RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (43 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "55566-6500-3",
      "PackageDescription": "1 CARTON in 1 CARTON (55566-6500-3)  / 21 BLISTER PACK in 1 CARTON (55566-6500-2)  / 1 INSERT in 1 BLISTER PACK (55566-6500-1) ",
      "NDC11Code": "55566-6500-03",
      "ProductNDC": "55566-6500",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Endometrin",
      "NonProprietaryName": "Progesterone",
      "DosageFormName": "INSERT",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "20070621",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022057",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "PROGESTERONE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Progesterone [CS], Progesterone [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20070621",
      "SamplePackage": "N",
      "IndicationAndUsage": "ENDOMETRIN® is indicated, as part of an Assisted Reproductive Technology (ART) treatment program, to support embryo implantation in infertile women less than 35 years of age by supplementation of corpus luteal function and to maintain pregnancy after implantation up to 10 weeks.",
      "Description": "ENDOMETRIN (progesterone) vaginal insert contains micronized progesterone. ENDOMETRIN is supplied with polyethylene vaginal applicators. The active ingredient, progesterone, is present (100 mg) along with inactive ingredients. The chemical name for progesterone is pregn-4-ene-3,20-dione, its empirical formula is C21H30O2, its molecular weight is 314.5. Progesterone exists in two polymorphic forms. The form used in ENDOMETRIN, the alpha-form, has a melting point of 127-131°C. The structural formula is. Each ENDOMETRIN vaginal insert delivers 100 mg of progesterone in a base containing lactose monohydrate, polyvinylpyrrolidone, adipic acid, sodium bicarbonate, sodium lauryl sulfate, magnesium stearate, pregelatinized starch, and colloidal silicon dioxide."
    },
    {
      "NDCCode": "55566-6500-8",
      "PackageDescription": "1 CARTON in 1 CARTON (55566-6500-8)  / 21 BLISTER PACK in 1 CARTON (55566-6500-7)  / 1 INSERT in 1 BLISTER PACK (55566-6500-4) ",
      "NDC11Code": "55566-6500-08",
      "ProductNDC": "55566-6500",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Endometrin",
      "NonProprietaryName": "Progesterone",
      "DosageFormName": "INSERT",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "20070621",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022057",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "PROGESTERONE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Progesterone [CS], Progesterone [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20070621",
      "SamplePackage": "Y",
      "IndicationAndUsage": "ENDOMETRIN® is indicated, as part of an Assisted Reproductive Technology (ART) treatment program, to support embryo implantation in infertile women less than 35 years of age by supplementation of corpus luteal function and to maintain pregnancy after implantation up to 10 weeks.",
      "Description": "ENDOMETRIN (progesterone) vaginal insert contains micronized progesterone. ENDOMETRIN is supplied with polyethylene vaginal applicators. The active ingredient, progesterone, is present (100 mg) along with inactive ingredients. The chemical name for progesterone is pregn-4-ene-3,20-dione, its empirical formula is C21H30O2, its molecular weight is 314.5. Progesterone exists in two polymorphic forms. The form used in ENDOMETRIN, the alpha-form, has a melting point of 127-131°C. The structural formula is. Each ENDOMETRIN vaginal insert delivers 100 mg of progesterone in a base containing lactose monohydrate, polyvinylpyrrolidone, adipic acid, sodium bicarbonate, sodium lauryl sulfate, magnesium stearate, pregelatinized starch, and colloidal silicon dioxide."
    },
    {
      "NDCCode": "55566-5050-1",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (55566-5050-1)  > 10 TABLET in 1 BLISTER PACK (55566-5050-0) ",
      "NDC11Code": "55566-5050-01",
      "ProductNDC": "55566-5050",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nocdurna",
      "NonProprietaryName": "Desmopressin Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "SUBLINGUAL",
      "StartMarketingDate": "20181022",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022517",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "DESMOPRESSIN ACETATE",
      "StrengthNumber": "27.7",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20181022",
      "EndMarketingDatePackage": "20220731",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55566-5070-1",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (55566-5070-1)  / 10 TABLET in 1 BLISTER PACK (55566-5070-0) ",
      "NDC11Code": "55566-5070-01",
      "ProductNDC": "55566-5070",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nocdurna",
      "NonProprietaryName": "Desmopressin Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "SUBLINGUAL",
      "StartMarketingDate": "20181022",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022517",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "DESMOPRESSIN ACETATE",
      "StrengthNumber": "55.3",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-03-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20181022",
      "EndMarketingDatePackage": "20230228",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55566-8401-1",
      "PackageDescription": "2 VIAL, GLASS in 1 CARTON (55566-8401-1)  > 3 mL in 1 VIAL, GLASS (55566-8401-0)",
      "NDC11Code": "55566-8401-01",
      "ProductNDC": "55566-8401",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Firmagon",
      "NonProprietaryName": "Degarelix",
      "DosageFormName": "POWDER, METERED",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20090302",
      "EndMarketingDate": "20150331",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022201",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "DEGARELIX ACETATE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-04-03"
    },
    {
      "NDCCode": "55566-8401-2",
      "PackageDescription": "2 VIAL, GLASS in 1 CARTON (55566-8401-2)  > 3 mL in 1 VIAL, GLASS (55566-8401-0)",
      "NDC11Code": "55566-8401-02",
      "ProductNDC": "55566-8401",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Firmagon",
      "NonProprietaryName": "Degarelix",
      "DosageFormName": "POWDER, METERED",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20090302",
      "EndMarketingDate": "20150331",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022201",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "DEGARELIX ACETATE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-04-03"
    },
    {
      "NDCCode": "55566-8403-1",
      "PackageDescription": "1 KIT in 1 CARTON (55566-8403-1)  *  3 mL in 1 SYRINGE *  3 mL in 1 VIAL, GLASS",
      "NDC11Code": "55566-8403-01",
      "ProductNDC": "55566-8403",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Firmagon",
      "NonProprietaryName": "Degarelix",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20090302",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022201",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20090302",
      "SamplePackage": "N",
      "IndicationAndUsage": "FIRMAGON® is indicated for treatment of patients with advanced prostate cancer.",
      "Description": "FIRMAGON is a sterile lyophilized powder for injection containing degarelix (as the acetate) and mannitol. Degarelix is a synthetic linear decapeptide amide containing seven unnatural amino acids, five of which are D-amino acids. The acetate salt of degarelix is a white to off-white amorphous powder of low density as obtained after lyophilization. The chemical name of degarelix is D-Alaninamide, N-acetyl-3-(2-naphthalenyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridinyl)-D-alanyl-L-seryl-4-[[[(4S)-hexahydro-2,6-dioxo-4-pyrimidinyl]carbonyl]amino]-L phenylalanyl-4-[(aminocarbonyl)amino]-D-phenylalanyl-L-leucyl-N6–(1-methylethyl)-L-lysyl-L-prolyl. It has an empirical formula of C82H103N18O16Cl and a molecular weight of 1632.3 Da. Degarelix acetate has the following structural formula. FIRMAGON is available in two packaging configurations: 1 Starting Dose: Two vial carton with each vial delivering 120 mg of degarelix (equivalent to the median value of 126 mg degarelix acetate). Each 120 mg dose contains 150 mg mannitol., 2 Maintenance Dose: One-vial carton delivering 80 mg of degarelix (equivalent to the median value of 84 mg degarelix acetate). Each 80 mg dose contains 200 mg mannitol."
    },
    {
      "NDCCode": "0113-6500-00",
      "PackageDescription": "3 BOTTLE in 1 CARTON (0113-6500-00)  / 60 mL in 1 BOTTLE (0113-6500-30) ",
      "NDC11Code": "00113-6500-00",
      "ProductNDC": "0113-6500",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Good Sense Hair Regrowth Treatment",
      "NonProprietaryName": "Minoxidil",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20251024",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075357",
      "LabelerName": "L. Perrigo Company",
      "SubstanceName": "MINOXIDIL",
      "StrengthNumber": "2",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251024",
      "SamplePackage": "N",
      "IndicationAndUsage": "to regrow hair on the scalp."
    },
    {
      "NDCCode": "0113-6500-30",
      "PackageDescription": "3 BOTTLE in 1 CARTON (0113-6500-30)  / 60 mL in 1 BOTTLE (0113-6500-00) ",
      "NDC11Code": "00113-6500-30",
      "ProductNDC": "0113-6500",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Good Sense Hair Regrowth Treatment",
      "NonProprietaryName": "Minoxidil",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20251024",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075357",
      "LabelerName": "L. Perrigo Company",
      "SubstanceName": "MINOXIDIL",
      "StrengthNumber": "2",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251024",
      "SamplePackage": "N",
      "IndicationAndUsage": "to regrow hair on the scalp."
