336-0602-30",
      "ProductNDC": "66336-602",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lovastatin",
      "NonProprietaryName": "Lovastatin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20021125",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075991",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "LOVASTATIN",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, lovastatin is indicated to reduce the risk of: : 1 Myocardial infarction , 2 Unstable angina , 3 Coronary revascularization procedures .",
      "Description": "Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1 S   -[1α(R *), 3α, 7β, 8β(2 S   *,4 S   *),8aβ]]-1,2,3, 7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H -pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C 24 H 36 O 5 and its molecular weight is 404.55. Its structural formula is:. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, pregelatinized starch, sodium starch glycolate, butylated hydroxyaniso and talc. Butylated hydroxyanisole (BHA) is added as a preservative."
    },
    {
      "NDCCode": "69918-602-60",
      "PackageDescription": "60 POUCH in 1 CARTON (69918-602-60)  / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER",
      "NDC11Code": "69918-0602-60",
      "ProductNDC": "69918-602",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Timoptic In Ocudose",
      "NonProprietaryName": "Timolol Maleate",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20220226",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212592",
      "LabelerName": "Nordic Pharma, Inc.",
      "SubstanceName": "TIMOLOL MALEATE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20220226",
      "SamplePackage": "N",
      "IndicationAndUsage": "Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial may be used when a patient is sensitive to the preservative in timolol maleate ophthalmic solution USP, benzalkonium chloride, or when use of a preservative-free topical medication is advisable.",
      "Description": "Timolol maleate USP is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is stable at room temperature. Timolol maleate ophthalmic solution is supplied in two formulations: timolol maleate ophthalmic solution, which contains the preservative benzalkonium chloride; and timolol maleate ophthalmic solution, the preservative-free formulation. Preservative-free timolol maleate ophthalmic solution, USP is supplied in a single-dose vial, as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of preservative-free timolol maleate ophthalmic solution USP 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7.0, and the osmolarity is 252-328 mOsm. Each mL of Preservative-free timolol maleate ophthalmic solution USP 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and water for injection."
    },
    {
      "NDCCode": "73954-602-42",
      "PackageDescription": ".946 L in 1 BOTTLE, PLASTIC (73954-602-42) ",
      "NDC11Code": "73954-0602-42",
      "ProductNDC": "73954-602",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution",
      "NonProprietaryName": "Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200413",
      "EndMarketingDate": "20220521",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Green Mountain Flavors Inc.",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "750",
      "StrengthUnit": "mL/L",
      "Status": "Deprecated",
      "LastUpdate": "2022-05-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200413",
      "EndMarketingDatePackage": "20220521",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "73954-602-43",
      "PackageDescription": "3.78541 L in 1 BOTTLE, PLASTIC (73954-602-43) ",
      "NDC11Code": "73954-0602-43",
      "ProductNDC": "73954-602",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution",
      "NonProprietaryName": "Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200413",
      "EndMarketingDate": "20220521",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Green Mountain Flavors Inc.",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "750",
      "StrengthUnit": "mL/L",
      "Status": "Deprecated",
      "LastUpdate": "2022-05-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200413",
      "EndMarketingDatePackage": "20220521",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "85786-101-90",
      "PackageDescription": "100 TABLET, COATED in 1 BOTTLE (85786-101-90) ",
      "NDC11Code": "85786-0101-90",
      "ProductNDC": "85786-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dr Simi Pain Reliever Pm",
      "NonProprietaryName": "Acetaminophen, Diphenhydramine Hydrochloride",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250811",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Farmacias De Similares TX LLC",
      "SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "500; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251215",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "85786-102-90",
      "PackageDescription": "100 TABLET, COATED in 1 BOTTLE (85786-102-90) ",
      "NDC11Code": "85786-0102-90",
      "ProductNDC": "85786-102",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dr Simi Pain Relief 100",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250813",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Farmacias De Similares TX LLC",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2026-01-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250813",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "85786-103-90",
      "PackageDescription": "100 TABLET, COATED in 1 BOTTLE (85786-103-90) ",
      "NDC11Code": "85786-0103-90",
      "ProductNDC": "85786-103",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dr Simi Pain Relief",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250813",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Farmacias De Similares TX LLC",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "325",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2026-01-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251215",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "85786-105-90",
      "PackageDescription": "100 TABLET, COATED in 1 BOTTLE, PLASTIC (85786-105-90) ",
      "NDC11Code": "85786-0105-90",
      "ProductNDC": "85786-105",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dr Simi Extra Strength Acetaminophen 250 Mg, Aspirin 250 Mg, And Caffeine 65 Mg",
      "NonProprietaryName": "Acetaminophen 250 Mg, Aspirin 250 Mg, And Caffeine 65 Mg",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Farmacias De Similares TX LLC",
      "SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
      "StrengthNumber": "250; 250; 65",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves minor aches and pains due to: - headache. - muscular aches. - a cold - arthritis. - toothache. - premenstrual and menstrual cramps."
    },
    {
      "NDCCode": "85786-106-60",
      "PackageDescription": "60 TABLET, COATED in 1 CARTON (85786-106-60) ",
      "NDC11Code": "85786-0106-60",
      "ProductNDC": "85786-106",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aspirin Delayed Release 81mg",
      "NonProprietaryName": "Aspirin Delayed Release 81mg",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Farmacias De Similares TX LLC",
      "SubstanceName": "ASPIRIN",
