RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "51114-0726-9",
      "PackageDescription": "1 BAG in 1 DRUM (51114-0726-9)  / 1 BAG in 1 BAG / 12000 TABLET in 1 BAG",
      "NDC11Code": "51114-0726-09",
      "ProductNDC": "51114-0726",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Pyrantel Pamoate",
      "DosageFormName": "TABLET",
      "StartMarketingDate": "20250829",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Vovantis Laboratories Private Limited",
      "SubstanceName": "PYRANTEL PAMOATE",
      "StrengthNumber": "720.5",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2025-11-10",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "29-AUG-25"
    },
    {
      "NDCCode": "51114-0725-9",
      "PackageDescription": "1 BAG in 1 DRUM (51114-0725-9)  / 1 BAG in 1 BAG / 12000 TABLET in 1 BAG",
      "NDC11Code": "51114-0725-09",
      "ProductNDC": "51114-0725",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Pyrantel Pamoate",
      "DosageFormName": "TABLET",
      "StartMarketingDate": "20250530",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Vovantis Laboratories Private Limited",
      "SubstanceName": "PYRANTEL PAMOATE",
      "StrengthNumber": "720.5",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2025-06-05",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "30-MAY-25"
    },
    {
      "NDCCode": "15455-0726-1",
      "PackageDescription": "4.9 g in 1 CONTAINER (15455-0726-1)",
      "NDC11Code": "15455-0726-01",
      "ProductNDC": "15455-0726",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Diclofenac Sodium",
      "DosageFormName": "POWDER, FOR SUSPENSION",
      "StartMarketingDate": "20150701",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Alvix Laboratories, LLC",
      "SubstanceName": "DICLOFENAC SODIUM",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "69968-0726-9",
      "PackageDescription": "1 KIT in 1 PACKAGE (69968-0726-9)  *  1 CLOTH in 1 PACKET *  2 TABLET, FILM COATED in 1 POUCH (50580-449-08)  *  1 TUBE in 1 CARTON (69968-0223-1)  / 28.3 g in 1 TUBE *  1 TUBE in 1 CARTON (69968-0055-2)  / 14.2 g in 1 TUBE",
      "NDC11Code": "69968-0726-09",
      "ProductNDC": "69968-0726",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Johnson And Johnson First Aid All Purpose",
      "ProprietaryNameSuffix": "160 Ct",
      "NonProprietaryName": "Acetaminophen, Diphenhydramine Hydrochloride, Zinc Acetate, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20220131",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Kenvue Brands LLC",
      "Status": "Active",
      "LastUpdate": "2025-11-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220131",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "42747-726-01",
      "PackageDescription": "1 POUCH in 1 CARTON (42747-726-01)  / 1 PATCH in 1 POUCH / 168 h in 1 PATCH",
      "NDC11Code": "42747-0726-01",
      "ProductNDC": "42747-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sancuso",
      "NonProprietaryName": "Granisetron",
      "DosageFormName": "PATCH",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20080912",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022198",
      "LabelerName": "Kyowa Kirin, Inc.",
      "SubstanceName": "GRANISETRON",
      "StrengthNumber": "3.1",
      "StrengthUnit": "mg/24h",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20080912",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sancuso® is indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration.",
      "Description": "Sancuso contains granisetron, which is a serotonin-3 (5-HT3) receptor antagonist. Chemically it is 1-methyl-N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide with a molecular weight of 312.4. Its empirical formula is C18H24N4O, while its chemical structure is. Granisetron is a white to off-white solid that is insoluble in water. The inactive ingredients are acrylate-vinylacetate copolymer, polyester, titanium dioxide, polyamide resin and polyethylene wax. Sancuso is a 52 cm2 thin, translucent, matrix-type transdermal system that is rectangular- shaped with rounded corners, consisting of a backing (polyester), the drug matrix (acrylate- vinylacetate copolymer) and a release liner (siliconized polyester)."
    },
    {
      "NDCCode": "42747-726-72",
      "PackageDescription": "1 POUCH in 1 CARTON (42747-726-72)  / 1 PATCH in 1 POUCH / 168 h in 1 PATCH",
      "NDC11Code": "42747-0726-72",
      "ProductNDC": "42747-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sancuso",
      "NonProprietaryName": "Granisetron",
      "DosageFormName": "PATCH",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20080912",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022198",
      "LabelerName": "Kyowa Kirin, Inc.",
      "SubstanceName": "GRANISETRON",
      "StrengthNumber": "3.1",
      "StrengthUnit": "mg/24h",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20080912",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sancuso® is indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration.",
      "Description": "Sancuso contains granisetron, which is a serotonin-3 (5-HT3) receptor antagonist. Chemically it is 1-methyl-N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide with a molecular weight of 312.4. Its empirical formula is C18H24N4O, while its chemical structure is. Granisetron is a white to off-white solid that is insoluble in water. The inactive ingredients are acrylate-vinylacetate copolymer, polyester, titanium dioxide, polyamide resin and polyethylene wax. Sancuso is a 52 cm2 thin, translucent, matrix-type transdermal system that is rectangular- shaped with rounded corners, consisting of a backing (polyester), the drug matrix (acrylate- vinylacetate copolymer) and a release liner (siliconized polyester)."
    },
    {
      "NDCCode": "43419-726-09",
      "PackageDescription": "1 CONTAINER in 1 CARTON (43419-726-09)  > 9 g in 1 CONTAINER",
      "NDC11Code": "43419-0726-09",
      "ProductNDC": "43419-726",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Laneige Forever Definite Compact Foundation No.1",
      "NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141030",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "AMOREPACIFIC",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": ".8379; .2646",
      "StrengthUnit": "g/9g; g/9g",
      "Status": "Deprecated",
      "LastUpdate": "2018-08-14",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "46708-726-30",
      "PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-726-30) ",
      "NDC11Code": "46708-0726-30",
      "ProductNDC": "46708-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diltiazem Hydrochloride",
      "NonProprietaryName": "Diltiazem Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216968",
      "LabelerName": "Alembic Pharmaceuticals Limited",
      "SubstanceName": "DILTIAZEM HYDROCHLORIDE",
      "StrengthNumber": "180",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241114",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
      "Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "46708-726-90",
      "PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-726-90) ",
      "NDC11Code": "46708-0726-90",
      "ProductNDC": "46708-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diltiazem Hydrochloride",
      "NonProprietaryName": "Diltiazem Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216968",
      "LabelerName": "Alembic Pharmaceuticals Limited",
      "SubstanceName": "DILTIAZEM HYDROCHLORIDE",
      "StrengthNumber": "180",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241114",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
      "Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "46708-726-91",
      "PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-726-91) ",
      "NDC11Code": "46708-0726-91",
      "ProductNDC": "46708-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diltiazem Hydrochloride",
      "NonProprietaryName": "Diltiazem Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216968",
      "LabelerName": "Alembic Pharmaceuticals Limited",
      "SubstanceName": "DILTIAZEM HYDROCHLORIDE",
      "StrengthNumber": "180",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241114",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
      "Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "49281-726-10",
      "PackageDescription": "10 SYRINGE in 1 CARTON (49281-726-10)  / .5 mL in 1 SYRINGE (49281-726-88) ",
      "NDC11Code": "49281-0726-10",
      "ProductNDC": "49281-726",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Flublok Trivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/missouri/11/2025 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/darwin/1415/2025 (h3n2) Recombinant Hemagglutinin Antigen, And Influenza B Virus B/pennsylvania/14/2025 Recombinant Hemagglutinin Antigen",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20260702",
      "EndMarketingDate": "20270630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125285",
      "LabelerName": "Sanofi Vaccines US Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/MISSOURI/11/2025 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/DARWIN/1415/2025 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/PENNSYLVANIA/14/2025 RECOMBINANT HEMAGGLUTININ ANTIGEN",
      "StrengthNumber": "45; 45; 45",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Active",
      "LastUpdate": "2026-07-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20260702",
      "EndMarketingDatePackage": "20270630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Flublok is a vaccine indicated for active immunization for the prevention of disease caused by influenza A virus subtypes and influenza type B virus represented by antigens contained in the vaccine. Flublok is approved for use in individuals 9 years of age and older.",
