RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "75786-228-78",
      "PackageDescription": "78 g in 1 TUBE (75786-228-78) ",
      "NDC11Code": "75786-0228-78",
      "ProductNDC": "75786-228",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "All Good Mineral Sport Sunscreen Butter Stick Spf 50",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160425",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "M020",
      "LabelerName": "Elemental Herbs, Inc.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-02-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210513",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including : 1 Limit time in the sun, especially from 10 a.m.-2 p.m., 2 Wear long-sleeved shirts, pants, hats, and sun glasses."
    },
    {
      "NDCCode": "65862-228-78",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (65862-228-78)  / 10 TABLET in 1 BLISTER PACK (65862-228-10) ",
      "NDC11Code": "65862-0228-78",
      "ProductNDC": "65862-228",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lamotrigine",
      "NonProprietaryName": "Lamotrigine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090127",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078956",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "LAMOTRIGINE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20090127",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lamotrigine tablets are indicated for:Epilepsy—adjunctive therapy in patients aged 2 years and older:. Epilepsy—monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (1.1)Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2) Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets in the acute treatment of mood episodes has not been established.",
      "Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine tablets USP are supplied for oral administration as 25 mg (white to off-white), 100 mg (peach), 150 mg (cream), and 200 mg (blue) tablets. Each tablet contains the labeled amount of lamotrigine USP and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, povidone, sodium starch glycolate, magnesium stearate; FD&C yellow No 6 (100 mg tablet only); ferric oxide yellow (150 mg tablet only); and FD&C blue No 2 lake (200 mg tablet only). Meets USP dissolution test 3."
    },
    {
      "NDCCode": "75786-229-78",
      "PackageDescription": "78 g in 1 TUBE (75786-229-78) ",
      "NDC11Code": "75786-0229-78",
      "ProductNDC": "75786-229",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "All Good Mineral Sport Sunscreen Butter Stick Spf 50",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220215",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Elemental Herbs, Inc.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2025-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: 1 Helps prevent sunburn, 2 if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. ."
    },
    {
      "NDCCode": "75786-230-78",
      "PackageDescription": "78 g in 1 TUBE (75786-230-78) ",
      "NDC11Code": "75786-0230-78",
      "ProductNDC": "75786-230",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "All Good Kids Mineral Sunscreen Butter Stick Spf 50",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160425",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Elemental Herbs, Inc.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2025-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210513",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: 1 Helps prevent sunburn, 2 If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. ."
    },
    {
      "NDCCode": "0555-0171-78",
      "PackageDescription": "25 BLISTER PACK in 1 CARTON (0555-0171-78)  / 1 TABLET in 1 BLISTER PACK (0555-0171-88) ",
      "NDC11Code": "00555-0171-78",
      "ProductNDC": "0555-0171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mefloquine Hydrochloride",
      "NonProprietaryName": "Mefloquine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040106",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076392",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "MEFLOQUINE HYDROCHLORIDE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antimalarial [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20040106",
      "SamplePackage": "N",
      "IndicationAndUsage": "Mefloquine hydrochloride tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax. There are insufficient clinical data to document the effect of mefloquine in malaria caused by P. ovale or P. malariae. Note: Patients with acute P. vivax malaria, treated with mefloquine, are at high risk of relapse because mefloquine does not eliminate exoerythrocytic (hepatic phase) parasites. To avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine).",
      "Description": "Mefloquine hydrochloride tablets, USP are an antimalarial agent available as 250 mg tablets of mefloquine hydrochloride (equivalent to 228 mg of the free base) for oral administration. Mefloquine hydrochloride, USP is a 4-quinolinemethanol derivative with the specific chemical name of (R*, S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. The structural formula is as follows. C17H16F6N2O.HCl M.W.: 414.78. The inactive ingredients are colloidal silicon dioxide, corn starch, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, poloxamer and talc. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "21695-561-10",
      "PackageDescription": "10 TABLET in 1 BOTTLE (21695-561-10)",
      "NDC11Code": "21695-0561-10",
      "ProductNDC": "21695-561",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mefloquine Hydrochloride",
      "NonProprietaryName": "Mefloquine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100421",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077699",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "MEFLOQUINE HYDROCHLORIDE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antimalarial [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Mefloquine Hydrochloride Tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax. There are insufficient clinical data to document the effect of mefloquine in malaria caused by P. ovale or P. malariae. : 1  Note: Patients with acute P. vivax malaria, treated with Mefloquine Hydrochloride Tablets, are at high risk of relapse because Mefloquine Hydrochloride Tablets do not eliminate exoerythrocytic (hepatic phase) parasites. To avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine).",
      "Description": "Mefloquine Hydrochloride Tablets are an antimalarial agent available as 250-mg tablets of mefloquine hydrochloride (equivalent to 228.0 mg of the free base) for oral administration. Mefloquine hydrochloride is a 4-quinolinemethanol derivative with the specific chemical name of (R*,S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. Mefloquine hydrochloride has a calculated molecular weight of 414.78 and the following structural formula. Each tablet, for oral administration, contains 250 mg mefloquine hydrochloride and the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, lactose monohydrate, lactose spray dried, magnesium stearate, microcrystalline cellulose, polysorbate 80, polyvinylpyrrolidone and talc."
    },
    {
      "NDCCode": "50090-2396-0",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (50090-2396-0)  / 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "50090-2396-00",
      "ProductNDC": "50090-2396",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mefloquine Hydrochloride",
      "NonProprietaryName": "Mefloquine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040106",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076392",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "MEFLOQUINE HYDROCHLORIDE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antimalarial [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-04-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160506",
      "SamplePackage": "N",
      "IndicationAndUsage": "Mefloquine Hydrochloride Tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax. There are insufficient clinical data to document the effect of mefloquine in malaria caused by P. ovale or P. malariae. Note: Patients with acute P. vivax malaria, treated with mefloquine, are at high risk of relapse because mefloquine does not eliminate exoerythrocytic (hepatic phase) parasites. To avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine).",
      "Description": "Mefloquine Hydrochloride Tablets USP are an antimalarial agent available as 250 mg tablets of mefloquine hydrochloride (equivalent to 228 mg of the free base) for oral administration. Mefloquine Hydrochloride USP is a 4-quinolinemethanol derivative with the specific chemical name of (R*, S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. The structural formula is as follows. C17H16F6N2O.HCl M.W.: 414.78. The inactive ingredients are colloidal silicon dioxide, corn starch, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, poloxamer and talc."