      "StrengthNumber": "81",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260101",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relief of headache or symptoms needing immediate relief."
    },
    {
      "NDCCode": "85786-107-30",
      "PackageDescription": "30 TABLET, COATED in 1 CARTON (85786-107-30) ",
      "NDC11Code": "85786-0107-30",
      "ProductNDC": "85786-107",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ibuprofen 200 Mg",
      "NonProprietaryName": "Ibuprofen 200 Mg",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079174",
      "LabelerName": "Farmacias De Similares TX LLC",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves minor aches and pains due to: - Headache - Backache - Muscular aches - Minor pain of arthritis - Menstrual cramps - Toothache - The common cold - Temporarily reduces fever."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"85786-602-24","ProprietaryName":"Dr. Simi Nighttime Cold And Flu","NonProprietaryName":"Acetaminophen 325 Mg, Dextromethorphan Hbr 15 Mg, Doxylamine Succinate 6.25 Mg"},{"NDCCode":"85786-104-24","ProprietaryName":"Dr Simi All Day Pain Relief","NonProprietaryName":"Naproxen Sodium"},{"NDCCode":"85786-108-24","ProprietaryName":"Dr. Simi Pain Reliever Pm","NonProprietaryName":"Acetaminophen, Diphenhydramine Hcl"},{"NDCCode":"85786-202-24","ProprietaryName":"Dr. Simi Allergy Relief","NonProprietaryName":"Diphenhydramine Hcl"},{"NDCCode":"85786-401-24","ProprietaryName":"Simethicone 180 Mg","NonProprietaryName":"Simethicone 180 Mg"},{"NDCCode":"85786-502-24","ProprietaryName":"Docusate Sodium 100mg","NonProprietaryName":"Docusate Sodium 100mg"},{"NDCCode":"24236-602-24","ProprietaryName":"Trazodone Hydrochloride","NonProprietaryName":"Trazodone Hydrochloride"},{"NDCCode":"44567-602-24","ProprietaryName":"Dexmedetomidine In Dextrose","NonProprietaryName":"Dexmedetomidine"},{"NDCCode":"65753-602-24","ProprietaryName":"Cortex Sunx 50 Thick","NonProprietaryName":"Avobenzone, Homosalate, Octisalate, Octocrylene"},{"NDCCode":"66915-602-24","ProprietaryName":"Sol Protect","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"67209-602-03","ProprietaryName":"Fluconazole","NonProprietaryName":"Fluconazole"},{"NDCCode":"10135-602-90","ProprietaryName":"Felbamate","NonProprietaryName":"Felbamate"},{"NDCCode":"29784-602-01","ProprietaryName":"Profoot Plantar Relief Strips","NonProprietaryName":"Camphor (natural), Menthol, Methyl Salicylate"},{"NDCCode":"33342-602-78","NonProprietaryName":"Atomoxetine Hydrochloride"},{"NDCCode":"44523-602-01","ProprietaryName":"Sodium Sulfacetamide And Sulfur","NonProprietaryName":"Sulfacetamide Sodium, Sulfur"},{"NDCCode":"52305-602-30","ProprietaryName":"Alaska Airlines","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"55316-602-06","ProprietaryName":"Epsom Salt","NonProprietaryName":"Magnesium Sulfate"},{"NDCCode":"55316-602-07","ProprietaryName":"Epsom Salt","NonProprietaryName":"Magnesium Sulfate"},{"NDCCode":"60687-602-01","ProprietaryName":"Gabapentin","NonProprietaryName":"Gabapentin"},{"NDCCode":"60793-602-10","ProprietaryName":"Bicillin C-r 900/300","NonProprietaryName":"Penicillin G Benzathine And Penicillin G Procaine"},{"NDCCode":"66336-602-30","ProprietaryName":"Lovastatin","NonProprietaryName":"Lovastatin"},{"NDCCode":"69918-602-60","ProprietaryName":"Timoptic In Ocudose","NonProprietaryName":"Timolol Maleate"},{"NDCCode":"73954-602-42","ProprietaryName":"Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution","NonProprietaryName":"Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution"},{"NDCCode":"73954-602-43","ProprietaryName":"Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution","NonProprietaryName":"Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution"},{"NDCCode":"85786-101-90","ProprietaryName":"Dr Simi Pain Reliever Pm","NonProprietaryName":"Acetaminophen, Diphenhydramine Hydrochloride"},{"NDCCode":"85786-102-90","ProprietaryName":"Dr Simi Pain Relief 100","NonProprietaryName":"Acetaminophen"},{"NDCCode":"85786-103-90","ProprietaryName":"Dr Simi Pain Relief","NonProprietaryName":"Acetaminophen"},{"NDCCode":"85786-105-90","ProprietaryName":"Dr Simi Extra Strength Acetaminophen 250 Mg, Aspirin 250 Mg, And Caffeine 65 Mg","NonProprietaryName":"Acetaminophen 250 Mg, Aspirin 250 Mg, And Caffeine 65 Mg"},{"NDCCode":"85786-106-60","ProprietaryName":"Aspirin Delayed Release 81mg","NonProprietaryName":"Aspirin Delayed Release 81mg"},{"NDCCode":"85786-107-30","ProprietaryName":"Ibuprofen 200 Mg","NonProprietaryName":"Ibuprofen 200 Mg"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>85786-602-24</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (85786-602-24)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>85786-0602-24</NDC11Code>
    <ProductNDC>85786-602</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dr. Simi Nighttime Cold And Flu</ProprietaryName>
    <NonProprietaryName>Acetaminophen 325 Mg, Dextromethorphan Hbr 15 Mg, Doxylamine Succinate 6.25 Mg</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Farmacias De Similares TX LLC</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>15; 6.25; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves common cold/flu symptoms: ■ cough due to minor throat &amp; bronchial irritation ■ sore throat ■ headache ■ minor aches &amp; pains ■ fever ■ runny nose &amp; sneezing.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>85786-104-24</NDCCode>
    <PackageDescription>24 TABLET, FILM COATED in 1 BOTTLE (85786-104-24) </PackageDescription>
    <NDC11Code>85786-0104-24</NDC11Code>
    <ProductNDC>85786-104</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dr Simi All Day Pain Relief</ProprietaryName>
    <NonProprietaryName>Naproxen Sodium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250817</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091353</ApplicationNumber>
    <LabelerName>Farmacias De Similares TX LLC</LabelerName>
    <SubstanceName>NAPROXEN SODIUM</SubstanceName>
    <StrengthNumber>220</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>2026-01-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250818</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Do not take more than directed. . The smallest effective dose should be used. Drink a full glass of water with each dose.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>85786-108-24</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (85786-108-24)  / 24 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>85786-0108-24</NDC11Code>
    <ProductNDC>85786-108</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dr. Simi Pain Reliever Pm</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Diphenhydramine Hcl</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260410</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>Farmacias De Similares TX LLC</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HCL; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>25; 500</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260410</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>85786-202-24</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (85786-202-24)  / 12 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>85786-0202-24</NDC11Code>