    },
    {
      "NDCCode": "50090-6500-0",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (50090-6500-0)  / 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "50090-6500-00",
      "ProductNDC": "50090-6500",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clomid",
      "NonProprietaryName": "Clomiphene Citrate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220909",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075528",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "CLOMIPHENE CITRATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230524",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clomiphene citrate is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiphene citrate therapy. Those patients most likely to achieve success with clomiphene therapy include patients with polycystic ovary syndrome (see WARNINGS: Ovarian Hyperstimulation Syndrome), amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology. Properly timed coitus in relationship to ovulation is important. A basal body temperature graph or other appropriate tests may help the patient and her physician determine if ovulation occurred. Once ovulation has been established, each course of clomiphene citrate should be started on or about the 5th day of the cycle. Long-term cyclic therapy is not recommended beyond a total of about six cycles (including three ovulatory cycles). (See DOSAGE AND ADMINISTRATION and PRECAUTIONS.). Clomiphene citrate is indicated only in patients with demonstrated ovulatory dysfunction who meet the conditions described below. 1. Patients who are not pregnant. 2. Patients without ovarian cysts. Clomiphene citrate should not be used in patients with ovarian enlargement except those with polycystic ovary syndrome. Pelvic examination is necessary prior to the first and each subsequent course of clomiphene citrate treatment. 3. Patients without abnormal vaginal bleeding. If abnormal vaginal bleeding is present, the patient should be carefully evaluated to ensure that neoplastic lesions are not present. 4. Patients with normal liver function. In addition, patients selected for clomiphene citrate therapy should be evaluated in regard to the following. 1. Estrogen Levels. Patients should have adequate levels of endogenous estrogen (as estimated from vaginal smears, endometrial biopsy, assay of urinary estrogen, or from bleeding in response to progesterone). Reduced estrogen levels, while less favorable, do not preclude successful therapy. 2. Primary Pituitary or Ovarian Failure. Clomiphene citrate therapy cannot be expected to substitute for specific treatment of other causes of ovulatory failure. 3. Endometriosis and Endometrial Carcinoma. The incidence of endometriosis and endometrial carcinoma increases with age as does the incidence of ovulatory disorders. Endometrial biopsy should always be performed prior to clomiphene citrate therapy in this population. 4. Other Impediments to Pregnancy. Impediments to pregnancy can include thyroid disorders, adrenal disorders, hyperprolactinemia, and male factor infertility. 5. Uterine Fibroids. Caution should be exercised when using clomiphene citrate in patients with uterine fibroids due to the potential for further enlargement of the fibroids. There are no adequate or well-controlled studies that demonstrate the effectiveness of clomiphene citrate in the treatment of male infertility. In addition, testicular tumors and gynecomastia have been reported in males using clomiphene. The cause and effect relationship between reports of testicular tumors and the administration of clomiphene citrate is not known. Although the medical literature suggests various methods, there is no universally accepted standard regimen for combined therapy (i.e., clomiphene citrate in conjunction with other ovulation-inducing drugs). Similarly, there is no standard clomiphene citrate regimen for ovulation induction  in vitro fertilization programs to produce ova for fertilization and reintroduction. Therefore, clomiphene citrate is not recommended for these uses.",
      "Description": "Clomid TM (clomiphene citrate) Tablets, USP is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-[p-(2-chloro-1,2-diphenylvinyl)phenoxy] triethylamine citrate (1:1). It has the molecular formula of C 26H 28CINO  C 6H 8O 7 and a molecular weight of 598.10. It is represented structurally as:. Clomiphene citrate is a white to pale yellow, essentially odorless, crystalline powder. It is freely soluble in methanol; soluble in ethanol; slightly soluble in acetone, water, and chloroform; and insoluble in ether. Clomiphene citrate is a mixture of two geometric isomers [cis (zuclomiphene) and trans (enclomiphene)] containing between 30% and 50% of the cis-isomer. Each off-white debossed tablet contains 50 mg Clomid  TM (clomiphene citrate) USP. The tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized corn starch, and sucrose."
    },
    {
      "NDCCode": "60232-6500-3",
      "PackageDescription": "85 g in 1 TUBE (60232-6500-3)",
      "NDC11Code": "60232-6500-03",
      "ProductNDC": "60232-6500",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Elta Block",
      "ProprietaryNameSuffix": "Spf 30 Waterproof",
      "NonProprietaryName": "Zinc Oxide, Octinoxate, Octisalate",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20020430",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Swiss-American Products",
      "SubstanceName": "OCTINOXATE; OCTISALATE; ZINC OXIDE",
      "StrengthNumber": "75; 50; 45",
      "StrengthUnit": "g/1000g; g/1000g; g/1000g",
      "Status": "Deprecated",
      "LastUpdate": "2015-08-14"
    },
    {
      "NDCCode": "61281-6500-3",
      "PackageDescription": "25 kg in 1 DRUM (61281-6500-3) ",
      "NDC11Code": "61281-6500-03",
      "ProductNDC": "61281-6500",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Dextromethorphan Hydrobromide",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20170131",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Supriya Lifescience Limited",
      "SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2022-11-30",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "31-JAN-17"
    },
    {
      "NDCCode": "62670-6500-3",
      "PackageDescription": "236 mL in 1 BOTTLE, PUMP (62670-6500-3) ",
      "NDC11Code": "62670-6500-03",
      "ProductNDC": "62670-6500",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Anti-bacterial Hand",
      "ProprietaryNameSuffix": "Sunrise Woods",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20221220",
      "EndMarketingDate": "20230620",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Bath & Body Works, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "68",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-06-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20221220",
      "EndMarketingDatePackage": "20230620",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55566-1010-1",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (55566-1010-1)  / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE",
      "NDC11Code": "55566-1010-01",
      "ProductNDC": "55566-1010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fyremadel",
      "NonProprietaryName": "Ganirelix Acetate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20220228",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204246",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "GANIRELIX ACETATE",
      "StrengthNumber": "250",
      "StrengthUnit": "ug/.5mL",
      "Pharm_Classes": "Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ganirelix acetate injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.",
      "Description": "FYREMADEL (ganirelix acetate) injection is a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotropin-releasing hormone (GnRH). Ganirelix acetate is derived from native GnRH with substitutions of amino acids at positions 1, 2, 3, 6, 8, and 10 to form the following molecular formula of the peptide: N-acetyl-3-(2-naphthyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridyl)-D-alanyl-L-seryl-L-tyrosyl-N9,N10-diethyl-D-homoarginyl-L-leucyl-N9,N10-diethyl-L-homoarginyl-L-prolyl-D-alanylamide acetate. The molecular weight for ganirelix acetate is 1570.4 as an anhydrous free base. The structural formula is as follows. Ganirelix Acetate. FYREMADEL (ganirelix acetate) injection is supplied as a colorless, sterile, ready-to-use, aqueous solution intended for SUBCUTANEOUS administration only. Each single-dose, sterile, prefilled syringe contains 250 mcg/0.5 mL of ganirelix acetate, 0.1 mg glacial acetic acid, 23.5 mg mannitol, and water for injection adjusted to pH 5 with acetic acid and/or sodium hydroxide."
    },
    {
      "NDCCode": "55566-1050-1",
      "PackageDescription": "4 VIAL in 1 CARTON (55566-1050-1)  / 20 mL in 1 VIAL (55566-1050-0) ",
      "NDC11Code": "55566-1050-01",
      "ProductNDC": "55566-1050",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Adstiladrin",
      "NonProprietaryName": "Nadofaragene Firadenovec-vncg",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAVESICAL",
      "StartMarketingDate": "20230905",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125700",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "NADOFARAGENE FIRADENOVEC",
      "StrengthNumber": "300000000000",
      "StrengthUnit": "{VP}/mL",
      "Status": "Active",
      "LastUpdate": "2026-03-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230905",
      "SamplePackage": "N",
      "IndicationAndUsage": "ADSTILADRIN® is indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.",
      "Description": "ADSTILADRIN (nadofaragene firadenovec-vncg) is a non-replicating adenoviral vector-based gene therapy for intravesical instillation. It is a recombinant adenovirus serotype 5 vector containing a transgene encoding the human interferon alfa-2b (IFNα2b). ADSTILADRIN has a nominal concentration of 3 x 1011 vp/mL. A single-use vial of ADSTILADRIN contains an extractable volume of 20 mL and the following excipients: [N-(3-cholamidopropyl)-N-(3-lactobionamidopropyl)]-cholamide (Syn3) (0.95 mg/mL), citric acid monohydrate (0.01 mg/mL), glycerol (84 mg/mL), hydroxypropyl-beta-cyclodextrin (7.9 mg/mL), magnesium chloride hexahydrate (0.34 mg/mL), polysorbate 80 (Tween 80) (0.48 mg/mL), sodium dihydrogen phosphate dihydrate (1.4 mg/mL), sucrose (17 mg/mL), tri-sodium citrate dihydrate (0.04 mg/mL), tromethamine (1.4 mg/mL) and Water for Injection (q.s. 1 mL). ADSTILADRIN is a sterile, clear to opalescent suspension, and contains no preservative."
    },
    {
      "NDCCode": "55566-1050-2",
      "PackageDescription": "20 mL in 1 VIAL (55566-1050-2) ",
      "NDC11Code": "55566-1050-02",
      "ProductNDC": "55566-1050",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Adstiladrin",
      "NonProprietaryName": "Nadofaragene Firadenovec-vncg",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAVESICAL",
      "StartMarketingDate": "20230905",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125700",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "NADOFARAGENE FIRADENOVEC",
      "StrengthNumber": "300000000000",
      "StrengthUnit": "{VP}/mL",
      "Status": "Active",
      "LastUpdate": "2026-03-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251013",
      "SamplePackage": "N",
      "IndicationAndUsage": "ADSTILADRIN® is indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.",
      "Description": "ADSTILADRIN (nadofaragene firadenovec-vncg) is a non-replicating adenoviral vector-based gene therapy for intravesical instillation. It is a recombinant adenovirus serotype 5 vector containing a transgene encoding the human interferon alfa-2b (IFNα2b). ADSTILADRIN has a nominal concentration of 3 x 1011 vp/mL. A single-use vial of ADSTILADRIN contains an extractable volume of 20 mL and the following excipients: [N-(3-cholamidopropyl)-N-(3-lactobionamidopropyl)]-cholamide (Syn3) (0.95 mg/mL), citric acid monohydrate (0.01 mg/mL), glycerol (84 mg/mL), hydroxypropyl-beta-cyclodextrin (7.9 mg/mL), magnesium chloride hexahydrate (0.34 mg/mL), polysorbate 80 (Tween 80) (0.48 mg/mL), sodium dihydrogen phosphate dihydrate (1.4 mg/mL), sucrose (17 mg/mL), tri-sodium citrate dihydrate (0.04 mg/mL), tromethamine (1.4 mg/mL) and Water for Injection (q.s. 1 mL). ADSTILADRIN is a sterile, clear to opalescent suspension, and contains no preservative."
    },
    {
      "NDCCode": "55566-1501-1",
      "PackageDescription": "1 KIT in 1 CARTON (55566-1501-1)  *  1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL *  10 mL in 1 VIAL (55566-1700-0) ",
      "NDC11Code": "55566-1501-01",
      "ProductNDC": "55566-1501",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Novarel",
      "NonProprietaryName": "Gonadotrophin, Chorionic",
      "DosageFormName": "KIT",
      "StartMarketingDate": "19740115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA017016",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2024-05-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "19740115",
      "SamplePackage": "N",
      "IndicationAndUsage": "HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR \"NORMAL\" DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS. : 1 Prepubertal cryptorchidism not due to anatomic obstruction. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help to predict whether or not orchiopexy will be needed in the future. Although, in some cases, descent following HCG administration is permanent, in most cases the response is temporary. Therapy is usually instituted between the ages of 4 and 9., 2 Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males., 3 Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.",
      "Description": "Human chorionic gonadotropin (HCG), a polypeptide hormone produced by the human placenta, is composed of an alpha and a beta subunit. The alpha subunit is essentially identical to the alpha subunits of the human pituitary gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to the alpha subunit of human thyroid-stimulating hormone (TSH). The beta subunits of these hormones differ in amino acid sequence. NOVAREL (chorionic gonadotropin) for injection is a water soluble glycoprotein derived from human pregnancy urine and administered intramuscularly after reconstitution. The sterile lyophilized powder is stable. When reconstituted with Bacteriostatic Water for Injection preserved with benzyl alcohol 0.9%, the solution should be refrigerated and used within 30 days. Each 5,000 USP units vial contains. chorionic gonadotropin 5,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg. Each 10,000 USP units vial contains. chorionic gonadotropin 10,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg."
