{
"NDC": [
{
"NDCCode": "70771-1036-0",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1036-0) ",
"NDC11Code": "70771-1036-00",
"ProductNDC": "70771-1036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiadylt Er",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206641",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171108",
"SamplePackage": "N",
"IndicationAndUsage": "Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.",
"Description": "Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution test 18."
},
{
"NDCCode": "70771-1036-1",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1036-1) ",
"NDC11Code": "70771-1036-01",
"ProductNDC": "70771-1036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiadylt Er",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206641",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171108",
"SamplePackage": "N",
"IndicationAndUsage": "Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.",
"Description": "Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution test 18."
},
{
"NDCCode": "70771-1036-3",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1036-3) ",
"NDC11Code": "70771-1036-03",
"ProductNDC": "70771-1036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiadylt Er",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206641",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171108",
"SamplePackage": "N",
"IndicationAndUsage": "Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.",
"Description": "Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution test 18."
},
{
"NDCCode": "70771-1036-5",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1036-5) ",
"NDC11Code": "70771-1036-05",
"ProductNDC": "70771-1036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiadylt Er",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206641",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171108",
"SamplePackage": "N",
"IndicationAndUsage": "Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.",
"Description": "Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution test 18."
},
{
"NDCCode": "70771-1036-9",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1036-9) ",
"NDC11Code": "70771-1036-09",
"ProductNDC": "70771-1036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiadylt Er",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206641",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171108",
"SamplePackage": "N",
"IndicationAndUsage": "Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.",
"Description": "Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution test 18."
},
{
"NDCCode": "0113-1036-63",
"PackageDescription": "1 BOTTLE in 1 CARTON (0113-1036-63) > 25 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "00113-1036-63",
"ProductNDC": "0113-1036",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Sense All Day Allergy",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20190824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207235",
"LabelerName": "L. Perrigo Company",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190824",
"SamplePackage": "N"
},
{
"NDCCode": "0121-1036-40",
"PackageDescription": "4 TRAY in 1 CASE (0121-1036-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1036-05) ",
"NDC11Code": "00121-1036-40",
"ProductNDC": "0121-1036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
"NonProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20240805",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA005213",
"LabelerName": "PAI Holdings, LLC dba PAI Pharma",
"SubstanceName": "HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE",
"StrengthNumber": "5; 1.5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240805",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in adult patients 18 years of age and older. Limitations of Use: 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]. , 2 Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4)]., 3 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 (5.1)], reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough.",
"Description": "Hydrocodone bitartrate and homatropine methylbromide oral solution contain hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist. Each spoonful (5 mL) of hydrocodone bitartrate and homatropine methylbromide oral solution contains 5 mg of hydrocodone bitartrate, USP and 1.5 mg of homatropine methylbromide, USP, for oral administration. Hydrocodone bitartrate and homatropine methylbromide oral solution also contains: anhydrous citric acid, FD&C Red 40, methylparaben, natural and artificial cherry flavor, propylparaben, purified water, sorbitol solution, sodium citrate dihydrate and sucrose. Hydrocodone Bitartrate. The chemical name for hydrocodone bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-,(5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5). It is also known as 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It occurs as a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine. It has a molecular weight of 494.50 and has the following chemical structure. Homatropine Methylbromide. The chemical name for homatropine methylbromide is 8-Azoniabicyclo [3.2.1]octane,3-[(hydroxyphenyl-acetyl)oxy]-8,8-dimethyl-,bromide, endo-. It occurs as a white crystal or fine white crystalline powder. It has a molecular weight of 370.29 and has the following chemical structure."
},
{
"NDCCode": "0220-1036-41",
"PackageDescription": "12 [hp_C] in 1 TUBE (0220-1036-41) ",
"NDC11Code": "00220-1036-41",
"ProductNDC": "0220-1036",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Caladium Seguinum",
"NonProprietaryName": "Dieffenbachia Seguine",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "DIEFFENBACHIA SEGUINE",
"StrengthNumber": "12",
"StrengthUnit": "[hp_C]/12[hp_C]",
"Status": "Active",
"LastUpdate": "2023-11-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830303",
"SamplePackage": "N",
"IndicationAndUsage": "Intense itching*."
