{
"NDC": [
{
"NDCCode": "68428-386-11",
"PackageDescription": "300 PELLET in 1 BOTTLE, GLASS (68428-386-11) ",
"NDC11Code": "68428-0386-11",
"ProductNDC": "68428-386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ferrum Picricum",
"NonProprietaryName": "Ferric Picrate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "FERRIC PICRATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "68428-386-03",
"PackageDescription": "75 PELLET in 1 VIAL, GLASS (68428-386-03) ",
"NDC11Code": "68428-0386-03",
"ProductNDC": "68428-386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ferrum Picricum",
"NonProprietaryName": "Ferric Picrate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "FERRIC PICRATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "68428-386-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-386-05) ",
"NDC11Code": "68428-0386-05",
"ProductNDC": "68428-386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ferrum Picricum",
"NonProprietaryName": "Ferric Picrate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "FERRIC PICRATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "68428-386-06",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (68428-386-06) ",
"NDC11Code": "68428-0386-06",
"ProductNDC": "68428-386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ferrum Picricum",
"NonProprietaryName": "Ferric Picrate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "FERRIC PICRATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "68428-386-12",
"PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-386-12) ",
"NDC11Code": "68428-0386-12",
"ProductNDC": "68428-386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ferrum Picricum",
"NonProprietaryName": "Ferric Picrate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "FERRIC PICRATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "16103-386-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (16103-386-11) ",
"NDC11Code": "16103-0386-11",
"ProductNDC": "16103-386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Meclizine",
"NonProprietaryName": "Meclizine Hcl 12.5 Mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M009",
"LabelerName": "Pharbest Pharmaceuticals, Inc.",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Active",
"LastUpdate": "2025-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180201",
"SamplePackage": "N",
"IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
},
{
"NDCCode": "43547-386-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (43547-386-11) ",
"NDC11Code": "43547-0386-11",
"ProductNDC": "43547-386",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosinopril Sodium",
"NonProprietaryName": "Fosinopirl Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205670",
"LabelerName": "Solco Healthcare LLC",
"SubstanceName": "FOSINOPRIL SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171001",
"SamplePackage": "N",
"IndicationAndUsage": "Fosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION). In using fosinopril sodium, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium does not have a similar risk (see WARNINGS). In considering use of fosinopril sodium, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Head and Neck Angioedema and Intestinal Angioedema).",
"Description": "Fosinopril sodium is the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy) propoxy] (4-phenylbutyl) phosphinyl] acetyl]-, sodium salt, trans-. Fosinopril sodium is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is. C30 H45NNaO7P M.W. 585.65. Fosinopril sodium, USP, is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: crospovidone, lactose monohydrate, microcrystalline cellulose, povidone, and sodium stearyl fumarate."
},
{
"NDCCode": "60687-386-21",
"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-386-21) / 1 CAPSULE in 1 BLISTER PACK (60687-386-11) ",
"NDC11Code": "60687-0386-21",
"ProductNDC": "60687-386",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dronabinol",
"NonProprietaryName": "Dronabinol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181002",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078292",
"LabelerName": "American Health Packaging",
"SubstanceName": "DRONABINOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cannabinoid [EPC], Cannabinoids [CS]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181002",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "DRONABINOL CAPSULES, USP are indicated in adults for the treatment of: 1 anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS)., 2 nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.",
"Description": "Dronabinol is a cannabinoid designated chemically as (6aR,10aR)-6a,7,8,10a-Tetrahydro-6,6,9‑trimethyl-3-pentyl-6H-dibenzo[b,d]-pyran-1-ol. Dronabinol has the following empirical and structural formulas. C 21H 30O 2 (molecular weight = 314.46). Dronabinol, the active ingredient in dronabinol capsules, USP, is synthetic delta-9‑tetrahydrocannabinol (delta-9-THC). Dronabinol is a light yellow resinous oil that is sticky at room temperature and hardens upon refrigeration. Dronabinol is insoluble in water and is formulated in sesame oil. It has a pKa of 10.6 and an octanol-water partition coefficient: 6,000:1 at pH 7. Dronabinol capsule strengths are formulated with the following inactive ingredients: FD&C Yellow No. 6, gelatin, glycerin, purified water, sesame oil, titanium dioxide, iron oxide black Ingredients in imprint ink, shellac glaze , isopropyl alcohol , n-butyl alcohol , propylene glycol , and ammonium hydroxide. The 2.5 mg and 5 mg capsules also contain FD&C Blue No. 1 and FD&C Red No. 40."