    },
    {
      "NDCCode": "55566-1502-1",
      "PackageDescription": "1 KIT in 1 CARTON (55566-1502-1)  *  1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL *  10 mL in 1 VIAL (55566-1700-0) ",
      "NDC11Code": "55566-1502-01",
      "ProductNDC": "55566-1502",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Novarel",
      "NonProprietaryName": "Gonadotrophin, Chorionic",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20170830",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA017016",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "Status": "Active",
      "LastUpdate": "2025-09-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170830",
      "SamplePackage": "N",
      "IndicationAndUsage": "HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR \"NORMAL\" DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS. : 1 Prepubertal cryptorchidism not due to anatomic obstruction. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help to predict whether or not orchiopexy will be needed in the future. Although, in some cases, descent following HCG administration is permanent, in most cases the response is temporary. Therapy is usually instituted between the ages of 4 and 9., 2 Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males., 3 Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.",
      "Description": "Human chorionic gonadotropin (HCG), a polypeptide hormone produced by the human placenta, is composed of an alpha and a beta subunit. The alpha subunit is essentially identical to the alpha subunits of the human pituitary gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to the alpha subunit of human thyroid-stimulating hormone (TSH). The beta subunits of these hormones differ in amino acid sequence. NOVAREL (chorionic gonadotropin) for injection is a water soluble glycoprotein derived from human pregnancy urine and administered intramuscularly after reconstitution. The sterile lyophilized powder is stable. When reconstituted with Bacteriostatic Water for Injection preserved with benzyl alcohol 0.9%, the solution should be refrigerated and used within 30 days. Each 5,000 USP units vial contains. chorionic gonadotropin 5,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg. Each 10,000 USP units vial contains. chorionic gonadotropin 10,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg."
    },
    {
      "NDCCode": "55566-2200-0",
      "PackageDescription": "10 AMPULE in 1 CARTON (55566-2200-0)  > 1 mL in 1 AMPULE",
      "NDC11Code": "55566-2200-00",
      "ProductNDC": "55566-2200",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ddavp",
      "NonProprietaryName": "Desmopressin Acetate",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19840501",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018938",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "DESMOPRESSIN ACETATE",
      "StrengthNumber": "4",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
      "Status": "Active",
      "LastUpdate": "2022-10-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19840501",
      "SamplePackage": "N",
      "IndicationAndUsage": "DDAVP Injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand's disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).",
      "Description": "DDAVP Injection (desmopressin acetate) is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows:. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2∙C2H4O2∙3H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. DDAVP solution for injection is a sterile solution in a 1 mL single-dose ampule: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. DDAVP solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH."
    },
    {
      "NDCCode": "55566-2300-0",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (55566-2300-0)  > 10 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "55566-2300-00",
      "ProductNDC": "55566-2300",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ddavp",
      "NonProprietaryName": "Desmopressin Acetate",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19840501",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018938",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "DESMOPRESSIN ACETATE",
      "StrengthNumber": "4",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
      "Status": "Active",
      "LastUpdate": "2022-10-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19840501",
      "SamplePackage": "N",
      "IndicationAndUsage": "DDAVP Injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand's disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).",
      "Description": "DDAVP Injection (desmopressin acetate) is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows:. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2∙C2H4O2∙3H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. DDAVP solution for injection is a sterile solution in a 1 mL single-dose ampule: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. DDAVP solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH."
    },
    {
      "NDCCode": "55566-2600-0",
      "PackageDescription": "1 BOTTLE in 1 CARTON (55566-2600-0)  / 100 TABLET in 1 BOTTLE",
      "NDC11Code": "55566-2600-00",
      "ProductNDC": "55566-2600",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ddavp",
      "NonProprietaryName": "Desmopressin Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950906",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019955",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "DESMOPRESSIN ACETATE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20080505",
      "SamplePackage": "N",
      "IndicationAndUsage": "DDAVP Tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. DDAVP is ineffective for the treatment of nephrogenic diabetes insipidus. Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to DDAVP can be monitored by measuring urine volume and osmolality.",
      "Description": "DDAVP® Tablets (desmopressin acetate) are a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2∙C2H4O2∙3H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. DDAVP Tablets contain either 0.1 or 0.2 mg desmopressin acetate. Inactive ingredients include: lactose, potato starch, magnesium stearate and povidone."
    },
    {
      "NDCCode": "55566-2700-0",
      "PackageDescription": "1 BOTTLE in 1 CARTON (55566-2700-0)  / 100 TABLET in 1 BOTTLE",
      "NDC11Code": "55566-2700-00",
      "ProductNDC": "55566-2700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ddavp",
      "NonProprietaryName": "Desmopressin Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950906",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019955",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "DESMOPRESSIN ACETATE",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20080505",
      "SamplePackage": "N",
      "IndicationAndUsage": "DDAVP Tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. DDAVP is ineffective for the treatment of nephrogenic diabetes insipidus. Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to DDAVP can be monitored by measuring urine volume and osmolality.",
      "Description": "DDAVP® Tablets (desmopressin acetate) are a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2∙C2H4O2∙3H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. DDAVP Tablets contain either 0.1 or 0.2 mg desmopressin acetate. Inactive ingredients include: lactose, potato starch, magnesium stearate and povidone."
    },
    {
      "NDCCode": "55566-2800-1",
      "PackageDescription": "1 POUCH in 1 CARTON (55566-2800-1)  / 10 mg in 1 POUCH (55566-2800-0) ",
      "NDC11Code": "55566-2800-01",
      "ProductNDC": "55566-2800",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cervidil",
      "NonProprietaryName": "Dinoprostone",
      "DosageFormName": "INSERT",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "19950330",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020411",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "DINOPROSTONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/241mg",
      "Pharm_Classes": "Prostaglandin Analog [EPC], Prostaglandins [CS]",
      "Status": "Active",
      "LastUpdate": "2023-06-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19950330",
      "SamplePackage": "N",
      "IndicationAndUsage": "CERVIDIL is indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor.",
      "Description": "CERVIDIL (dinoprostone) vaginal insert contains dinoprostone, a prostaglandin analog. Each vaginal insert contains 10 mg of dinoprostone in 241 mg of a cross-linked polyethylene oxide/urethane polymer (hydrogel polymer) that is semi-opaque, beige colored, flat, rectangular in shape with rounded corners and measuring 29 mm by 9.5 mm by 0.8 mm. The vaginal insert is contained within a pouch of an off-white knitted polyester yarn retrieval system. When placed in a moist environment, the yarn absorbs water, swells, and releases the enclosed dinoprostone. The knitted polyester retrieval system has a long tape-like end that is designed to aid retrieval of CERVIDIL at the end of the dosing interval or earlier if clinically indicated. The finished product is a controlled-release formulation that has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg per hour. The chemical name for dinoprostone (known as prostaglandin E2 or PGE2) is 11α,15S-dihydroxy-9-oxo-prosta-5Z,13E-dien-1-oic acid and the structural formula is represented below. The molecular formula is C20H32O5 and its molecular weight is 352.47. Dinoprostone occurs as a white to off-white crystalline powder. It has a melting point within the range of 65° to 69°C. Dinoprostone is soluble in ethanol and in 25% ethanol in water."
    },
    {
      "NDCCode": "55566-3000-0",
      "PackageDescription": "2.5 mL in 1 BOTTLE, SPRAY (55566-3000-0) ",
      "NDC11Code": "55566-3000-00",
      "ProductNDC": "55566-3000",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Stimate",
      "NonProprietaryName": "Desmopressin Acetate",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20250625",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020355",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "DESMOPRESSIN ACETATE",
      "StrengthNumber": "1.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
      "Status": "Active",
      "LastUpdate": "2026-07-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250625",
      "SamplePackage": "N",
      "IndicationAndUsage": "STIMATE is a vasopressin analog used for: 1 Hemophilia A - for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.1), 2 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2).",
      "Description": "STIMATE (desmopressin acetate) is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows. Molecular weight: 1183.34. Empirical formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. STIMATE is an aqueous solution for intranasal use.  Each mL contains: Benzalkonium chloride solution 0.1 mg, Citric acid monohydrate 1.7 mg, Desmopressin acetate 1.5 mg, Disodium phosphate dihydrate 3 mg, Purified water to 1 mL, Sodium chloride 7.5 mg."
    },
    {
      "NDCCode": "55566-6700-1",
      "PackageDescription": "2 BOTTLE in 1 CARTON (55566-6700-1)  > 160 mL in 1 BOTTLE (55566-6700-0) ",
      "NDC11Code": "55566-6700-01",
      "ProductNDC": "55566-6700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clenpiq",
      "NonProprietaryName": "Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180629",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209589",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "ANHYDROUS CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE",
      "StrengthNumber": "12; 3.5; 10",
      "StrengthUnit": "g/160mL; g/160mL; mg/160mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-09-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180629",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLENPIQ is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older.",
      "Description": "CLENPIQ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution is a stimulant and osmotic laxative that is provided as a cranberry-flavored, colorless to slightly yellow, clear solution with possible presence of visible particles. CLENPIQ is supplied as two bottles in each carton. Each bottle of CLENPIQ contains 10 mg sodium picosulfate, USP; 3.5 g magnesium oxide, USP; and 12 g anhydrous citric acid, USP. The product also contains the following inactive ingredients. acesulfame potassium, cranberry flavor, disodium edetate, malic acid, sodium benzoate, sodium hydroxide, sodium metabisulfite, sucralose, and water. The cranberry flavor contains glyceryl triacetate (triacetin), maltodextrin, and sodium octenyl succinated starch. The following is a description of the three active ingredients contained in CLENPIQ. Sodium picosulfate is a stimulant laxative."
