{
"NDC": [
{
"NDCCode": "17089-472-23",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (17089-472-23) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "17089-0472-23",
"ProductNDC": "17089-472",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna Sinus Plus",
"NonProprietaryName": "Althaea Officinalis Leaf - Calcium Sulfide - Copper - Drimia Maritima Bulb - Echinacea Angustifolia - Hydrastis Canadensis Whole - Lobaria Pulmonaria - Manganese - Mercuric Sulfide - Onion - Plantago Major Whole - Potassium Dichromate - Pulsatilla Vulgaris - Silicon Dioxide - Silver Nitrate - Sinusitisinum - Sus Scrofa Nasal Mucosa -",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20210217",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "ONION; ALTHAEA OFFICINALIS LEAF; SILVER NITRATE; ASCORBIC ACID; HYDRASTIS CANADENSIS WHOLE; LOBARIA PULMONARIA; COPPER; ECHINACEA ANGUSTIFOLIA; CALCIUM SULFIDE; POTASSIUM DICHROMATE; MANGANESE; MERCURIC SULFIDE; SUS SCROFA NASAL MUCOSA; PULSATILLA VULGARIS; SILICON DIOXIDE; SINUSITISINUM; PLANTAGO MAJOR WHOLE; DRIMIA MARITIMA BULB",
"StrengthNumber": "6; 2; 10; 3; 6; 2; 8; 3; 6; 6; 8; 8; 6; 6; 6; 12; 2; 12",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Pharm_Classes": "Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2021-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210217",
"SamplePackage": "N",
"IndicationAndUsage": "Directions:. tilt head forward slightly, insert the canister tip in the nose, aiming the tip toward the back of the head. Squeeze the pump and spray intro nostril."
},
{
"NDCCode": "49349-472-23",
"PackageDescription": "180 TABLET in 1 BLISTER PACK (49349-472-23)",
"NDC11Code": "49349-0472-23",
"ProductNDC": "49349-472",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077397",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-03-23"
},
{
"NDCCode": "17089-419-23",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (17089-419-23) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "17089-0419-23",
"ProductNDC": "17089-419",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna-rhino Nose",
"NonProprietaryName": "Apis Mellifera - Aralia Racemosa Root - Ascorbic Acid - Black Currant - Copper - Euphorbia Resinifera Resin - European Elderberry - Helianthemum Canadense - Histamine Dihydrochloride - Human Interleukin 12 - Human Interleukin-10 (nonglycosylated) - Interferon Gamma-1b - Manganese Gluconate - Melilotus - Onion - Plantago Major - Rosa Canina Fruit - Silver Nitrate -",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20100527",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "ONION; APIS MELLIFERA; ARALIA RACEMOSA ROOT; SILVER NITRATE; ASCORBIC ACID; BLACK CURRANT; HELIANTHEMUM CANADENSE; COPPER; EUPHORBIA RESINIFERA RESIN; HISTAMINE DIHYDROCHLORIDE; INTERFERON GAMMA-1B; INTERLEUKIN-10; HUMAN INTERLEUKIN 12; MANGANESE GLUCONATE; MELILOTUS; PLANTAGO MAJOR; ROSA CANINA FRUIT; EUROPEAN ELDERBERRY",
"StrengthNumber": "8; 12; 1; 10; 2; 1; 4; 4; 4; 200; 4; 4; 4; 4; 3; 2; 1; 2",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Ascorbic Acid [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Interferon gamma [EPC], Interferon-gamma [CS], Magnetic Resonance Contrast Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Paramagnetic Contrast Agent [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2019-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111008",
"SamplePackage": "N",
"IndicationAndUsage": "Tilt head slightly forward, place tip of bottle into nose, compress bottle once for each spray, aiming towards the back of the nose."
},
{
"NDCCode": "17089-451-23",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (17089-451-23) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "17089-0451-23",
"ProductNDC": "17089-451",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna-sinus Nose",
"NonProprietaryName": "Althaea Officinalis Leaf - Ascorbic Acid - Black Currant - Calcium Sulfide - Copper - Echinacea Angustifolia - Goldenseal - Lachesis Muta Venom - Lobaria Pulmonaria - Manganese - Mercuric Sulfide - Onion - Plantago Major - Potassium Carbonate - Pulsatilla Vulgaris - Silicon Dioxide - Silver Nitrate - Sinusitisinum - Sus Scrofa Nasal Mucosa - Sus Scrofa Thymus - Sus Scrofa Urinary Bladder -",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20100527",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "ONION; ALTHAEA OFFICINALIS LEAF; SILVER NITRATE; ASCORBIC ACID; BLACK CURRANT; LOBARIA PULMONARIA; COPPER; ECHINACEA ANGUSTIFOLIA; CALCIUM SULFIDE; GOLDENSEAL; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; MANGANESE; MERCURIC SULFIDE; SUS SCROFA NASAL MUCOSA; PLANTAGO MAJOR; PULSATILLA VULGARIS; SILICON DIOXIDE; SINUSITISINUM; SUS SCROFA THYMUS; SUS SCROFA URINARY BLADDER",
"StrengthNumber": "8; 2; 10; 2; 1; 2; 3; 3; 8; 8; 8; 30; 3; 8; 12; 2; 8; 8; 30; 12; 30",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Pharm_Classes": "Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2019-04-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Directions:. tilt head slightly forward, place tip of bottle into nose, compress bottle once for each spray, aiming towards the back of the nose."
},
{
"NDCCode": "42291-472-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (42291-472-01) ",
"NDC11Code": "42291-0472-01",
"ProductNDC": "42291-472",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074260",
"LabelerName": "AvKARE",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220315",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.",
"Description": "Carbidopa and levodopa tablets, USP are a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C 10H 14N 2O 4H 2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C 9H 11NO 4, and its structural formula is:. Carbidopa and Levodopa Tablets, USP for oral administration, are supplied in three strengths. 10 mg/100 mg, containing 10 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/100 mg, containing 25 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/250 mg, containing 25 mg of carbidopa, USP and 250 mg of levodopa, USP. In addition, each tablet contains the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize). In addition, the 25 mg/100 mg strength contain D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake (sunset yellow lake). The 10 mg/100 mg and 25 mg/250 mg strengths contain FD&C blue #2 aluminum lake."
},
{
"NDCCode": "42291-472-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (42291-472-10) ",
"NDC11Code": "42291-0472-10",
"ProductNDC": "42291-472",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074260",
"LabelerName": "AvKARE",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220315",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.",
"Description": "Carbidopa and levodopa tablets, USP are a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C 10H 14N 2O 4H 2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C 9H 11NO 4, and its structural formula is:. Carbidopa and Levodopa Tablets, USP for oral administration, are supplied in three strengths. 10 mg/100 mg, containing 10 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/100 mg, containing 25 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/250 mg, containing 25 mg of carbidopa, USP and 250 mg of levodopa, USP. In addition, each tablet contains the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize). In addition, the 25 mg/100 mg strength contain D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake (sunset yellow lake). The 10 mg/100 mg and 25 mg/250 mg strengths contain FD&C blue #2 aluminum lake."