},
{
"NDCCode": "60687-386-94",
"PackageDescription": "20 BLISTER PACK in 1 CARTON (60687-386-94) / 1 CAPSULE in 1 BLISTER PACK (60687-386-11) ",
"NDC11Code": "60687-0386-94",
"ProductNDC": "60687-386",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dronabinol",
"NonProprietaryName": "Dronabinol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181002",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078292",
"LabelerName": "American Health Packaging",
"SubstanceName": "DRONABINOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cannabinoid [EPC], Cannabinoids [CS]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240508",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N",
"IndicationAndUsage": "DRONABINOL CAPSULES, USP are indicated in adults for the treatment of: 1 anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS)., 2 nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.",
"Description": "Dronabinol is a cannabinoid designated chemically as (6aR,10aR)-6a,7,8,10a-Tetrahydro-6,6,9‑trimethyl-3-pentyl-6H-dibenzo[b,d]-pyran-1-ol. Dronabinol has the following empirical and structural formulas. C 21H 30O 2 (molecular weight = 314.46). Dronabinol, the active ingredient in dronabinol capsules, USP, is synthetic delta-9‑tetrahydrocannabinol (delta-9-THC). Dronabinol is a light yellow resinous oil that is sticky at room temperature and hardens upon refrigeration. Dronabinol is insoluble in water and is formulated in sesame oil. It has a pKa of 10.6 and an octanol-water partition coefficient: 6,000:1 at pH 7. Dronabinol capsule strengths are formulated with the following inactive ingredients: FD&C Yellow No. 6, gelatin, glycerin, purified water, sesame oil, titanium dioxide, iron oxide black Ingredients in imprint ink, shellac glaze , isopropyl alcohol , n-butyl alcohol , propylene glycol , and ammonium hydroxide. The 2.5 mg and 5 mg capsules also contain FD&C Blue No. 1 and FD&C Red No. 40."
},
{
"NDCCode": "73057-386-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (73057-386-11) ",
"NDC11Code": "73057-0386-11",
"ProductNDC": "73057-386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Meclizine",
"NonProprietaryName": "Meclizine Hcl 12.5mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190708",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M009",
"LabelerName": "Ulai Health LLC",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Active",
"LastUpdate": "2025-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190708",
"SamplePackage": "N",
"IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
},
{
"NDCCode": "0046-1105-11",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0046-1105-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK",
"NDC11Code": "00046-1105-11",
"ProductNDC": "0046-1105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prempro",
"NonProprietaryName": "Conjugated Estrogens And Medroxyprogesterone Acetate",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020527",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE",
"StrengthNumber": ".3; 1.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090921",
"SamplePackage": "N",
"Description": "Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is. PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide, yellow iron oxide, propylene glycol and black iron oxide. PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, propylene glycol, titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide. PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, Eudragit NE 30D, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, titanium dioxide, triethyl citrate, FD&C Blue No. 2, black iron oxide, and propylene glycol."
},
{
"NDCCode": "0046-1106-11",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0046-1106-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK",
"NDC11Code": "00046-1106-11",
"ProductNDC": "0046-1106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prempro",
"NonProprietaryName": "Conjugated Estrogens And Medroxyprogesterone Acetate",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020527",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE",
"StrengthNumber": ".45; 1.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090921",
"SamplePackage": "N",
"Description": "Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is. PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide, yellow iron oxide, propylene glycol and black iron oxide. PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, propylene glycol, titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide. PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, Eudragit NE 30D, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, titanium dioxide, triethyl citrate, FD&C Blue No. 2, black iron oxide, and propylene glycol."
},
{
"NDCCode": "0046-1107-11",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0046-1107-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK",
"NDC11Code": "00046-1107-11",
"ProductNDC": "0046-1107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prempro",
"NonProprietaryName": "Conjugated Estrogens And Medroxyprogesterone Acetate",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020527",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE",
"StrengthNumber": ".625; 2.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090921",
"SamplePackage": "N",
"Description": "Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is. PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide, yellow iron oxide, propylene glycol and black iron oxide. PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, propylene glycol, titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide. PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, Eudragit NE 30D, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, titanium dioxide, triethyl citrate, FD&C Blue No. 2, black iron oxide, and propylene glycol."
},
{
"NDCCode": "0046-1108-11",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0046-1108-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK",
"NDC11Code": "00046-1108-11",
"ProductNDC": "0046-1108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prempro",
"NonProprietaryName": "Conjugated Estrogens And Medroxyprogesterone Acetate",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121203",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020527",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE",
"StrengthNumber": ".625; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121203",
"SamplePackage": "N",
"Description": "Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is. PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide, yellow iron oxide, propylene glycol and black iron oxide. PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, propylene glycol, titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide. PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, Eudragit NE 30D, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, titanium dioxide, triethyl citrate, FD&C Blue No. 2, black iron oxide, and propylene glycol."
},
{
"NDCCode": "0069-0151-11",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (0069-0151-11) ",
"NDC11Code": "00069-0151-11",
"ProductNDC": "0069-0151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inlyta",
"NonProprietaryName": "Axitinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120127",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202324",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "AXITINIB",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120127",
"SamplePackage": "N",
"IndicationAndUsage": "INLYTA is a kinase inhibitor indicated: 1 in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). (1.1), 2 in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. (1.1), 3 as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. (1.2).",
"Description": "INLYTA (axitinib) is a kinase inhibitor. Axitinib has the chemical name N-methyl-2-[3-((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl]-benzamide. The molecular formula is C22H18N4OS and the molecular weight is 386.47 Daltons. The chemical structure is. Axitinib is a white to light-yellow powder with a pKa of 4.8. The solubility of axitinib in aqueous media over the range pH 1.1 to pH 7.8 is in excess of 0.2 µg/mL. The partition coefficient (n-octanol/water) is 3.5. INLYTA is supplied as red, film-coated tablets containing either 1 mg or 5 mg of axitinib together with microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, and Opadry® II red 32K15441 as inactive ingredients. The Opadry II red 32K15441 film coating contains lactose monohydrate, HPMC 2910/Hypromellose 15cP, titanium dioxide, triacetin (glycerol triacetate), and red iron oxide."