    <ProductNDC>85786-202</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dr. Simi Allergy Relief</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260420</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Farmacias De Similares TX LLC</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HCL</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260420</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>■ Temporarily relieves these symptoms due to hay fever, common cold or other respiratory allergies: ■ sneezing ■ runny nose ■ itchy, watery eyes ■ itching of the nose or throat ■ Temporarily relieves these symptoms due to the common cold: ■ runny nose ■ sneezing.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>85786-401-24</NDCCode>
    <PackageDescription>24 CAPSULE, LIQUID FILLED in 1 CARTON (85786-401-24) </PackageDescription>
    <NDC11Code>85786-0401-24</NDC11Code>
    <ProductNDC>85786-401</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Simethicone 180 Mg</ProprietaryName>
    <NonProprietaryName>Simethicone 180 Mg</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M002</ApplicationNumber>
    <LabelerName>Farmacias De Similares TX LLC</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Relieves - bloating - pressure -fullness commonly referred to as gas.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>85786-502-24</NDCCode>
    <PackageDescription>24 CAPSULE, LIQUID FILLED in 1 CARTON (85786-502-24) </PackageDescription>
    <NDC11Code>85786-0502-24</NDC11Code>
    <ProductNDC>85786-502</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Docusate Sodium 100mg</ProprietaryName>
    <NonProprietaryName>Docusate Sodium 100mg</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>Farmacias De Similares TX LLC</LabelerName>
    <SubstanceName>DOCUSATE SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-02-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Relieves occasional constipation (irregularity) . Generally produces bowel movement in 12 to 72 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>24236-602-24</NDCCode>
    <PackageDescription>200 TABLET in 1 CANISTER (24236-602-24)</PackageDescription>
    <NDC11Code>24236-0602-24</NDC11Code>
    <ProductNDC>24236-602</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071524</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>44567-602-24</NDCCode>
    <PackageDescription>24 BAG in 1 CARTON (44567-602-24)  / 50 mL in 1 BAG</PackageDescription>
    <NDC11Code>44567-0602-24</NDC11Code>
    <ProductNDC>44567-602</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexmedetomidine In Dextrose</ProprietaryName>
    <NonProprietaryName>Dexmedetomidine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20160419</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA206628</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection is a alpha2 adrenergic receptor agonist indicated for: 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection by continuous infusion not to exceed 24 hours. (1.1) , 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2) .</IndicationAndUsage>
    <Description>Dexmedetomidine Injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine in 5% Dextrose Injection is a sterile ready-to-use, nonpyrogenic solution suitable for intravenous infusion. Dexmedetomidine Injection and Dexmedetomidine in Dextrose Injection contains the dexmedetomidine as active pharmaceutical ingredient in the form of the hydrochloride salt form. Dexmedetomidine hydrochloride is a central alpha-2 adrenergic agonist. Structurally it is the S-enantiomer of medetomidine and is chemically described as 4-[(S)-α,2,3-Trimethylbenzyl]imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.74 and the empirical formula is C13H16N2  HCl and the structural formula is. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7. Each mL contains 118 mcg of dexmedetomidine hydrochloride USP, equivalent to 100 mcg (0.1 mg) of dexmedetomidine, 1.6 mg of methylparaben NF and 0.2 mg of propylparaben NF, as preservatives and 9 mg of sodium chloride USP, as tonicity agent in water for injection. Dexmedetomidine in 5% Dextrose Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride USP, equivalent to 4 mcg of dexmedetomidine, and 50 mg dextrose monohydrate USP, as tonicity agent, in water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>65753-602-24</NDCCode>
    <PackageDescription>50 POUCH in 1 CONTAINER (65753-602-24)  / 7 g in 1 POUCH</PackageDescription>
    <NDC11Code>65753-0602-24</NDC11Code>
    <ProductNDC>65753-602</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cortex Sunx 50 Thick</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230309</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>CoreTex Products Inc</LabelerName>
    <SubstanceName>HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE</SubstanceName>
    <StrengthNumber>10; 5; 5; 3</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230309</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. higher SPF gives more sunburn protection. retains SPF after 80 minutes of activity in the water or sweating. provides high protection against sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>66915-602-24</NDCCode>
    <PackageDescription>50 g in 1 JAR (66915-602-24)</PackageDescription>
    <NDC11Code>66915-0602-24</NDC11Code>
    <ProductNDC>66915-602</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sol Protect</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CoValence, Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>.0702</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>67209-602-03</NDCCode>
    <PackageDescription>24 BOTTLE in 1 BOX (67209-602-03)  &gt; 30 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>67209-0602-03</NDC11Code>
    <ProductNDC>67209-602</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluconazole</ProprietaryName>
    <NonProprietaryName>Fluconazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110307</StartMarketingDate>
    <MarketingCategoryName>APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT</MarketingCategoryName>
    <ApplicationNumber>ANDA078423</ApplicationNumber>
    <LabelerName>WellSpring Pharma Services Inc.</LabelerName>
    <SubstanceName>FLUCONAZOLE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-07</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>10135-602-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (10135-602-90)</PackageDescription>
    <NDC11Code>10135-0602-90</NDC11Code>
    <ProductNDC>10135-602</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Felbamate</ProprietaryName>
    <NonProprietaryName>Felbamate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201680</ApplicationNumber>
    <LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
    <SubstanceName>FELBAMATE</SubstanceName>
    <StrengthNumber>600</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>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings). Felbamate tablets, USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, felbamate tablets, USP can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.</IndicationAndUsage>