    },
    {
      "NDCCode": "55566-6800-1",
      "PackageDescription": "2 BOTTLE in 1 CARTON (55566-6800-1)  / 175 mL in 1 BOTTLE (55566-6800-0) ",
      "NDC11Code": "55566-6800-01",
      "ProductNDC": "55566-6800",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clenpiq",
      "NonProprietaryName": "Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230329",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209589",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "SODIUM PICOSULFATE; MAGNESIUM OXIDE; ANHYDROUS CITRIC ACID",
      "StrengthNumber": "10; 3.5; 12",
      "StrengthUnit": "mg/175mL; g/175mL; g/175mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230329",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLENPIQ is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older.",
      "Description": "CLENPIQ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution is a stimulant and osmotic laxative that is provided as a cranberry-flavored, colorless to slightly yellow, clear solution with possible presence of visible particles. CLENPIQ is supplied as two bottles in each carton. Each bottle of CLENPIQ contains 10 mg sodium picosulfate, USP; 3.5 g magnesium oxide, USP; and 12 g anhydrous citric acid, USP. The product also contains the following inactive ingredients. acesulfame potassium, cranberry flavor, disodium edetate, malic acid, sodium benzoate, sodium hydroxide, sodium metabisulfite, sucralose, and water. The cranberry flavor contains glyceryl triacetate (triacetin), maltodextrin, and sodium octenyl succinated starch. The following is a description of the three active ingredients contained in CLENPIQ. Sodium picosulfate is a stimulant laxative."
    },
    {
      "NDCCode": "55566-6800-2",
      "PackageDescription": "2 BOTTLE in 1 CARTON (55566-6800-2)  / 175 mL in 1 BOTTLE (55566-6800-0) ",
      "NDC11Code": "55566-6800-02",
      "ProductNDC": "55566-6800",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clenpiq",
      "NonProprietaryName": "Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230329",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209589",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "SODIUM PICOSULFATE; MAGNESIUM OXIDE; ANHYDROUS CITRIC ACID",
      "StrengthNumber": "10; 3.5; 12",
      "StrengthUnit": "mg/175mL; g/175mL; g/175mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230330",
      "SamplePackage": "Y",
      "IndicationAndUsage": "CLENPIQ is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older.",
      "Description": "CLENPIQ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution is a stimulant and osmotic laxative that is provided as a cranberry-flavored, colorless to slightly yellow, clear solution with possible presence of visible particles. CLENPIQ is supplied as two bottles in each carton. Each bottle of CLENPIQ contains 10 mg sodium picosulfate, USP; 3.5 g magnesium oxide, USP; and 12 g anhydrous citric acid, USP. The product also contains the following inactive ingredients. acesulfame potassium, cranberry flavor, disodium edetate, malic acid, sodium benzoate, sodium hydroxide, sodium metabisulfite, sucralose, and water. The cranberry flavor contains glyceryl triacetate (triacetin), maltodextrin, and sodium octenyl succinated starch. The following is a description of the three active ingredients contained in CLENPIQ. Sodium picosulfate is a stimulant laxative."
    },
    {
      "NDCCode": "55566-8303-1",
      "PackageDescription": "1 KIT in 1 CARTON (55566-8303-1)  *  4 mL in 1 VIAL, GLASS *  4.2 mL in 1 SYRINGE",
      "NDC11Code": "55566-8303-01",
      "ProductNDC": "55566-8303",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Firmagon",
      "NonProprietaryName": "Degarelix",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20090302",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022201",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20090302",
      "SamplePackage": "N",
      "IndicationAndUsage": "FIRMAGON® is indicated for treatment of patients with advanced prostate cancer.",
      "Description": "FIRMAGON is a sterile lyophilized powder for injection containing degarelix (as the acetate) and mannitol. Degarelix is a synthetic linear decapeptide amide containing seven unnatural amino acids, five of which are D-amino acids. The acetate salt of degarelix is a white to off-white amorphous powder of low density as obtained after lyophilization. The chemical name of degarelix is D-Alaninamide, N-acetyl-3-(2-naphthalenyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridinyl)-D-alanyl-L-seryl-4-[[[(4S)-hexahydro-2,6-dioxo-4-pyrimidinyl]carbonyl]amino]-L phenylalanyl-4-[(aminocarbonyl)amino]-D-phenylalanyl-L-leucyl-N6–(1-methylethyl)-L-lysyl-L-prolyl. It has an empirical formula of C82H103N18O16Cl and a molecular weight of 1632.3 Da. Degarelix acetate has the following structural formula. FIRMAGON is available in two packaging configurations: 1 Starting Dose: Two vial carton with each vial delivering 120 mg of degarelix (equivalent to the median value of 126 mg degarelix acetate). Each 120 mg dose contains 150 mg mannitol., 2 Maintenance Dose: One-vial carton delivering 80 mg of degarelix (equivalent to the median value of 84 mg degarelix acetate). Each 80 mg dose contains 200 mg mannitol."
    },
    {
      "NDCCode": "55566-9300-2",
      "PackageDescription": "2 PACKET in 1 CARTON (55566-9300-2)  > 16.1 g in 1 PACKET (55566-9300-0) ",
      "NDC11Code": "55566-9300-02",
      "ProductNDC": "55566-9300",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prepopik",
      "NonProprietaryName": "Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid",
      "DosageFormName": "POWDER, METERED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120716",
      "EndMarketingDate": "20200531",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA202535",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "SODIUM PICOSULFATE; MAGNESIUM OXIDE; ANHYDROUS CITRIC ACID",
      "StrengthNumber": "10; 3.5; 12",
      "StrengthUnit": "mg/16.1g; g/16.1g; g/16.1g",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE],Stimulant Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20120716",
      "EndMarketingDatePackage": "20200531",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55566-9400-1",
      "PackageDescription": "2 POUCH in 1 CARTON (55566-9400-1)  > 7 d in 1 POUCH (55566-9400-0) ",
      "NDC11Code": "55566-9400-01",
      "ProductNDC": "55566-9400",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ferring Pharmaceuticals Inc.",
      "NonProprietaryName": "Progesterone",
      "DosageFormName": "RING",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "20220501",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA201110",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "PROGESTERONE",
      "StrengthNumber": "11",
      "StrengthUnit": "mg/d",
      "Pharm_Classes": "Progesterone [CS], Progesterone [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20220501",
      "SamplePackage": "N",
      "IndicationAndUsage": "MILPROSA is indicated to support embryo implantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women up to and including 34 years of age.",
      "Description": "MILPROSA (progesterone) vaginal system is a white to off-white, flexible, non-biodegradable silicone ring (toroidal-shaped) containing 1.78 grams of progesterone. MILPROSA has a cross-sectional diameter of approximately 8.5 mm, and an outer and inner diameter of approximately 55 mm and 38 mm, respectively. The chemical name for progesterone is pregn-4-ene-3,20-dione. It has an empirical formula of C21H30O2 and a molecular weight of 314.5. Progesterone has a melting point of 126-131°C. The structural formula is. When placed in the vagina, each vaginal system is estimated to provide an average release rate of 11 mg/day of progesterone over 7 days. The inactive components of the vaginal system are light mineral oil and silicone elastomer."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"55566-6500-3","ProprietaryName":"Endometrin","NonProprietaryName":"Progesterone"},{"NDCCode":"55566-6500-8","ProprietaryName":"Endometrin","NonProprietaryName":"Progesterone"},{"NDCCode":"55566-5050-1","ProprietaryName":"Nocdurna","NonProprietaryName":"Desmopressin Acetate"},{"NDCCode":"55566-5070-1","ProprietaryName":"Nocdurna","NonProprietaryName":"Desmopressin Acetate"},{"NDCCode":"55566-8401-1","ProprietaryName":"Firmagon","NonProprietaryName":"Degarelix"},{"NDCCode":"55566-8401-2","ProprietaryName":"Firmagon","NonProprietaryName":"Degarelix"},{"NDCCode":"55566-8403-1","ProprietaryName":"Firmagon","NonProprietaryName":"Degarelix"},{"NDCCode":"0113-6500-00","ProprietaryName":"Good Sense Hair Regrowth Treatment","NonProprietaryName":"Minoxidil"},{"NDCCode":"0113-6500-30","ProprietaryName":"Good Sense Hair Regrowth Treatment","NonProprietaryName":"Minoxidil"},{"NDCCode":"50090-6500-0","ProprietaryName":"Clomid","NonProprietaryName":"Clomiphene Citrate"},{"NDCCode":"60232-6500-3","ProprietaryName":"Elta Block","NonProprietaryName":"Zinc Oxide, Octinoxate, Octisalate"},{"NDCCode":"61281-6500-3","NonProprietaryName":"Dextromethorphan Hydrobromide"},{"NDCCode":"62670-6500-3","ProprietaryName":"Anti-bacterial Hand","NonProprietaryName":"Alcohol"},{"NDCCode":"55566-1010-1","ProprietaryName":"Fyremadel","NonProprietaryName":"Ganirelix Acetate"},{"NDCCode":"55566-1050-1","ProprietaryName":"Adstiladrin","NonProprietaryName":"Nadofaragene Firadenovec-vncg"},{"NDCCode":"55566-1050-2","ProprietaryName":"Adstiladrin","NonProprietaryName":"Nadofaragene Firadenovec-vncg"},{"NDCCode":"55566-1501-1","ProprietaryName":"Novarel","NonProprietaryName":"Gonadotrophin, Chorionic"},{"NDCCode":"55566-1502-1","ProprietaryName":"Novarel","NonProprietaryName":"Gonadotrophin, Chorionic"},{"NDCCode":"55566-2200-0","ProprietaryName":"Ddavp","NonProprietaryName":"Desmopressin Acetate"},{"NDCCode":"55566-2300-0","ProprietaryName":"Ddavp","NonProprietaryName":"Desmopressin Acetate"},{"NDCCode":"55566-2600-0","ProprietaryName":"Ddavp","NonProprietaryName":"Desmopressin Acetate"},{"NDCCode":"55566-2700-0","ProprietaryName":"Ddavp","NonProprietaryName":"Desmopressin Acetate"},{"NDCCode":"55566-2800-1","ProprietaryName":"Cervidil","NonProprietaryName":"Dinoprostone"},{"NDCCode":"55566-3000-0","ProprietaryName":"Stimate","NonProprietaryName":"Desmopressin Acetate"},{"NDCCode":"55566-6700-1","ProprietaryName":"Clenpiq","NonProprietaryName":"Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid"},{"NDCCode":"55566-6800-1","ProprietaryName":"Clenpiq","NonProprietaryName":"Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid"},{"NDCCode":"55566-6800-2","ProprietaryName":"Clenpiq","NonProprietaryName":"Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid"},{"NDCCode":"55566-8303-1","ProprietaryName":"Firmagon","NonProprietaryName":"Degarelix"},{"NDCCode":"55566-9300-2","ProprietaryName":"Prepopik","NonProprietaryName":"Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid"},{"NDCCode":"55566-9400-1","ProprietaryName":"Ferring Pharmaceuticals Inc.","NonProprietaryName":"Progesterone"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>55566-6500-3</NDCCode>
    <PackageDescription>1 CARTON in 1 CARTON (55566-6500-3)  / 21 BLISTER PACK in 1 CARTON (55566-6500-2)  / 1 INSERT in 1 BLISTER PACK (55566-6500-1) </PackageDescription>
    <NDC11Code>55566-6500-03</NDC11Code>
    <ProductNDC>55566-6500</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Endometrin</ProprietaryName>
    <NonProprietaryName>Progesterone</NonProprietaryName>
    <DosageFormName>INSERT</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>20070621</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022057</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PROGESTERONE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070621</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ENDOMETRIN® is indicated, as part of an Assisted Reproductive Technology (ART) treatment program, to support embryo implantation in infertile women less than 35 years of age by supplementation of corpus luteal function and to maintain pregnancy after implantation up to 10 weeks.</IndicationAndUsage>