},
{
"NDCCode": "24385-386-89",
"PackageDescription": "18 BLISTER PACK in 1 CARTON (24385-386-89) > 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "24385-0386-89",
"ProductNDC": "24385-386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Neighbor Pharmacy Anti Diarrheal",
"NonProprietaryName": "Loperamide Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075232",
"LabelerName": "Amerisource Bergen",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20080626",
"SamplePackage": "N"
},
{
"NDCCode": "31722-386-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (31722-386-01) ",
"NDC11Code": "31722-0386-01",
"ProductNDC": "31722-386",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluphenazine Hydrochloride",
"NonProprietaryName": "Fluphenazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218769",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "FLUPHENAZINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251118",
"SamplePackage": "N",
"IndicationAndUsage": "Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.",
"Description": "Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 2-[4-[3-[2-(trifluoromethyl)-10H-phenothiazin-10-yl] propyl]piperazin-1-yl-ethanol dihydrochloride. The structural formula is represented below:. Molecular Formula: C 22H 26F 3N 3OS2HCl MW: 510.44 Fluphenazine Hydrochloride Tablets, USP, for oral administration, contain 1 mg, 2.5 mg, 5 mg, or 10 mg fluphenazine hydrochloride, USP per tablet. Each tablet also contains croscarmellose sodium, D&C yellow # 10 (for 2.5 mg and 5 mg tablet), FD&C blue # 1 (for 5 mg tablet) and FD&C red # 40 (for 10 mg tablet), hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "31722-386-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (31722-386-05) ",
"NDC11Code": "31722-0386-05",
"ProductNDC": "31722-386",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluphenazine Hydrochloride",
"NonProprietaryName": "Fluphenazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218769",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "FLUPHENAZINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251118",
"SamplePackage": "N",
"IndicationAndUsage": "Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.",
"Description": "Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 2-[4-[3-[2-(trifluoromethyl)-10H-phenothiazin-10-yl] propyl]piperazin-1-yl-ethanol dihydrochloride. The structural formula is represented below:. Molecular Formula: C 22H 26F 3N 3OS2HCl MW: 510.44 Fluphenazine Hydrochloride Tablets, USP, for oral administration, contain 1 mg, 2.5 mg, 5 mg, or 10 mg fluphenazine hydrochloride, USP per tablet. Each tablet also contains croscarmellose sodium, D&C yellow # 10 (for 2.5 mg and 5 mg tablet), FD&C blue # 1 (for 5 mg tablet) and FD&C red # 40 (for 10 mg tablet), hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "33342-386-08",
"PackageDescription": "50 CAPSULE in 1 BOTTLE (33342-386-08) ",
"NDC11Code": "33342-0386-08",
"ProductNDC": "33342-386",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20251209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211137",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251209",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment: Doxycycline is indicated for the treatment of the following infections: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis.Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species.In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Prophylaxis: Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS section.).",
"Description": "Doxycycline hyclate capsules are an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules (doxycycline hydrochloride hemiethanolate hemihydrate); for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8.HCl)2. C2H6O.H2O and the molecular weight is 1025.87. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2: 1), monohydrate. Doxycycline is a light-yellowish crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients in the capsule formulations are: colloidal silicon dioxide, croscarmellose sodium, hard gelatin capsules, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The hard gelatin capsules contain gelatin, sodium lauryl sulfate, FD & C Blue 1 and titanium dioxide. The capsules are printed with edible ink containing shellac, and black iron oxide."
},
{
"NDCCode": "33342-386-12",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-386-12) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "33342-0386-12",
"ProductNDC": "33342-386",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20251209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211137",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251209",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment: Doxycycline is indicated for the treatment of the following infections: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis.Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species.In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Prophylaxis: Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS section.).",
"Description": "Doxycycline hyclate capsules are an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules (doxycycline hydrochloride hemiethanolate hemihydrate); for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8.HCl)2. C2H6O.H2O and the molecular weight is 1025.87. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2: 1), monohydrate. Doxycycline is a light-yellowish crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients in the capsule formulations are: colloidal silicon dioxide, croscarmellose sodium, hard gelatin capsules, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The hard gelatin capsules contain gelatin, sodium lauryl sulfate, FD & C Blue 1 and titanium dioxide. The capsules are printed with edible ink containing shellac, and black iron oxide."