    <Description>Felbamate, USP is an antiepileptic available as 400mg and 600mg tablets for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate, USP is a white to off-white crystalline powder with a characteristic odor. It is very slightly soluble in water, slightly soluble in ethanol, sparingly soluble in methanol, and freely soluble in dimethyl sulfoxide. The molecular weight is 238.24; felbamate’s molecular formula is C₁₁H₁₄N₂O₄; its structural formula is:. The inactive ingredients for felbamate tablets, USP 400 mg and 600 mg are croscarmellose sodium. FD&amp;C Yellow No. 6, D&amp;C Yellow No. 10 and FD&amp;C Red No. 40 (600 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>29784-602-01</NDCCode>
    <PackageDescription>1 POUCH in 1 BOX (29784-602-01)  / 4 PATCH in 1 POUCH / 1.03 g in 1 PATCH</PackageDescription>
    <NDC11Code>29784-0602-01</NDC11Code>
    <ProductNDC>29784-602</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Profoot Plantar Relief Strips</ProprietaryName>
    <NonProprietaryName>Camphor (natural), Menthol, Methyl Salicylate</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20231018</StartMarketingDate>
    <EndMarketingDate>20270531</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Rooftop Consumer Health, Inc.</LabelerName>
    <SubstanceName>CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE</SubstanceName>
    <StrengthNumber>12; 57; 63</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20231018</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For temporary relief of minor aches &amp; pains of muscles &amp; joints associated with:  arthritis  strains  bruises  sprains.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>33342-602-78</NDCCode>
    <PackageDescription>5 kg in 1 CONTAINER (33342-602-78) </PackageDescription>
    <NDC11Code>33342-0602-78</NDC11Code>
    <ProductNDC>33342-602</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20240226</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>kg/5kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-12-28</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>26-FEB-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>44523-602-01</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (44523-602-01)  / 25 g in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>44523-0602-01</NDC11Code>
    <ProductNDC>44523-602</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Sulfacetamide And Sulfur</ProprietaryName>
    <NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110430</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>BioComp Pharma, Inc.</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
    <StrengthNumber>100; 50</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
    <Description>Each mL contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
  </NDC>
  <NDC>
    <NDCCode>52305-602-30</NDCCode>
    <PackageDescription>250 mL in 1 BOTTLE, PUMP (52305-602-30) </PackageDescription>
    <NDC11Code>52305-0602-30</NDC11Code>
    <ProductNDC>52305-602</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Alaska Airlines</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200629</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Freshorize Ltd.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.13</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-10-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200629</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55316-602-06</NDCCode>
    <PackageDescription>454 g in 1 POUCH (55316-602-06) </PackageDescription>
    <NDC11Code>55316-0602-06</NDC11Code>
    <ProductNDC>55316-602</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Epsom Salt</ProprietaryName>
    <NonProprietaryName>Magnesium Sulfate</NonProprietaryName>
    <DosageFormName>GRANULE, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL; TOPICAL</RouteName>
    <StartMarketingDate>20080227</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>DZA Brands, LLC</LabelerName>
    <SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for relief of occasional constipation (irregularity). this product generally produces bowel movement in 1/2 to 6 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55316-602-07</NDCCode>
    <PackageDescription>1814 g in 1 POUCH (55316-602-07) </PackageDescription>
    <NDC11Code>55316-0602-07</NDC11Code>
    <ProductNDC>55316-602</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Epsom Salt</ProprietaryName>
    <NonProprietaryName>Magnesium Sulfate</NonProprietaryName>
    <DosageFormName>GRANULE, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL; TOPICAL</RouteName>
    <StartMarketingDate>20080227</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>DZA Brands, LLC</LabelerName>
    <SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for relief of occasional constipation (irregularity). this product generally produces bowel movement in 1/2 to 6 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>60687-602-01</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-602-01)  / 1 CAPSULE in 1 BLISTER PACK (60687-602-11) </PackageDescription>
    <NDC11Code>60687-0602-01</NDC11Code>
    <ProductNDC>60687-602</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090858</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
    <Description>The active ingredient in gabapentin capsules is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: anhydrous lactose, cornstarch, and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate, and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propyl glycol, strong ammonia solution, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>60793-602-10</NDCCode>
    <PackageDescription>10 SYRINGE in 1 PACKAGE (60793-602-10)  / 2 mL in 1 SYRINGE (60793-602-02) </PackageDescription>
    <NDC11Code>60793-0602-10</NDC11Code>
    <ProductNDC>60793-602</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bicillin C-r 900/300</ProprietaryName>
    <NonProprietaryName>Penicillin G Benzathine And Penicillin G Procaine</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>19530518</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050138</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE</SubstanceName>
    <StrengthNumber>900000; 300000</StrengthNumber>
    <StrengthUnit>[iU]/2mL; [iU]/2mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19530518</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bicillin C-R 900/300 and other antibacterial drugs, Bicillin C-R 900/300 should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Bicillin C-R 900/300 is indicated in the treatment of infections as described below that are susceptible to serum levels characteristic of this particular dosage form. Therapy should be guided by bacteriological studies (including susceptibility testing) and by clinical response. Bicillin C-R 900/300 is indicated in the treatment of the following in pediatric patients. Moderately severe to severe infections of the upper-respiratory tract, scarlet fever, erysipelas, and skin and soft-tissue infections due to susceptible streptococci. NOTE: Streptococci in Groups A, C, G, H, L, and M are very susceptible to penicillin G. Other groups, including Group D (enterococci), are resistant. Penicillin G sodium or potassium is recommended for streptococcal infections with bacteremia. Moderately severe pneumonia and otitis media due to susceptible Streptococcus pneumoniae. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, peritonitis, and arthritis of pneumococcal etiology are better treated with penicillin G sodium or potassium during the acute stage. When high, sustained serum levels are required, penicillin G sodium or potassium, either IM or IV, should be used. This drug should not be used in the treatment of venereal diseases, including syphilis, gonorrhea, yaws, bejel, and pinta.</IndicationAndUsage>