    },
    {
      "NDCCode": "50090-2396-1",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (50090-2396-1)  / 25 TABLET in 1 BLISTER PACK",
      "NDC11Code": "50090-2396-01",
      "ProductNDC": "50090-2396",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mefloquine Hydrochloride",
      "NonProprietaryName": "Mefloquine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040106",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076392",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "MEFLOQUINE HYDROCHLORIDE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antimalarial [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-04-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20160506",
      "SamplePackage": "N",
      "IndicationAndUsage": "Mefloquine Hydrochloride Tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax. There are insufficient clinical data to document the effect of mefloquine in malaria caused by P. ovale or P. malariae. Note: Patients with acute P. vivax malaria, treated with mefloquine, are at high risk of relapse because mefloquine does not eliminate exoerythrocytic (hepatic phase) parasites. To avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine).",
      "Description": "Mefloquine Hydrochloride Tablets USP are an antimalarial agent available as 250 mg tablets of mefloquine hydrochloride (equivalent to 228 mg of the free base) for oral administration. Mefloquine Hydrochloride USP is a 4-quinolinemethanol derivative with the specific chemical name of (R*, S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. The structural formula is as follows. C17H16F6N2O.HCl M.W.: 414.78. The inactive ingredients are colloidal silicon dioxide, corn starch, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, poloxamer and talc."
    },
    {
      "NDCCode": "50090-2396-2",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (50090-2396-2)  / 8 TABLET in 1 BLISTER PACK",
      "NDC11Code": "50090-2396-02",
      "ProductNDC": "50090-2396",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mefloquine Hydrochloride",
      "NonProprietaryName": "Mefloquine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040106",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076392",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "MEFLOQUINE HYDROCHLORIDE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antimalarial [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-04-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20160506",
      "SamplePackage": "N",
      "IndicationAndUsage": "Mefloquine Hydrochloride Tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax. There are insufficient clinical data to document the effect of mefloquine in malaria caused by P. ovale or P. malariae. Note: Patients with acute P. vivax malaria, treated with mefloquine, are at high risk of relapse because mefloquine does not eliminate exoerythrocytic (hepatic phase) parasites. To avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine).",
      "Description": "Mefloquine Hydrochloride Tablets USP are an antimalarial agent available as 250 mg tablets of mefloquine hydrochloride (equivalent to 228 mg of the free base) for oral administration. Mefloquine Hydrochloride USP is a 4-quinolinemethanol derivative with the specific chemical name of (R*, S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. The structural formula is as follows. C17H16F6N2O.HCl M.W.: 414.78. The inactive ingredients are colloidal silicon dioxide, corn starch, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, poloxamer and talc."
    },
    {
      "NDCCode": "52959-803-25",
      "PackageDescription": "25 TABLET in 1 BOTTLE (52959-803-25)",
      "NDC11Code": "52959-0803-25",
      "ProductNDC": "52959-803",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mefloquine Hydrochloride",
      "NonProprietaryName": "Mefloquine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100421",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077699",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "MEFLOQUINE HYDROCHLORIDE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antimalarial [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Mefloquine Hydrochloride Tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax. There are insufficient clinical data to document the effect of mefloquine in malaria caused by P. ovale or P. malariae. : 1  Note: Patients with acute P. vivax malaria, treated with Mefloquine Hydrochloride Tablets, are at high risk of relapse because Mefloquine Hydrochloride Tablets do not eliminate exoerythrocytic (hepatic phase) parasites. To avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine).",
      "Description": "Mefloquine Hydrochloride Tablets are an antimalarial agent available as 250-mg tablets of mefloquine hydrochloride (equivalent to 228.0 mg of the free base) for oral administration. Mefloquine hydrochloride is a 4-quinolinemethanol derivative with the specific chemical name of (R*,S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. Mefloquine hydrochloride has a calculated molecular weight of 414.78 and the following structural formula. Each tablet, for oral administration, contains 250 mg mefloquine hydrochloride and the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, lactose monohydrate, lactose spray dried, magnesium stearate, microcrystalline cellulose, polysorbate 80, polyvinylpyrrolidone and talc."
    },
    {
      "NDCCode": "61314-228-94",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (61314-228-94)  / 1.7 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "61314-0228-94",
      "ProductNDC": "61314-228",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Wyost",
      "NonProprietaryName": "Denosumab",
      "DosageFormName": "INJECTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20250602",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761362",
      "LabelerName": "Sandoz Inc",
      "SubstanceName": "DENOSUMAB",
      "StrengthNumber": "120",
      "StrengthUnit": "mg/1.7mL",
      "Pharm_Classes": "RANK Ligand Blocking Activity [MoA], RANK Ligand Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250602",
      "SamplePackage": "N",
      "IndicationAndUsage": "Wyost is a RANK ligand (RANKL) inhibitor indicated for: 1 Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. (1.1), 2 Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. (1.2, 14.3), 3 Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. (1.3).",
      "Description": "Denosumab-bbdz is a human IgG2 monoclonal antibody that binds to human RANKL. Denosumab-bbdz has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Wyost (denosumab-bbdz) injection is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellowish to slightly brownish solution for subcutaneous use. Each single-dose vial contains 1.7 mL solution of 120 mg denosumab-bbdz, glacial acetic acid (1.85 mg), polysorbate 20 (0.17 mg), sodium hydroxide (0.91 mg), sorbitol (78.9 mg), and Water for Injection (USP). Hydrochloric acid and sodium hydroxide may be added to adjust the pH to 5.2."