},
{
"NDCCode": "33342-386-15",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (33342-386-15) ",
"NDC11Code": "33342-0386-15",
"ProductNDC": "33342-386",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20251209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211137",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251209",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment: Doxycycline is indicated for the treatment of the following infections: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis.Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species.In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Prophylaxis: Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS section.).",
"Description": "Doxycycline hyclate capsules are an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules (doxycycline hydrochloride hemiethanolate hemihydrate); for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8.HCl)2. C2H6O.H2O and the molecular weight is 1025.87. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2: 1), monohydrate. Doxycycline is a light-yellowish crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients in the capsule formulations are: colloidal silicon dioxide, croscarmellose sodium, hard gelatin capsules, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The hard gelatin capsules contain gelatin, sodium lauryl sulfate, FD & C Blue 1 and titanium dioxide. The capsules are printed with edible ink containing shellac, and black iron oxide."
},
{
"NDCCode": "43598-386-62",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (43598-386-62) > 4 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "43598-0386-62",
"ProductNDC": "43598-386",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pemetrexed Disodium",
"NonProprietaryName": "Pemetrexed Disodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202596",
"LabelerName": "Dr. Reddys Laboratories Inc",
"SubstanceName": "PEMETREXED DISODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-11-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220525",
"SamplePackage": "N"
},
{
"NDCCode": "49349-386-02",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (49349-386-02)",
"NDC11Code": "49349-0386-02",
"ProductNDC": "49349-386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Enteric Coated Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100423",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-11-03",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50222-361-02",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (50222-361-02) / 1 mL in 1 SYRINGE, GLASS (50222-361-11) ",
"NDC11Code": "50222-0361-02",
"ProductNDC": "50222-361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spevigo",
"NonProprietaryName": "Spesolimab",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260309",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761244",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "SPESOLIMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260309",
"SamplePackage": "N",
"IndicationAndUsage": "SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.",
"Description": "Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8."
},
{
"NDCCode": "51346-386-02",
"PackageDescription": "1 TUBE in 1 CARTON (51346-386-02) > 150 mL in 1 TUBE (51346-386-01)",
"NDC11Code": "51346-0386-02",
"ProductNDC": "51346-386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Provence Calendula Perfect Sun Block 150ml",
"NonProprietaryName": "Octinoxate, Homosalate, Octisalate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "NATURE REPUBLIC CO., LTD.",
"SubstanceName": "OCTINOXATE; HOMOSALATE; OCTISALATE",
"StrengthNumber": "10.5; 9; 6.75",
"StrengthUnit": "g/150mL; g/150mL; g/150mL",
"Status": "Deprecated",
"LastUpdate": "2018-11-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55319-386-01",
"PackageDescription": "700 mL in 1 BOTTLE, PLASTIC (55319-386-01) ",
"NDC11Code": "55319-0386-01",
"ProductNDC": "55319-386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Family Wellness Everyday Clean 2 In 1 Dandruff Plus Conditioner",
"ProprietaryNameSuffix": "Anti-dandruff",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240506",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "FAMILY DOLLAR SERVICES INC",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240506",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "55319-386-02",
"PackageDescription": "400 mL in 1 BOTTLE, PLASTIC (55319-386-02) ",
"NDC11Code": "55319-0386-02",
"ProductNDC": "55319-386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Family Wellness Everyday Clean 2 In 1 Dandruff Plus Conditioner",
"ProprietaryNameSuffix": "Anti-dandruff",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240506",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "FAMILY DOLLAR SERVICES INC",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240506",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "55319-386-03",
"PackageDescription": "950 mL in 1 BOTTLE, PUMP (55319-386-03) ",
"NDC11Code": "55319-0386-03",
"ProductNDC": "55319-386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Family Wellness Everyday Clean 2 In 1 Dandruff Plus Conditioner",
"ProprietaryNameSuffix": "Anti-dandruff",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240506",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "FAMILY DOLLAR SERVICES INC",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240506",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "61621-430-11",
"PackageDescription": "10 TABLET in 1 CARTON (61621-430-11) ",
"NDC11Code": "61621-0430-11",
"ProductNDC": "61621-430",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dsuvia",
"NonProprietaryName": "Sufentanil",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20181102",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209128",
"LabelerName": "AcelRx Pharmaceuticals, Inc.",
"SubstanceName": "SUFENTANIL",
"StrengthNumber": "30",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181102",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "DSUVIA is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Not for home use or for use in children. Discontinue treatment with DSUVIA before patients leave the certified medically supervised healthcare setting. , 2 Not for use for more than 72 hours. The use of DSUVIA beyond 72 hours has not been studied., 3 Only to be administered by a healthcare provider., 4 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, [see Warnings and Precautions (5.3)], reserve opioid analgesics, including DSUVIA, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "DSUVIA contains one 30 mcg sufentanil tablet housed in a disposable single-dose applicator (SDA). The DSUVIA tablet is an immediate release formulation intended for sublingual administration. Each tablet is blue, flat-faced with a diameter of 3 mm. The IUPAC chemical name for sufentanil is N-[4-(methoxymethyl)-1-[2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenylpropanamide citrate. Sufentanil citrate has a molecular weight of 578.4 (molecular weight of free sufentanil base is 386.55), its empirical formula is C 28H 38N 2O 9S ● C 6H 8N 2O 7, and its chemical structure is shown below:. DSUVIA tablets inactive ingredients are: mannitol; dicalcium phosphate anhydrous; hypromellose; croscarmellose sodium; FD&C Blue #2; stearic acid and magnesium stearate."