    <Description>Bicillin C-R 900/300 (penicillin G benzathine and penicillin G procaine injectable suspension) contains the equivalent of 900,000 units of penicillin G as the benzathine and 300,000 units of penicillin G as the procaine salts. It is available for deep intramuscular injection. Penicillin G benzathine is prepared by the reaction of dibenzylethylene diamine with two molecules of penicillin G. It is chemically designated as (2S ,5R,6R)-3,3-Dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid compound with N,N'-dibenzylethylenediamine (2:1), tetrahydrate. It occurs as a white, crystalline powder and is very slightly soluble in water and sparingly soluble in alcohol. Its chemical structure is as follows. Penicillin G procaine, (2S ,5R,6R)-3,3-Dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid compound with 2-(diethylamino)ethyl p-aminobenzoate (1:1) monohydrate, is an equimolar salt of procaine and penicillin G. It occurs as white crystals or a white, microcrystalline powder and is slightly soluble in water. Its chemical structure is as follows. Each 2 mL syringe contains the equivalent of 1,200,000 units of penicillin G as follows: penicillin G benzathine equivalent to 900,000 units of penicillin G and penicillin G procaine equivalent to 300,000 units of penicillin G in a stabilized aqueous suspension with sodium citrate buffer; and as w/v, approximately 0.5% lecithin, 0.55% carboxymethylcellulose, 0.55% povidone, 0.1% methylparaben, and 0.01% propylparaben. Bicillin C-R 900/300 injectable suspension is viscous and opaque. Read CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections prior to use.</Description>
  </NDC>
  <NDC>
    <NDCCode>66336-602-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (66336-602-30)</PackageDescription>
    <NDC11Code>66336-0602-30</NDC11Code>
    <ProductNDC>66336-602</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lovastatin</ProprietaryName>
    <NonProprietaryName>Lovastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20021125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075991</ApplicationNumber>
    <LabelerName>Dispensing Solutions, Inc.</LabelerName>
    <SubstanceName>LOVASTATIN</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>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, lovastatin is indicated to reduce the risk of: : 1 Myocardial infarction , 2 Unstable angina , 3 Coronary revascularization procedures .</IndicationAndUsage>
    <Description>Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1 S   -[1α(R *), 3α, 7β, 8β(2 S   *,4 S   *),8aβ]]-1,2,3, 7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H -pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C 24 H 36 O 5 and its molecular weight is 404.55. Its structural formula is:. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, pregelatinized starch, sodium starch glycolate, butylated hydroxyaniso and talc. Butylated hydroxyanisole (BHA) is added as a preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>69918-602-60</NDCCode>
    <PackageDescription>60 POUCH in 1 CARTON (69918-602-60)  / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>69918-0602-60</NDC11Code>
    <ProductNDC>69918-602</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Timoptic In Ocudose</ProprietaryName>
    <NonProprietaryName>Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20220226</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212592</ApplicationNumber>
    <LabelerName>Nordic Pharma, Inc.</LabelerName>
    <SubstanceName>TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220226</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial may be used when a patient is sensitive to the preservative in timolol maleate ophthalmic solution USP, benzalkonium chloride, or when use of a preservative-free topical medication is advisable.</IndicationAndUsage>
    <Description>Timolol maleate USP is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is stable at room temperature. Timolol maleate ophthalmic solution is supplied in two formulations: timolol maleate ophthalmic solution, which contains the preservative benzalkonium chloride; and timolol maleate ophthalmic solution, the preservative-free formulation. Preservative-free timolol maleate ophthalmic solution, USP is supplied in a single-dose vial, as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of preservative-free timolol maleate ophthalmic solution USP 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7.0, and the osmolarity is 252-328 mOsm. Each mL of Preservative-free timolol maleate ophthalmic solution USP 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>73954-602-42</NDCCode>
    <PackageDescription>.946 L in 1 BOTTLE, PLASTIC (73954-602-42) </PackageDescription>
    <NDC11Code>73954-0602-42</NDC11Code>
    <ProductNDC>73954-602</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200413</StartMarketingDate>
    <EndMarketingDate>20220521</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Green Mountain Flavors Inc.</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-05-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200413</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220521</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>73954-602-43</NDCCode>
    <PackageDescription>3.78541 L in 1 BOTTLE, PLASTIC (73954-602-43) </PackageDescription>
    <NDC11Code>73954-0602-43</NDC11Code>
    <ProductNDC>73954-602</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200413</StartMarketingDate>
    <EndMarketingDate>20220521</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Green Mountain Flavors Inc.</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-05-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200413</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220521</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>85786-101-90</NDCCode>
    <PackageDescription>100 TABLET, COATED in 1 BOTTLE (85786-101-90) </PackageDescription>
    <NDC11Code>85786-0101-90</NDC11Code>
    <ProductNDC>85786-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dr Simi Pain Reliever Pm</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Diphenhydramine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250811</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>Farmacias De Similares TX LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>85786-102-90</NDCCode>
    <PackageDescription>100 TABLET, COATED in 1 BOTTLE (85786-102-90) </PackageDescription>
    <NDC11Code>85786-0102-90</NDC11Code>
    <ProductNDC>85786-102</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dr Simi Pain Relief 100</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250813</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>Farmacias De Similares TX LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250813</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>85786-103-90</NDCCode>
    <PackageDescription>100 TABLET, COATED in 1 BOTTLE (85786-103-90) </PackageDescription>
    <NDC11Code>85786-0103-90</NDC11Code>