},
{
"NDCCode": "47335-472-13",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (47335-472-13) ",
"NDC11Code": "47335-0472-13",
"ProductNDC": "47335-472",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imatinib Mesylate",
"NonProprietaryName": "Imatinib Mesylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078340",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "IMATINIB MESYLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160201",
"SamplePackage": "N",
"IndicationAndUsage": "Imatinib mesylate is a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1) , 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. ( 1.2) , 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). ( 1.3) , 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. ( 1.5) , 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. ( 1.6) , 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. ( 1.7) , 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). ( 1.8) , 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9), 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).",
"Description": "Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.45 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 477.8 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is:. Imatinib mesylate is an off-white to creamish yellow crystalline powder. Its molecular formula is C 29H 31N 7O CH 4SO 3and its molecular weight is 589.7 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: silicified microcrystalline cellulose, mannitol, copovidone, crospovidone, magnesium stearate, hypromellose, iron oxide yellow, polyethylene glycol, titanium dioxide, FD&C yellow # 6 aluminum lake and iron oxide red."
},
{
"NDCCode": "47335-472-81",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (47335-472-81) ",
"NDC11Code": "47335-0472-81",
"ProductNDC": "47335-472",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imatinib Mesylate",
"NonProprietaryName": "Imatinib Mesylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078340",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "IMATINIB MESYLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160201",
"SamplePackage": "N",
"IndicationAndUsage": "Imatinib mesylate is a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. (1.2), 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). (1.3), 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. (1.5), 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. (1.6), 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. (1.7), 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). (1.8), 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9), 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).",
"Description": "Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.45 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 477.8 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is. Imatinib mesylate is an off-white to creamish yellow crystalline powder. Its molecular formula is C29H31N7O CH4SO3 and its molecular weight is 589.7 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: silicified microcrystalline cellulose, mannitol, copovidone, crospovidone, magnesium stearate, hypromellose, iron oxide yellow, polyethylene glycol, titanium dioxide, FD&C yellow # 6 aluminum lake and iron oxide red."
},
{
"NDCCode": "47335-472-83",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (47335-472-83) ",
"NDC11Code": "47335-0472-83",
"ProductNDC": "47335-472",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imatinib Mesylate",
"NonProprietaryName": "Imatinib Mesylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078340",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "IMATINIB MESYLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160201",
"SamplePackage": "N",
"IndicationAndUsage": "Imatinib mesylate is a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1) , 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. ( 1.2) , 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). ( 1.3) , 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. ( 1.5) , 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. ( 1.6) , 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. ( 1.7) , 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). ( 1.8) , 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9), 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).",
"Description": "Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.45 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 477.8 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is:. Imatinib mesylate is an off-white to creamish yellow crystalline powder. Its molecular formula is C 29H 31N 7O CH 4SO 3and its molecular weight is 589.7 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: silicified microcrystalline cellulose, mannitol, copovidone, crospovidone, magnesium stearate, hypromellose, iron oxide yellow, polyethylene glycol, titanium dioxide, FD&C yellow # 6 aluminum lake and iron oxide red."
},
{
"NDCCode": "47335-472-88",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (47335-472-88) ",
"NDC11Code": "47335-0472-88",
"ProductNDC": "47335-472",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imatinib Mesylate",
"NonProprietaryName": "Imatinib Mesylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078340",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "IMATINIB MESYLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160201",
"SamplePackage": "N",
"IndicationAndUsage": "Imatinib mesylate is a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1) , 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. ( 1.2) , 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). ( 1.3) , 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. ( 1.5) , 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. ( 1.6) , 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. ( 1.7) , 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). ( 1.8) , 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9), 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).",
"Description": "Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.45 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 477.8 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is:. Imatinib mesylate is an off-white to creamish yellow crystalline powder. Its molecular formula is C 29H 31N 7O CH 4SO 3and its molecular weight is 589.7 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: silicified microcrystalline cellulose, mannitol, copovidone, crospovidone, magnesium stearate, hypromellose, iron oxide yellow, polyethylene glycol, titanium dioxide, FD&C yellow # 6 aluminum lake and iron oxide red."
},
{
"NDCCode": "55150-472-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (55150-472-10) / 30 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55150-0472-10",
"ProductNDC": "55150-472",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217401",
"LabelerName": "Eugia US LLC",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/30mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2023-08-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230804",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin hydrochloride for injection is a glycopeptide antibacterial indicated in adult and pediatric patients (neonates and older) for the treatment of: 1 Septicemia (1.1), 2 Infective Endocarditis (1.2), 3 Skin and Skin Structure Infections (1.3), 4 Bone Infections (1.4), 5 Lower Respiratory Tract Infections (1.5).",
"Description": "Vancomycin hydrochloride for injection, USP, contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride, USP is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24ꞏHCl and the molecular weight is 1,485.71. Vancomycin hydrochloride, USP has the following structural formula. Vancomycin hydrochloride for injection, USP is a sterile white or off-white to light tan colored lyophilized cake or powder for injection. Vancomycin hydrochloride for injection, USP is supplied in single-dose vials, containing 1.28 g or 1.54 g of vancomycin hydrochloride, USP equivalent to 1.25 g or 1.5 g of vancomycin base. The lyophilized powder is reconstituted with sterile water for injection, USP which forms a clear, colorless to light tan color solution and subsequently diluted prior to intravenous administration [see Dosage and Administration (2.5)]."
},
{
"NDCCode": "62175-472-32",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-472-32) ",
"NDC11Code": "62175-0472-32",
"ProductNDC": "62175-472",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine Hydrochloride",
"NonProprietaryName": "Paroxetine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20141031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204744",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141031",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine is indicated in adults for the treatment of: : 1 Major depressive disorder (MDD) , 2 Panic disorder (PD), 3 Social anxiety disorder (SAD) , 4 Premenstrual dysphoric disorder (PMDD) .",
"Description": "Paroxetine Extended-Release Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 g/mol (329.4 g/mol as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120° C to 138°C and a solubility of 5.4 mg/mL in water. Paroxetine Extended-Release Tablets, USP are intended for oral administration. Each enteric, film-coated, extended-release tablet contains paroxetine hydrochloride equivalent to paroxetine as follows: 12.5 mg–white, 25 mg–pink and 37.5 mg–blue. Inactive ingredients consist of hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycols, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide, triethyl citrate. In addition, the 25 mg and 37.5 mg colorant contains FD&C Blue No. 2 aluminum lake. In addition, the 25 mg colorant also contains carmine. Paroxetine meets USP Dissolution Test 3."