},
{
"NDCCode": "61786-386-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (61786-386-02) ",
"NDC11Code": "61786-0386-02",
"ProductNDC": "61786-386",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norvir",
"NonProprietaryName": "Ritonavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150806",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022417",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "RITONAVIR",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150806",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>68428-386-11</NDCCode>
<PackageDescription>300 PELLET in 1 BOTTLE, GLASS (68428-386-11) </PackageDescription>
<NDC11Code>68428-0386-11</NDC11Code>
<ProductNDC>68428-386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ferrum Picricum</ProprietaryName>
<NonProprietaryName>Ferric Picrate</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>FERRIC PICRATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68428-386-03</NDCCode>
<PackageDescription>75 PELLET in 1 VIAL, GLASS (68428-386-03) </PackageDescription>
<NDC11Code>68428-0386-03</NDC11Code>
<ProductNDC>68428-386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ferrum Picricum</ProprietaryName>
<NonProprietaryName>Ferric Picrate</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>FERRIC PICRATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68428-386-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-386-05) </PackageDescription>
<NDC11Code>68428-0386-05</NDC11Code>
<ProductNDC>68428-386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ferrum Picricum</ProprietaryName>
<NonProprietaryName>Ferric Picrate</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>FERRIC PICRATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68428-386-06</NDCCode>
<PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (68428-386-06) </PackageDescription>
<NDC11Code>68428-0386-06</NDC11Code>
<ProductNDC>68428-386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ferrum Picricum</ProprietaryName>
<NonProprietaryName>Ferric Picrate</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>FERRIC PICRATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68428-386-12</NDCCode>
<PackageDescription>600 PELLET in 1 BOTTLE, GLASS (68428-386-12) </PackageDescription>
<NDC11Code>68428-0386-12</NDC11Code>
<ProductNDC>68428-386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ferrum Picricum</ProprietaryName>
<NonProprietaryName>Ferric Picrate</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>FERRIC PICRATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16103-386-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (16103-386-11) </PackageDescription>
<NDC11Code>16103-0386-11</NDC11Code>
<ProductNDC>16103-386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Meclizine</ProprietaryName>
<NonProprietaryName>Meclizine Hcl 12.5 Mg</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M009</ApplicationNumber>
<LabelerName>Pharbest Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>prevents and treats nausea, vomiting or dizziness associated with motion sickness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43547-386-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (43547-386-11) </PackageDescription>
<NDC11Code>43547-0386-11</NDC11Code>
<ProductNDC>43547-386</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosinopril Sodium</ProprietaryName>
<NonProprietaryName>Fosinopirl Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205670</ApplicationNumber>
<LabelerName>Solco Healthcare LLC</LabelerName>
<SubstanceName>FOSINOPRIL SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION). In using fosinopril sodium, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium does not have a similar risk (see WARNINGS). In considering use of fosinopril sodium, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Head and Neck Angioedema and Intestinal Angioedema).</IndicationAndUsage>
<Description>Fosinopril sodium is the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy) propoxy] (4-phenylbutyl) phosphinyl] acetyl]-, sodium salt, trans-. Fosinopril sodium is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is. C30 H45NNaO7P M.W. 585.65. Fosinopril sodium, USP, is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: crospovidone, lactose monohydrate, microcrystalline cellulose, povidone, and sodium stearyl fumarate.</Description>
</NDC>
<NDC>
<NDCCode>60687-386-21</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-386-21) / 1 CAPSULE in 1 BLISTER PACK (60687-386-11) </PackageDescription>
<NDC11Code>60687-0386-21</NDC11Code>
<ProductNDC>60687-386</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dronabinol</ProprietaryName>
<NonProprietaryName>Dronabinol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181002</StartMarketingDate>
<EndMarketingDate>20260228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078292</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>DRONABINOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cannabinoid [EPC], Cannabinoids [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181002</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DRONABINOL CAPSULES, USP are indicated in adults for the treatment of: 1 anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS)., 2 nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.</IndicationAndUsage>
<Description>Dronabinol is a cannabinoid designated chemically as (6aR,10aR)-6a,7,8,10a-Tetrahydro-6,6,9‑trimethyl-3-pentyl-6H-dibenzo[b,d]-pyran-1-ol. Dronabinol has the following empirical and structural formulas. C 21H 30O 2 (molecular weight = 314.46). Dronabinol, the active ingredient in dronabinol capsules, USP, is synthetic delta-9‑tetrahydrocannabinol (delta-9-THC). Dronabinol is a light yellow resinous oil that is sticky at room temperature and hardens upon refrigeration. Dronabinol is insoluble in water and is formulated in sesame oil. It has a pKa of 10.6 and an octanol-water partition coefficient: 6,000:1 at pH 7. Dronabinol capsule strengths are formulated with the following inactive ingredients: FD&C Yellow No. 6, gelatin, glycerin, purified water, sesame oil, titanium dioxide, iron oxide black Ingredients in imprint ink, shellac glaze , isopropyl alcohol , n-butyl alcohol , propylene glycol , and ammonium hydroxide. The 2.5 mg and 5 mg capsules also contain FD&C Blue No. 1 and FD&C Red No. 40.</Description>
</NDC>
<NDC>
<NDCCode>60687-386-94</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 CARTON (60687-386-94) / 1 CAPSULE in 1 BLISTER PACK (60687-386-11) </PackageDescription>
<NDC11Code>60687-0386-94</NDC11Code>
<ProductNDC>60687-386</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dronabinol</ProprietaryName>
<NonProprietaryName>Dronabinol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181002</StartMarketingDate>