},
{
"NDCCode": "0268-1036-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (0268-1036-10) ",
"NDC11Code": "00268-1036-10",
"ProductNDC": "0268-1036",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Paspalum Notatum Pollen",
"NonProprietaryName": "Bahia Grass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19650101",
"EndMarketingDate": "20211130",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "PASPALUM NOTATUM POLLEN",
"StrengthNumber": "40000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19650101",
"EndMarketingDatePackage": "20211130",
"SamplePackage": "N"
},
{
"NDCCode": "0268-1036-50",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-1036-50) ",
"NDC11Code": "00268-1036-50",
"ProductNDC": "0268-1036",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Paspalum Notatum Pollen",
"NonProprietaryName": "Bahia Grass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19650101",
"EndMarketingDate": "20211130",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "PASPALUM NOTATUM POLLEN",
"StrengthNumber": "40000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19650101",
"EndMarketingDatePackage": "20211130",
"SamplePackage": "N"
},
{
"NDCCode": "0409-1036-30",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1036-30) > 30 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-1036-30",
"ProductNDC": "0409-1036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbocaine",
"NonProprietaryName": "Mepivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION",
"StartMarketingDate": "20060323",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA012250",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MEPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20060323",
"SamplePackage": "N"
},
{
"NDCCode": "0781-1036-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0781-1036-01) ",
"NDC11Code": "00781-1036-01",
"ProductNDC": "0781-1036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trifluoperazine Hydrochloride",
"NonProprietaryName": "Trifluoperazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19811120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085788",
"LabelerName": "Sandoz Inc",
"SubstanceName": "TRIFLUOPERAZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19811120",
"SamplePackage": "N"
},
{
"NDCCode": "0781-1036-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (0781-1036-05) ",
"NDC11Code": "00781-1036-05",
"ProductNDC": "0781-1036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trifluoperazine Hydrochloride",
"NonProprietaryName": "Trifluoperazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19811120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085788",
"LabelerName": "Sandoz Inc",
"SubstanceName": "TRIFLUOPERAZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19811120",
"SamplePackage": "N"
},
{
"NDCCode": "0781-1036-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (0781-1036-10) ",
"NDC11Code": "00781-1036-10",
"ProductNDC": "0781-1036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trifluoperazine Hydrochloride",
"NonProprietaryName": "Trifluoperazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19811120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085788",
"LabelerName": "Sandoz Inc",
"SubstanceName": "TRIFLUOPERAZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19811120",
"SamplePackage": "N"
},
{
"NDCCode": "0781-1036-13",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (0781-1036-13) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00781-1036-13",
"ProductNDC": "0781-1036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trifluoperazine Hydrochloride",
"NonProprietaryName": "Trifluoperazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19811120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085788",
"LabelerName": "Sandoz Inc",
"SubstanceName": "TRIFLUOPERAZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19811120",
"SamplePackage": "N"
},
{
"NDCCode": "10191-1036-2",
"PackageDescription": "172 PELLET in 1 VIAL, GLASS (10191-1036-2) ",
"NDC11Code": "10191-1036-02",
"ProductNDC": "10191-1036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Codeinum",
"NonProprietaryName": "Codeine",
"DosageFormName": "PELLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20150715",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Remedy Makers",
"SubstanceName": "CODEINE ANHYDROUS",
"StrengthNumber": "12",
"StrengthUnit": "[hp_X]/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150715",
"SamplePackage": "N",
"IndicationAndUsage": "ITCHING WITH WARMTH SPASMODIC COUGH, OR OTHER INDICATIONS."