    },
    {
      "NDCCode": "62135-973-11",
      "PackageDescription": "5 TABLET in 1 BOTTLE (62135-973-11) ",
      "NDC11Code": "62135-0973-11",
      "ProductNDC": "62135-973",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mefloquine Hydrochloride",
      "NonProprietaryName": "Mefloquine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076175",
      "LabelerName": "Chartwell RX, LLC",
      "SubstanceName": "MEFLOQUINE HYDROCHLORIDE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antimalarial [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-11-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241115",
      "SamplePackage": "N",
      "Description": "Mefloquine hydrochloride is an antimalarial agent available as 250 mg tablets of mefloquine hydrochloride (equivalent to 228.0 mg of the free base) for oral administration. Mefloquine hydrochloride is a 4-quinolinemethanol derivative with the specific chemical name of (R*, S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. Mefloquine hydrochloride has a calculated molecular weight of 414.78 and the following structural formula. Mefloquine Hydrochloride Tablets USP, 250 mg meets USP Dissolution Test 2. The inactive ingredients are crospovidone, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc."
    },
    {
      "NDCCode": "62135-973-25",
      "PackageDescription": "25 TABLET in 1 BOTTLE (62135-973-25) ",
      "NDC11Code": "62135-0973-25",
      "ProductNDC": "62135-973",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mefloquine Hydrochloride",
      "NonProprietaryName": "Mefloquine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076175",
      "LabelerName": "Chartwell RX, LLC",
      "SubstanceName": "MEFLOQUINE HYDROCHLORIDE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antimalarial [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-11-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241115",
      "SamplePackage": "N",
      "Description": "Mefloquine hydrochloride is an antimalarial agent available as 250 mg tablets of mefloquine hydrochloride (equivalent to 228.0 mg of the free base) for oral administration. Mefloquine hydrochloride is a 4-quinolinemethanol derivative with the specific chemical name of (R*, S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. Mefloquine hydrochloride has a calculated molecular weight of 414.78 and the following structural formula. Mefloquine Hydrochloride Tablets USP, 250 mg meets USP Dissolution Test 2. The inactive ingredients are crospovidone, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc."
    },
    {
      "NDCCode": "65162-228-08",
      "PackageDescription": "8 POUCH in 1 CARTON (65162-228-08)  / 1 d in 1 POUCH (65162-228-04) ",
      "NDC11Code": "65162-0228-08",
      "ProductNDC": "65162-228",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lyllana",
      "NonProprietaryName": "Estradiol",
      "DosageFormName": "PATCH, EXTENDED RELEASE",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20200930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211396",
      "LabelerName": "Amneal Pharmaceuticals LLC",
      "SubstanceName": "ESTRADIOL",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/d",
      "Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200930",
      "SamplePackage": "N",
      "IndicationAndUsage": "LYLLANA is indicated for.",
      "Description": "LYLLANA (estradiol transdermal system, USP), contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of LYLLANA are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39. LYLLANA is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. Meets USP Drug Release Test 6."
    },
    {
      "NDCCode": "68071-4702-8",
      "PackageDescription": "1 TABLET in 1 BOTTLE (68071-4702-8) ",
      "NDC11Code": "68071-4702-08",
      "ProductNDC": "68071-4702",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mefloquine Hydrochloride",
      "NonProprietaryName": "Mefloquine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040106",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076392",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "MEFLOQUINE HYDROCHLORIDE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antimalarial [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190109",
      "SamplePackage": "N",
      "IndicationAndUsage": "Mefloquine Hydrochloride Tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax. There are insufficient clinical data to document the effect of mefloquine in malaria caused by P. ovale or P. malariae. Note: Patients with acute P. vivax malaria, treated with mefloquine, are at high risk of relapse because mefloquine does not eliminate exoerythrocytic (hepatic phase) parasites. To avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine).",
      "Description": "Mefloquine Hydrochloride Tablets USP are an antimalarial agent available as 250 mg tablets of mefloquine hydrochloride (equivalent to 228 mg of the free base) for oral administration. Mefloquine Hydrochloride USP is a 4-quinolinemethanol derivative with the specific chemical name of (R*, S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. The structural formula is as follows. C 17H 16F 6N 2O.HCl M.W.: 414.78. The inactive ingredients are colloidal silicon dioxide, corn starch, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, poloxamer and talc."
    },
    {
      "NDCCode": "75786-102-55",
      "PackageDescription": "80 mL in 1 BOTTLE, SPRAY (75786-102-55) ",
      "NDC11Code": "75786-0102-55",
      "ProductNDC": "75786-102",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200424",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Elemental Herbs, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200424",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "75786-102-56",
      "PackageDescription": "60 mL in 1 BOTTLE, SPRAY (75786-102-56) ",
      "NDC11Code": "75786-0102-56",
      "ProductNDC": "75786-102",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200424",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Elemental Herbs, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200521",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "75786-106-57",
      "PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (75786-106-57) ",
      "NDC11Code": "75786-0106-57",
      "ProductNDC": "75786-106",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200724",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Elemental Herbs, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "62",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200724",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "75786-107-59",
      "PackageDescription": "60 mL in 1 BOTTLE, SPRAY (75786-107-59) ",
      "NDC11Code": "75786-0107-59",
      "ProductNDC": "75786-107",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200729",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Elemental Herbs, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200729",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "75786-107-64",
      "PackageDescription": "60 mL in 1 BOTTLE, SPRAY (75786-107-64) ",
      "NDC11Code": "75786-0107-64",
      "ProductNDC": "75786-107",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200729",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Elemental Herbs, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20220411",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "75786-108-60",
      "PackageDescription": "60 mL in 1 BOTTLE, SPRAY (75786-108-60) ",
      "NDC11Code": "75786-0108-60",
      "ProductNDC": "75786-108",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200812",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Elemental Herbs, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "60",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200812",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "75786-111-61",
      "PackageDescription": "59.1 mL in 1 BOTTLE, PLASTIC (75786-111-61) ",
      "NDC11Code": "75786-0111-61",
      "ProductNDC": "75786-111",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201111",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Elemental Herbs, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "62",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20201111",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "75786-112-63",
      "PackageDescription": "60 mL in 1 BOTTLE, SPRAY (75786-112-63) ",
      "NDC11Code": "75786-0112-63",
      "ProductNDC": "75786-112",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220411",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Elemental Herbs, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20220411",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "75786-220-01",
      "PackageDescription": "17 g in 1 TUBE (75786-220-01) ",
      "NDC11Code": "75786-0220-01",
      "ProductNDC": "75786-220",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "All Good Mineral Sport Sunscreen Sunstick Spf 30",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260331",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Elemental Herbs, Inc.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2026-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260331",
      "SamplePackage": "N",
      "IndicationAndUsage": "UsesHelps prevent sunburn  If used as directed with other sun protection. measures (see Directions), decreases the risk of skin cancer and early skin. aging caused by the sun."