},
{
"NDCCode": "62175-472-41",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-472-41) ",
"NDC11Code": "62175-0472-41",
"ProductNDC": "62175-472",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine Hydrochloride",
"NonProprietaryName": "Paroxetine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20141031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204744",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141031",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine is indicated in adults for the treatment of: : 1 Major depressive disorder (MDD) , 2 Panic disorder (PD), 3 Social anxiety disorder (SAD) , 4 Premenstrual dysphoric disorder (PMDD) .",
"Description": "Paroxetine Extended-Release Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 g/mol (329.4 g/mol as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120° C to 138°C and a solubility of 5.4 mg/mL in water. Paroxetine Extended-Release Tablets, USP are intended for oral administration. Each enteric, film-coated, extended-release tablet contains paroxetine hydrochloride equivalent to paroxetine as follows: 12.5 mg–white, 25 mg–pink and 37.5 mg–blue. Inactive ingredients consist of hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycols, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide, triethyl citrate. In addition, the 25 mg and 37.5 mg colorant contains FD&C Blue No. 2 aluminum lake. In addition, the 25 mg colorant also contains carmine. Paroxetine meets USP Dissolution Test 3."
},
{
"NDCCode": "68083-472-01",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (68083-472-01) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "68083-0472-01",
"ProductNDC": "68083-472",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ganirelix Acetate",
"NonProprietaryName": "Ganirelix Acetate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215658",
"LabelerName": "Gland Pharma Limited",
"SubstanceName": "GANIRELIX ACETATE",
"StrengthNumber": "250",
"StrengthUnit": "ug/.5mL",
"Pharm_Classes": "Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230228",
"SamplePackage": "N",
"IndicationAndUsage": "Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.",
"Description": "Ganirelix Acetate Injection is a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotropin-releasing hormone (GnRH). Ganirelix Acetate is derived from native GnRH with substitutions of amino acids at positions 1, 2, 3, 6, 8, and 10 to form the following molecular formula of the peptide: N-acetyl-3-(2-naphthyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridyl)-D-alanyl-L-seryl-L-tyrosyl-N9,N10-diethyl-D-homoarginyl-L-leucyl- N9,N10-diethyl-L-homoarginyl-L-prolyl-D-alanylamide acetate. The molecular weight for Ganirelix Acetate is 1570.4 as an anhydrous free base. The structural formula is as follows. Ganirelix Acetate. Ganirelix Acetate Injection is supplied as a colorless, sterile, ready-to-use, aqueous solution intended for SUBCUTANEOUS administration only. Each single dose, sterile, prefilled syringe contains 250 mcg/0.5 mL of Ganirelix Acetate, 0.1 mg glacial acetic acid, 23.5 mg mannitol, and water for injection adjusted to pH 5.0 with acetic acid, NF and/or sodium hydroxide, NF."
},
{
"NDCCode": "72482-100-12",
"PackageDescription": "40 CARTON in 1 BOX (72482-100-12) / 1 BOTTLE in 1 CARTON / 120 CAPSULE in 1 BOTTLE",
"NDC11Code": "72482-0100-12",
"ProductNDC": "72482-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vonjo",
"NonProprietaryName": "Pacritinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208712",
"LabelerName": "Sobi, Inc.",
"SubstanceName": "PACRITINIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Janus Kinase Inhibitors [MoA], Kinase Inhibitor [EPC], Organic Cation Transporter 1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Tyrosine Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220228",
"SamplePackage": "N",
"IndicationAndUsage": "VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a platelet count below 50 × 10 9/L. This indication is approved under accelerated approval based on spleen volume reduction [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
"Description": "VONJO contains pacritinib citrate, a kinase inhibitor with the chemical name (2E,16E)-11-[2-(pyrrolidin-1-yl)ethoxy]-14,19-dioxa-5,7,27-triazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2,4,6,8,10,12(26),16,21,23-decaene citrate and a molecular weight of 664.7 as citrate salt and 472.59 as a free base. The molecular formula is C28H32N4O3C6H8O7 and the structural formula is. VONJO capsule is for oral administration. Each capsule contains 100 mg of pacritinib equivalent to 140.65 mg of pacritinib citrate and the inactive ingredients are microcrystalline cellulose NF, polyethylene glycol 8000 (PEG 8000) NF, and magnesium stearate NF. The gelatin capsule is bovine derived. The capsule shell contains gelatin, titanium dioxide, black iron oxide, erythrosine, red iron oxide, and printing ink containing shellac, propylene glycol, titanium dioxide, sodium hydroxide, and povidone."
},
{
"NDCCode": "17089-025-17",
"PackageDescription": "6 TUBE in 1 BOX (17089-025-17) > 1 g in 1 TUBE",
"NDC11Code": "17089-0025-17",
"ProductNDC": "17089-025",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna-flu",
"NonProprietaryName": "Aconitum Napellus - Asclepias Curassavica - Atropa Belladonna - Cairina Moschata Heart/liver Autolysate - Copper - Echinacea Angustifolia - Haemophilus Influenzae Type B -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "ACONITUM NAPELLUS; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ASCLEPIAS CURASSAVICA; ATROPA BELLADONNA; COPPER; ECHINACEA ANGUSTIFOLIA; HAEMOPHILUS INFLUENZAE TYPE B",
"StrengthNumber": "5; 7; 5; 5; 3; 3; 9",
"StrengthUnit": "[hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g",
"Pharm_Classes": "Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]",
"Status": "Active",
"LastUpdate": "2022-11-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060523",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: pour the content of 1 tube directly into the mouth and allow to dissolve under the tongue. Take on an empty stomach. ."
},
{
"NDCCode": "17089-046-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-046-20) > 4 g in 1 TUBE",
"NDC11Code": "17089-0046-20",
"ProductNDC": "17089-046",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Age Skin",
"NonProprietaryName": "Alpha-tocopherol - Ascophyllum Nodosum - Botryoglossum Platycarpum - Fucus Serratus - Fucus Vesiculosus - Isoleucine - Leucine - Retinol - Selenium - Sus Scrofa Capillary Tissue - Sus Scrofa Collagen - Sus Scrofa Placenta - Sus Scrofa Skin - Ubidecarenone - Ulva Lactuca Extract - Laminaria Digitata",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "ALPHA-TOCOPHEROL; LAMINARIA DIGITATA; BOTRYOGLOSSUM PLATYCARPUM; FUCUS SERRATUS; SUS SCROFA CAPILLARY TISSUE; UBIDECARENONE; SUS SCROFA COLLAGEN; FUCUS VESICULOSUS; ISOLEUCINE; ASCOPHYLLUM NODOSUM; LEUCINE; SUS SCROFA PLACENTA; RETINOL; ULVA LACTUCA EXTRACT; SELENIUM; SUS SCROFA SKIN",
"StrengthNumber": "4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4",
"StrengthUnit": "[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2019-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve Take 15 minutes before meals."