    <Description>ENDOMETRIN (progesterone) vaginal insert contains micronized progesterone. ENDOMETRIN is supplied with polyethylene vaginal applicators. The active ingredient, progesterone, is present (100 mg) along with inactive ingredients. The chemical name for progesterone is pregn-4-ene-3,20-dione, its empirical formula is C21H30O2, its molecular weight is 314.5. Progesterone exists in two polymorphic forms. The form used in ENDOMETRIN, the alpha-form, has a melting point of 127-131°C. The structural formula is. Each ENDOMETRIN vaginal insert delivers 100 mg of progesterone in a base containing lactose monohydrate, polyvinylpyrrolidone, adipic acid, sodium bicarbonate, sodium lauryl sulfate, magnesium stearate, pregelatinized starch, and colloidal silicon dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-6500-8</NDCCode>
    <PackageDescription>1 CARTON in 1 CARTON (55566-6500-8)  / 21 BLISTER PACK in 1 CARTON (55566-6500-7)  / 1 INSERT in 1 BLISTER PACK (55566-6500-4) </PackageDescription>
    <NDC11Code>55566-6500-08</NDC11Code>
    <ProductNDC>55566-6500</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Endometrin</ProprietaryName>
    <NonProprietaryName>Progesterone</NonProprietaryName>
    <DosageFormName>INSERT</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>20070621</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022057</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PROGESTERONE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070621</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>ENDOMETRIN® is indicated, as part of an Assisted Reproductive Technology (ART) treatment program, to support embryo implantation in infertile women less than 35 years of age by supplementation of corpus luteal function and to maintain pregnancy after implantation up to 10 weeks.</IndicationAndUsage>
    <Description>ENDOMETRIN (progesterone) vaginal insert contains micronized progesterone. ENDOMETRIN is supplied with polyethylene vaginal applicators. The active ingredient, progesterone, is present (100 mg) along with inactive ingredients. The chemical name for progesterone is pregn-4-ene-3,20-dione, its empirical formula is C21H30O2, its molecular weight is 314.5. Progesterone exists in two polymorphic forms. The form used in ENDOMETRIN, the alpha-form, has a melting point of 127-131°C. The structural formula is. Each ENDOMETRIN vaginal insert delivers 100 mg of progesterone in a base containing lactose monohydrate, polyvinylpyrrolidone, adipic acid, sodium bicarbonate, sodium lauryl sulfate, magnesium stearate, pregelatinized starch, and colloidal silicon dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-5050-1</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (55566-5050-1)  &gt; 10 TABLET in 1 BLISTER PACK (55566-5050-0) </PackageDescription>
    <NDC11Code>55566-5050-01</NDC11Code>
    <ProductNDC>55566-5050</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nocdurna</ProprietaryName>
    <NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>SUBLINGUAL</RouteName>
    <StartMarketingDate>20181022</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022517</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
    <StrengthNumber>27.7</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181022</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55566-5070-1</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (55566-5070-1)  / 10 TABLET in 1 BLISTER PACK (55566-5070-0) </PackageDescription>
    <NDC11Code>55566-5070-01</NDC11Code>
    <ProductNDC>55566-5070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nocdurna</ProprietaryName>
    <NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>SUBLINGUAL</RouteName>
    <StartMarketingDate>20181022</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022517</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
    <StrengthNumber>55.3</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-03-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181022</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55566-8401-1</NDCCode>
    <PackageDescription>2 VIAL, GLASS in 1 CARTON (55566-8401-1)  &gt; 3 mL in 1 VIAL, GLASS (55566-8401-0)</PackageDescription>
    <NDC11Code>55566-8401-01</NDC11Code>
    <ProductNDC>55566-8401</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Firmagon</ProprietaryName>
    <NonProprietaryName>Degarelix</NonProprietaryName>
    <DosageFormName>POWDER, METERED</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20090302</StartMarketingDate>
    <EndMarketingDate>20150331</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022201</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DEGARELIX ACETATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-04-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>55566-8401-2</NDCCode>
    <PackageDescription>2 VIAL, GLASS in 1 CARTON (55566-8401-2)  &gt; 3 mL in 1 VIAL, GLASS (55566-8401-0)</PackageDescription>
    <NDC11Code>55566-8401-02</NDC11Code>
    <ProductNDC>55566-8401</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Firmagon</ProprietaryName>
    <NonProprietaryName>Degarelix</NonProprietaryName>
    <DosageFormName>POWDER, METERED</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20090302</StartMarketingDate>
    <EndMarketingDate>20150331</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022201</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DEGARELIX ACETATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-04-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>55566-8403-1</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (55566-8403-1)  *  3 mL in 1 SYRINGE *  3 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>55566-8403-01</NDC11Code>
    <ProductNDC>55566-8403</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Firmagon</ProprietaryName>
    <NonProprietaryName>Degarelix</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20090302</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022201</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2024-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090302</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>FIRMAGON® is indicated for treatment of patients with advanced prostate cancer.</IndicationAndUsage>
    <Description>FIRMAGON is a sterile lyophilized powder for injection containing degarelix (as the acetate) and mannitol. Degarelix is a synthetic linear decapeptide amide containing seven unnatural amino acids, five of which are D-amino acids. The acetate salt of degarelix is a white to off-white amorphous powder of low density as obtained after lyophilization. The chemical name of degarelix is D-Alaninamide, N-acetyl-3-(2-naphthalenyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridinyl)-D-alanyl-L-seryl-4-[[[(4S)-hexahydro-2,6-dioxo-4-pyrimidinyl]carbonyl]amino]-L phenylalanyl-4-[(aminocarbonyl)amino]-D-phenylalanyl-L-leucyl-N6–(1-methylethyl)-L-lysyl-L-prolyl. It has an empirical formula of C82H103N18O16Cl and a molecular weight of 1632.3 Da. Degarelix acetate has the following structural formula. FIRMAGON is available in two packaging configurations: 1 Starting Dose: Two vial carton with each vial delivering 120 mg of degarelix (equivalent to the median value of 126 mg degarelix acetate). Each 120 mg dose contains 150 mg mannitol., 2 Maintenance Dose: One-vial carton delivering 80 mg of degarelix (equivalent to the median value of 84 mg degarelix acetate). Each 80 mg dose contains 200 mg mannitol.</Description>
  </NDC>
  <NDC>
    <NDCCode>0113-6500-00</NDCCode>
    <PackageDescription>3 BOTTLE in 1 CARTON (0113-6500-00)  / 60 mL in 1 BOTTLE (0113-6500-30) </PackageDescription>
    <NDC11Code>00113-6500-00</NDC11Code>
    <ProductNDC>0113-6500</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Good Sense Hair Regrowth Treatment</ProprietaryName>
    <NonProprietaryName>Minoxidil</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20251024</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075357</ApplicationNumber>
    <LabelerName>L. Perrigo Company</LabelerName>
    <SubstanceName>MINOXIDIL</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251024</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>to regrow hair on the scalp.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0113-6500-30</NDCCode>
    <PackageDescription>3 BOTTLE in 1 CARTON (0113-6500-30)  / 60 mL in 1 BOTTLE (0113-6500-00) </PackageDescription>
    <NDC11Code>00113-6500-30</NDC11Code>
    <ProductNDC>0113-6500</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Good Sense Hair Regrowth Treatment</ProprietaryName>
    <NonProprietaryName>Minoxidil</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20251024</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075357</ApplicationNumber>
    <LabelerName>L. Perrigo Company</LabelerName>
    <SubstanceName>MINOXIDIL</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251024</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>to regrow hair on the scalp.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50090-6500-0</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (50090-6500-0)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>50090-6500-00</NDC11Code>
    <ProductNDC>50090-6500</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clomid</ProprietaryName>
    <NonProprietaryName>Clomiphene Citrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220909</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075528</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>CLOMIPHENE CITRATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230524</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clomiphene citrate is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiphene citrate therapy. Those patients most likely to achieve success with clomiphene therapy include patients with polycystic ovary syndrome (see WARNINGS: Ovarian Hyperstimulation Syndrome), amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology. Properly timed coitus in relationship to ovulation is important. A basal body temperature graph or other appropriate tests may help the patient and her physician determine if ovulation occurred. Once ovulation has been established, each course of clomiphene citrate should be started on or about the 5th day of the cycle. Long-term cyclic therapy is not recommended beyond a total of about six cycles (including three ovulatory cycles). (See DOSAGE AND ADMINISTRATION and PRECAUTIONS.). Clomiphene citrate is indicated only in patients with demonstrated ovulatory dysfunction who meet the conditions described below. 1. Patients who are not pregnant. 2. Patients without ovarian cysts. Clomiphene citrate should not be used in patients with ovarian enlargement except those with polycystic ovary syndrome. Pelvic examination is necessary prior to the first and each subsequent course of clomiphene citrate treatment. 3. Patients without abnormal vaginal bleeding. If abnormal vaginal bleeding is present, the patient should be carefully evaluated to ensure that neoplastic lesions are not present. 4. Patients with normal liver function. In addition, patients selected for clomiphene citrate therapy should be evaluated in regard to the following. 1. Estrogen Levels. Patients should have adequate levels of endogenous estrogen (as estimated from vaginal smears, endometrial biopsy, assay of urinary estrogen, or from bleeding in response to progesterone). Reduced estrogen levels, while less favorable, do not preclude successful therapy. 2. Primary Pituitary or Ovarian Failure. Clomiphene citrate therapy cannot be expected to substitute for specific treatment of other causes of ovulatory failure. 3. Endometriosis and Endometrial Carcinoma. The incidence of endometriosis and endometrial carcinoma increases with age as does the incidence of ovulatory disorders. Endometrial biopsy should always be performed prior to clomiphene citrate therapy in this population. 4. Other Impediments to Pregnancy. Impediments to pregnancy can include thyroid disorders, adrenal disorders, hyperprolactinemia, and male factor infertility. 5. Uterine Fibroids. Caution should be exercised when using clomiphene citrate in patients with uterine fibroids due to the potential for further enlargement of the fibroids. There are no adequate or well-controlled studies that demonstrate the effectiveness of clomiphene citrate in the treatment of male infertility. In addition, testicular tumors and gynecomastia have been reported in males using clomiphene. The cause and effect relationship between reports of testicular tumors and the administration of clomiphene citrate is not known. Although the medical literature suggests various methods, there is no universally accepted standard regimen for combined therapy (i.e., clomiphene citrate in conjunction with other ovulation-inducing drugs). Similarly, there is no standard clomiphene citrate regimen for ovulation induction  in vitro fertilization programs to produce ova for fertilization and reintroduction. Therefore, clomiphene citrate is not recommended for these uses.</IndicationAndUsage>