    },
    {
      "NDCCode": "75786-221-01",
      "PackageDescription": "17 g in 1 TUBE (75786-221-01) ",
      "NDC11Code": "75786-0221-01",
      "ProductNDC": "75786-221",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "All Good Coconut Mineral Sunscreen Sunstick Spf 30",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260331",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Elemental Herbs, Inc.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2026-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260331",
      "SamplePackage": "N",
      "IndicationAndUsage": "UsesHelps prevent sunburn  If used as directed with other sun protection. measures (see Directions), decreases the risk of skin cancer and early skin. aging caused by the sun."
    },
    {
      "NDCCode": "75786-222-29",
      "PackageDescription": "29 g in 1 CAN (75786-222-29) ",
      "NDC11Code": "75786-0222-29",
      "ProductNDC": "75786-222",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "All Good",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210513",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Elemental Herbs, Inc.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2023-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210513",
      "SamplePackage": "N",
      "IndicationAndUsage": "apply liberally 15 minutes before sun exposure: 1 reapply:, 2 after 80 minutes of swimmming or sweating, 3 immediately after towel drying, 4 at least eery 2 hours, 5 Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early sking aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: , 6 limit time in the sun, especially from 10 a.m. - 2 p.m., 7 wear long-sleeved shirts, pants, hats and sunglasses."
    },
    {
      "NDCCode": "75786-223-29",
      "PackageDescription": "29 g in 1 CAN (75786-223-29) ",
      "NDC11Code": "75786-0223-29",
      "ProductNDC": "75786-223",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "All Good Mineral Sport Sunscreen Butter",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220201",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Elemental Herbs, Inc.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2026-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses.  Helps prevent sunburn  If used as directed with other. sun protection measures (see Directions), decreases the. risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "75786-224-01",
      "PackageDescription": "1 TUBE in 1 BOX (75786-224-01)  / 4.25 g in 1 TUBE",
      "NDC11Code": "75786-0224-01",
      "ProductNDC": "75786-224",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "All Good Coconut Spf 20 Zinc Oxide Lip Balm",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140108",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Elemental Herbs, Inc.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "8",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2024-07-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140108",
      "SamplePackage": "N",
      "IndicationAndUsage": "Use: Helps prevent sunburn."
    },
    {
      "NDCCode": "75786-226-29",
      "PackageDescription": "29 g in 1 CAN (75786-226-29) ",
      "NDC11Code": "75786-0226-29",
      "ProductNDC": "75786-226",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "All Good Tinted Mineral Sunscreen Butter Spf 50",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210513",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Elemental Herbs, Inc.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2026-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210513",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses.  Helps prevent sunburn  If used as directed with other. sun protection measures (see Directions), decreases the. risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "75786-234-41",
      "PackageDescription": "60 mL in 1 BOTTLE (75786-234-41) ",
      "NDC11Code": "75786-0234-41",
      "ProductNDC": "75786-234",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "All Good Unscented Hand Sanitizer",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200401",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Elemental Herbs, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "62",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200401",
      "SamplePackage": "N",
      "IndicationAndUsage": "For hand washing to decrease bacteria on skin. Recommended for repeated use."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"75786-228-78","ProprietaryName":"All Good Mineral Sport Sunscreen Butter Stick Spf 50","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"65862-228-78","ProprietaryName":"Lamotrigine","NonProprietaryName":"Lamotrigine"},{"NDCCode":"75786-229-78","ProprietaryName":"All Good Mineral Sport Sunscreen Butter Stick Spf 50","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"75786-230-78","ProprietaryName":"All Good Kids Mineral Sunscreen Butter Stick Spf 50","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"0555-0171-78","ProprietaryName":"Mefloquine Hydrochloride","NonProprietaryName":"Mefloquine Hydrochloride"},{"NDCCode":"21695-561-10","ProprietaryName":"Mefloquine Hydrochloride","NonProprietaryName":"Mefloquine Hydrochloride"},{"NDCCode":"50090-2396-0","ProprietaryName":"Mefloquine Hydrochloride","NonProprietaryName":"Mefloquine Hydrochloride"},{"NDCCode":"50090-2396-1","ProprietaryName":"Mefloquine Hydrochloride","NonProprietaryName":"Mefloquine Hydrochloride"},{"NDCCode":"50090-2396-2","ProprietaryName":"Mefloquine Hydrochloride","NonProprietaryName":"Mefloquine Hydrochloride"},{"NDCCode":"52959-803-25","ProprietaryName":"Mefloquine Hydrochloride","NonProprietaryName":"Mefloquine Hydrochloride"},{"NDCCode":"61314-228-94","ProprietaryName":"Wyost","NonProprietaryName":"Denosumab"},{"NDCCode":"62135-973-11","ProprietaryName":"Mefloquine Hydrochloride","NonProprietaryName":"Mefloquine Hydrochloride"},{"NDCCode":"62135-973-25","ProprietaryName":"Mefloquine Hydrochloride","NonProprietaryName":"Mefloquine Hydrochloride"},{"NDCCode":"65162-228-08","ProprietaryName":"Lyllana","NonProprietaryName":"Estradiol"},{"NDCCode":"68071-4702-8","ProprietaryName":"Mefloquine Hydrochloride","NonProprietaryName":"Mefloquine Hydrochloride"},{"NDCCode":"75786-102-55","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"75786-102-56","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"75786-106-57","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"75786-107-59","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"75786-107-64","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"75786-108-60","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"75786-111-61","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"75786-112-63","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"75786-220-01","ProprietaryName":"All Good Mineral Sport Sunscreen Sunstick Spf 30","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"75786-221-01","ProprietaryName":"All Good Coconut Mineral Sunscreen Sunstick Spf 30","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"75786-222-29","ProprietaryName":"All Good","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"75786-223-29","ProprietaryName":"All Good Mineral Sport Sunscreen Butter","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"75786-224-01","ProprietaryName":"All Good Coconut Spf 20 Zinc Oxide Lip Balm","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"75786-226-29","ProprietaryName":"All Good Tinted Mineral Sunscreen Butter Spf 50","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"75786-234-41","ProprietaryName":"All Good Unscented Hand Sanitizer","NonProprietaryName":"Ethyl Alcohol"}]}
                    

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    <NDCCode>75786-228-78</NDCCode>
    <PackageDescription>78 g in 1 TUBE (75786-228-78) </PackageDescription>
    <NDC11Code>75786-0228-78</NDC11Code>