},
{
"NDCCode": "17089-061-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-061-20) > 4 g in 1 TUBE",
"NDC11Code": "17089-0061-20",
"ProductNDC": "17089-061",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Age Face",
"NonProprietaryName": "Asian Ginseng - Canakinumab - Eleuthero - Germanium Dioxide - Isoleucine - Leucine - Proline - Sus Scrofa Collagen - Sus Scrofa Skin - Valine - Witch Hazel -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"EndMarketingDate": "20180701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "SUS SCROFA COLLAGEN; GERMANIUM DIOXIDE; ASIAN GINSENG; HAMAMELIS VIRGINIANA LEAF; CANAKINUMAB; ISOLEUCINE; LEUCINE; PROLINE; ELEUTHERO; SUS SCROFA SKIN; VALINE",
"StrengthNumber": "4; 4; 3; 3; 5; 4; 4; 4; 3; 4; 9",
"StrengthUnit": "[hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g",
"Status": "Deprecated",
"LastUpdate": "2018-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060523",
"EndMarketingDatePackage": "20180701",
"SamplePackage": "N"
},
{
"NDCCode": "17089-067-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-067-20) / 4 g in 1 TUBE",
"NDC11Code": "17089-0067-20",
"ProductNDC": "17089-067",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Age Stress",
"NonProprietaryName": "Acetylcysteine - Ballota Foetida - Epinephrine - Glutathione - Interferon Gamma-1b - Lenograstim - Lithium Carbonate - Melatonin - Penicillium Glabrum - Potassium Carbonate - Pummelo - Rhodotorula Rubra - Silver Nitrate - Strychnos Nux-vomica Seed - Sus Scrofa Cerebral Cortex - Sus Scrofa Stomach - Sus Scrofa Superior Gastric Plexus - Sus Scrofa Thalamus -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "MELATONIN; ACETYLCYSTEINE; STRYCHNOS NUX-VOMICA SEED; PENICILLIUM GLABRUM; RHODOTORULA RUBRA; SUS SCROFA STOMACH; SUS SCROFA SUPERIOR GASTRIC PLEXUS; SUS SCROFA THALAMUS; EPINEPHRINE; SILVER NITRATE; BALLOTA FOETIDA; PUMMELO; SUS SCROFA CEREBRAL CORTEX; POTASSIUM CARBONATE; LENOGRASTIM; GLUTATHIONE; INTERFERON GAMMA-1B; LITHIUM CARBONATE",
"StrengthNumber": "15; 4; 5; 8; 8; 7; 7; 7; 9; 9; 3; 3; 4; 9; 4; 4; 5; 8",
"StrengthUnit": "[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Decreased Respiratory Secretion Viscosity [PE], Fungal Proteins [CS], Increased Glutathione Concentration [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Interferon gamma [EPC], Interferon-gamma [CS], Mood Stabilizer [EPC], Mucolytic [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Reduction Activity [MoA], Seed Storage Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve. Take 15 minutes before meals. ."
},
{
"NDCCode": "17089-068-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-068-20) / 4 g in 1 TUBE",
"NDC11Code": "17089-0068-20",
"ProductNDC": "17089-068",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Age Vein",
"NonProprietaryName": "Aconitum Napellus - Apis Mellifera - Arnica Montana - Arsenic Trioxide - Atropa Belladonna - Calcium Fluoride - Centella Asiatica - Cinchona Officinalis Bark - Cranberry - Horse Chestnut - Iron - Lachesis Muta Venom - Mercury - Pineapple - Pulsatilla Vulgaris - Sus Scrofa Artery - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Sus Scrofa Vein - Viscum Album Fruit - Witch Hazel -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "ACONITUM NAPELLUS; HORSE CHESTNUT; PINEAPPLE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; SUS SCROFA ARTERY; ATROPA BELLADONNA; CALCIUM FLUORIDE; CINCHONA OFFICINALIS BARK; IRON; WITCH HAZEL; CENTELLA ASIATICA; LACHESIS MUTA VENOM; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; MERCURY; CRANBERRY; PULSATILLA VULGARIS; SUS SCROFA VEIN; VISCUM ALBUM FRUIT",
"StrengthNumber": "10; 3; 3; 10; 10; 12; 4; 10; 8; 10; 10; 3; 3; 10; 7; 10; 3; 10; 4; 3",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Fruit Proteins [EXT], Fruit Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve. Take 15 minutes before meals. ."
},
{
"NDCCode": "17089-075-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-075-20) > 4 g in 1 TUBE",
"NDC11Code": "17089-0075-20",
"ProductNDC": "17089-075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Omeosport",
"NonProprietaryName": ".alpha.-ketoglutaric Acid - Aconitic Acid, Cis - Adenosine Triphosphate - Alpha Lipoic Acid - Ascorbic Acid - Asian Ginseng - Barium Cation - Beet - Cerous Oxalate Nonahydrate - Coenzyme A - Cysteine - Fumaric Acid - Lactic Acid, Dl - Magnesium Carbonate - Malic Acid - Manganese Phosphate, Dibasic - Pork - Pyridoxine Hydrochloride - Riboflavin - Sodium Diethyl Oxalacetate - Sodium Pyruvate - Succinic Acid - Sus Scrofa Adrenal Gland - Thiamine Hydrochloride - Sus Scrofa Embryo -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "ADENOSINE TRIPHOSPHATE; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ASCORBIC ACID; BARIUM OXALOSUCCINATE; BEET; CEROUS OXALATE NONAHYDRATE; ACONITIC ACID, (Z)-; COENZYME A; CYSTEINE; SUS SCROFA EMBRYO; FUMARIC ACID; ASIAN GINSENG; SUS SCROFA ADRENAL GLAND; LACTIC ACID; MAGNESIUM CARBONATE; MALIC ACID; MANGANESE PHOSPHATE, DIBASIC; PORK; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SUCCINIC ACID; THIAMINE HYDROCHLORIDE",
"StrengthNumber": "8; 6; 6; 4; 6; 2; 6; 6; 6; 6; 6; 6; 3; 10; 8; 2; 6; 6; 6; 6; 6; 6; 6; 6; 4",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Magnetic Resonance Contrast Activity [MoA], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Paramagnetic Contrast Agent [EPC], Plant Proteins [CS], Vegetable Proteins [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2019-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: 1 Turn tube upside down and rotate cap to release pellets into cap., 2 Unscrew cap and without touching pellets tip them into the mouth under the tongue., 3 Allow to dissolve, 4 Take 15 minutes before meals. ."
},
{
"NDCCode": "17089-076-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-076-20) / 4 g in 1 TUBE",
"NDC11Code": "17089-0076-20",
"ProductNDC": "17089-076",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Citomix",
"NonProprietaryName": "Aldesleukin - Binetrakin - Canakinumab - Centella Asiatica - Cranberry - Human Interleukin-6 (nonglycosylated) - Interferon Gamma-1b - Lenograstim - Pineapple - Sus Scrofa Bone Marrow - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Sus Scrofa Thymus -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "PINEAPPLE; LENOGRASTIM; CENTELLA ASIATICA; INTERFERON GAMMA-1B; CANAKINUMAB; ALDESLEUKIN; BINETRAKIN; HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED); SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA BONE MARROW; CRANBERRY; SUS SCROFA THYMUS",
"StrengthNumber": "3; 4; 3; 4; 5; 5; 4; 7; 4; 4; 3; 4",
"StrengthUnit": "[hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Fruit Proteins [EXT], Fruit Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Lymphocyte Activation [PE], Increased Lymphocyte Cell Production [PE], Interferon gamma [EPC], Interferon-gamma [CS], Interleukin-2 [CS], Lymphocyte Growth Factor [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060523",
"SamplePackage": "N",
"IndicationAndUsage": "Immune support suring times of: : 1 Seasonal colds and flu."