      "Description": "Flublok [Influenza Vaccine] is a sterile, clear, colorless injection containing recombinant hemagglutinin (HA) proteins from three influenza viruses for intramuscular use. It contains purified HA proteins produced in a continuous insect cell line (expresSF+®) that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda (which is related to moths, caterpillars and butterflies), and grown in serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts. Each of the three HAs is expressed in this cell line using a baculovirus vector (Autographa californica nuclear polyhedrosis virus), extracted from the cells with Triton X-100 and further purified by column chromatography. The purified HAs are then blended and filled into single-dose syringes. For the 2026-2027 influenza season it is formulated to contain 135 mcg HA per 0.5 mL dose, with 45 mcg HA of each of the following 3 influenza virus strains: A/Missouri/11/2025 (H1N1), A/Darwin/1415/2025 (H3N2) and B/Pennsylvania/14/2025. These three influenza virus strains are recommended by FDA for the 2026-2027 influenza season. A single 0.5 mL dose of Flublok contains sodium chloride (4.4 mg), monobasic sodium phosphate (0.2 mg), dibasic sodium phosphate (0.5 mg), and polysorbate 20 (Tween®20) (27.5 mcg). Each 0.5 mL dose of Flublok may also contain residual amounts of baculovirus and Spodoptera frugiperda cell proteins (≤ 14.3 mcg), baculovirus and cellular DNA (≤ 10 ng), and Triton X-100 (≤ 100 mcg). Flublok contains no egg proteins, antibiotics, or preservatives. The single-dose, prefilled syringes contain no natural rubber latex."
    },
    {
      "NDCCode": "55648-726-01",
      "PackageDescription": "5 VIAL, SINGLE-DOSE in 1 CARTON (55648-726-01)  > 2 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "55648-0726-01",
      "ProductNDC": "55648-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ondansetron Hydrochloride",
      "NonProprietaryName": "Ondansetron Hydrochloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20061227",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077716",
      "LabelerName": "WOCKHARDT LIMITED",
      "SubstanceName": "ONDANSETRON HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. Efficacy of the 32-mg single dose beyond 24 hours in these patients has not been established. . Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron injection is recommended even where the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic ondansetron injection and experience nausea and/or vomiting postoperatively, ondansetron injection may be given to prevent further episodes (see CLINICAL TRIALS).",
      "Description": "The active ingredient in Ondansetron Injection is ondansetron hydrochloride (HCl), the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron HCl is a white to off-white powder that is soluble in water and normal saline. Sterile Injection for Intravenous (I.V.) or Intramuscular (I.M.) Administration: Each 1 mL of aqueous solution in the 2-mL single-dose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 9 mg of sodium chloride, USP; and 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers in Water for Injection, USP.Each 1 mL of aqueous solution in the 20-mL multidose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 8.3 mg of sodium chloride, USP; 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers; and 1.2 mg of methylparaben, NF and 0.15 mg of propylparaben, NF as preservatives in Water for Injection, USP.Ondansetron Injection is a clear, colorless, nonpyrogenic, sterile solution. The pH of the injection solution is 3.3 to 4.0."
    },
    {
      "NDCCode": "59923-726-30",
      "PackageDescription": "1 BOTTLE in 1 BOX (59923-726-30)  > 30 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "59923-0726-30",
      "ProductNDC": "59923-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Erlotinib",
      "NonProprietaryName": "Erlotinib",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211960",
      "LabelerName": "Areva Pharmaceuticals",
      "SubstanceName": "ERLOTINIB HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-11-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Erlotinib tablet is a kinase inhibitor indicated for: 1 The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1), 2 First-line treatment of patients with locally advanced, unrespectable or metastatic pancreatic cancer, in combination with gemcitabine. (1.2).",
      "Description": "Erlotinib a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine Hydrochloride. Erlotinib contains erlotinib as the hydrochloride salt that has the following structural formula. Erlotinib hydrochloride has the molecular formula C 22H 23N 3O 4.HCl and a molecular weight of 429.90. The molecule has a pKa of 5.4. Erlotinib hydrochloride is slightly soluble in Dimethyl sulfoxide, Dimethyl formamide and Methanol. Aqueous solubility of erlotinib hydrochloride is dependent on pH with increased solubility at a pH of less than 5 due to protonation of the secondary amine. Over the pH range of 1.4 to 9.6, maximal solubility of approximately 1.69 mg/mL occurs at a pH of approximately 2. Erlotinib tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: micro crystalline cellulose, lactose monohydrate, sodium starch glycolate, sodium lauryl sulfate, magnesium stearate, and finished tablets are coated with opadry white[Y-5-7068] contains following ingredients hypromellose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol."
    },
    {
      "NDCCode": "62332-726-30",
      "PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-726-30) ",
      "NDC11Code": "62332-0726-30",
      "ProductNDC": "62332-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diltiazem Hydrochloride",
      "NonProprietaryName": "Diltiazem Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216968",
      "LabelerName": "Alembic Pharmaceuticals Inc.",
      "SubstanceName": "DILTIAZEM HYDROCHLORIDE",
      "StrengthNumber": "180",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-09-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241114",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
      "Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain acetyl tributyl citrate, ethylcellulose, hypromellose, microcrystalline cellulose, povidone K-30, sucrose stearate, talc. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, gelatin and titanium dioxide. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing FD&C Blue # 2 Aluminum Lake and shellac. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing potassium hydroxide, shellac and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "62332-726-90",
      "PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-726-90) ",
      "NDC11Code": "62332-0726-90",
      "ProductNDC": "62332-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diltiazem Hydrochloride",
      "NonProprietaryName": "Diltiazem Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216968",
      "LabelerName": "Alembic Pharmaceuticals Inc.",
      "SubstanceName": "DILTIAZEM HYDROCHLORIDE",
      "StrengthNumber": "180",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-09-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241114",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
      "Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain acetyl tributyl citrate, ethylcellulose, hypromellose, microcrystalline cellulose, povidone K-30, sucrose stearate, talc. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, gelatin and titanium dioxide. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing FD&C Blue # 2 Aluminum Lake and shellac. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing potassium hydroxide, shellac and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "62332-726-91",
      "PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-726-91) ",
      "NDC11Code": "62332-0726-91",
      "ProductNDC": "62332-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diltiazem Hydrochloride",
      "NonProprietaryName": "Diltiazem Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216968",
      "LabelerName": "Alembic Pharmaceuticals Inc.",
      "SubstanceName": "DILTIAZEM HYDROCHLORIDE",
      "StrengthNumber": "180",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-09-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241114",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
      "Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain acetyl tributyl citrate, ethylcellulose, hypromellose, microcrystalline cellulose, povidone K-30, sucrose stearate, talc. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, gelatin and titanium dioxide. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing FD&C Blue # 2 Aluminum Lake and shellac. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing potassium hydroxide, shellac and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "64679-726-01",
      "PackageDescription": "5 VIAL, SINGLE-DOSE in 1 CARTON (64679-726-01)  > 2 mL in 1 VIAL, SINGLE-DOSE (64679-726-03) ",
      "NDC11Code": "64679-0726-01",
      "ProductNDC": "64679-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ondansetron Hydrochloride",
      "NonProprietaryName": "Ondansetron Hydrochloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20061227",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077716",
      "LabelerName": "Wockhardt USA LLC.",
      "SubstanceName": "ONDANSETRON HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20061227",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ondansetron Injection is a 5-HT3 receptor antagonist indicated for the prevention of: : 1 nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. (1.1), 2 postoperative nausea and/or vomiting. (1.2).",
      "Description": "The active ingredient in ondansetron injection, USP is ondansetron hydrochloride, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron HCl is a white to off-white powder that is soluble in water and normal saline. Each 1 mL of aqueous solution in the 2-mL single-dose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 9 mg of sodium chloride, USP; and 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers in Water for Injection, USP. Each 1 mL of aqueous solution in the 20-mL multi-dose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 8.3 mg of sodium chloride, USP; 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers; and 1.2 mg of methylparaben, NF and 0.15 mg of propylparaben, NF as preservatives in Water for Injection, USP. Ondansetron injection is a clear, colorless, nonpyrogenic, sterile solution for intravenous use. The pH of the injection solution is 3.3 to 4.0."