},
{
"NDCCode": "12502-1036-0",
"PackageDescription": "50 kg in 1 DRUM (12502-1036-0)",
"NDC11Code": "12502-1036-00",
"ProductNDC": "12502-1036",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Etodolac",
"DosageFormName": "POWDER",
"StartMarketingDate": "19941130",
"EndMarketingDate": "20130709",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Cilag AG",
"SubstanceName": "ETODOLAC",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130709"
},
{
"NDCCode": "17373-1036-0",
"PackageDescription": "25 kg in 1 DRUM (17373-1036-0) ",
"NDC11Code": "17373-1036-00",
"ProductNDC": "17373-1036",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20170102",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Anonima Materie Sintetiche and Affini (AMSA) Spa",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-01-21",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "02-JAN-17"
},
{
"NDCCode": "36987-1036-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-1036-1)",
"NDC11Code": "36987-1036-01",
"ProductNDC": "36987-1036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Goose Feathers",
"NonProprietaryName": "Goose Feathers",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "ANSER ANSER FEATHER",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [CS],Allergens [CS],Increased IgG Production [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-1036-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1036-2)",
"NDC11Code": "36987-1036-02",
"ProductNDC": "36987-1036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Goose Feathers",
"NonProprietaryName": "Goose Feathers",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "ANSER ANSER FEATHER",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [CS],Allergens [CS],Increased IgG Production [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-1036-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-1036-3)",
"NDC11Code": "36987-1036-03",
"ProductNDC": "36987-1036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Goose Feathers",
"NonProprietaryName": "Goose Feathers",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "ANSER ANSER FEATHER",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [CS],Allergens [CS],Increased IgG Production [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-1036-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-1036-4)",
"NDC11Code": "36987-1036-04",
"ProductNDC": "36987-1036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Goose Feathers",
"NonProprietaryName": "Goose Feathers",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "ANSER ANSER FEATHER",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [CS],Allergens [CS],Increased IgG Production [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-1036-1",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-1036-1) ",
"NDC11Code": "37662-1036-01",
"ProductNDC": "37662-1036",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Magnesia Sulphurica",
"NonProprietaryName": "Magnesia Sulphurica",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220722",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "MAGNESIUM SULFATE HEPTAHYDRATE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_Q]/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2022-07-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220722",
"SamplePackage": "N"
},
{
"NDCCode": "43742-1036-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-1036-1) ",
"NDC11Code": "43742-1036-01",
"ProductNDC": "43742-1036",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Elevate",
"NonProprietaryName": "Lycopodium Clavatum, Natrum Muriaticum, Sepia, Causticum, Phosphorus, Sulphur, 5-hydroxytryptophan, Alumina, Silicea, Acetylcholine Chloride, Dopamine Hydrochloride, Norepinephrine, Phenylethylamine (hydrochloride), Serotonin (hydrochloride), Adenosinum Cyclophosphoricum, Cerebrum (suis), Diencephalon (suis), Funiculus Umbilicalis Suis, Pantothenic Acid, Pineal Gland (suis), Sarcolacticum Acidum, Faecalis (alkaligenes), Gaertner Bacillus (bach), Proteus (vulgaris)",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170720",
"EndMarketingDate": "20240204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "ACETYLCHOLINE CHLORIDE; ADENOSINE CYCLIC PHOSPHATE; ALCALIGENES FAECALIS; ALUMINUM OXIDE; CAUSTICUM; DOPAMINE HYDROCHLORIDE; LACTIC ACID, L-; LYCOPODIUM CLAVATUM SPORE; NOREPINEPHRINE; OXITRIPTAN; PANTOTHENIC ACID; PHENETHYLAMINE HYDROCHLORIDE; PHOSPHORUS; PROTEUS VULGARIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SEPIA OFFICINALIS JUICE; SEROTONIN HYDROCHLORIDE; SILICON DIOXIDE; SODIUM CHLORIDE; SULFUR; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA UMBILICAL CORD",
"StrengthNumber": "8; 10; 30; 8; 4; 8; 10; 3; 8; 6; 10; 8; 4; 30; 30; 3; 8; 8; 3; 4; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Catecholamine [EPC], Catecholamine [EPC], Catecholamines [CS], Catecholamines [CS], Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170720",
"EndMarketingDatePackage": "20240204",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of symptoms including difficulty sleeping or concentrating, loss of appetite, irritability, feelings of hopelessness and self-loathing.**. **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "44946-1036-8",
"PackageDescription": "50 mL in 1 BOTTLE, PLASTIC (44946-1036-8)",
"NDC11Code": "44946-1036-08",
"ProductNDC": "44946-1036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri-vitamin With Fluoride",
"NonProprietaryName": "Vitamin A, Ascorbic Acid, Vitamin D, And Sodium Fluoride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20111220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; VITAMIN D; SODIUM FLUORIDE",
"StrengthNumber": "1500; 35; 400; .5",
"StrengthUnit": "[iU]/mL; mg/mL; [iU]/mL; mg/mL",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-01-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "46014-1036-0",
"PackageDescription": "50 kg in 1 BOX (46014-1036-0)",
"NDC11Code": "46014-1036-00",
"ProductNDC": "46014-1036",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Baclofen(r)",
"DosageFormName": "NOT APPLICABLE",
"StartMarketingDate": "20080505",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Excella GmbH",
"SubstanceName": "ARBACLOFEN",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "48951-1036-2",
"PackageDescription": "1350 PELLET in 1 BOTTLE, GLASS (48951-1036-2) ",
"NDC11Code": "48951-1036-02",
"ProductNDC": "48951-1036",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anise Pyrite",
"NonProprietaryName": "Anise Pyrite",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "ANISE; FERROUS DISULFIDE; SUCROSE",
"StrengthNumber": "3; 3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: FOR ORAL USE ONLY."