},
{
"NDCCode": "17089-231-18",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (17089-231-18) / 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17089-0231-18",
"ProductNDC": "17089-231",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna-fem",
"NonProprietaryName": "Adenosinum Ciclophosphoricum - Lilium Tigrinum - Melatonin - Sus Scrofa Adrenal Gland - Sus Scrofa Corpus Luteum - Sus Scrofa Hypothalamus - Sus Scrofa Ovary - Sus Scrofa Pancreas - Sus Scrofa Pineal Gland - Sus Scrofa Pituitary Gland - Sus Scrofa Thymus - Thyroid -",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA CORPUS LUTEUM; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA HYPOTHALAMUS; LILIUM LANCIFOLIUM BULB; MELATONIN; SUS SCROFA OVARY; SUS SCROFA PANCREAS; SUS SCROFA PINEAL GLAND; SUS SCROFA THYMUS; THYROID",
"StrengthNumber": "6; 30; 30; 30; 30; 6; 200; 6; 30; 30; 30; 6",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Status": "Active",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Take 15 minutes before meals."
},
{
"NDCCode": "17089-233-18",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (17089-233-18) > 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17089-0233-18",
"ProductNDC": "17089-233",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna-male",
"NonProprietaryName": "Adenosinum Ciclophosphoricum - Melatonin - Phosphorus - Sus Scrofa Adrenal Gland - Sus Scrofa Hypothalamus - Sus Scrofa Pancreas - Sus Scrofa Pineal Gland - Sus Scrofa Pituitary Gland - Sus Scrofa Testicle - Sus Scrofa Thymus - Thyroid - Turnera Diffusa Top -",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "ADENOSINE CYCLIC PHOSPHATE; TURNERA DIFFUSA LEAFY TWIG; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA HYPOTHALAMUS; MELATONIN; SUS SCROFA TESTICLE; SUS SCROFA PANCREAS; PHOSPHORUS; SUS SCROFA PINEAL GLAND; SUS SCROFA THYMUS; THYROID",
"StrengthNumber": "6; 6; 30; 30; 30; 30; 30; 30; 6; 30; 30; 30",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Status": "Active",
"LastUpdate": "2019-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Take 15 minutes before meals."
},
{
"NDCCode": "17089-235-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-235-20) > 4 g in 1 TUBE",
"NDC11Code": "17089-0235-20",
"ProductNDC": "17089-235",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna-tonsils",
"NonProprietaryName": "Angelica Sinensis Root - Binetrakin - Interleukin-3 - Lenograstim - Melatonin - Reishi - Shiitake Mushroom - Sus Scrofa Blood - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Sus Scrofa Spleen - Interleukin-11 -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "ANGELICA SINENSIS ROOT; SUS SCROFA BLOOD; LENOGRASTIM; INTERLEUKIN-11; INTERLEUKIN-3; BINETRAKIN; SHIITAKE MUSHROOM; REISHI; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; MELATONIN; SUS SCROFA SPLEEN",
"StrengthNumber": "3; 7; 4; 5; 5; 4; 8; 8; 4; 4; 4",
"StrengthUnit": "[hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g",
"Status": "Active",
"LastUpdate": "2019-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve Take 15 minutes before meals."
},
{
"NDCCode": "17089-237-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-237-20) > 4 g in 1 TUBE",
"NDC11Code": "17089-0237-20",
"ProductNDC": "17089-237",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna-react",
"NonProprietaryName": "Angelica Sinensis Root - Arnica Montana - Asian Ginseng - Echinacea Angustifolia - Fomitopsis Pinicola Fruiting Body - Interferon Gamma-1b - Paeonia Officinalis Root - Pork Liver - Reishi - Silybum Marianum Seed - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Turmeric -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "TURMERIC; ANGELICA SINENSIS ROOT; ARNICA MONTANA; SILYBUM MARIANUM SEED; ECHINACEA ANGUSTIFOLIA; ASIAN GINSENG; PORK LIVER; INTERFERON GAMMA-1B; REISHI; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; PAEONIA OFFICINALIS ROOT; FOMITOPSIS PINICOLA FRUITING BODY",
"StrengthNumber": "3; 3; 4; 3; 3; 1; 4; 4; 8; 4; 3; 8",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g",
"Pharm_Classes": "Interferon gamma [EPC], Interferon-gamma [CS]",
"Status": "Active",
"LastUpdate": "2019-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Directions:. Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve Take 15 minutes before meals."
},
{
"NDCCode": "17089-242-18",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (17089-242-18) > 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17089-0242-18",
"ProductNDC": "17089-242",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna-addict 1",
"NonProprietaryName": "Caffeine - Chelidonium Majus - Dieffenbachia Seguine - Juniper - Matricaria Recutita - Nicotine - Papaver Rhoeas Flower - Plantago Major - Scrophularia Nodosa - Sodium Chloride - Strychnos Nux-vomica Seed - Sugarcane - Tobacco Leaf -",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"EndMarketingDate": "20210228",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "CAFFEINE; DIEFFENBACHIA SEGUINE; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; JUNIPER; SODIUM CHLORIDE; NICOTINE; STRYCHNOS NUX-VOMICA SEED; PAPAVER RHOEAS FLOWER; PLANTAGO MAJOR; SUGARCANE; SCROPHULARIA NODOSA; TOBACCO LEAF",
"StrengthNumber": "6; 4; 1; 1; 1; 9; 6; 9; 12; 1; 6; 1; 6",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060523",
"EndMarketingDatePackage": "20210228",
"SamplePackage": "N"
},
{
"NDCCode": "17089-243-18",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (17089-243-18) > 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17089-0243-18",
"ProductNDC": "17089-243",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna-addict 2",
"NonProprietaryName": "Asian Ginseng - Avena Sativa Flowering Top - Black Currant - Matricaria Recutita - Eleuthero - Eschscholzia Californica - Hops - Hypericum Perforatum - Passiflora Incarnata Top - Potassium Phosphate,",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "AVENA SATIVA FLOWERING TOP; BLACK CURRANT; MATRICARIA RECUTITA; ESCHSCHOLZIA CALIFORNICA; ASIAN GINSENG; HOPS; HYPERICUM PERFORATUM; POTASSIUM PHOSPHATE, DIBASIC; PASSIFLORA INCARNATA TOP; PULSATILLA VULGARIS; PULSATILLA VULGARIS; PULSATILLA VULGARIS; ELEUTHERO; STEVIA LEAF; VALERIAN",
"StrengthNumber": "1; 1; 3; 1; 2; 1; 3; 8; 1; 6; 9; 12; 1; 1; 1",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Status": "Deprecated",
"LastUpdate": "2018-04-11",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "17089-251-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-251-20) > 4 g in 1 TUBE",
"NDC11Code": "17089-0251-20",
"ProductNDC": "17089-251",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna-virus",
"NonProprietaryName": "Aldesleukin - Everlasting Extract - Fomitopsis Pinicola Fruiting Body - Interferon Gamma-1b - Melatonin - Metenkefalin - Reishi - Rice - Serotonin - Soybean - Sus Scrofa Blood - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Sus Scrofa Spleen -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "ALDESLEUKIN; EVERLASTING EXTRACT; FOMITOPSIS PINICOLA FRUITING BODY; INTERFERON GAMMA-1B; METENKEFALIN; REISHI; BROWN RICE; SEROTONIN; SOYBEAN; SUS SCROFA BLOOD; SUS SCROFA SPLEEN; MELATONIN; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE",
"StrengthNumber": "5; 3; 8; 3; 4; 8; 3; 6; 3; 4; 4; 15; 7",
"StrengthUnit": "[hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Lymphocyte Activation [PE], Increased Lymphocyte Cell Production [PE], Interferon gamma [EPC], Interferon-gamma [CS], Interleukin-2 [CS], Lymphocyte Growth Factor [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2022-11-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve. Take 15 minutes before meals. ."