    },
    {
      "NDCCode": "71288-726-52",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (71288-726-52)  / 50 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "71288-0726-52",
      "ProductNDC": "71288-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupivacaine Hydrochloride",
      "NonProprietaryName": "Bupivacaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERINEURAL",
      "StartMarketingDate": "20230623",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216039",
      "LabelerName": "Meitheal Pharmaceuticals Inc",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2023-06-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230623",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bupivacaine Hydrochloride Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)]. Limitations of Use. Not all blocks are indicated for use with Bupivacaine Hydrochloride Injection given clinically significant risks associated with use [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.4, 5.5, 5.7, 5.9)].",
      "Description": "Bupivacaine Hydrochloride Injection, USP contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Bupivacaine Hydrochloride Injection, USP is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. Multiple dose vials contain methylparaben [see Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. Bupivacaine Hydrochloride Injection, USP is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4.0 and 6.5, in water for injection. For the multiple dose vials, each mL also contains 1 mg methylparaben as preservative."
    },
    {
      "NDCCode": "72275-726-77",
      "PackageDescription": "1 PACKAGE in 1 CARTON (72275-726-77)  > 20 PACKAGE in 1 PACKAGE > 20 TUBE in 1 PACKAGE > 1 KIT in 1 TUBE *  30 g in 1 TUBE *  30 g in 1 TUBE *  30 g in 1 TUBE",
      "NDC11Code": "72275-0726-77",
      "ProductNDC": "72275-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prilovixil",
      "ProprietaryNameSuffix": "Plus",
      "NonProprietaryName": "Lidocaine 2.5% And Prilocaine 2.5%",
      "DosageFormName": "KIT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200120",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Primary Pharmaceuticals, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200120",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lidocaine and prilocaine cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on. - normal intact skin for local analgesia. - genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. Lidocaine and prilocaine cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS).",
      "Description": "Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine cream in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 5 gram and 30 gram tubes. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure. Prilocaine is chemically designated as propanamide, N-(2-methylphenyl)-2-(propylamino), has an octanol: water partition ratio of 25 at pH 7.4, and has the following structure. Each gram of lidocaine and prilocaine cream contains lidocaine 25 mg, prilocaine 25 mg, polyoxyethylene fatty acid esters (as emulsifiers), carboxypolymethylene (as a thickening agent), sodium hydroxide to adjust to a pH approximating 9, and purified water to 1 gram. Lidocaine and prilocaine cream contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine and prilocaine cream is 1.00."
    },
    {
      "NDCCode": "51114-0214-5",
      "PackageDescription": "1600 POWDER in 1 CONTAINER (51114-0214-5) ",
      "NDC11Code": "51114-0214-05",
      "ProductNDC": "51114-0214",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Psyllium Husk",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20140306",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Vovantis Laboratories Private Limited",
      "SubstanceName": "PSYLLIUM HUSK",
      "StrengthNumber": "3.4",
      "StrengthUnit": "g/1",
      "Status": "Unfinished",
      "LastUpdate": "2025-03-12",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "06-MAR-14"
    },
    {
      "NDCCode": "51114-0218-6",
      "PackageDescription": "24 POUCH in 1 CARTON (51114-0218-6)  / 32 TABLET, EFFERVESCENT in 1 POUCH",
      "NDC11Code": "51114-0218-06",
      "ProductNDC": "51114-0218",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "StartMarketingDate": "20150209",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Vovantis Laboratories Private Limited",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2025-03-12",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "09-FEB-15"
    },
    {
      "NDCCode": "51114-0219-6",
      "PackageDescription": "24 POUCH in 1 CARTON (51114-0219-6)  / 32 TABLET, EFFERVESCENT in 1 POUCH",
      "NDC11Code": "51114-0219-06",
      "ProductNDC": "51114-0219",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "StartMarketingDate": "20150209",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Vovantis Laboratories Private Limited",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "160",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2025-03-12",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "09-FEB-15"
    },
    {
      "NDCCode": "51114-0220-6",
      "PackageDescription": "24 POUCH in 1 CARTON (51114-0220-6)  / 32 TABLET, EFFERVESCENT in 1 POUCH",
      "NDC11Code": "51114-0220-06",
      "ProductNDC": "51114-0220",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Diphenhydramine Hydrochloride",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "StartMarketingDate": "20150209",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Vovantis Laboratories Private Limited",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2025-03-12",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "09-FEB-15"
    },
    {
      "NDCCode": "51114-0221-6",
      "PackageDescription": "24 POUCH in 1 CARTON (51114-0221-6)  / 32 BLISTER PACK in 1 POUCH / 4 TABLET, EFFERVESCENT in 1 BLISTER PACK",
      "NDC11Code": "51114-0221-06",
      "ProductNDC": "51114-0221",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "StartMarketingDate": "20150209",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Vovantis Laboratories Private Limited",
      "SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "500; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2025-10-16",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "09-FEB-15"
    },
    {
      "NDCCode": "51114-0222-6",
      "PackageDescription": "175 PACKAGE in 1 CONTAINER (51114-0222-6)  / 10 BLISTER PACK in 1 PACKAGE / 2 TABLET, EFFERVESCENT in 1 BLISTER PACK",
      "NDC11Code": "51114-0222-06",
      "ProductNDC": "51114-0222",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "StartMarketingDate": "20150515",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Vovantis Laboratories Private Limited",
      "SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "250; 2; 10; 5",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2025-03-12",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "15-MAY-15"
    },
    {
      "NDCCode": "51114-0225-1",
      "PackageDescription": "1000 TABLET in 1 POUCH (51114-0225-1) ",
      "NDC11Code": "51114-0225-01",
      "ProductNDC": "51114-0225",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Sennosides",
      "DosageFormName": "TABLET",
      "StartMarketingDate": "20220228",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Vovantis Laboratories Private Limited",
      "SubstanceName": "SENNOSIDES",
      "StrengthNumber": "8.6",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2025-03-12",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "28-FEB-22"
    },
    {
      "NDCCode": "51114-0450-5",
      "PackageDescription": "25 g in 1 DRUM (51114-0450-5) ",
      "NDC11Code": "51114-0450-05",
      "ProductNDC": "51114-0450",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide",
      "DosageFormName": "GRANULE",
      "StartMarketingDate": "20260101",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Vovantis Laboratories Private Limited",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE",
      "StrengthNumber": "500; 20",
      "StrengthUnit": "mg/.9g; mg/.9g",
      "Status": "Unfinished",
      "LastUpdate": "2026-09-25",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "01-JAN-26"
    },
    {
      "NDCCode": "51114-0451-5",
      "PackageDescription": "25 g in 1 DRUM (51114-0451-5) ",
      "NDC11Code": "51114-0451-05",
      "ProductNDC": "51114-0451",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide",
      "DosageFormName": "GRANULE",
      "StartMarketingDate": "20260101",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Vovantis Laboratories Private Limited",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE",
      "StrengthNumber": "650; 20",
      "StrengthUnit": "mg/.9g; mg/.9g",
      "Status": "Unfinished",
      "LastUpdate": "2026-09-25",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "01-JAN-26"
    },
    {
      "NDCCode": "51114-0452-5",
      "PackageDescription": "25 g in 1 DRUM (51114-0452-5) ",