    <ProductNDC>75786-228</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>All Good Mineral Sport Sunscreen Butter Stick Spf 50</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160425</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Elemental Herbs, Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including : 1 Limit time in the sun, especially from 10 a.m.-2 p.m., 2 Wear long-sleeved shirts, pants, hats, and sun glasses.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65862-228-78</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (65862-228-78)  / 10 TABLET in 1 BLISTER PACK (65862-228-10) </PackageDescription>
    <NDC11Code>65862-0228-78</NDC11Code>
    <ProductNDC>65862-228</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamotrigine</ProprietaryName>
    <NonProprietaryName>Lamotrigine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090127</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078956</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>LAMOTRIGINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090127</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lamotrigine tablets are indicated for:Epilepsy—adjunctive therapy in patients aged 2 years and older:. Epilepsy—monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (1.1)Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2) Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets in the acute treatment of mood episodes has not been established.</IndicationAndUsage>
    <Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine tablets USP are supplied for oral administration as 25 mg (white to off-white), 100 mg (peach), 150 mg (cream), and 200 mg (blue) tablets. Each tablet contains the labeled amount of lamotrigine USP and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, povidone, sodium starch glycolate, magnesium stearate; FD&amp;C yellow No 6 (100 mg tablet only); ferric oxide yellow (150 mg tablet only); and FD&amp;C blue No 2 lake (200 mg tablet only). Meets USP dissolution test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>75786-229-78</NDCCode>
    <PackageDescription>78 g in 1 TUBE (75786-229-78) </PackageDescription>
    <NDC11Code>75786-0229-78</NDC11Code>
    <ProductNDC>75786-229</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>All Good Mineral Sport Sunscreen Butter Stick Spf 50</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220215</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Elemental Herbs, Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 Helps prevent sunburn, 2 if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75786-230-78</NDCCode>
    <PackageDescription>78 g in 1 TUBE (75786-230-78) </PackageDescription>
    <NDC11Code>75786-0230-78</NDC11Code>
    <ProductNDC>75786-230</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>All Good Kids Mineral Sunscreen Butter Stick Spf 50</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160425</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Elemental Herbs, Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 Helps prevent sunburn, 2 If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0555-0171-78</NDCCode>
    <PackageDescription>25 BLISTER PACK in 1 CARTON (0555-0171-78)  / 1 TABLET in 1 BLISTER PACK (0555-0171-88) </PackageDescription>
    <NDC11Code>00555-0171-78</NDC11Code>
    <ProductNDC>0555-0171</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mefloquine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Mefloquine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040106</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076392</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>MEFLOQUINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20040106</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mefloquine hydrochloride tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax. There are insufficient clinical data to document the effect of mefloquine in malaria caused by P. ovale or P. malariae. Note: Patients with acute P. vivax malaria, treated with mefloquine, are at high risk of relapse because mefloquine does not eliminate exoerythrocytic (hepatic phase) parasites. To avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine).</IndicationAndUsage>
    <Description>Mefloquine hydrochloride tablets, USP are an antimalarial agent available as 250 mg tablets of mefloquine hydrochloride (equivalent to 228 mg of the free base) for oral administration. Mefloquine hydrochloride, USP is a 4-quinolinemethanol derivative with the specific chemical name of (R*, S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. The structural formula is as follows. C17H16F6N2O.HCl M.W.: 414.78. The inactive ingredients are colloidal silicon dioxide, corn starch, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, poloxamer and talc. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-561-10</NDCCode>
    <PackageDescription>10 TABLET in 1 BOTTLE (21695-561-10)</PackageDescription>
    <NDC11Code>21695-0561-10</NDC11Code>
    <ProductNDC>21695-561</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mefloquine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Mefloquine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100421</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077699</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>MEFLOQUINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Mefloquine Hydrochloride Tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax. There are insufficient clinical data to document the effect of mefloquine in malaria caused by P. ovale or P. malariae. : 1  Note: Patients with acute P. vivax malaria, treated with Mefloquine Hydrochloride Tablets, are at high risk of relapse because Mefloquine Hydrochloride Tablets do not eliminate exoerythrocytic (hepatic phase) parasites. To avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine).</IndicationAndUsage>
    <Description>Mefloquine Hydrochloride Tablets are an antimalarial agent available as 250-mg tablets of mefloquine hydrochloride (equivalent to 228.0 mg of the free base) for oral administration. Mefloquine hydrochloride is a 4-quinolinemethanol derivative with the specific chemical name of (R*,S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. Mefloquine hydrochloride has a calculated molecular weight of 414.78 and the following structural formula. Each tablet, for oral administration, contains 250 mg mefloquine hydrochloride and the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, lactose monohydrate, lactose spray dried, magnesium stearate, microcrystalline cellulose, polysorbate 80, polyvinylpyrrolidone and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-2396-0</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (50090-2396-0)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>50090-2396-00</NDC11Code>
    <ProductNDC>50090-2396</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mefloquine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Mefloquine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040106</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076392</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>MEFLOQUINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160506</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mefloquine Hydrochloride Tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax. There are insufficient clinical data to document the effect of mefloquine in malaria caused by P. ovale or P. malariae. Note: Patients with acute P. vivax malaria, treated with mefloquine, are at high risk of relapse because mefloquine does not eliminate exoerythrocytic (hepatic phase) parasites. To avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine).</IndicationAndUsage>
    <Description>Mefloquine Hydrochloride Tablets USP are an antimalarial agent available as 250 mg tablets of mefloquine hydrochloride (equivalent to 228 mg of the free base) for oral administration. Mefloquine Hydrochloride USP is a 4-quinolinemethanol derivative with the specific chemical name of (R*, S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. The structural formula is as follows. C17H16F6N2O.HCl M.W.: 414.78. The inactive ingredients are colloidal silicon dioxide, corn starch, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, poloxamer and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-2396-1</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (50090-2396-1)  / 25 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>50090-2396-01</NDC11Code>