    <ProductNDC>85786-103</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dr Simi Pain Relief</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250813</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>Farmacias De Similares TX LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>325</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>85786-105-90</NDCCode>
    <PackageDescription>100 TABLET, COATED in 1 BOTTLE, PLASTIC (85786-105-90) </PackageDescription>
    <NDC11Code>85786-0105-90</NDC11Code>
    <ProductNDC>85786-105</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dr Simi Extra Strength Acetaminophen 250 Mg, Aspirin 250 Mg, And Caffeine 65 Mg</ProprietaryName>
    <NonProprietaryName>Acetaminophen 250 Mg, Aspirin 250 Mg, And Caffeine 65 Mg</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>Farmacias De Similares TX LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
    <StrengthNumber>250; 250; 65</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves minor aches and pains due to: - headache. - muscular aches. - a cold - arthritis. - toothache. - premenstrual and menstrual cramps.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>85786-106-60</NDCCode>
    <PackageDescription>60 TABLET, COATED in 1 CARTON (85786-106-60) </PackageDescription>
    <NDC11Code>85786-0106-60</NDC11Code>
    <ProductNDC>85786-106</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aspirin Delayed Release 81mg</ProprietaryName>
    <NonProprietaryName>Aspirin Delayed Release 81mg</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>Farmacias De Similares TX LLC</LabelerName>
    <SubstanceName>ASPIRIN</SubstanceName>
    <StrengthNumber>81</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relief of headache or symptoms needing immediate relief.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>85786-107-30</NDCCode>
    <PackageDescription>30 TABLET, COATED in 1 CARTON (85786-107-30) </PackageDescription>
    <NDC11Code>85786-0107-30</NDC11Code>
    <ProductNDC>85786-107</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen 200 Mg</ProprietaryName>
    <NonProprietaryName>Ibuprofen 200 Mg</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079174</ApplicationNumber>
    <LabelerName>Farmacias De Similares TX LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</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>2026-02-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves minor aches and pains due to: - Headache - Backache - Muscular aches - Minor pain of arthritis - Menstrual cramps - Toothache - The common cold - Temporarily reduces fever.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>85786-602-24</NDCCode><ProprietaryName>Dr. Simi Nighttime Cold And Flu</ProprietaryName><NonProprietaryName>Acetaminophen 325 Mg, Dextromethorphan Hbr 15 Mg, Doxylamine Succinate 6.25 Mg</NonProprietaryName></NDC><NDC><NDCCode>85786-104-24</NDCCode><ProprietaryName>Dr Simi All Day Pain Relief</ProprietaryName><NonProprietaryName>Naproxen Sodium</NonProprietaryName></NDC><NDC><NDCCode>85786-108-24</NDCCode><ProprietaryName>Dr. Simi Pain Reliever Pm</ProprietaryName><NonProprietaryName>Acetaminophen, Diphenhydramine Hcl</NonProprietaryName></NDC><NDC><NDCCode>85786-202-24</NDCCode><ProprietaryName>Dr. Simi Allergy Relief</ProprietaryName><NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName></NDC><NDC><NDCCode>85786-401-24</NDCCode><ProprietaryName>Simethicone 180 Mg</ProprietaryName><NonProprietaryName>Simethicone 180 Mg</NonProprietaryName></NDC><NDC><NDCCode>85786-502-24</NDCCode><ProprietaryName>Docusate Sodium 100mg</ProprietaryName><NonProprietaryName>Docusate Sodium 100mg</NonProprietaryName></NDC><NDC><NDCCode>24236-602-24</NDCCode><ProprietaryName>Trazodone Hydrochloride</ProprietaryName><NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>44567-602-24</NDCCode><ProprietaryName>Dexmedetomidine In Dextrose</ProprietaryName><NonProprietaryName>Dexmedetomidine</NonProprietaryName></NDC><NDC><NDCCode>65753-602-24</NDCCode><ProprietaryName>Cortex Sunx 50 Thick</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>66915-602-24</NDCCode><ProprietaryName>Sol Protect</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>67209-602-03</NDCCode><ProprietaryName>Fluconazole</ProprietaryName><NonProprietaryName>Fluconazole</NonProprietaryName></NDC><NDC><NDCCode>10135-602-90</NDCCode><ProprietaryName>Felbamate</ProprietaryName><NonProprietaryName>Felbamate</NonProprietaryName></NDC><NDC><NDCCode>29784-602-01</NDCCode><ProprietaryName>Profoot Plantar Relief Strips</ProprietaryName><NonProprietaryName>Camphor (natural), Menthol, Methyl Salicylate</NonProprietaryName></NDC><NDC><NDCCode>33342-602-78</NDCCode><NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>44523-602-01</NDCCode><ProprietaryName>Sodium Sulfacetamide And Sulfur</ProprietaryName><NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName></NDC><NDC><NDCCode>52305-602-30</NDCCode><ProprietaryName>Alaska Airlines</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>55316-602-06</NDCCode><ProprietaryName>Epsom Salt</ProprietaryName><NonProprietaryName>Magnesium Sulfate</NonProprietaryName></NDC><NDC><NDCCode>55316-602-07</NDCCode><ProprietaryName>Epsom Salt</ProprietaryName><NonProprietaryName>Magnesium Sulfate</NonProprietaryName></NDC><NDC><NDCCode>60687-602-01</NDCCode><ProprietaryName>Gabapentin</ProprietaryName><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>60793-602-10</NDCCode><ProprietaryName>Bicillin C-r 900/300</ProprietaryName><NonProprietaryName>Penicillin G Benzathine And Penicillin G Procaine</NonProprietaryName></NDC><NDC><NDCCode>66336-602-30</NDCCode><ProprietaryName>Lovastatin</ProprietaryName><NonProprietaryName>Lovastatin</NonProprietaryName></NDC><NDC><NDCCode>69918-602-60</NDCCode><ProprietaryName>Timoptic In Ocudose</ProprietaryName><NonProprietaryName>Timolol Maleate</NonProprietaryName></NDC><NDC><NDCCode>73954-602-42</NDCCode><ProprietaryName>Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution</ProprietaryName><NonProprietaryName>Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution</NonProprietaryName></NDC><NDC><NDCCode>73954-602-43</NDCCode><ProprietaryName>Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution</ProprietaryName><NonProprietaryName>Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution</NonProprietaryName></NDC><NDC><NDCCode>85786-101-90</NDCCode><ProprietaryName>Dr Simi Pain Reliever Pm</ProprietaryName><NonProprietaryName>Acetaminophen, Diphenhydramine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>85786-102-90</NDCCode><ProprietaryName>Dr Simi Pain Relief 100</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>85786-103-90</NDCCode><ProprietaryName>Dr Simi Pain Relief</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>85786-105-90</NDCCode><ProprietaryName>Dr Simi Extra Strength Acetaminophen 250 Mg, Aspirin 250 Mg, And Caffeine 65 Mg</ProprietaryName><NonProprietaryName>Acetaminophen 250 Mg, Aspirin 250 Mg, And Caffeine 65 Mg</NonProprietaryName></NDC><NDC><NDCCode>85786-106-60</NDCCode><ProprietaryName>Aspirin Delayed Release 81mg</ProprietaryName><NonProprietaryName>Aspirin Delayed Release 81mg</NonProprietaryName></NDC><NDC><NDCCode>85786-107-30</NDCCode><ProprietaryName>Ibuprofen 200 Mg</ProprietaryName><NonProprietaryName>Ibuprofen 200 Mg</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