      "NDC11Code": "51114-0452-05",
      "ProductNDC": "51114-0452",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Chlorpheniramine Maleate",
      "DosageFormName": "GRANULE",
      "StartMarketingDate": "20260101",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Vovantis Laboratories Private Limited",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE",
      "StrengthNumber": "500; 20; 2",
      "StrengthUnit": "mg/.9g; mg/.9g; mg/.9g",
      "Status": "Unfinished",
      "LastUpdate": "2026-09-25",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "01-JAN-26"
    },
    {
      "NDCCode": "51114-0453-5",
      "PackageDescription": "25 g in 1 DRUM (51114-0453-5) ",
      "NDC11Code": "51114-0453-05",
      "ProductNDC": "51114-0453",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide",
      "DosageFormName": "GRANULE",
      "StartMarketingDate": "20260101",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Vovantis Laboratories Private Limited",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE",
      "StrengthNumber": "1000; 30",
      "StrengthUnit": "mg/1.5g; mg/1.5g",
      "Status": "Unfinished",
      "LastUpdate": "2026-09-25",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "01-JAN-26"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"51114-0726-9","NonProprietaryName":"Pyrantel Pamoate"},{"NDCCode":"51114-0725-9","NonProprietaryName":"Pyrantel Pamoate"},{"NDCCode":"15455-0726-1","NonProprietaryName":"Diclofenac Sodium"},{"NDCCode":"69968-0726-9","ProprietaryName":"Johnson And Johnson First Aid All Purpose","NonProprietaryName":"Acetaminophen, Diphenhydramine Hydrochloride, Zinc Acetate, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride"},{"NDCCode":"42747-726-01","ProprietaryName":"Sancuso","NonProprietaryName":"Granisetron"},{"NDCCode":"42747-726-72","ProprietaryName":"Sancuso","NonProprietaryName":"Granisetron"},{"NDCCode":"43419-726-09","ProprietaryName":"Laneige Forever Definite Compact Foundation No.1","NonProprietaryName":"Titanium Dioxide And Zinc Oxide"},{"NDCCode":"46708-726-30","ProprietaryName":"Diltiazem Hydrochloride","NonProprietaryName":"Diltiazem Hydrochloride"},{"NDCCode":"46708-726-90","ProprietaryName":"Diltiazem Hydrochloride","NonProprietaryName":"Diltiazem Hydrochloride"},{"NDCCode":"46708-726-91","ProprietaryName":"Diltiazem Hydrochloride","NonProprietaryName":"Diltiazem Hydrochloride"},{"NDCCode":"49281-726-10","ProprietaryName":"Flublok Trivalent Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/missouri/11/2025 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/darwin/1415/2025 (h3n2) Recombinant Hemagglutinin Antigen, And Influenza B Virus B/pennsylvania/14/2025 Recombinant Hemagglutinin Antigen"},{"NDCCode":"55648-726-01","ProprietaryName":"Ondansetron Hydrochloride","NonProprietaryName":"Ondansetron Hydrochloride"},{"NDCCode":"59923-726-30","ProprietaryName":"Erlotinib","NonProprietaryName":"Erlotinib"},{"NDCCode":"62332-726-30","ProprietaryName":"Diltiazem Hydrochloride","NonProprietaryName":"Diltiazem Hydrochloride"},{"NDCCode":"62332-726-90","ProprietaryName":"Diltiazem Hydrochloride","NonProprietaryName":"Diltiazem Hydrochloride"},{"NDCCode":"62332-726-91","ProprietaryName":"Diltiazem Hydrochloride","NonProprietaryName":"Diltiazem Hydrochloride"},{"NDCCode":"64679-726-01","ProprietaryName":"Ondansetron Hydrochloride","NonProprietaryName":"Ondansetron Hydrochloride"},{"NDCCode":"71288-726-52","ProprietaryName":"Bupivacaine Hydrochloride","NonProprietaryName":"Bupivacaine Hydrochloride"},{"NDCCode":"72275-726-77","ProprietaryName":"Prilovixil","NonProprietaryName":"Lidocaine 2.5% And Prilocaine 2.5%"},{"NDCCode":"51114-0214-5","NonProprietaryName":"Psyllium Husk"},{"NDCCode":"51114-0218-6","NonProprietaryName":"Acetaminophen"},{"NDCCode":"51114-0219-6","NonProprietaryName":"Acetaminophen"},{"NDCCode":"51114-0220-6","NonProprietaryName":"Diphenhydramine Hydrochloride"},{"NDCCode":"51114-0221-6","NonProprietaryName":"Acetaminophen"},{"NDCCode":"51114-0222-6","NonProprietaryName":"Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"},{"NDCCode":"51114-0225-1","NonProprietaryName":"Sennosides"},{"NDCCode":"51114-0450-5","NonProprietaryName":"Acetaminophen, Dextromethorphan Hydrobromide"},{"NDCCode":"51114-0451-5","NonProprietaryName":"Acetaminophen, Dextromethorphan Hydrobromide"},{"NDCCode":"51114-0452-5","NonProprietaryName":"Acetaminophen, Dextromethorphan Hydrobromide, Chlorpheniramine Maleate"},{"NDCCode":"51114-0453-5","NonProprietaryName":"Acetaminophen, Dextromethorphan Hydrobromide"}]}
                    

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    <NDCCode>51114-0726-9</NDCCode>
    <PackageDescription>1 BAG in 1 DRUM (51114-0726-9)  / 1 BAG in 1 BAG / 12000 TABLET in 1 BAG</PackageDescription>
    <NDC11Code>51114-0726-09</NDC11Code>
    <ProductNDC>51114-0726</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Pyrantel Pamoate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <StartMarketingDate>20250829</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Vovantis Laboratories Private Limited</LabelerName>
    <SubstanceName>PYRANTEL PAMOATE</SubstanceName>
    <StrengthNumber>720.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-11-10</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>29-AUG-25</StartMarketingDatePackage>
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    <NDCCode>51114-0725-9</NDCCode>
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    <NDC11Code>51114-0725-09</NDC11Code>
    <ProductNDC>51114-0725</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Pyrantel Pamoate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <StartMarketingDate>20250530</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Vovantis Laboratories Private Limited</LabelerName>
    <SubstanceName>PYRANTEL PAMOATE</SubstanceName>
    <StrengthNumber>720.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-06-05</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>30-MAY-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>15455-0726-1</NDCCode>
    <PackageDescription>4.9 g in 1 CONTAINER (15455-0726-1)</PackageDescription>
    <NDC11Code>15455-0726-01</NDC11Code>
    <ProductNDC>15455-0726</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <StartMarketingDate>20150701</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Alvix Laboratories, LLC</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>69968-0726-9</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE (69968-0726-9)  *  1 CLOTH in 1 PACKET *  2 TABLET, FILM COATED in 1 POUCH (50580-449-08)  *  1 TUBE in 1 CARTON (69968-0223-1)  / 28.3 g in 1 TUBE *  1 TUBE in 1 CARTON (69968-0055-2)  / 14.2 g in 1 TUBE</PackageDescription>
    <NDC11Code>69968-0726-09</NDC11Code>
    <ProductNDC>69968-0726</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Johnson And Johnson First Aid All Purpose</ProprietaryName>
    <ProprietaryNameSuffix>160 Ct</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen, Diphenhydramine Hydrochloride, Zinc Acetate, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20220131</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Kenvue Brands LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-11-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220131</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42747-726-01</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (42747-726-01)  / 1 PATCH in 1 POUCH / 168 h in 1 PATCH</PackageDescription>
    <NDC11Code>42747-0726-01</NDC11Code>
    <ProductNDC>42747-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sancuso</ProprietaryName>
    <NonProprietaryName>Granisetron</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20080912</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022198</ApplicationNumber>
    <LabelerName>Kyowa Kirin, Inc.</LabelerName>
    <SubstanceName>GRANISETRON</SubstanceName>
    <StrengthNumber>3.1</StrengthNumber>
    <StrengthUnit>mg/24h</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080912</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sancuso® is indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration.</IndicationAndUsage>
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  </NDC>
  <NDC>
    <NDCCode>42747-726-72</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (42747-726-72)  / 1 PATCH in 1 POUCH / 168 h in 1 PATCH</PackageDescription>
    <NDC11Code>42747-0726-72</NDC11Code>
    <ProductNDC>42747-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sancuso</ProprietaryName>
    <NonProprietaryName>Granisetron</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20080912</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022198</ApplicationNumber>
    <LabelerName>Kyowa Kirin, Inc.</LabelerName>
    <SubstanceName>GRANISETRON</SubstanceName>
    <StrengthNumber>3.1</StrengthNumber>
    <StrengthUnit>mg/24h</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080912</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sancuso® is indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration.</IndicationAndUsage>