<EndMarketingDate>20260228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078292</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>DRONABINOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cannabinoid [EPC], Cannabinoids [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240508</StartMarketingDatePackage>
<EndMarketingDatePackage>20260228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DRONABINOL CAPSULES, USP are indicated in adults for the treatment of: 1 anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS)., 2 nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.</IndicationAndUsage>
<Description>Dronabinol is a cannabinoid designated chemically as (6aR,10aR)-6a,7,8,10a-Tetrahydro-6,6,9‑trimethyl-3-pentyl-6H-dibenzo[b,d]-pyran-1-ol. Dronabinol has the following empirical and structural formulas. C 21H 30O 2 (molecular weight = 314.46). Dronabinol, the active ingredient in dronabinol capsules, USP, is synthetic delta-9‑tetrahydrocannabinol (delta-9-THC). Dronabinol is a light yellow resinous oil that is sticky at room temperature and hardens upon refrigeration. Dronabinol is insoluble in water and is formulated in sesame oil. It has a pKa of 10.6 and an octanol-water partition coefficient: 6,000:1 at pH 7. Dronabinol capsule strengths are formulated with the following inactive ingredients: FD&C Yellow No. 6, gelatin, glycerin, purified water, sesame oil, titanium dioxide, iron oxide black Ingredients in imprint ink, shellac glaze , isopropyl alcohol , n-butyl alcohol , propylene glycol , and ammonium hydroxide. The 2.5 mg and 5 mg capsules also contain FD&C Blue No. 1 and FD&C Red No. 40.</Description>
</NDC>
<NDC>
<NDCCode>73057-386-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (73057-386-11) </PackageDescription>
<NDC11Code>73057-0386-11</NDC11Code>
<ProductNDC>73057-386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Meclizine</ProprietaryName>
<NonProprietaryName>Meclizine Hcl 12.5mg</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190708</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M009</ApplicationNumber>
<LabelerName>Ulai Health LLC</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190708</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>prevents and treats nausea, vomiting or dizziness associated with motion sickness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0046-1105-11</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0046-1105-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00046-1105-11</NDC11Code>
<ProductNDC>0046-1105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prempro</ProprietaryName>
<NonProprietaryName>Conjugated Estrogens And Medroxyprogesterone Acetate</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020527</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE</SubstanceName>
<StrengthNumber>.3; 1.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is. PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide, yellow iron oxide, propylene glycol and black iron oxide. PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, propylene glycol, titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide. PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, Eudragit NE 30D, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, titanium dioxide, triethyl citrate, FD&C Blue No. 2, black iron oxide, and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>0046-1106-11</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0046-1106-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00046-1106-11</NDC11Code>
<ProductNDC>0046-1106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prempro</ProprietaryName>
<NonProprietaryName>Conjugated Estrogens And Medroxyprogesterone Acetate</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020527</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE</SubstanceName>
<StrengthNumber>.45; 1.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is. PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide, yellow iron oxide, propylene glycol and black iron oxide. PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, propylene glycol, titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide. PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, Eudragit NE 30D, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, titanium dioxide, triethyl citrate, FD&C Blue No. 2, black iron oxide, and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>0046-1107-11</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0046-1107-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00046-1107-11</NDC11Code>
<ProductNDC>0046-1107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prempro</ProprietaryName>
<NonProprietaryName>Conjugated Estrogens And Medroxyprogesterone Acetate</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020527</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE</SubstanceName>
<StrengthNumber>.625; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is. PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide, yellow iron oxide, propylene glycol and black iron oxide. PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, propylene glycol, titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide. PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, Eudragit NE 30D, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, titanium dioxide, triethyl citrate, FD&C Blue No. 2, black iron oxide, and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>0046-1108-11</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0046-1108-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00046-1108-11</NDC11Code>
<ProductNDC>0046-1108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prempro</ProprietaryName>
<NonProprietaryName>Conjugated Estrogens And Medroxyprogesterone Acetate</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121203</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020527</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE</SubstanceName>
<StrengthNumber>.625; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is. PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide, yellow iron oxide, propylene glycol and black iron oxide. PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, propylene glycol, titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide. PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, Eudragit NE 30D, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, titanium dioxide, triethyl citrate, FD&C Blue No. 2, black iron oxide, and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>0069-0151-11</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0069-0151-11) </PackageDescription>
<NDC11Code>00069-0151-11</NDC11Code>
<ProductNDC>0069-0151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inlyta</ProprietaryName>