},
{
"NDCCode": "50090-1036-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (50090-1036-0) ",
"NDC11Code": "50090-1036-00",
"ProductNDC": "50090-1036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Januvia",
"NonProprietaryName": "Sitagliptin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061016",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021995",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "SITAGLIPTIN PHOSPHATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate, and propyl gallate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide."
},
{
"NDCCode": "50090-1036-2",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50090-1036-2) ",
"NDC11Code": "50090-1036-02",
"ProductNDC": "50090-1036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Januvia",
"NonProprietaryName": "Sitagliptin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061016",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021995",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "SITAGLIPTIN PHOSPHATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180612",
"SamplePackage": "N",
"IndicationAndUsage": "JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate, and propyl gallate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide."
},
{
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"PackageDescription": "1 JAR in 1 BOX (50184-1036-2) > 9.1 g in 1 JAR (50184-1036-1)",
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"ProductNDC": "50184-1036",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Supernatural Airbrushed Canvas Broad Spectrum Spf 15 Sunscreen",
"ProprietaryNameSuffix": "Beige",
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<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240805</StartMarketingDate>
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<StrengthNumber>5; 1.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in adult patients 18 years of age and older. Limitations of Use: 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]. , 2 Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4)]., 3 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 (5.1)], reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough.</IndicationAndUsage>
<Description>Hydrocodone bitartrate and homatropine methylbromide oral solution contain hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist. Each spoonful (5 mL) of hydrocodone bitartrate and homatropine methylbromide oral solution contains 5 mg of hydrocodone bitartrate, USP and 1.5 mg of homatropine methylbromide, USP, for oral administration. Hydrocodone bitartrate and homatropine methylbromide oral solution also contains: anhydrous citric acid, FD&C Red 40, methylparaben, natural and artificial cherry flavor, propylparaben, purified water, sorbitol solution, sodium citrate dihydrate and sucrose. Hydrocodone Bitartrate. The chemical name for hydrocodone bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-,(5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5). It is also known as 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It occurs as a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine. It has a molecular weight of 494.50 and has the following chemical structure. Homatropine Methylbromide. The chemical name for homatropine methylbromide is 8-Azoniabicyclo [3.2.1]octane,3-[(hydroxyphenyl-acetyl)oxy]-8,8-dimethyl-,bromide, endo-. It occurs as a white crystal or fine white crystalline powder. It has a molecular weight of 370.29 and has the following chemical structure.</Description>
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<Status>Active</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Intense itching*.</IndicationAndUsage>
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<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Paspalum Notatum Pollen</ProprietaryName>
<NonProprietaryName>Bahia Grass</NonProprietaryName>
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<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19650101</StartMarketingDate>
<EndMarketingDate>20211130</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>PASPALUM NOTATUM POLLEN</SubstanceName>
<StrengthNumber>40000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19650101</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
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<NDC>
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<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19650101</StartMarketingDate>
<EndMarketingDate>20211130</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>PASPALUM NOTATUM POLLEN</SubstanceName>
<StrengthNumber>40000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19650101</StartMarketingDatePackage>
<EndMarketingDatePackage>20211130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-1036-30</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1036-30) > 30 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-1036-30</NDC11Code>
<ProductNDC>0409-1036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbocaine</ProprietaryName>
<NonProprietaryName>Mepivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION</RouteName>
<StartMarketingDate>20060323</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA012250</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MEPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1036-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0781-1036-01) </PackageDescription>
<NDC11Code>00781-1036-01</NDC11Code>