    <Description>Sancuso contains granisetron, which is a serotonin-3 (5-HT3) receptor antagonist. Chemically it is 1-methyl-N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide with a molecular weight of 312.4. Its empirical formula is C18H24N4O, while its chemical structure is. Granisetron is a white to off-white solid that is insoluble in water. The inactive ingredients are acrylate-vinylacetate copolymer, polyester, titanium dioxide, polyamide resin and polyethylene wax. Sancuso is a 52 cm2 thin, translucent, matrix-type transdermal system that is rectangular- shaped with rounded corners, consisting of a backing (polyester), the drug matrix (acrylate- vinylacetate copolymer) and a release liner (siliconized polyester).</Description>
  </NDC>
  <NDC>
    <NDCCode>43419-726-09</NDCCode>
    <PackageDescription>1 CONTAINER in 1 CARTON (43419-726-09)  &gt; 9 g in 1 CONTAINER</PackageDescription>
    <NDC11Code>43419-0726-09</NDC11Code>
    <ProductNDC>43419-726</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Laneige Forever Definite Compact Foundation No.1</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141030</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>AMOREPACIFIC</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>.8379; .2646</StrengthNumber>
    <StrengthUnit>g/9g; g/9g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-08-14</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>46708-726-30</NDCCode>
    <PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-726-30) </PackageDescription>
    <NDC11Code>46708-0726-30</NDC11Code>
    <ProductNDC>46708-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
    <NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216968</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
    <Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&amp;C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&amp;C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-726-90</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-726-90) </PackageDescription>
    <NDC11Code>46708-0726-90</NDC11Code>
    <ProductNDC>46708-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
    <NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216968</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
    <Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&amp;C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&amp;C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-726-91</NDCCode>
    <PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-726-91) </PackageDescription>
    <NDC11Code>46708-0726-91</NDC11Code>
    <ProductNDC>46708-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
    <NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216968</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
    <Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&amp;C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&amp;C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>49281-726-10</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (49281-726-10)  / .5 mL in 1 SYRINGE (49281-726-88) </PackageDescription>
    <NDC11Code>49281-0726-10</NDC11Code>
    <ProductNDC>49281-726</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Flublok Trivalent Northern Hemisphere</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/missouri/11/2025 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/darwin/1415/2025 (h3n2) Recombinant Hemagglutinin Antigen, And Influenza B Virus B/pennsylvania/14/2025 Recombinant Hemagglutinin Antigen</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20260702</StartMarketingDate>
    <EndMarketingDate>20270630</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125285</ApplicationNumber>
    <LabelerName>Sanofi Vaccines US Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/MISSOURI/11/2025 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/DARWIN/1415/2025 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/PENNSYLVANIA/14/2025 RECOMBINANT HEMAGGLUTININ ANTIGEN</SubstanceName>
    <StrengthNumber>45; 45; 45</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20260702</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Flublok is a vaccine indicated for active immunization for the prevention of disease caused by influenza A virus subtypes and influenza type B virus represented by antigens contained in the vaccine. Flublok is approved for use in individuals 9 years of age and older.</IndicationAndUsage>
    <Description>Flublok [Influenza Vaccine] is a sterile, clear, colorless injection containing recombinant hemagglutinin (HA) proteins from three influenza viruses for intramuscular use. It contains purified HA proteins produced in a continuous insect cell line (expresSF+®) that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda (which is related to moths, caterpillars and butterflies), and grown in serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts. Each of the three HAs is expressed in this cell line using a baculovirus vector (Autographa californica nuclear polyhedrosis virus), extracted from the cells with Triton X-100 and further purified by column chromatography. The purified HAs are then blended and filled into single-dose syringes. For the 2026-2027 influenza season it is formulated to contain 135 mcg HA per 0.5 mL dose, with 45 mcg HA of each of the following 3 influenza virus strains: A/Missouri/11/2025 (H1N1), A/Darwin/1415/2025 (H3N2) and B/Pennsylvania/14/2025. These three influenza virus strains are recommended by FDA for the 2026-2027 influenza season. A single 0.5 mL dose of Flublok contains sodium chloride (4.4 mg), monobasic sodium phosphate (0.2 mg), dibasic sodium phosphate (0.5 mg), and polysorbate 20 (Tween®20) (27.5 mcg). Each 0.5 mL dose of Flublok may also contain residual amounts of baculovirus and Spodoptera frugiperda cell proteins (≤ 14.3 mcg), baculovirus and cellular DNA (≤ 10 ng), and Triton X-100 (≤ 100 mcg). Flublok contains no egg proteins, antibiotics, or preservatives. The single-dose, prefilled syringes contain no natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>55648-726-01</NDCCode>
    <PackageDescription>5 VIAL, SINGLE-DOSE in 1 CARTON (55648-726-01)  &gt; 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>55648-0726-01</NDC11Code>
    <ProductNDC>55648-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20061227</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077716</ApplicationNumber>
    <LabelerName>WOCKHARDT LIMITED</LabelerName>
    <SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. Efficacy of the 32-mg single dose beyond 24 hours in these patients has not been established. . Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron injection is recommended even where the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic ondansetron injection and experience nausea and/or vomiting postoperatively, ondansetron injection may be given to prevent further episodes (see CLINICAL TRIALS).</IndicationAndUsage>
    <Description>The active ingredient in Ondansetron Injection is ondansetron hydrochloride (HCl), the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron HCl is a white to off-white powder that is soluble in water and normal saline. Sterile Injection for Intravenous (I.V.) or Intramuscular (I.M.) Administration: Each 1 mL of aqueous solution in the 2-mL single-dose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 9 mg of sodium chloride, USP; and 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers in Water for Injection, USP.Each 1 mL of aqueous solution in the 20-mL multidose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 8.3 mg of sodium chloride, USP; 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers; and 1.2 mg of methylparaben, NF and 0.15 mg of propylparaben, NF as preservatives in Water for Injection, USP.Ondansetron Injection is a clear, colorless, nonpyrogenic, sterile solution. The pH of the injection solution is 3.3 to 4.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>59923-726-30</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (59923-726-30)  &gt; 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>59923-0726-30</NDC11Code>
    <ProductNDC>59923-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Erlotinib</ProprietaryName>
    <NonProprietaryName>Erlotinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211960</ApplicationNumber>
    <LabelerName>Areva Pharmaceuticals</LabelerName>
    <SubstanceName>ERLOTINIB HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-11-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Erlotinib tablet is a kinase inhibitor indicated for: 1 The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1), 2 First-line treatment of patients with locally advanced, unrespectable or metastatic pancreatic cancer, in combination with gemcitabine. (1.2).</IndicationAndUsage>