},
{
"NDCCode": "17089-259-18",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (17089-259-18) > 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17089-0259-18",
"ProductNDC": "17089-259",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Osteobios",
"NonProprietaryName": "Calcitonin Human - Calcium Carbonate - Calcium Fluoride - Calcium Phosphate - Isoleucine - Leucine - Lysine - Methionine - Phenylalanine - Sus Scrofa Bone - Sus Scrofa Parathyroid Gland - Threonine - Tryptophan - Valine -",
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"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "CALCITONIN HUMAN; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; CALCIUM CARBONATE; CALCIUM FLUORIDE; CALCIUM PHOSPHATE; SUS SCROFA BONE; SUS SCROFA PARATHYROID GLAND",
"StrengthNumber": "6; 3; 3; 3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Calcium [CS], Cations, Divalent [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2022-11-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20180501",
"SamplePackage": "N",
"IndicationAndUsage": "Take 15 minutes before meals."
}
]
}
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<NDCList>
<NDC>
<NDCCode>17089-472-23</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (17089-472-23) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>17089-0472-23</NDC11Code>
<ProductNDC>17089-472</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna Sinus Plus</ProprietaryName>
<NonProprietaryName>Althaea Officinalis Leaf - Calcium Sulfide - Copper - Drimia Maritima Bulb - Echinacea Angustifolia - Hydrastis Canadensis Whole - Lobaria Pulmonaria - Manganese - Mercuric Sulfide - Onion - Plantago Major Whole - Potassium Dichromate - Pulsatilla Vulgaris - Silicon Dioxide - Silver Nitrate - Sinusitisinum - Sus Scrofa Nasal Mucosa -</NonProprietaryName>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>ONION; ALTHAEA OFFICINALIS LEAF; SILVER NITRATE; ASCORBIC ACID; HYDRASTIS CANADENSIS WHOLE; LOBARIA PULMONARIA; COPPER; ECHINACEA ANGUSTIFOLIA; CALCIUM SULFIDE; POTASSIUM DICHROMATE; MANGANESE; MERCURIC SULFIDE; SUS SCROFA NASAL MUCOSA; PULSATILLA VULGARIS; SILICON DIOXIDE; SINUSITISINUM; PLANTAGO MAJOR WHOLE; DRIMIA MARITIMA BULB</SubstanceName>
<StrengthNumber>6; 2; 10; 3; 6; 2; 8; 3; 6; 6; 8; 8; 6; 6; 6; 12; 2; 12</StrengthNumber>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20210217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions:. tilt head forward slightly, insert the canister tip in the nose, aiming the tip toward the back of the head. Squeeze the pump and spray intro nostril.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49349-472-23</NDCCode>
<PackageDescription>180 TABLET in 1 BLISTER PACK (49349-472-23)</PackageDescription>
<NDC11Code>49349-0472-23</NDC11Code>
<ProductNDC>49349-472</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077397</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-03-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>17089-419-23</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (17089-419-23) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>17089-0419-23</NDC11Code>
<ProductNDC>17089-419</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna-rhino Nose</ProprietaryName>
<NonProprietaryName>Apis Mellifera - Aralia Racemosa Root - Ascorbic Acid - Black Currant - Copper - Euphorbia Resinifera Resin - European Elderberry - Helianthemum Canadense - Histamine Dihydrochloride - Human Interleukin 12 - Human Interleukin-10 (nonglycosylated) - Interferon Gamma-1b - Manganese Gluconate - Melilotus - Onion - Plantago Major - Rosa Canina Fruit - Silver Nitrate -</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100527</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>ONION; APIS MELLIFERA; ARALIA RACEMOSA ROOT; SILVER NITRATE; ASCORBIC ACID; BLACK CURRANT; HELIANTHEMUM CANADENSE; COPPER; EUPHORBIA RESINIFERA RESIN; HISTAMINE DIHYDROCHLORIDE; INTERFERON GAMMA-1B; INTERLEUKIN-10; HUMAN INTERLEUKIN 12; MANGANESE GLUCONATE; MELILOTUS; PLANTAGO MAJOR; ROSA CANINA FRUIT; EUROPEAN ELDERBERRY</SubstanceName>
<StrengthNumber>8; 12; 1; 10; 2; 1; 4; 4; 4; 200; 4; 4; 4; 4; 3; 2; 1; 2</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Ascorbic Acid [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Interferon gamma [EPC], Interferon-gamma [CS], Magnetic Resonance Contrast Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Paramagnetic Contrast Agent [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tilt head slightly forward, place tip of bottle into nose, compress bottle once for each spray, aiming towards the back of the nose.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-451-23</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (17089-451-23) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>17089-0451-23</NDC11Code>
<ProductNDC>17089-451</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna-sinus Nose</ProprietaryName>
<NonProprietaryName>Althaea Officinalis Leaf - Ascorbic Acid - Black Currant - Calcium Sulfide - Copper - Echinacea Angustifolia - Goldenseal - Lachesis Muta Venom - Lobaria Pulmonaria - Manganese - Mercuric Sulfide - Onion - Plantago Major - Potassium Carbonate - Pulsatilla Vulgaris - Silicon Dioxide - Silver Nitrate - Sinusitisinum - Sus Scrofa Nasal Mucosa - Sus Scrofa Thymus - Sus Scrofa Urinary Bladder -</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20100527</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>ONION; ALTHAEA OFFICINALIS LEAF; SILVER NITRATE; ASCORBIC ACID; BLACK CURRANT; LOBARIA PULMONARIA; COPPER; ECHINACEA ANGUSTIFOLIA; CALCIUM SULFIDE; GOLDENSEAL; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; MANGANESE; MERCURIC SULFIDE; SUS SCROFA NASAL MUCOSA; PLANTAGO MAJOR; PULSATILLA VULGARIS; SILICON DIOXIDE; SINUSITISINUM; SUS SCROFA THYMUS; SUS SCROFA URINARY BLADDER</SubstanceName>
<StrengthNumber>8; 2; 10; 2; 1; 2; 3; 3; 8; 8; 8; 30; 3; 8; 12; 2; 8; 8; 30; 12; 30</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-04-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions:. tilt head slightly forward, place tip of bottle into nose, compress bottle once for each spray, aiming towards the back of the nose.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42291-472-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (42291-472-01) </PackageDescription>
<NDC11Code>42291-0472-01</NDC11Code>
<ProductNDC>42291-472</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074260</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.</IndicationAndUsage>
<Description>Carbidopa and levodopa tablets, USP are a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C 10H 14N 2O 4H 2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C 9H 11NO 4, and its structural formula is:. Carbidopa and Levodopa Tablets, USP for oral administration, are supplied in three strengths. 10 mg/100 mg, containing 10 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/100 mg, containing 25 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/250 mg, containing 25 mg of carbidopa, USP and 250 mg of levodopa, USP. In addition, each tablet contains the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize). In addition, the 25 mg/100 mg strength contain D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake (sunset yellow lake). The 10 mg/100 mg and 25 mg/250 mg strengths contain FD&C blue #2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>42291-472-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (42291-472-10) </PackageDescription>
<NDC11Code>42291-0472-10</NDC11Code>
<ProductNDC>42291-472</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074260</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.</IndicationAndUsage>