<NonProprietaryName>Axitinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120127</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202324</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>AXITINIB</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INLYTA is a kinase inhibitor indicated: 1 in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). (1.1), 2 in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. (1.1), 3 as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. (1.2).</IndicationAndUsage>
<Description>INLYTA (axitinib) is a kinase inhibitor. Axitinib has the chemical name N-methyl-2-[3-((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl]-benzamide. The molecular formula is C22H18N4OS and the molecular weight is 386.47 Daltons. The chemical structure is. Axitinib is a white to light-yellow powder with a pKa of 4.8. The solubility of axitinib in aqueous media over the range pH 1.1 to pH 7.8 is in excess of 0.2 µg/mL. The partition coefficient (n-octanol/water) is 3.5. INLYTA is supplied as red, film-coated tablets containing either 1 mg or 5 mg of axitinib together with microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, and Opadry® II red 32K15441 as inactive ingredients. The Opadry II red 32K15441 film coating contains lactose monohydrate, HPMC 2910/Hypromellose 15cP, titanium dioxide, triacetin (glycerol triacetate), and red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>24385-386-89</NDCCode>
<PackageDescription>18 BLISTER PACK in 1 CARTON (24385-386-89) > 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>24385-0386-89</NDC11Code>
<ProductNDC>24385-386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Neighbor Pharmacy Anti Diarrheal</ProprietaryName>
<NonProprietaryName>Loperamide Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075232</ApplicationNumber>
<LabelerName>Amerisource Bergen</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>31722-386-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (31722-386-01) </PackageDescription>
<NDC11Code>31722-0386-01</NDC11Code>
<ProductNDC>31722-386</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluphenazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fluphenazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218769</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FLUPHENAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 2-[4-[3-[2-(trifluoromethyl)-10H-phenothiazin-10-yl] propyl]piperazin-1-yl-ethanol dihydrochloride. The structural formula is represented below:. Molecular Formula: C 22H 26F 3N 3OS2HCl MW: 510.44 Fluphenazine Hydrochloride Tablets, USP, for oral administration, contain 1 mg, 2.5 mg, 5 mg, or 10 mg fluphenazine hydrochloride, USP per tablet. Each tablet also contains croscarmellose sodium, D&C yellow # 10 (for 2.5 mg and 5 mg tablet), FD&C blue # 1 (for 5 mg tablet) and FD&C red # 40 (for 10 mg tablet), hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>31722-386-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (31722-386-05) </PackageDescription>
<NDC11Code>31722-0386-05</NDC11Code>
<ProductNDC>31722-386</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluphenazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fluphenazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218769</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FLUPHENAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
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<IndicationAndUsage>Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 2-[4-[3-[2-(trifluoromethyl)-10H-phenothiazin-10-yl] propyl]piperazin-1-yl-ethanol dihydrochloride. The structural formula is represented below:. Molecular Formula: C 22H 26F 3N 3OS2HCl MW: 510.44 Fluphenazine Hydrochloride Tablets, USP, for oral administration, contain 1 mg, 2.5 mg, 5 mg, or 10 mg fluphenazine hydrochloride, USP per tablet. Each tablet also contains croscarmellose sodium, D&C yellow # 10 (for 2.5 mg and 5 mg tablet), FD&C blue # 1 (for 5 mg tablet) and FD&C red # 40 (for 10 mg tablet), hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, titanium dioxide. Meets USP Dissolution Test 2.</Description>
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<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211137</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
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<LastUpdate>2026-01-08</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment: Doxycycline is indicated for the treatment of the following infections: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis.Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species.In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Prophylaxis: Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS section.).</IndicationAndUsage>
<Description>Doxycycline hyclate capsules are an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules (doxycycline hydrochloride hemiethanolate hemihydrate); for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8.HCl)2. C2H6O.H2O and the molecular weight is 1025.87. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2: 1), monohydrate. Doxycycline is a light-yellowish crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients in the capsule formulations are: colloidal silicon dioxide, croscarmellose sodium, hard gelatin capsules, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The hard gelatin capsules contain gelatin, sodium lauryl sulfate, FD & C Blue 1 and titanium dioxide. The capsules are printed with edible ink containing shellac, and black iron oxide.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment: Doxycycline is indicated for the treatment of the following infections: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis.Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species.In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Prophylaxis: Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS section.).</IndicationAndUsage>
<Description>Doxycycline hyclate capsules are an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules (doxycycline hydrochloride hemiethanolate hemihydrate); for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8.HCl)2. C2H6O.H2O and the molecular weight is 1025.87. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2: 1), monohydrate. Doxycycline is a light-yellowish crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients in the capsule formulations are: colloidal silicon dioxide, croscarmellose sodium, hard gelatin capsules, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The hard gelatin capsules contain gelatin, sodium lauryl sulfate, FD & C Blue 1 and titanium dioxide. The capsules are printed with edible ink containing shellac, and black iron oxide.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment: Doxycycline is indicated for the treatment of the following infections: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis.Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species.In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Prophylaxis: Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS section.).</IndicationAndUsage>