    <Description>Erlotinib a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine Hydrochloride. Erlotinib contains erlotinib as the hydrochloride salt that has the following structural formula. Erlotinib hydrochloride has the molecular formula C 22H 23N 3O 4.HCl and a molecular weight of 429.90. The molecule has a pKa of 5.4. Erlotinib hydrochloride is slightly soluble in Dimethyl sulfoxide, Dimethyl formamide and Methanol. Aqueous solubility of erlotinib hydrochloride is dependent on pH with increased solubility at a pH of less than 5 due to protonation of the secondary amine. Over the pH range of 1.4 to 9.6, maximal solubility of approximately 1.69 mg/mL occurs at a pH of approximately 2. Erlotinib tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: micro crystalline cellulose, lactose monohydrate, sodium starch glycolate, sodium lauryl sulfate, magnesium stearate, and finished tablets are coated with opadry white[Y-5-7068] contains following ingredients hypromellose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-726-30</NDCCode>
    <PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-726-30) </PackageDescription>
    <NDC11Code>62332-0726-30</NDC11Code>
    <ProductNDC>62332-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
    <NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216968</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
    <Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain acetyl tributyl citrate, ethylcellulose, hypromellose, microcrystalline cellulose, povidone K-30, sucrose stearate, talc. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&amp;C Blue 1, gelatin and titanium dioxide. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing FD&amp;C Blue # 2 Aluminum Lake and shellac. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing potassium hydroxide, shellac and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-726-90</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-726-90) </PackageDescription>
    <NDC11Code>62332-0726-90</NDC11Code>
    <ProductNDC>62332-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
    <NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216968</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
    <Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain acetyl tributyl citrate, ethylcellulose, hypromellose, microcrystalline cellulose, povidone K-30, sucrose stearate, talc. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&amp;C Blue 1, gelatin and titanium dioxide. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing FD&amp;C Blue # 2 Aluminum Lake and shellac. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing potassium hydroxide, shellac and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-726-91</NDCCode>
    <PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-726-91) </PackageDescription>
    <NDC11Code>62332-0726-91</NDC11Code>
    <ProductNDC>62332-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
    <NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216968</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
    <Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain acetyl tributyl citrate, ethylcellulose, hypromellose, microcrystalline cellulose, povidone K-30, sucrose stearate, talc. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&amp;C Blue 1, gelatin and titanium dioxide. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing FD&amp;C Blue # 2 Aluminum Lake and shellac. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing potassium hydroxide, shellac and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>64679-726-01</NDCCode>
    <PackageDescription>5 VIAL, SINGLE-DOSE in 1 CARTON (64679-726-01)  &gt; 2 mL in 1 VIAL, SINGLE-DOSE (64679-726-03) </PackageDescription>
    <NDC11Code>64679-0726-01</NDC11Code>
    <ProductNDC>64679-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20061227</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077716</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ondansetron Injection is a 5-HT3 receptor antagonist indicated for the prevention of: : 1 nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. (1.1), 2 postoperative nausea and/or vomiting. (1.2).</IndicationAndUsage>
    <Description>The active ingredient in ondansetron injection, USP is ondansetron hydrochloride, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron HCl is a white to off-white powder that is soluble in water and normal saline. Each 1 mL of aqueous solution in the 2-mL single-dose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 9 mg of sodium chloride, USP; and 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers in Water for Injection, USP. Each 1 mL of aqueous solution in the 20-mL multi-dose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 8.3 mg of sodium chloride, USP; 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers; and 1.2 mg of methylparaben, NF and 0.15 mg of propylparaben, NF as preservatives in Water for Injection, USP. Ondansetron injection is a clear, colorless, nonpyrogenic, sterile solution for intravenous use. The pH of the injection solution is 3.3 to 4.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>71288-726-52</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (71288-726-52)  / 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>71288-0726-52</NDC11Code>
    <ProductNDC>71288-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERINEURAL</RouteName>
    <StartMarketingDate>20230623</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216039</ApplicationNumber>
    <LabelerName>Meitheal Pharmaceuticals Inc</LabelerName>
    <SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-06-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230623</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupivacaine Hydrochloride Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)]. Limitations of Use. Not all blocks are indicated for use with Bupivacaine Hydrochloride Injection given clinically significant risks associated with use [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.4, 5.5, 5.7, 5.9)].</IndicationAndUsage>
    <Description>Bupivacaine Hydrochloride Injection, USP contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Bupivacaine Hydrochloride Injection, USP is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. Multiple dose vials contain methylparaben [see Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. Bupivacaine Hydrochloride Injection, USP is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4.0 and 6.5, in water for injection. For the multiple dose vials, each mL also contains 1 mg methylparaben as preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>72275-726-77</NDCCode>
    <PackageDescription>1 PACKAGE in 1 CARTON (72275-726-77)  &gt; 20 PACKAGE in 1 PACKAGE &gt; 20 TUBE in 1 PACKAGE &gt; 1 KIT in 1 TUBE *  30 g in 1 TUBE *  30 g in 1 TUBE *  30 g in 1 TUBE</PackageDescription>
    <NDC11Code>72275-0726-77</NDC11Code>
    <ProductNDC>72275-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prilovixil</ProprietaryName>
    <ProprietaryNameSuffix>Plus</ProprietaryNameSuffix>
    <NonProprietaryName>Lidocaine 2.5% And Prilocaine 2.5%</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200120</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Primary Pharmaceuticals, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lidocaine and prilocaine cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on. - normal intact skin for local analgesia. - genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. Lidocaine and prilocaine cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS).</IndicationAndUsage>
    <Description>Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine cream in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 5 gram and 30 gram tubes. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure. Prilocaine is chemically designated as propanamide, N-(2-methylphenyl)-2-(propylamino), has an octanol: water partition ratio of 25 at pH 7.4, and has the following structure. Each gram of lidocaine and prilocaine cream contains lidocaine 25 mg, prilocaine 25 mg, polyoxyethylene fatty acid esters (as emulsifiers), carboxypolymethylene (as a thickening agent), sodium hydroxide to adjust to a pH approximating 9, and purified water to 1 gram. Lidocaine and prilocaine cream contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine and prilocaine cream is 1.00.</Description>
  </NDC>
  <NDC>
    <NDCCode>51114-0214-5</NDCCode>
    <PackageDescription>1600 POWDER in 1 CONTAINER (51114-0214-5) </PackageDescription>
    <NDC11Code>51114-0214-05</NDC11Code>
    <ProductNDC>51114-0214</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Psyllium Husk</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20140306</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Vovantis Laboratories Private Limited</LabelerName>
    <SubstanceName>PSYLLIUM HUSK</SubstanceName>