    <Description>Clomid TM (clomiphene citrate) Tablets, USP is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-[p-(2-chloro-1,2-diphenylvinyl)phenoxy] triethylamine citrate (1:1). It has the molecular formula of C 26H 28CINO  C 6H 8O 7 and a molecular weight of 598.10. It is represented structurally as:. Clomiphene citrate is a white to pale yellow, essentially odorless, crystalline powder. It is freely soluble in methanol; soluble in ethanol; slightly soluble in acetone, water, and chloroform; and insoluble in ether. Clomiphene citrate is a mixture of two geometric isomers [cis (zuclomiphene) and trans (enclomiphene)] containing between 30% and 50% of the cis-isomer. Each off-white debossed tablet contains 50 mg Clomid  TM (clomiphene citrate) USP. The tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized corn starch, and sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>60232-6500-3</NDCCode>
    <PackageDescription>85 g in 1 TUBE (60232-6500-3)</PackageDescription>
    <NDC11Code>60232-6500-03</NDC11Code>
    <ProductNDC>60232-6500</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Elta Block</ProprietaryName>
    <ProprietaryNameSuffix>Spf 30 Waterproof</ProprietaryNameSuffix>
    <NonProprietaryName>Zinc Oxide, Octinoxate, Octisalate</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20020430</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Swiss-American Products</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>75; 50; 45</StrengthNumber>
    <StrengthUnit>g/1000g; g/1000g; g/1000g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-08-14</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>61281-6500-3</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (61281-6500-3) </PackageDescription>
    <NDC11Code>61281-6500-03</NDC11Code>
    <ProductNDC>61281-6500</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Dextromethorphan Hydrobromide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20170131</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Supriya Lifescience Limited</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-11-30</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>31-JAN-17</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>62670-6500-3</NDCCode>
    <PackageDescription>236 mL in 1 BOTTLE, PUMP (62670-6500-3) </PackageDescription>
    <NDC11Code>62670-6500-03</NDC11Code>
    <ProductNDC>62670-6500</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Anti-bacterial Hand</ProprietaryName>
    <ProprietaryNameSuffix>Sunrise Woods</ProprietaryNameSuffix>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20221220</StartMarketingDate>
    <EndMarketingDate>20230620</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Bath &amp; Body Works, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>68</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-06-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20221220</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230620</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55566-1010-1</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (55566-1010-1)  / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>55566-1010-01</NDC11Code>
    <ProductNDC>55566-1010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fyremadel</ProprietaryName>
    <NonProprietaryName>Ganirelix Acetate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20220228</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204246</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>GANIRELIX ACETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Pharm_Classes>Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ganirelix acetate injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.</IndicationAndUsage>
    <Description>FYREMADEL (ganirelix acetate) injection is a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotropin-releasing hormone (GnRH). Ganirelix acetate is derived from native GnRH with substitutions of amino acids at positions 1, 2, 3, 6, 8, and 10 to form the following molecular formula of the peptide: N-acetyl-3-(2-naphthyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridyl)-D-alanyl-L-seryl-L-tyrosyl-N9,N10-diethyl-D-homoarginyl-L-leucyl-N9,N10-diethyl-L-homoarginyl-L-prolyl-D-alanylamide acetate. The molecular weight for ganirelix acetate is 1570.4 as an anhydrous free base. The structural formula is as follows. Ganirelix Acetate. FYREMADEL (ganirelix acetate) injection is supplied as a colorless, sterile, ready-to-use, aqueous solution intended for SUBCUTANEOUS administration only. Each single-dose, sterile, prefilled syringe contains 250 mcg/0.5 mL of ganirelix acetate, 0.1 mg glacial acetic acid, 23.5 mg mannitol, and water for injection adjusted to pH 5 with acetic acid and/or sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-1050-1</NDCCode>
    <PackageDescription>4 VIAL in 1 CARTON (55566-1050-1)  / 20 mL in 1 VIAL (55566-1050-0) </PackageDescription>
    <NDC11Code>55566-1050-01</NDC11Code>
    <ProductNDC>55566-1050</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adstiladrin</ProprietaryName>
    <NonProprietaryName>Nadofaragene Firadenovec-vncg</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>INTRAVESICAL</RouteName>
    <StartMarketingDate>20230905</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125700</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>NADOFARAGENE FIRADENOVEC</SubstanceName>
    <StrengthNumber>300000000000</StrengthNumber>
    <StrengthUnit>{VP}/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230905</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ADSTILADRIN® is indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.</IndicationAndUsage>
    <Description>ADSTILADRIN (nadofaragene firadenovec-vncg) is a non-replicating adenoviral vector-based gene therapy for intravesical instillation. It is a recombinant adenovirus serotype 5 vector containing a transgene encoding the human interferon alfa-2b (IFNα2b). ADSTILADRIN has a nominal concentration of 3 x 1011 vp/mL. A single-use vial of ADSTILADRIN contains an extractable volume of 20 mL and the following excipients: [N-(3-cholamidopropyl)-N-(3-lactobionamidopropyl)]-cholamide (Syn3) (0.95 mg/mL), citric acid monohydrate (0.01 mg/mL), glycerol (84 mg/mL), hydroxypropyl-beta-cyclodextrin (7.9 mg/mL), magnesium chloride hexahydrate (0.34 mg/mL), polysorbate 80 (Tween 80) (0.48 mg/mL), sodium dihydrogen phosphate dihydrate (1.4 mg/mL), sucrose (17 mg/mL), tri-sodium citrate dihydrate (0.04 mg/mL), tromethamine (1.4 mg/mL) and Water for Injection (q.s. 1 mL). ADSTILADRIN is a sterile, clear to opalescent suspension, and contains no preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-1050-2</NDCCode>
    <PackageDescription>20 mL in 1 VIAL (55566-1050-2) </PackageDescription>
    <NDC11Code>55566-1050-02</NDC11Code>
    <ProductNDC>55566-1050</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adstiladrin</ProprietaryName>
    <NonProprietaryName>Nadofaragene Firadenovec-vncg</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>INTRAVESICAL</RouteName>
    <StartMarketingDate>20230905</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125700</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>NADOFARAGENE FIRADENOVEC</SubstanceName>
    <StrengthNumber>300000000000</StrengthNumber>
    <StrengthUnit>{VP}/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251013</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ADSTILADRIN® is indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.</IndicationAndUsage>
    <Description>ADSTILADRIN (nadofaragene firadenovec-vncg) is a non-replicating adenoviral vector-based gene therapy for intravesical instillation. It is a recombinant adenovirus serotype 5 vector containing a transgene encoding the human interferon alfa-2b (IFNα2b). ADSTILADRIN has a nominal concentration of 3 x 1011 vp/mL. A single-use vial of ADSTILADRIN contains an extractable volume of 20 mL and the following excipients: [N-(3-cholamidopropyl)-N-(3-lactobionamidopropyl)]-cholamide (Syn3) (0.95 mg/mL), citric acid monohydrate (0.01 mg/mL), glycerol (84 mg/mL), hydroxypropyl-beta-cyclodextrin (7.9 mg/mL), magnesium chloride hexahydrate (0.34 mg/mL), polysorbate 80 (Tween 80) (0.48 mg/mL), sodium dihydrogen phosphate dihydrate (1.4 mg/mL), sucrose (17 mg/mL), tri-sodium citrate dihydrate (0.04 mg/mL), tromethamine (1.4 mg/mL) and Water for Injection (q.s. 1 mL). ADSTILADRIN is a sterile, clear to opalescent suspension, and contains no preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-1501-1</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (55566-1501-1)  *  1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL *  10 mL in 1 VIAL (55566-1700-0) </PackageDescription>
    <NDC11Code>55566-1501-01</NDC11Code>
    <ProductNDC>55566-1501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Novarel</ProprietaryName>
    <NonProprietaryName>Gonadotrophin, Chorionic</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19740115</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA017016</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2024-05-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19740115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR "NORMAL" DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS. : 1 Prepubertal cryptorchidism not due to anatomic obstruction. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help to predict whether or not orchiopexy will be needed in the future. Although, in some cases, descent following HCG administration is permanent, in most cases the response is temporary. Therapy is usually instituted between the ages of 4 and 9., 2 Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males., 3 Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.</IndicationAndUsage>
    <Description>Human chorionic gonadotropin (HCG), a polypeptide hormone produced by the human placenta, is composed of an alpha and a beta subunit. The alpha subunit is essentially identical to the alpha subunits of the human pituitary gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to the alpha subunit of human thyroid-stimulating hormone (TSH). The beta subunits of these hormones differ in amino acid sequence. NOVAREL (chorionic gonadotropin) for injection is a water soluble glycoprotein derived from human pregnancy urine and administered intramuscularly after reconstitution. The sterile lyophilized powder is stable. When reconstituted with Bacteriostatic Water for Injection preserved with benzyl alcohol 0.9%, the solution should be refrigerated and used within 30 days. Each 5,000 USP units vial contains. chorionic gonadotropin 5,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg. Each 10,000 USP units vial contains. chorionic gonadotropin 10,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-1502-1</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (55566-1502-1)  *  1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL *  10 mL in 1 VIAL (55566-1700-0) </PackageDescription>
    <NDC11Code>55566-1502-01</NDC11Code>
    <ProductNDC>55566-1502</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Novarel</ProprietaryName>