<Description>Doxycycline hyclate capsules are an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules (doxycycline hydrochloride hemiethanolate hemihydrate); for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8.HCl)2. C2H6O.H2O and the molecular weight is 1025.87. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2: 1), monohydrate. Doxycycline is a light-yellowish crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients in the capsule formulations are: colloidal silicon dioxide, croscarmellose sodium, hard gelatin capsules, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The hard gelatin capsules contain gelatin, sodium lauryl sulfate, FD & C Blue 1 and titanium dioxide. The capsules are printed with edible ink containing shellac, and black iron oxide.</Description>
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<ProprietaryName>Pemetrexed Disodium</ProprietaryName>
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<LabelerName>Dr. Reddys Laboratories Inc</LabelerName>
<SubstanceName>PEMETREXED DISODIUM</SubstanceName>
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<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2022-11-05</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>49349-386-02</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (49349-386-02)</PackageDescription>
<NDC11Code>49349-0386-02</NDC11Code>
<ProductNDC>49349-386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Enteric Coated Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100423</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-11-03</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (50222-361-02) / 1 mL in 1 SYRINGE, GLASS (50222-361-11) </PackageDescription>
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<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761244</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>SPESOLIMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.</IndicationAndUsage>
<Description>Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8.</Description>
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<ProductNDC>51346-386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Provence Calendula Perfect Sun Block 150ml</ProprietaryName>
<NonProprietaryName>Octinoxate, Homosalate, Octisalate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
<SubstanceName>OCTINOXATE; HOMOSALATE; OCTISALATE</SubstanceName>
<StrengthNumber>10.5; 9; 6.75</StrengthNumber>
<StrengthUnit>g/150mL; g/150mL; g/150mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-11-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
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<NDCCode>55319-386-01</NDCCode>
<PackageDescription>700 mL in 1 BOTTLE, PLASTIC (55319-386-01) </PackageDescription>
<NDC11Code>55319-0386-01</NDC11Code>
<ProductNDC>55319-386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Family Wellness Everyday Clean 2 In 1 Dandruff Plus Conditioner</ProprietaryName>
<ProprietaryNameSuffix>Anti-dandruff</ProprietaryNameSuffix>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240506</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>FAMILY DOLLAR SERVICES INC</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55319-386-02</NDCCode>
<PackageDescription>400 mL in 1 BOTTLE, PLASTIC (55319-386-02) </PackageDescription>
<NDC11Code>55319-0386-02</NDC11Code>
<ProductNDC>55319-386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Family Wellness Everyday Clean 2 In 1 Dandruff Plus Conditioner</ProprietaryName>
<ProprietaryNameSuffix>Anti-dandruff</ProprietaryNameSuffix>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240506</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>FAMILY DOLLAR SERVICES INC</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55319-386-03</NDCCode>
<PackageDescription>950 mL in 1 BOTTLE, PUMP (55319-386-03) </PackageDescription>
<NDC11Code>55319-0386-03</NDC11Code>
<ProductNDC>55319-386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Family Wellness Everyday Clean 2 In 1 Dandruff Plus Conditioner</ProprietaryName>
<ProprietaryNameSuffix>Anti-dandruff</ProprietaryNameSuffix>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240506</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>FAMILY DOLLAR SERVICES INC</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61621-430-11</NDCCode>
<PackageDescription>10 TABLET in 1 CARTON (61621-430-11) </PackageDescription>
<NDC11Code>61621-0430-11</NDC11Code>
<ProductNDC>61621-430</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dsuvia</ProprietaryName>
<NonProprietaryName>Sufentanil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20181102</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209128</ApplicationNumber>
<LabelerName>AcelRx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SUFENTANIL</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181102</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DSUVIA is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Not for home use or for use in children. Discontinue treatment with DSUVIA before patients leave the certified medically supervised healthcare setting. , 2 Not for use for more than 72 hours. The use of DSUVIA beyond 72 hours has not been studied., 3 Only to be administered by a healthcare provider., 4 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, [see Warnings and Precautions (5.3)], reserve opioid analgesics, including DSUVIA, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>DSUVIA contains one 30 mcg sufentanil tablet housed in a disposable single-dose applicator (SDA). The DSUVIA tablet is an immediate release formulation intended for sublingual administration. Each tablet is blue, flat-faced with a diameter of 3 mm. The IUPAC chemical name for sufentanil is N-[4-(methoxymethyl)-1-[2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenylpropanamide citrate. Sufentanil citrate has a molecular weight of 578.4 (molecular weight of free sufentanil base is 386.55), its empirical formula is C 28H 38N 2O 9S ● C 6H 8N 2O 7, and its chemical structure is shown below:. DSUVIA tablets inactive ingredients are: mannitol; dicalcium phosphate anhydrous; hypromellose; croscarmellose sodium; FD&C Blue #2; stearic acid and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>61786-386-02</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (61786-386-02) </PackageDescription>
<NDC11Code>61786-0386-02</NDC11Code>
<ProductNDC>61786-386</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norvir</ProprietaryName>
<NonProprietaryName>Ritonavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150806</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022417</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>RITONAVIR</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>