    <StrengthNumber>3.4</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-03-12</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>06-MAR-14</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>51114-0218-6</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (51114-0218-6)  / 32 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
    <NDC11Code>51114-0218-06</NDC11Code>
    <ProductNDC>51114-0218</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
    <StartMarketingDate>20150209</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Vovantis Laboratories Private Limited</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-03-12</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>09-FEB-15</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>51114-0219-6</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (51114-0219-6)  / 32 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
    <NDC11Code>51114-0219-06</NDC11Code>
    <ProductNDC>51114-0219</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
    <StartMarketingDate>20150209</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Vovantis Laboratories Private Limited</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-03-12</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>09-FEB-15</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>51114-0220-6</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (51114-0220-6)  / 32 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
    <NDC11Code>51114-0220-06</NDC11Code>
    <ProductNDC>51114-0220</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
    <StartMarketingDate>20150209</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Vovantis Laboratories Private Limited</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-03-12</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>09-FEB-15</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>51114-0221-6</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (51114-0221-6)  / 32 BLISTER PACK in 1 POUCH / 4 TABLET, EFFERVESCENT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>51114-0221-06</NDC11Code>
    <ProductNDC>51114-0221</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
    <StartMarketingDate>20150209</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Vovantis Laboratories Private Limited</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-10-16</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>09-FEB-15</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>51114-0222-6</NDCCode>
    <PackageDescription>175 PACKAGE in 1 CONTAINER (51114-0222-6)  / 10 BLISTER PACK in 1 PACKAGE / 2 TABLET, EFFERVESCENT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>51114-0222-06</NDC11Code>
    <ProductNDC>51114-0222</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
    <StartMarketingDate>20150515</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Vovantis Laboratories Private Limited</LabelerName>
    <SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>250; 2; 10; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-03-12</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>15-MAY-15</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>51114-0225-1</NDCCode>
    <PackageDescription>1000 TABLET in 1 POUCH (51114-0225-1) </PackageDescription>
    <NDC11Code>51114-0225-01</NDC11Code>
    <ProductNDC>51114-0225</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Sennosides</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <StartMarketingDate>20220228</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Vovantis Laboratories Private Limited</LabelerName>
    <SubstanceName>SENNOSIDES</SubstanceName>
    <StrengthNumber>8.6</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-03-12</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>28-FEB-22</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>51114-0450-5</NDCCode>
    <PackageDescription>25 g in 1 DRUM (51114-0450-5) </PackageDescription>
    <NDC11Code>51114-0450-05</NDC11Code>
    <ProductNDC>51114-0450</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide</NonProprietaryName>
    <DosageFormName>GRANULE</DosageFormName>
    <StartMarketingDate>20260101</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Vovantis Laboratories Private Limited</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
    <StrengthNumber>500; 20</StrengthNumber>
    <StrengthUnit>mg/.9g; mg/.9g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-09-25</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-JAN-26</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>51114-0451-5</NDCCode>
    <PackageDescription>25 g in 1 DRUM (51114-0451-5) </PackageDescription>
    <NDC11Code>51114-0451-05</NDC11Code>
    <ProductNDC>51114-0451</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide</NonProprietaryName>
    <DosageFormName>GRANULE</DosageFormName>
    <StartMarketingDate>20260101</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Vovantis Laboratories Private Limited</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
    <StrengthNumber>650; 20</StrengthNumber>
    <StrengthUnit>mg/.9g; mg/.9g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-09-25</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-JAN-26</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>51114-0452-5</NDCCode>
    <PackageDescription>25 g in 1 DRUM (51114-0452-5) </PackageDescription>
    <NDC11Code>51114-0452-05</NDC11Code>
    <ProductNDC>51114-0452</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Chlorpheniramine Maleate</NonProprietaryName>
    <DosageFormName>GRANULE</DosageFormName>
    <StartMarketingDate>20260101</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Vovantis Laboratories Private Limited</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE</SubstanceName>
    <StrengthNumber>500; 20; 2</StrengthNumber>
    <StrengthUnit>mg/.9g; mg/.9g; mg/.9g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-09-25</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-JAN-26</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>51114-0453-5</NDCCode>
    <PackageDescription>25 g in 1 DRUM (51114-0453-5) </PackageDescription>
    <NDC11Code>51114-0453-05</NDC11Code>
    <ProductNDC>51114-0453</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide</NonProprietaryName>
    <DosageFormName>GRANULE</DosageFormName>
    <StartMarketingDate>20260101</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Vovantis Laboratories Private Limited</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
    <StrengthNumber>1000; 30</StrengthNumber>
    <StrengthUnit>mg/1.5g; mg/1.5g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-09-25</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-JAN-26</StartMarketingDatePackage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>51114-0726-9</NDCCode><NonProprietaryName>Pyrantel Pamoate</NonProprietaryName></NDC><NDC><NDCCode>51114-0725-9</NDCCode><NonProprietaryName>Pyrantel Pamoate</NonProprietaryName></NDC><NDC><NDCCode>15455-0726-1</NDCCode><NonProprietaryName>Diclofenac Sodium</NonProprietaryName></NDC><NDC><NDCCode>69968-0726-9</NDCCode><ProprietaryName>Johnson And Johnson First Aid All Purpose</ProprietaryName><NonProprietaryName>Acetaminophen, Diphenhydramine Hydrochloride, Zinc Acetate, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42747-726-01</NDCCode><ProprietaryName>Sancuso</ProprietaryName><NonProprietaryName>Granisetron</NonProprietaryName></NDC><NDC><NDCCode>42747-726-72</NDCCode><ProprietaryName>Sancuso</ProprietaryName><NonProprietaryName>Granisetron</NonProprietaryName></NDC><NDC><NDCCode>43419-726-09</NDCCode><ProprietaryName>Laneige Forever Definite Compact Foundation No.1</ProprietaryName><NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>46708-726-30</NDCCode><ProprietaryName>Diltiazem Hydrochloride</ProprietaryName><NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>46708-726-90</NDCCode><ProprietaryName>Diltiazem Hydrochloride</ProprietaryName><NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>46708-726-91</NDCCode><ProprietaryName>Diltiazem Hydrochloride</ProprietaryName><NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>49281-726-10</NDCCode><ProprietaryName>Flublok Trivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/missouri/11/2025 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/darwin/1415/2025 (h3n2) Recombinant Hemagglutinin Antigen, And Influenza B Virus B/pennsylvania/14/2025 Recombinant Hemagglutinin Antigen</NonProprietaryName></NDC><NDC><NDCCode>55648-726-01</NDCCode><ProprietaryName>Ondansetron Hydrochloride</ProprietaryName><NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>59923-726-30</NDCCode><ProprietaryName>Erlotinib</ProprietaryName><NonProprietaryName>Erlotinib</NonProprietaryName></NDC><NDC><NDCCode>62332-726-30</NDCCode><ProprietaryName>Diltiazem Hydrochloride</ProprietaryName><NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>62332-726-90</NDCCode><ProprietaryName>Diltiazem