This document is intended for developers who want to write applications that can interact with the DataLabs REST API. With DataLabs Web Services, you can create a customized services for your own website or application. You can use the REST API to retrieve DataLabs Web Services results programmatically.

Important: The REST API requires the use of an API key, which you can get from the DataLabs MyAccount Console.

Working With DataLabs REST API

You can retrieve results for a particular operation (search, getcode, etc) by sending an HTTP GET request to its URI.
For instance, the URI for a “search” request has the following format:

https://www.datalabs.health/api/{domain}/{operation}?q={query}&rt={result type}&token={token}

If the request succeeds, the server responds with a 200 OK HTTP status code and the response data.

Four parameters are required with each “search” request:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.

Optional parameter:

• Use the rt (result type) parameter to specify required result type (json/xml/min.json/min.xml).

All other query parameters (if any) are optional.

Full list of API parameters:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.
• Use the tin (tin number) parameter to specify your query about tin number.
• Use the tinname (tin name) parameter to specify your query about tin name.
• Use the zipcode (zip code) parameter to specify your query about zip code.
• Use the radius (radius) parameter to specify your query about radius.
• Use the fromdate (fromdate) parameter to specify your query about from date.
• Use the todate (todate) parameter to specify your query about to date.

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

• check_status — this method allows to get current code status.
• getcode — this method allows retrieval of full infrormation regarding one item based on the provided key.
• getcodes — this method allows retrieval of full infrormation regarding number of items based on the provided keys (q=1285636522,1730198755,1427145176,1487730636).
• search — allows retrieval of set of items based on the free-form lookup query.
• search_and_keywords — returns not only free-form lookup results but also keywords relevant to the original query.

Plus there are three NPI-specific operations:

• validate — allows to determine whether provider's information is valid based on data in the CMS database.
• paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
• search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
• zipradius — allows to get npis by zipcode & radius.
• npideactivated — allows to get deactivated npis between two dates.

REST Search Examples

Query Parameter Reference

The query parameters you can use with the DataLabs REST API are summarized in the following table.
All parameter values need to be URL encoded.

Use Case #1 - I Need to Find Healthcare Provider (Doctor or Orgranization) Having Just Partial Information

So, you have to find healthcare provider having just partial information. For instance all you have is "EYE doctor RANIA in REDMOND". Strictly speaking, it is necessary to perform a search with minimum information and the maximum level of relevance of the result.