<Description>Carbidopa and levodopa tablets, USP are a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C 10H 14N 2O 4H 2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C 9H 11NO 4, and its structural formula is:. Carbidopa and Levodopa Tablets, USP for oral administration, are supplied in three strengths. 10 mg/100 mg, containing 10 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/100 mg, containing 25 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/250 mg, containing 25 mg of carbidopa, USP and 250 mg of levodopa, USP. In addition, each tablet contains the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize). In addition, the 25 mg/100 mg strength contain D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake (sunset yellow lake). The 10 mg/100 mg and 25 mg/250 mg strengths contain FD&C blue #2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>47335-472-13</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (47335-472-13) </PackageDescription>
<NDC11Code>47335-0472-13</NDC11Code>
<ProductNDC>47335-472</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imatinib Mesylate</ProprietaryName>
<NonProprietaryName>Imatinib Mesylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078340</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>IMATINIB MESYLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Imatinib mesylate is a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1) , 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. ( 1.2) , 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). ( 1.3) , 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. ( 1.5) , 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. ( 1.6) , 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. ( 1.7) , 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). ( 1.8) , 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9), 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).</IndicationAndUsage>
<Description>Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.45 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 477.8 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is:. Imatinib mesylate is an off-white to creamish yellow crystalline powder. Its molecular formula is C 29H 31N 7O CH 4SO 3and its molecular weight is 589.7 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: silicified microcrystalline cellulose, mannitol, copovidone, crospovidone, magnesium stearate, hypromellose, iron oxide yellow, polyethylene glycol, titanium dioxide, FD&C yellow # 6 aluminum lake and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>47335-472-81</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (47335-472-81) </PackageDescription>
<NDC11Code>47335-0472-81</NDC11Code>
<ProductNDC>47335-472</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imatinib Mesylate</ProprietaryName>
<NonProprietaryName>Imatinib Mesylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078340</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>IMATINIB MESYLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Imatinib mesylate is a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. (1.2), 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). (1.3), 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. (1.5), 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. (1.6), 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. (1.7), 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). (1.8), 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9), 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).</IndicationAndUsage>
<Description>Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.45 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 477.8 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is. Imatinib mesylate is an off-white to creamish yellow crystalline powder. Its molecular formula is C29H31N7O CH4SO3 and its molecular weight is 589.7 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: silicified microcrystalline cellulose, mannitol, copovidone, crospovidone, magnesium stearate, hypromellose, iron oxide yellow, polyethylene glycol, titanium dioxide, FD&C yellow # 6 aluminum lake and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>47335-472-83</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (47335-472-83) </PackageDescription>
<NDC11Code>47335-0472-83</NDC11Code>
<ProductNDC>47335-472</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imatinib Mesylate</ProprietaryName>
<NonProprietaryName>Imatinib Mesylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078340</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>IMATINIB MESYLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Imatinib mesylate is a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1) , 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. ( 1.2) , 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). ( 1.3) , 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. ( 1.5) , 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. ( 1.6) , 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. ( 1.7) , 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). ( 1.8) , 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9), 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).</IndicationAndUsage>
<Description>Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.45 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 477.8 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is:. Imatinib mesylate is an off-white to creamish yellow crystalline powder. Its molecular formula is C 29H 31N 7O CH 4SO 3and its molecular weight is 589.7 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: silicified microcrystalline cellulose, mannitol, copovidone, crospovidone, magnesium stearate, hypromellose, iron oxide yellow, polyethylene glycol, titanium dioxide, FD&C yellow # 6 aluminum lake and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>47335-472-88</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (47335-472-88) </PackageDescription>
<NDC11Code>47335-0472-88</NDC11Code>
<ProductNDC>47335-472</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imatinib Mesylate</ProprietaryName>
<NonProprietaryName>Imatinib Mesylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078340</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>IMATINIB MESYLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Imatinib mesylate is a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1) , 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. ( 1.2) , 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). ( 1.3) , 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. ( 1.5) , 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. ( 1.6) , 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. ( 1.7) , 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). ( 1.8) , 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9), 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).</IndicationAndUsage>
<Description>Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.45 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 477.8 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is:. Imatinib mesylate is an off-white to creamish yellow crystalline powder. Its molecular formula is C 29H 31N 7O CH 4SO 3and its molecular weight is 589.7 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: silicified microcrystalline cellulose, mannitol, copovidone, crospovidone, magnesium stearate, hypromellose, iron oxide yellow, polyethylene glycol, titanium dioxide, FD&C yellow # 6 aluminum lake and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>55150-472-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (55150-472-10) / 30 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55150-0472-10</NDC11Code>
<ProductNDC>55150-472</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217401</ApplicationNumber>
<LabelerName>Eugia US LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/30mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin hydrochloride for injection is a glycopeptide antibacterial indicated in adult and pediatric patients (neonates and older) for the treatment of: 1 Septicemia (1.1), 2 Infective Endocarditis (1.2), 3 Skin and Skin Structure Infections (1.3), 4 Bone Infections (1.4), 5 Lower Respiratory Tract Infections (1.5).</IndicationAndUsage>