Hydrochloride</ProprietaryName><NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>62332-726-91</NDCCode><ProprietaryName>Diltiazem Hydrochloride</ProprietaryName><NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>64679-726-01</NDCCode><ProprietaryName>Ondansetron Hydrochloride</ProprietaryName><NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71288-726-52</NDCCode><ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName><NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>72275-726-77</NDCCode><ProprietaryName>Prilovixil</ProprietaryName><NonProprietaryName>Lidocaine 2.5% And Prilocaine 2.5%</NonProprietaryName></NDC><NDC><NDCCode>51114-0214-5</NDCCode><NonProprietaryName>Psyllium Husk</NonProprietaryName></NDC><NDC><NDCCode>51114-0218-6</NDCCode><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>51114-0219-6</NDCCode><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>51114-0220-6</NDCCode><NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>51114-0221-6</NDCCode><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>51114-0222-6</NDCCode><NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>51114-0225-1</NDCCode><NonProprietaryName>Sennosides</NonProprietaryName></NDC><NDC><NDCCode>51114-0450-5</NDCCode><NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>51114-0451-5</NDCCode><NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>51114-0452-5</NDCCode><NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Chlorpheniramine Maleate</NonProprietaryName></NDC><NDC><NDCCode>51114-0453-5</NDCCode><NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide</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.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "EnumerationDate": "05/04/2007",
      "LastUpdateDate": "07/08/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "LicenseNumber1": "MD00039796",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1659320539",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MONTECILLO",
      "FirstName": "RANIA",
      "MiddleName": "B",
      "NamePrefix": "DR.",
      "Credential": "OD",
      "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": "05/09/2006",
      "LastUpdateDate": "12/19/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3680",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1427560267",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ABOU SHADI",
      "FirstName": "RANIA",
      "NamePrefix": "MRS.",
      "Credential": "RPH",
      "FirstLineMailingAddress": "8862 161ST AVENUE NE",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-883-9532",
      "MailingAddressFaxNumber": "425-882-2743",
      "FirstLinePracticeLocationAddress": "8862 161ST AVENUE NE",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-883-9532",
      "PracticeLocationAddressFaxNumber": "425-882-2743",
      "EnumerationDate": "11/02/2017",
      "LastUpdateDate": "11/02/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "3336C0003X",
      "Taxonomy1": "Community/Retail Pharmacy",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1528050523",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "DESCHUTES EYE CLINIC PC",
      "OtherOrgName": "THE EYE SURGERY INSTITUTE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "813 SW HIGHLAND AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-3123",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-548-7170",
      "MailingAddressFaxNumber": "541-548-3842",
      "FirstLinePracticeLocationAddress": "813 SW HIGHLAND AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-3123",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-548-7170",
      "PracticeLocationAddressFaxNumber": "541-548-3842",
      "EnumerationDate": "08/17/2005",
      "LastUpdateDate": "12/01/2010",
      "AuthorizedOfficialLastName": "TRAUSTASON",
      "AuthorizedOfficialFirstName": "OLI",
      "AuthorizedOfficialMiddleName": "I",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "541-548-7170",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "053857000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "OR",
      "OtherIdentifierIssuer1": "REGENCE BCBS",
      "OtherIdentifier2": "CJ8770",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OR",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE",
      "OtherIdentifier3": "38080A",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "OR",
      "OtherIdentifierIssuer3": "CLEAR CHOICE",
      "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": "1477596252",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE CARE SPECIALISTS NORTHWEST PLLC",
      "OtherOrgName": "THE CHILDRENS EYE DOCTORS, THE FAMILY EYE DOCTORS, WOODLAWN OPTICAL",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "17130 AVONDALE WAY NE",
      "SecondLineMailingAddress": "SUITE 111",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-6600",
      "MailingAddressFaxNumber": "425-885-6580",
      "FirstLinePracticeLocationAddress": "17130 AVONDALE WAY NE",
      "SecondLinePracticeLocationAddress": "SUITE 111",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-6600",
      "PracticeLocationAddressFaxNumber": "425-885-6580",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "03/03/2008",
      "AuthorizedOfficialLastName": "LENART",
      "AuthorizedOfficialFirstName": "THOMAS",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "MD PHD",
      "AuthorizedOfficialTelephoneNumber": "425-885-6600",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "156FX1800X",
      "Taxonomy2": "Optician",
      "PrimaryTaxonomySwitch2": "N",
      "TaxonomyCode3": "207W00000X",
      "Taxonomy3": "Ophthalmology",
      "PrimaryTaxonomySwitch3": "Y",
      "OtherIdentifier1": "1568514032",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "NPI",
      "OtherIdentifier2": "1740297829",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierIssuer2": "NPI",
      "OtherIdentifier3": "1205989522",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "NPI",
      "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.",
      "HealthcareProviderTaxonomyGroup2": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription2": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup3": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription3": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1215029343",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE HEALTH PROFESSIONALS, P.C.",
      "FirstLineMailingAddress": "85 BARNES RD",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "WALLINGFORD",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06492-1832",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "203-284-9448",
      "MailingAddressFaxNumber": "203-269-1361",
      "FirstLinePracticeLocationAddress": "85 BARNES RD",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "WALLINGFORD",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06492-1832",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "203-284-9448",
      "PracticeLocationAddressFaxNumber": "203-269-1361",
      "EnumerationDate": "09/28/2006",
      "LastUpdateDate": "03/07/2008",
      "AuthorizedOfficialLastName": "REDMOND",
      "AuthorizedOfficialFirstName": "JOHN",
      "AuthorizedOfficialMiddleName": "W",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "203-284-9448",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "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": "1982789863",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "OVERLAKE EYE DESIGNS, P.C.",
      "FirstLineMailingAddress": "15230 NE 24TH ST STE Q",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-5540",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-562-2015",
      "MailingAddressFaxNumber": "425-562-2010",
      "FirstLinePracticeLocationAddress": "15230 NE 24TH ST STE Q",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-5540",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-562-2015",
      "PracticeLocationAddressFaxNumber": "425-562-2010",
      "EnumerationDate": "10/26/2006",
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      "PracticeLocationAddressPostalCode": "32810-3002",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "407-905-8827",
      "PracticeLocationAddressFaxNumber": "407-645-4587",
      "EnumerationDate": "02/28/2006",
      "LastUpdateDate": "07/28/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1223G0001X",
      "Taxonomy1": "General Practice",
      "LicenseNumber1": "DN15582",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "122300000X",
      "Taxonomy2": "Dentist",
      "LicenseNumber2": "DN15582",
      "LicenseNumberStateCode2": "FL",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "075156100",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "FL"
    },
    {
      "NPI": "1720032899",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ALBATAINEH",
      "FirstName": "RANIA",
      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
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}
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