<ProductNDC>0781-1036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trifluoperazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Trifluoperazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19811120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085788</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>TRIFLUOPERAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19811120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1036-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (0781-1036-05) </PackageDescription>
<NDC11Code>00781-1036-05</NDC11Code>
<ProductNDC>0781-1036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trifluoperazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Trifluoperazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19811120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085788</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>TRIFLUOPERAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19811120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1036-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (0781-1036-10) </PackageDescription>
<NDC11Code>00781-1036-10</NDC11Code>
<ProductNDC>0781-1036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trifluoperazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Trifluoperazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19811120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085788</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>TRIFLUOPERAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19811120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1036-13</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (0781-1036-13) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00781-1036-13</NDC11Code>
<ProductNDC>0781-1036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trifluoperazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Trifluoperazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19811120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085788</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>TRIFLUOPERAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19811120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10191-1036-2</NDCCode>
<PackageDescription>172 PELLET in 1 VIAL, GLASS (10191-1036-2) </PackageDescription>
<NDC11Code>10191-1036-02</NDC11Code>
<ProductNDC>10191-1036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Codeinum</ProprietaryName>
<NonProprietaryName>Codeine</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20150715</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Remedy Makers</LabelerName>
<SubstanceName>CODEINE ANHYDROUS</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ITCHING WITH WARMTH SPASMODIC COUGH, OR OTHER INDICATIONS.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>12502-1036-0</NDCCode>
<PackageDescription>50 kg in 1 DRUM (12502-1036-0)</PackageDescription>
<NDC11Code>12502-1036-00</NDC11Code>
<ProductNDC>12502-1036</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Etodolac</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19941130</StartMarketingDate>
<EndMarketingDate>20130709</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Cilag AG</LabelerName>
<SubstanceName>ETODOLAC</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130709</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>17373-1036-0</NDCCode>
<PackageDescription>25 kg in 1 DRUM (17373-1036-0) </PackageDescription>
<NDC11Code>17373-1036-00</NDC11Code>
<ProductNDC>17373-1036</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20170102</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Anonima Materie Sintetiche and Affini (AMSA) Spa</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-21</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>02-JAN-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>36987-1036-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-1036-1)</PackageDescription>
<NDC11Code>36987-1036-01</NDC11Code>
<ProductNDC>36987-1036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Goose Feathers</ProprietaryName>
<NonProprietaryName>Goose Feathers</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>ANSER ANSER FEATHER</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [CS],Allergens [CS],Increased IgG Production [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-1036-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-1036-2)</PackageDescription>
<NDC11Code>36987-1036-02</NDC11Code>
<ProductNDC>36987-1036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Goose Feathers</ProprietaryName>
<NonProprietaryName>Goose Feathers</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>ANSER ANSER FEATHER</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [CS],Allergens [CS],Increased IgG Production [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-1036-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-1036-3)</PackageDescription>
<NDC11Code>36987-1036-03</NDC11Code>
<ProductNDC>36987-1036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Goose Feathers</ProprietaryName>
<NonProprietaryName>Goose Feathers</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>ANSER ANSER FEATHER</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [CS],Allergens [CS],Increased IgG Production [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-1036-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-1036-4)</PackageDescription>
<NDC11Code>36987-1036-04</NDC11Code>
<ProductNDC>36987-1036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Goose Feathers</ProprietaryName>
<NonProprietaryName>Goose Feathers</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>ANSER ANSER FEATHER</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [CS],Allergens [CS],Increased IgG Production [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-1036-1</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (37662-1036-1) </PackageDescription>