    <NonProprietaryName>Gonadotrophin, Chorionic</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20170830</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA017016</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170830</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR "NORMAL" DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS. : 1 Prepubertal cryptorchidism not due to anatomic obstruction. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help to predict whether or not orchiopexy will be needed in the future. Although, in some cases, descent following HCG administration is permanent, in most cases the response is temporary. Therapy is usually instituted between the ages of 4 and 9., 2 Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males., 3 Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.</IndicationAndUsage>
    <Description>Human chorionic gonadotropin (HCG), a polypeptide hormone produced by the human placenta, is composed of an alpha and a beta subunit. The alpha subunit is essentially identical to the alpha subunits of the human pituitary gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to the alpha subunit of human thyroid-stimulating hormone (TSH). The beta subunits of these hormones differ in amino acid sequence. NOVAREL (chorionic gonadotropin) for injection is a water soluble glycoprotein derived from human pregnancy urine and administered intramuscularly after reconstitution. The sterile lyophilized powder is stable. When reconstituted with Bacteriostatic Water for Injection preserved with benzyl alcohol 0.9%, the solution should be refrigerated and used within 30 days. Each 5,000 USP units vial contains. chorionic gonadotropin 5,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg. Each 10,000 USP units vial contains. chorionic gonadotropin 10,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-2200-0</NDCCode>
    <PackageDescription>10 AMPULE in 1 CARTON (55566-2200-0)  &gt; 1 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>55566-2200-00</NDC11Code>
    <ProductNDC>55566-2200</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ddavp</ProprietaryName>
    <NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19840501</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018938</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-10-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19840501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DDAVP Injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand's disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).</IndicationAndUsage>
    <Description>DDAVP Injection (desmopressin acetate) is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows:. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2∙C2H4O2∙3H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. DDAVP solution for injection is a sterile solution in a 1 mL single-dose ampule: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. DDAVP solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-2300-0</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (55566-2300-0)  &gt; 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>55566-2300-00</NDC11Code>
    <ProductNDC>55566-2300</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ddavp</ProprietaryName>
    <NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19840501</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018938</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-10-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19840501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DDAVP Injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand's disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).</IndicationAndUsage>
    <Description>DDAVP Injection (desmopressin acetate) is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows:. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2∙C2H4O2∙3H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. DDAVP solution for injection is a sterile solution in a 1 mL single-dose ampule: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. DDAVP solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-2600-0</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (55566-2600-0)  / 100 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>55566-2600-00</NDC11Code>
    <ProductNDC>55566-2600</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ddavp</ProprietaryName>
    <NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19950906</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019955</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080505</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DDAVP Tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. DDAVP is ineffective for the treatment of nephrogenic diabetes insipidus. Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to DDAVP can be monitored by measuring urine volume and osmolality.</IndicationAndUsage>
    <Description>DDAVP® Tablets (desmopressin acetate) are a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2∙C2H4O2∙3H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. DDAVP Tablets contain either 0.1 or 0.2 mg desmopressin acetate. Inactive ingredients include: lactose, potato starch, magnesium stearate and povidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-2700-0</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (55566-2700-0)  / 100 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>55566-2700-00</NDC11Code>
    <ProductNDC>55566-2700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ddavp</ProprietaryName>
    <NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19950906</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019955</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080505</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DDAVP Tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. DDAVP is ineffective for the treatment of nephrogenic diabetes insipidus. Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to DDAVP can be monitored by measuring urine volume and osmolality.</IndicationAndUsage>
    <Description>DDAVP® Tablets (desmopressin acetate) are a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2∙C2H4O2∙3H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. DDAVP Tablets contain either 0.1 or 0.2 mg desmopressin acetate. Inactive ingredients include: lactose, potato starch, magnesium stearate and povidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-2800-1</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (55566-2800-1)  / 10 mg in 1 POUCH (55566-2800-0) </PackageDescription>
    <NDC11Code>55566-2800-01</NDC11Code>
    <ProductNDC>55566-2800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cervidil</ProprietaryName>
    <NonProprietaryName>Dinoprostone</NonProprietaryName>
    <DosageFormName>INSERT</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>19950330</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020411</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DINOPROSTONE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/241mg</StrengthUnit>
    <Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-06-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19950330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CERVIDIL is indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor.</IndicationAndUsage>
    <Description>CERVIDIL (dinoprostone) vaginal insert contains dinoprostone, a prostaglandin analog. Each vaginal insert contains 10 mg of dinoprostone in 241 mg of a cross-linked polyethylene oxide/urethane polymer (hydrogel polymer) that is semi-opaque, beige colored, flat, rectangular in shape with rounded corners and measuring 29 mm by 9.5 mm by 0.8 mm. The vaginal insert is contained within a pouch of an off-white knitted polyester yarn retrieval system. When placed in a moist environment, the yarn absorbs water, swells, and releases the enclosed dinoprostone. The knitted polyester retrieval system has a long tape-like end that is designed to aid retrieval of CERVIDIL at the end of the dosing interval or earlier if clinically indicated. The finished product is a controlled-release formulation that has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg per hour. The chemical name for dinoprostone (known as prostaglandin E2 or PGE2) is 11α,15S-dihydroxy-9-oxo-prosta-5Z,13E-dien-1-oic acid and the structural formula is represented below. The molecular formula is C20H32O5 and its molecular weight is 352.47. Dinoprostone occurs as a white to off-white crystalline powder. It has a melting point within the range of 65° to 69°C. Dinoprostone is soluble in ethanol and in 25% ethanol in water.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-3000-0</NDCCode>
    <PackageDescription>2.5 mL in 1 BOTTLE, SPRAY (55566-3000-0) </PackageDescription>
    <NDC11Code>55566-3000-00</NDC11Code>
    <ProductNDC>55566-3000</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Stimate</ProprietaryName>
    <NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20250625</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020355</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250625</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>STIMATE is a vasopressin analog used for: 1 Hemophilia A - for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.1), 2 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2).</IndicationAndUsage>
    <Description>STIMATE (desmopressin acetate) is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows. Molecular weight: 1183.34. Empirical formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. STIMATE is an aqueous solution for intranasal use.  Each mL contains: Benzalkonium chloride solution 0.1 mg, Citric acid monohydrate 1.7 mg, Desmopressin acetate 1.5 mg, Disodium phosphate dihydrate 3 mg, Purified water to 1 mL, Sodium chloride 7.5 mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-6700-1</NDCCode>
    <PackageDescription>2 BOTTLE in 1 CARTON (55566-6700-1)  &gt; 160 mL in 1 BOTTLE (55566-6700-0) </PackageDescription>
    <NDC11Code>55566-6700-01</NDC11Code>
    <ProductNDC>55566-6700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clenpiq</ProprietaryName>
    <NonProprietaryName>Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180629</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209589</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ANHYDROUS CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE</SubstanceName>
    <StrengthNumber>12; 3.5; 10</StrengthNumber>
    <StrengthUnit>g/160mL; g/160mL; mg/160mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180629</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CLENPIQ is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older.</IndicationAndUsage>
    <Description>CLENPIQ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution is a stimulant and osmotic laxative that is provided as a cranberry-flavored, colorless to slightly yellow, clear solution with possible presence of visible particles. CLENPIQ is supplied as two bottles in each carton. Each bottle of CLENPIQ contains 10 mg sodium picosulfate, USP; 3.5 g magnesium oxide, USP; and 12 g anhydrous citric acid, USP. The product also contains the following inactive ingredients. acesulfame potassium, cranberry flavor, disodium edetate, malic acid, sodium benzoate, sodium hydroxide, sodium metabisulfite, sucralose, and water. The cranberry flavor contains glyceryl triacetate (triacetin), maltodextrin, and sodium octenyl succinated starch. The following is a description of the three active ingredients contained in CLENPIQ. Sodium picosulfate is a stimulant laxative.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-6800-1</NDCCode>
    <PackageDescription>2 BOTTLE in 1 CARTON (55566-6800-1)  / 175 mL in 1 BOTTLE (55566-6800-0) </PackageDescription>
    <NDC11Code>55566-6800-01</NDC11Code>
    <ProductNDC>55566-6800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clenpiq</ProprietaryName>
    <NonProprietaryName>Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230329</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209589</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>SODIUM PICOSULFATE; MAGNESIUM OXIDE; ANHYDROUS CITRIC ACID</SubstanceName>
    <StrengthNumber>10; 3.5; 12</StrengthNumber>
    <StrengthUnit>mg/175mL; g/175mL; g/175mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230329</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CLENPIQ is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older.</IndicationAndUsage>