Coding example below demonstrates simplest implementation in C# language. By default DataLabs full text search API returns 30 results and, as you may see below, the first result in the list is "REDMOND EYE DOCTORS, PLLC" where dr. Rania Montecillo specified an owner.

Feel free to use and modify this code to find doctors you may know. If you provide more or less meaningfull information you will be pleasantly surprised to see them in the search results.

            
//--------------------------------------------------------------------------------------
// Fulltext search on NPI registry. Perform "search" operation to get most relevant results.
//--------------------------------------------------------------------------------------
using System;
using System.Net.Http;
using System.Threading.Tasks;

public class Program
{
    private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

    static async Task Main(string[] args)
    {
        string endPoint = $"https://www.datalabs.health/api/npi/search?q=EYE%20RANIA%20REDMOND&token={token}";
        using HttpClient client = new HttpClient();
        string response = await client.GetStringAsync(endPoint);

        Console.WriteLine(response);

        Console.WriteLine("Done. Press any key to exit ...");
        Console.ReadKey();
    }
}
            
        

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
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      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Use Case #2 - I Need to Find Detailed Healthcare Provider Information Using Known NPI Number

This is very common scenario. You need to get full replica of NPI record. Again, it simple. Just use code provided below. API response may contain single NPI record, or empty list in case NPI does not exist in the CMS National Plan and Provider Enumeration System (NPPES) Registry.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcode" operation to get healthcare provider information using NPI number.
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcode?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "EntityType": "Organization",
          "EIN": "N/A",
          "IsOrgSubpart": "N",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLineMailingAddress": "PO BOX 418283",
          "MailingAddressCityName": "BOSTON",
          "MailingAddressStateName": "MA",
          "MailingAddressPostalCode": "02241-8283",
          "MailingAddressCountryCode": "US",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400",
          "EnumerationDate": "06/01/2005",
          "LastUpdateDate": "11/25/2011",
          "AuthorizedOfficialLastName": "SCHNEIDER",
          "AuthorizedOfficialFirstName": "STEPHANIE",
          "AuthorizedOfficialTitle": "VP",
          "AuthorizedOfficialTelephoneNumber": "703-558-1403",
          "TaxonomyCode1": "207R00000X",
          "Taxonomy1": "Internal Medicine",
          "LicenseNumber1": "=========",
          "LicenseNumberStateCode1": "DC",
          "PrimaryTaxonomySwitch1": "Y",
          "OtherIdentifier1": "W677",
          "OtherIdentifierType1": "OTHER",
          "OtherIdentifierState1": "DC",
          "OtherIdentifierIssuer1": "BLUE SHIELD ADULT PCP GRP",
          "OtherIdentifier2": "027174100",
          "OtherIdentifierType2": "MEDICAID",
          "OtherIdentifierState2": "DC",
          "OtherIdentifier3": "097005100",
          "OtherIdentifierType3": "MEDICAID",
          "OtherIdentifierState3": "MD",
          "OtherIdentifier4": "442AGE",
          "OtherIdentifierType4": "OTHER",
          "OtherIdentifierState4": "MD",
          "OtherIdentifierIssuer4": "BLUE SHIELD PEDS PCP GRP#",
          "OtherIdentifier5": "6572",
          "OtherIdentifierType5": "OTHER",
          "OtherIdentifierState5": "DC",
          "OtherIdentifierIssuer5": "BLUE SHIELD GROUP NUMBER",
          "OtherIdentifier6": "W675",
          "OtherIdentifierType6": "OTHER",
          "OtherIdentifierState6": "DC",
          "OtherIdentifierIssuer6": "BLUE SHIELD PEDS PCP GRP#",
          "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
          "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #3 - I Need to Get Multiple Healthcare Providers Using List of NPI Numbers

You may need to perform bulk search for performance optimization. The "getcodes" operation allows you to decrease number of round trips in orders of magnitude. For instance you can get information about hundred NPI in one REST call, instead of sending NPI numbers one-by-one.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcodes" operation to get multiple healthcare providers using list of NPIs. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcodes?q=1285636522,1730198755,1427145176&rt=minjson&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1730198755",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1427145176",
          "OrgName": "MEDSTAR - GEORGETOWN MEDICAL CENTER, INC.",
          "OtherOrgName": "GEORGETOWN UNIVERSITY HOSPITAL",
          "OtherOrgNameTypeCode": "3",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD., NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "202-444-3000",
          "PracticeLocationAddressFaxNumber": "202-444-3095"
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #4 - I Need to Check NPI Number Status

Again, very common scenario. You just need to check NPI number status. It is simple. Take a look at the code below. Expected result contains requested NPI number, status, and short status description.

                
    //--------------------------------------------------------------------------------------
    // Perform "check_status" operation to get NPI Number status (active, deactivated, etc).
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/check_status?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "Code": "1285636522",
      "Status": "Active",
      "Message": "\"1285636522\" NPI Number does exist and has \"active\" status"
    }
                
    Done. Press any key to exit ...
                
            

Use Case #5 - I need to retrieve a list of healthcare providers based on specified search parameters.

The system allows users to retrieve a list of healthcare providers by filtering on specified fields (e.g., organization name, state, city, ZIP code, etc.). The example below demonstrates how to retrieve all providers with a specified city, state, and ZIP code.

                
    //--------------------------------------------------------------------------------------
    // Perform "search_with_predicates" operation to get multiple healthcare providers using specified city, state, and ZIP code. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/search_with_predicates?q=&qf=City:true:REDMOND&qf=State:true:OR&qf=Zip:true:97756-9069&rt=json&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
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      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
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      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
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      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
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      "PracticeLocationAddressCityName": "REDMOND",
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      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
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      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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