    <ProductNDC>50090-2396</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mefloquine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Mefloquine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040106</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076392</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>MEFLOQUINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-04-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160506</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mefloquine Hydrochloride Tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax. There are insufficient clinical data to document the effect of mefloquine in malaria caused by P. ovale or P. malariae. Note: Patients with acute P. vivax malaria, treated with mefloquine, are at high risk of relapse because mefloquine does not eliminate exoerythrocytic (hepatic phase) parasites. To avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine).</IndicationAndUsage>
    <Description>Mefloquine Hydrochloride Tablets USP are an antimalarial agent available as 250 mg tablets of mefloquine hydrochloride (equivalent to 228 mg of the free base) for oral administration. Mefloquine Hydrochloride USP is a 4-quinolinemethanol derivative with the specific chemical name of (R*, S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. The structural formula is as follows. C17H16F6N2O.HCl M.W.: 414.78. The inactive ingredients are colloidal silicon dioxide, corn starch, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, poloxamer and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-2396-2</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (50090-2396-2)  / 8 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>50090-2396-02</NDC11Code>
    <ProductNDC>50090-2396</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mefloquine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Mefloquine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040106</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076392</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>MEFLOQUINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-04-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160506</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mefloquine Hydrochloride Tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax. There are insufficient clinical data to document the effect of mefloquine in malaria caused by P. ovale or P. malariae. Note: Patients with acute P. vivax malaria, treated with mefloquine, are at high risk of relapse because mefloquine does not eliminate exoerythrocytic (hepatic phase) parasites. To avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine).</IndicationAndUsage>
    <Description>Mefloquine Hydrochloride Tablets USP are an antimalarial agent available as 250 mg tablets of mefloquine hydrochloride (equivalent to 228 mg of the free base) for oral administration. Mefloquine Hydrochloride USP is a 4-quinolinemethanol derivative with the specific chemical name of (R*, S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. The structural formula is as follows. C17H16F6N2O.HCl M.W.: 414.78. The inactive ingredients are colloidal silicon dioxide, corn starch, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, poloxamer and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>52959-803-25</NDCCode>
    <PackageDescription>25 TABLET in 1 BOTTLE (52959-803-25)</PackageDescription>
    <NDC11Code>52959-0803-25</NDC11Code>
    <ProductNDC>52959-803</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mefloquine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Mefloquine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100421</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077699</ApplicationNumber>
    <LabelerName>H.J. Harkins Company, Inc.</LabelerName>
    <SubstanceName>MEFLOQUINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Mefloquine Hydrochloride Tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax. There are insufficient clinical data to document the effect of mefloquine in malaria caused by P. ovale or P. malariae. : 1  Note: Patients with acute P. vivax malaria, treated with Mefloquine Hydrochloride Tablets, are at high risk of relapse because Mefloquine Hydrochloride Tablets do not eliminate exoerythrocytic (hepatic phase) parasites. To avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine).</IndicationAndUsage>
    <Description>Mefloquine Hydrochloride Tablets are an antimalarial agent available as 250-mg tablets of mefloquine hydrochloride (equivalent to 228.0 mg of the free base) for oral administration. Mefloquine hydrochloride is a 4-quinolinemethanol derivative with the specific chemical name of (R*,S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. Mefloquine hydrochloride has a calculated molecular weight of 414.78 and the following structural formula. Each tablet, for oral administration, contains 250 mg mefloquine hydrochloride and the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, lactose monohydrate, lactose spray dried, magnesium stearate, microcrystalline cellulose, polysorbate 80, polyvinylpyrrolidone and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>61314-228-94</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (61314-228-94)  / 1.7 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>61314-0228-94</NDC11Code>
    <ProductNDC>61314-228</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Wyost</ProprietaryName>
    <NonProprietaryName>Denosumab</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20250602</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761362</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>DENOSUMAB</SubstanceName>
    <StrengthNumber>120</StrengthNumber>
    <StrengthUnit>mg/1.7mL</StrengthUnit>
    <Pharm_Classes>RANK Ligand Blocking Activity [MoA], RANK Ligand Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250602</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Wyost is a RANK ligand (RANKL) inhibitor indicated for: 1 Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. (1.1), 2 Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. (1.2, 14.3), 3 Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. (1.3).</IndicationAndUsage>
    <Description>Denosumab-bbdz is a human IgG2 monoclonal antibody that binds to human RANKL. Denosumab-bbdz has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Wyost (denosumab-bbdz) injection is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellowish to slightly brownish solution for subcutaneous use. Each single-dose vial contains 1.7 mL solution of 120 mg denosumab-bbdz, glacial acetic acid (1.85 mg), polysorbate 20 (0.17 mg), sodium hydroxide (0.91 mg), sorbitol (78.9 mg), and Water for Injection (USP). Hydrochloric acid and sodium hydroxide may be added to adjust the pH to 5.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>62135-973-11</NDCCode>
    <PackageDescription>5 TABLET in 1 BOTTLE (62135-973-11) </PackageDescription>
    <NDC11Code>62135-0973-11</NDC11Code>
    <ProductNDC>62135-973</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mefloquine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Mefloquine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076175</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC</LabelerName>
    <SubstanceName>MEFLOQUINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Mefloquine hydrochloride is an antimalarial agent available as 250 mg tablets of mefloquine hydrochloride (equivalent to 228.0 mg of the free base) for oral administration. Mefloquine hydrochloride is a 4-quinolinemethanol derivative with the specific chemical name of (R*, S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. Mefloquine hydrochloride has a calculated molecular weight of 414.78 and the following structural formula. Mefloquine Hydrochloride Tablets USP, 250 mg meets USP Dissolution Test 2. The inactive ingredients are crospovidone, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>62135-973-25</NDCCode>