    <Description>CLENPIQ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution is a stimulant and osmotic laxative that is provided as a cranberry-flavored, colorless to slightly yellow, clear solution with possible presence of visible particles. CLENPIQ is supplied as two bottles in each carton. Each bottle of CLENPIQ contains 10 mg sodium picosulfate, USP; 3.5 g magnesium oxide, USP; and 12 g anhydrous citric acid, USP. The product also contains the following inactive ingredients. acesulfame potassium, cranberry flavor, disodium edetate, malic acid, sodium benzoate, sodium hydroxide, sodium metabisulfite, sucralose, and water. The cranberry flavor contains glyceryl triacetate (triacetin), maltodextrin, and sodium octenyl succinated starch. The following is a description of the three active ingredients contained in CLENPIQ. Sodium picosulfate is a stimulant laxative.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-6800-2</NDCCode>
    <PackageDescription>2 BOTTLE in 1 CARTON (55566-6800-2)  / 175 mL in 1 BOTTLE (55566-6800-0) </PackageDescription>
    <NDC11Code>55566-6800-02</NDC11Code>
    <ProductNDC>55566-6800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clenpiq</ProprietaryName>
    <NonProprietaryName>Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230329</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209589</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>SODIUM PICOSULFATE; MAGNESIUM OXIDE; ANHYDROUS CITRIC ACID</SubstanceName>
    <StrengthNumber>10; 3.5; 12</StrengthNumber>
    <StrengthUnit>mg/175mL; g/175mL; g/175mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230330</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>CLENPIQ is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older.</IndicationAndUsage>
    <Description>CLENPIQ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution is a stimulant and osmotic laxative that is provided as a cranberry-flavored, colorless to slightly yellow, clear solution with possible presence of visible particles. CLENPIQ is supplied as two bottles in each carton. Each bottle of CLENPIQ contains 10 mg sodium picosulfate, USP; 3.5 g magnesium oxide, USP; and 12 g anhydrous citric acid, USP. The product also contains the following inactive ingredients. acesulfame potassium, cranberry flavor, disodium edetate, malic acid, sodium benzoate, sodium hydroxide, sodium metabisulfite, sucralose, and water. The cranberry flavor contains glyceryl triacetate (triacetin), maltodextrin, and sodium octenyl succinated starch. The following is a description of the three active ingredients contained in CLENPIQ. Sodium picosulfate is a stimulant laxative.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-8303-1</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (55566-8303-1)  *  4 mL in 1 VIAL, GLASS *  4.2 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>55566-8303-01</NDC11Code>
    <ProductNDC>55566-8303</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Firmagon</ProprietaryName>
    <NonProprietaryName>Degarelix</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20090302</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022201</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2024-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090302</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>FIRMAGON® is indicated for treatment of patients with advanced prostate cancer.</IndicationAndUsage>
    <Description>FIRMAGON is a sterile lyophilized powder for injection containing degarelix (as the acetate) and mannitol. Degarelix is a synthetic linear decapeptide amide containing seven unnatural amino acids, five of which are D-amino acids. The acetate salt of degarelix is a white to off-white amorphous powder of low density as obtained after lyophilization. The chemical name of degarelix is D-Alaninamide, N-acetyl-3-(2-naphthalenyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridinyl)-D-alanyl-L-seryl-4-[[[(4S)-hexahydro-2,6-dioxo-4-pyrimidinyl]carbonyl]amino]-L phenylalanyl-4-[(aminocarbonyl)amino]-D-phenylalanyl-L-leucyl-N6–(1-methylethyl)-L-lysyl-L-prolyl. It has an empirical formula of C82H103N18O16Cl and a molecular weight of 1632.3 Da. Degarelix acetate has the following structural formula. FIRMAGON is available in two packaging configurations: 1 Starting Dose: Two vial carton with each vial delivering 120 mg of degarelix (equivalent to the median value of 126 mg degarelix acetate). Each 120 mg dose contains 150 mg mannitol., 2 Maintenance Dose: One-vial carton delivering 80 mg of degarelix (equivalent to the median value of 84 mg degarelix acetate). Each 80 mg dose contains 200 mg mannitol.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-9300-2</NDCCode>
    <PackageDescription>2 PACKET in 1 CARTON (55566-9300-2)  &gt; 16.1 g in 1 PACKET (55566-9300-0) </PackageDescription>
    <NDC11Code>55566-9300-02</NDC11Code>
    <ProductNDC>55566-9300</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prepopik</ProprietaryName>
    <NonProprietaryName>Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid</NonProprietaryName>
    <DosageFormName>POWDER, METERED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120716</StartMarketingDate>
    <EndMarketingDate>20200531</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA202535</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>SODIUM PICOSULFATE; MAGNESIUM OXIDE; ANHYDROUS CITRIC ACID</SubstanceName>
    <StrengthNumber>10; 3.5; 12</StrengthNumber>
    <StrengthUnit>mg/16.1g; g/16.1g; g/16.1g</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE],Stimulant Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20120716</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55566-9400-1</NDCCode>
    <PackageDescription>2 POUCH in 1 CARTON (55566-9400-1)  &gt; 7 d in 1 POUCH (55566-9400-0) </PackageDescription>
    <NDC11Code>55566-9400-01</NDC11Code>
    <ProductNDC>55566-9400</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ferring Pharmaceuticals Inc.</ProprietaryName>
    <NonProprietaryName>Progesterone</NonProprietaryName>
    <DosageFormName>RING</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>20220501</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA201110</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PROGESTERONE</SubstanceName>
    <StrengthNumber>11</StrengthNumber>
    <StrengthUnit>mg/d</StrengthUnit>
    <Pharm_Classes>Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>MILPROSA is indicated to support embryo implantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women up to and including 34 years of age.</IndicationAndUsage>
    <Description>MILPROSA (progesterone) vaginal system is a white to off-white, flexible, non-biodegradable silicone ring (toroidal-shaped) containing 1.78 grams of progesterone. MILPROSA has a cross-sectional diameter of approximately 8.5 mm, and an outer and inner diameter of approximately 55 mm and 38 mm, respectively. The chemical name for progesterone is pregn-4-ene-3,20-dione. It has an empirical formula of C21H30O2 and a molecular weight of 314.5. Progesterone has a melting point of 126-131°C. The structural formula is. When placed in the vagina, each vaginal system is estimated to provide an average release rate of 11 mg/day of progesterone over 7 days. The inactive components of the vaginal system are light mineral oil and silicone elastomer.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>55566-6500-3</NDCCode><ProprietaryName>Endometrin</ProprietaryName><NonProprietaryName>Progesterone</NonProprietaryName></NDC><NDC><NDCCode>55566-6500-8</NDCCode><ProprietaryName>Endometrin</ProprietaryName><NonProprietaryName>Progesterone</NonProprietaryName></NDC><NDC><NDCCode>55566-5050-1</NDCCode><ProprietaryName>Nocdurna</ProprietaryName><NonProprietaryName>Desmopressin Acetate</NonProprietaryName></NDC><NDC><NDCCode>55566-5070-1</NDCCode><ProprietaryName>Nocdurna</ProprietaryName><NonProprietaryName>Desmopressin Acetate</NonProprietaryName></NDC><NDC><NDCCode>55566-8401-1</NDCCode><ProprietaryName>Firmagon</ProprietaryName><NonProprietaryName>Degarelix</NonProprietaryName></NDC><NDC><NDCCode>55566-8401-2</NDCCode><ProprietaryName>Firmagon</ProprietaryName><NonProprietaryName>Degarelix</NonProprietaryName></NDC><NDC><NDCCode>55566-8403-1</NDCCode><ProprietaryName>Firmagon</ProprietaryName><NonProprietaryName>Degarelix</NonProprietaryName></NDC><NDC><NDCCode>0113-6500-00</NDCCode><ProprietaryName>Good Sense Hair Regrowth Treatment</ProprietaryName><NonProprietaryName>Minoxidil</NonProprietaryName></NDC><NDC><NDCCode>0113-6500-30</NDCCode><ProprietaryName>Good Sense Hair Regrowth Treatment</ProprietaryName><NonProprietaryName>Minoxidil</NonProprietaryName></NDC><NDC><NDCCode>50090-6500-0</NDCCode><ProprietaryName>Clomid</ProprietaryName><NonProprietaryName>Clomiphene Citrate</NonProprietaryName></NDC><NDC><NDCCode>60232-6500-3</NDCCode><ProprietaryName>Elta Block</ProprietaryName><NonProprietaryName>Zinc Oxide, Octinoxate, Octisalate</NonProprietaryName></NDC><NDC><NDCCode>61281-6500-3</NDCCode><NonProprietaryName>Dextromethorphan Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>62670-6500-3</NDCCode><ProprietaryName>Anti-bacterial Hand</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>55566-1010-1</NDCCode><ProprietaryName>Fyremadel</ProprietaryName><NonProprietaryName>Ganirelix Acetate</NonProprietaryName></NDC><NDC><NDCCode>55566-1050-1</NDCCode><ProprietaryName>Adstiladrin</ProprietaryName><NonProprietaryName>Nadofaragene Firadenovec-vncg</NonProprietaryName></NDC><NDC><NDCCode>55566-1050-2</NDCCode><ProprietaryName>Adstiladrin</ProprietaryName><NonProprietaryName>Nadofaragene Firadenovec-vncg</NonProprietaryName></NDC><NDC><NDCCode>55566-1501-1</NDCCode><ProprietaryName>Novarel</ProprietaryName><NonProprietaryName>Gonadotrophin, Chorionic</NonProprietaryName></NDC><NDC><NDCCode>55566-1502-1</NDCCode><ProprietaryName>Novarel</ProprietaryName><NonProprietaryName>Gonadotrophin, Chorionic</NonProprietaryName></NDC><NDC><NDCCode>55566-2200-0</NDCCode><ProprietaryName>Ddavp</ProprietaryName><NonProprietaryName>Desmopressin Acetate</NonProprietaryName></NDC><NDC><NDCCode>55566-2300-0</NDCCode><ProprietaryName>Ddavp</ProprietaryName><NonProprietaryName>Desmopressin Acetate</NonProprietaryName></NDC><NDC><NDCCode>55566-2600-0</NDCCode><ProprietaryName>Ddavp</ProprietaryName><NonProprietaryName>Desmopressin Acetate</NonProprietaryName></NDC><NDC><NDCCode>55566-2700-0</NDCCode><ProprietaryName>Ddavp</ProprietaryName><NonProprietaryName>Desmopressin Acetate</NonProprietaryName></NDC><NDC><NDCCode>55566-2800-1</NDCCode><ProprietaryName>Cervidil</ProprietaryName><NonProprietaryName>Dinoprostone</NonProprietaryName></NDC><NDC><NDCCode>55566-3000-0</NDCCode><ProprietaryName>Stimate</ProprietaryName><NonProprietaryName>Desmopressin Acetate</NonProprietaryName></NDC><NDC><NDCCode>55566-6700-1</NDCCode><ProprietaryName>Clenpiq</ProprietaryName><NonProprietaryName>Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid</NonProprietaryName></NDC><NDC><NDCCode>55566-6800-1</NDCCode><ProprietaryName>Clenpiq</ProprietaryName><NonProprietaryName>Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid</NonProprietaryName></NDC><NDC><NDCCode>55566-6800-2</NDCCode><ProprietaryName>Clenpiq</ProprietaryName><NonProprietaryName>Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid</NonProprietaryName></NDC><NDC><NDCCode>55566-8303-1</NDCCode><ProprietaryName>Firmagon</ProprietaryName><NonProprietaryName>Degarelix</NonProprietaryName></NDC><NDC><NDCCode>55566-9300-2</NDCCode><ProprietaryName>Prepopik</ProprietaryName><NonProprietaryName>Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid</NonProprietaryName></NDC><NDC><NDCCode>55566-9400-1</NDCCode><ProprietaryName>Ferring Pharmaceuticals Inc.</ProprietaryName><NonProprietaryName>Progesterone</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",
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      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
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      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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