<NDC11Code>37662-1036-01</NDC11Code>
<ProductNDC>37662-1036</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Magnesia Sulphurica</ProprietaryName>
<NonProprietaryName>Magnesia Sulphurica</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220722</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_Q]/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43742-1036-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-1036-1) </PackageDescription>
<NDC11Code>43742-1036-01</NDC11Code>
<ProductNDC>43742-1036</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Elevate</ProprietaryName>
<NonProprietaryName>Lycopodium Clavatum, Natrum Muriaticum, Sepia, Causticum, Phosphorus, Sulphur, 5-hydroxytryptophan, Alumina, Silicea, Acetylcholine Chloride, Dopamine Hydrochloride, Norepinephrine, Phenylethylamine (hydrochloride), Serotonin (hydrochloride), Adenosinum Cyclophosphoricum, Cerebrum (suis), Diencephalon (suis), Funiculus Umbilicalis Suis, Pantothenic Acid, Pineal Gland (suis), Sarcolacticum Acidum, Faecalis (alkaligenes), Gaertner Bacillus (bach), Proteus (vulgaris)</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170720</StartMarketingDate>
<EndMarketingDate>20240204</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>ACETYLCHOLINE CHLORIDE; ADENOSINE CYCLIC PHOSPHATE; ALCALIGENES FAECALIS; ALUMINUM OXIDE; CAUSTICUM; DOPAMINE HYDROCHLORIDE; LACTIC ACID, L-; LYCOPODIUM CLAVATUM SPORE; NOREPINEPHRINE; OXITRIPTAN; PANTOTHENIC ACID; PHENETHYLAMINE HYDROCHLORIDE; PHOSPHORUS; PROTEUS VULGARIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SEPIA OFFICINALIS JUICE; SEROTONIN HYDROCHLORIDE; SILICON DIOXIDE; SODIUM CHLORIDE; SULFUR; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA UMBILICAL CORD</SubstanceName>
<StrengthNumber>8; 10; 30; 8; 4; 8; 10; 3; 8; 6; 10; 8; 4; 30; 30; 3; 8; 8; 3; 4; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC], Catecholamine [EPC], Catecholamines [CS], Catecholamines [CS], Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170720</StartMarketingDatePackage>
<EndMarketingDatePackage>20240204</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of symptoms including difficulty sleeping or concentrating, loss of appetite, irritability, feelings of hopelessness and self-loathing.**. **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>44946-1036-8</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, PLASTIC (44946-1036-8)</PackageDescription>
<NDC11Code>44946-1036-08</NDC11Code>
<ProductNDC>44946-1036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri-vitamin With Fluoride</ProprietaryName>
<NonProprietaryName>Vitamin A, Ascorbic Acid, Vitamin D, And Sodium Fluoride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; VITAMIN D; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1500; 35; 400; .5</StrengthNumber>
<StrengthUnit>[iU]/mL; mg/mL; [iU]/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>46014-1036-0</NDCCode>
<PackageDescription>50 kg in 1 BOX (46014-1036-0)</PackageDescription>
<NDC11Code>46014-1036-00</NDC11Code>
<ProductNDC>46014-1036</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Baclofen(r)</NonProprietaryName>
<DosageFormName>NOT APPLICABLE</DosageFormName>
<StartMarketingDate>20080505</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Excella GmbH</LabelerName>
<SubstanceName>ARBACLOFEN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>48951-1036-2</NDCCode>
<PackageDescription>1350 PELLET in 1 BOTTLE, GLASS (48951-1036-2) </PackageDescription>
<NDC11Code>48951-1036-02</NDC11Code>
<ProductNDC>48951-1036</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anise Pyrite</ProprietaryName>
<NonProprietaryName>Anise Pyrite</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>ANISE; FERROUS DISULFIDE; SUCROSE</SubstanceName>
<StrengthNumber>3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: FOR ORAL USE ONLY.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-1036-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (50090-1036-0) </PackageDescription>
<NDC11Code>50090-1036-00</NDC11Code>
<ProductNDC>50090-1036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Januvia</ProprietaryName>
<NonProprietaryName>Sitagliptin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061016</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021995</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate, and propyl gallate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>50090-1036-2</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50090-1036-2) </PackageDescription>
<NDC11Code>50090-1036-02</NDC11Code>
<ProductNDC>50090-1036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Januvia</ProprietaryName>
<NonProprietaryName>Sitagliptin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061016</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021995</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate, and propyl gallate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>50184-1036-2</NDCCode>
<PackageDescription>1 JAR in 1 BOX (50184-1036-2) > 9.1 g in 1 JAR (50184-1036-1)</PackageDescription>
<NDC11Code>50184-1036-02</NDC11Code>
<ProductNDC>50184-1036</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Supernatural Airbrushed Canvas Broad Spectrum Spf 15 Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Beige</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide, Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>philosophy</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>882.7; 5.49</StrengthNumber>
<StrengthUnit>mg/9.1g; mg/9.1g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>