    <PackageDescription>25 TABLET in 1 BOTTLE (62135-973-25) </PackageDescription>
    <NDC11Code>62135-0973-25</NDC11Code>
    <ProductNDC>62135-973</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mefloquine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Mefloquine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076175</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC</LabelerName>
    <SubstanceName>MEFLOQUINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Mefloquine hydrochloride is an antimalarial agent available as 250 mg tablets of mefloquine hydrochloride (equivalent to 228.0 mg of the free base) for oral administration. Mefloquine hydrochloride is a 4-quinolinemethanol derivative with the specific chemical name of (R*, S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. Mefloquine hydrochloride has a calculated molecular weight of 414.78 and the following structural formula. Mefloquine Hydrochloride Tablets USP, 250 mg meets USP Dissolution Test 2. The inactive ingredients are crospovidone, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>65162-228-08</NDCCode>
    <PackageDescription>8 POUCH in 1 CARTON (65162-228-08)  / 1 d in 1 POUCH (65162-228-04) </PackageDescription>
    <NDC11Code>65162-0228-08</NDC11Code>
    <ProductNDC>65162-228</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lyllana</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20200930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211396</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>ESTRADIOL</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/d</StrengthUnit>
    <Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200930</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LYLLANA is indicated for.</IndicationAndUsage>
    <Description>LYLLANA (estradiol transdermal system, USP), contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of LYLLANA are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39. LYLLANA is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. Meets USP Drug Release Test 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>68071-4702-8</NDCCode>
    <PackageDescription>1 TABLET in 1 BOTTLE (68071-4702-8) </PackageDescription>
    <NDC11Code>68071-4702-08</NDC11Code>
    <ProductNDC>68071-4702</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mefloquine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Mefloquine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040106</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076392</ApplicationNumber>
    <LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>MEFLOQUINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mefloquine Hydrochloride Tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax. There are insufficient clinical data to document the effect of mefloquine in malaria caused by P. ovale or P. malariae. Note: Patients with acute P. vivax malaria, treated with mefloquine, are at high risk of relapse because mefloquine does not eliminate exoerythrocytic (hepatic phase) parasites. To avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine).</IndicationAndUsage>
    <Description>Mefloquine Hydrochloride Tablets USP are an antimalarial agent available as 250 mg tablets of mefloquine hydrochloride (equivalent to 228 mg of the free base) for oral administration. Mefloquine Hydrochloride USP is a 4-quinolinemethanol derivative with the specific chemical name of (R*, S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. The structural formula is as follows. C 17H 16F 6N 2O.HCl M.W.: 414.78. The inactive ingredients are colloidal silicon dioxide, corn starch, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, poloxamer and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>75786-102-55</NDCCode>
    <PackageDescription>80 mL in 1 BOTTLE, SPRAY (75786-102-55) </PackageDescription>
    <NDC11Code>75786-0102-55</NDC11Code>
    <ProductNDC>75786-102</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200424</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Elemental Herbs, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200424</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75786-102-56</NDCCode>
    <PackageDescription>60 mL in 1 BOTTLE, SPRAY (75786-102-56) </PackageDescription>
    <NDC11Code>75786-0102-56</NDC11Code>
    <ProductNDC>75786-102</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200424</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Elemental Herbs, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200521</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75786-106-57</NDCCode>
    <PackageDescription>60 mL in 1 BOTTLE, PLASTIC (75786-106-57) </PackageDescription>
    <NDC11Code>75786-0106-57</NDC11Code>
    <ProductNDC>75786-106</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200724</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Elemental Herbs, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200724</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75786-107-59</NDCCode>
    <PackageDescription>60 mL in 1 BOTTLE, SPRAY (75786-107-59) </PackageDescription>
    <NDC11Code>75786-0107-59</NDC11Code>
    <ProductNDC>75786-107</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200729</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Elemental Herbs, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200729</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75786-107-64</NDCCode>
    <PackageDescription>60 mL in 1 BOTTLE, SPRAY (75786-107-64) </PackageDescription>
    <NDC11Code>75786-0107-64</NDC11Code>
    <ProductNDC>75786-107</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200729</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Elemental Herbs, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220411</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75786-108-60</NDCCode>
    <PackageDescription>60 mL in 1 BOTTLE, SPRAY (75786-108-60) </PackageDescription>
    <NDC11Code>75786-0108-60</NDC11Code>
    <ProductNDC>75786-108</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200812</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Elemental Herbs, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200812</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75786-111-61</NDCCode>
    <PackageDescription>59.1 mL in 1 BOTTLE, PLASTIC (75786-111-61) </PackageDescription>
    <NDC11Code>75786-0111-61</NDC11Code>
    <ProductNDC>75786-111</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201111</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Elemental Herbs, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201111</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75786-112-63</NDCCode>
    <PackageDescription>60 mL in 1 BOTTLE, SPRAY (75786-112-63) </PackageDescription>
    <NDC11Code>75786-0112-63</NDC11Code>
    <ProductNDC>75786-112</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220411</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Elemental Herbs, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220411</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75786-220-01</NDCCode>
    <PackageDescription>17 g in 1 TUBE (75786-220-01) </PackageDescription>
    <NDC11Code>75786-0220-01</NDC11Code>
    <ProductNDC>75786-220</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>All Good Mineral Sport Sunscreen Sunstick Spf 30</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260331</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Elemental Herbs, Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>UsesHelps prevent sunburn  If used as directed with other sun protection. measures (see Directions), decreases the risk of skin cancer and early skin. aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75786-221-01</NDCCode>
    <PackageDescription>17 g in 1 TUBE (75786-221-01) </PackageDescription>
    <NDC11Code>75786-0221-01</NDC11Code>
    <ProductNDC>75786-221</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>All Good Coconut Mineral Sunscreen Sunstick Spf 30</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260331</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Elemental Herbs, Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>UsesHelps prevent sunburn  If used as directed with other sun protection. measures (see Directions), decreases the risk of skin cancer and early skin. aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75786-222-29</NDCCode>
    <PackageDescription>29 g in 1 CAN (75786-222-29) </PackageDescription>
    <NDC11Code>75786-0222-29</NDC11Code>
    <ProductNDC>75786-222</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>All Good</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210513</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Elemental Herbs, Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>apply liberally 15 minutes before sun exposure: 1 reapply:, 2 after 80 minutes of swimmming or sweating, 3 immediately after towel drying, 4 at least eery 2 hours, 5 Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early sking aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: , 6 limit time in the sun, especially from 10 a.m. - 2 p.m., 7 wear long-sleeved shirts, pants, hats and sunglasses.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75786-223-29</NDCCode>
    <PackageDescription>29 g in 1 CAN (75786-223-29) </PackageDescription>
    <NDC11Code>75786-0223-29</NDC11Code>
    <ProductNDC>75786-223</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>All Good Mineral Sport Sunscreen Butter</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Elemental Herbs, Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses.  Helps prevent sunburn  If used as directed with other. sun protection measures (see Directions), decreases the. risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75786-224-01</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (75786-224-01)  / 4.25 g in 1 TUBE</PackageDescription>
    <NDC11Code>75786-0224-01</NDC11Code>
    <ProductNDC>75786-224</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>All Good Coconut Spf 20 Zinc Oxide Lip Balm</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140108</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Elemental Herbs, Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140108</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Use: Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75786-226-29</NDCCode>
    <PackageDescription>29 g in 1 CAN (75786-226-29) </PackageDescription>
    <NDC11Code>75786-0226-29</NDC11Code>
    <ProductNDC>75786-226</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>All Good Tinted Mineral Sunscreen Butter Spf 50</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210513</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Elemental Herbs, Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses.  Helps prevent sunburn  If used as directed with other. sun protection measures (see Directions), decreases the. risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75786-234-41</NDCCode>
    <PackageDescription>60 mL in 1 BOTTLE (75786-234-41) </PackageDescription>
    <NDC11Code>75786-0234-41</NDC11Code>
    <ProductNDC>75786-234</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>All Good Unscented Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200401</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Elemental Herbs, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For hand washing to decrease bacteria on skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>75786-228-78</NDCCode><ProprietaryName>All Good Mineral Sport Sunscreen Butter Stick Spf 50</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>65862-228-78</NDCCode><ProprietaryName>Lamotrigine</ProprietaryName><NonProprietaryName>Lamotrigine</NonProprietaryName></NDC><NDC><NDCCode>75786-229-78</NDCCode><ProprietaryName>All Good Mineral Sport Sunscreen Butter Stick Spf 50</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>75786-230-78</NDCCode><ProprietaryName>All Good Kids Mineral Sunscreen Butter Stick Spf 50</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>0555-0171-78</NDCCode><ProprietaryName>Mefloquine Hydrochloride</ProprietaryName><NonProprietaryName>Mefloquine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>21695-561-10</NDCCode><ProprietaryName>Mefloquine Hydrochloride</ProprietaryName><NonProprietaryName>Mefloquine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50090-2396-0</NDCCode><ProprietaryName>Mefloquine Hydrochloride</ProprietaryName><NonProprietaryName>Mefloquine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50090-2396-1</NDCCode><ProprietaryName>Mefloquine Hydrochloride</ProprietaryName><NonProprietaryName>Mefloquine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50090-2396-2</NDCCode><ProprietaryName>Mefloquine Hydrochloride</ProprietaryName><NonProprietaryName>Mefloquine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>52959-803-25</NDCCode><ProprietaryName>Mefloquine Hydrochloride</ProprietaryName><NonProprietaryName>Mefloquine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>61314-228-94</NDCCode><ProprietaryName>Wyost</ProprietaryName><NonProprietaryName>Denosumab</NonProprietaryName></NDC><NDC><NDCCode>62135-973-11</NDCCode><ProprietaryName>Mefloquine Hydrochloride</ProprietaryName><NonProprietaryName>Mefloquine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>62135-973-25</NDCCode><ProprietaryName>Mefloquine Hydrochloride</ProprietaryName><NonProprietaryName>Mefloquine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>65162-228-08</NDCCode><ProprietaryName>Lyllana</ProprietaryName><NonProprietaryName>Estradiol</NonProprietaryName></NDC><NDC><NDCCode>68071-4702-8</NDCCode><ProprietaryName>Mefloquine Hydrochloride</ProprietaryName><NonProprietaryName>Mefloquine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>75786-102-55</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>75786-102-56</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>75786-106-57</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>75786-107-59</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>75786-107-64</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>75786-108-60</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>75786-111-61</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>75786-112-63</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>75786-220-01</NDCCode><ProprietaryName>All Good Mineral Sport Sunscreen Sunstick Spf 30</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>75786-221-01</NDCCode><ProprietaryName>All Good Coconut Mineral Sunscreen Sunstick Spf 30</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>75786-222-29</NDCCode><ProprietaryName>All Good</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>75786-223-29</NDCCode><ProprietaryName>All Good Mineral Sport Sunscreen Butter</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>75786-224-01</NDCCode><ProprietaryName>All Good Coconut Spf 20 Zinc Oxide Lip Balm</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>75786-226-29</NDCCode><ProprietaryName>All Good Tinted Mineral Sunscreen Butter Spf 50</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>75786-234-41</NDCCode><ProprietaryName>All Good Unscented Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethyl Alcohol</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",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "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."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
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      "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",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "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",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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