<Description>Vancomycin hydrochloride for injection, USP, contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride, USP is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24ꞏHCl and the molecular weight is 1,485.71. Vancomycin hydrochloride, USP has the following structural formula. Vancomycin hydrochloride for injection, USP is a sterile white or off-white to light tan colored lyophilized cake or powder for injection. Vancomycin hydrochloride for injection, USP is supplied in single-dose vials, containing 1.28 g or 1.54 g of vancomycin hydrochloride, USP equivalent to 1.25 g or 1.5 g of vancomycin base. The lyophilized powder is reconstituted with sterile water for injection, USP which forms a clear, colorless to light tan color solution and subsequently diluted prior to intravenous administration [see Dosage and Administration (2.5)].</Description>
</NDC>
<NDC>
<NDCCode>62175-472-32</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-472-32) </PackageDescription>
<NDC11Code>62175-0472-32</NDC11Code>
<ProductNDC>62175-472</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204744</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine is indicated in adults for the treatment of: : 1 Major depressive disorder (MDD) , 2 Panic disorder (PD), 3 Social anxiety disorder (SAD) , 4 Premenstrual dysphoric disorder (PMDD) .</IndicationAndUsage>
<Description>Paroxetine Extended-Release Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 g/mol (329.4 g/mol as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120° C to 138°C and a solubility of 5.4 mg/mL in water. Paroxetine Extended-Release Tablets, USP are intended for oral administration. Each enteric, film-coated, extended-release tablet contains paroxetine hydrochloride equivalent to paroxetine as follows: 12.5 mg–white, 25 mg–pink and 37.5 mg–blue. Inactive ingredients consist of hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycols, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide, triethyl citrate. In addition, the 25 mg and 37.5 mg colorant contains FD&C Blue No. 2 aluminum lake. In addition, the 25 mg colorant also contains carmine. Paroxetine meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>62175-472-41</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-472-41) </PackageDescription>
<NDC11Code>62175-0472-41</NDC11Code>
<ProductNDC>62175-472</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204744</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine is indicated in adults for the treatment of: : 1 Major depressive disorder (MDD) , 2 Panic disorder (PD), 3 Social anxiety disorder (SAD) , 4 Premenstrual dysphoric disorder (PMDD) .</IndicationAndUsage>
<Description>Paroxetine Extended-Release Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 g/mol (329.4 g/mol as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120° C to 138°C and a solubility of 5.4 mg/mL in water. Paroxetine Extended-Release Tablets, USP are intended for oral administration. Each enteric, film-coated, extended-release tablet contains paroxetine hydrochloride equivalent to paroxetine as follows: 12.5 mg–white, 25 mg–pink and 37.5 mg–blue. Inactive ingredients consist of hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycols, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide, triethyl citrate. In addition, the 25 mg and 37.5 mg colorant contains FD&C Blue No. 2 aluminum lake. In addition, the 25 mg colorant also contains carmine. Paroxetine meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>68083-472-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (68083-472-01) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>68083-0472-01</NDC11Code>
<ProductNDC>68083-472</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ganirelix Acetate</ProprietaryName>
<NonProprietaryName>Ganirelix Acetate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215658</ApplicationNumber>
<LabelerName>Gland Pharma Limited</LabelerName>
<SubstanceName>GANIRELIX ACETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Pharm_Classes>Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.</IndicationAndUsage>
<Description>Ganirelix Acetate Injection is a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotropin-releasing hormone (GnRH). Ganirelix Acetate is derived from native GnRH with substitutions of amino acids at positions 1, 2, 3, 6, 8, and 10 to form the following molecular formula of the peptide: N-acetyl-3-(2-naphthyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridyl)-D-alanyl-L-seryl-L-tyrosyl-N9,N10-diethyl-D-homoarginyl-L-leucyl- N9,N10-diethyl-L-homoarginyl-L-prolyl-D-alanylamide acetate. The molecular weight for Ganirelix Acetate is 1570.4 as an anhydrous free base. The structural formula is as follows. Ganirelix Acetate. Ganirelix Acetate Injection is supplied as a colorless, sterile, ready-to-use, aqueous solution intended for SUBCUTANEOUS administration only. Each single dose, sterile, prefilled syringe contains 250 mcg/0.5 mL of Ganirelix Acetate, 0.1 mg glacial acetic acid, 23.5 mg mannitol, and water for injection adjusted to pH 5.0 with acetic acid, NF and/or sodium hydroxide, NF.</Description>
</NDC>
<NDC>
<NDCCode>72482-100-12</NDCCode>
<PackageDescription>40 CARTON in 1 BOX (72482-100-12) / 1 BOTTLE in 1 CARTON / 120 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>72482-0100-12</NDC11Code>
<ProductNDC>72482-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vonjo</ProprietaryName>
<NonProprietaryName>Pacritinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220228</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208712</ApplicationNumber>
<LabelerName>Sobi, Inc.</LabelerName>
<SubstanceName>PACRITINIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Janus Kinase Inhibitors [MoA], Kinase Inhibitor [EPC], Organic Cation Transporter 1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Tyrosine Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a platelet count below 50 × 10 9/L. This indication is approved under accelerated approval based on spleen volume reduction [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).</IndicationAndUsage>
<Description>VONJO contains pacritinib citrate, a kinase inhibitor with the chemical name (2E,16E)-11-[2-(pyrrolidin-1-yl)ethoxy]-14,19-dioxa-5,7,27-triazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2,4,6,8,10,12(26),16,21,23-decaene citrate and a molecular weight of 664.7 as citrate salt and 472.59 as a free base. The molecular formula is C28H32N4O3C6H8O7 and the structural formula is. VONJO capsule is for oral administration. Each capsule contains 100 mg of pacritinib equivalent to 140.65 mg of pacritinib citrate and the inactive ingredients are microcrystalline cellulose NF, polyethylene glycol 8000 (PEG 8000) NF, and magnesium stearate NF. The gelatin capsule is bovine derived. The capsule shell contains gelatin, titanium dioxide, black iron oxide, erythrosine, red iron oxide, and printing ink containing shellac, propylene glycol, titanium dioxide, sodium hydroxide, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>17089-025-17</NDCCode>
<PackageDescription>6 TUBE in 1 BOX (17089-025-17) > 1 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0025-17</NDC11Code>
<ProductNDC>17089-025</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna-flu</ProprietaryName>
<NonProprietaryName>Aconitum Napellus - Asclepias Curassavica - Atropa Belladonna - Cairina Moschata Heart/liver Autolysate - Copper - Echinacea Angustifolia - Haemophilus Influenzae Type B -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ASCLEPIAS CURASSAVICA; ATROPA BELLADONNA; COPPER; ECHINACEA ANGUSTIFOLIA; HAEMOPHILUS INFLUENZAE TYPE B</SubstanceName>
<StrengthNumber>5; 7; 5; 5; 3; 3; 9</StrengthNumber>
<StrengthUnit>[hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g</StrengthUnit>
<Pharm_Classes>Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: pour the content of 1 tube directly into the mouth and allow to dissolve under the tongue. Take on an empty stomach. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-046-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-046-20) > 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0046-20</NDC11Code>
<ProductNDC>17089-046</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti Age Skin</ProprietaryName>
<NonProprietaryName>Alpha-tocopherol - Ascophyllum Nodosum - Botryoglossum Platycarpum - Fucus Serratus - Fucus Vesiculosus - Isoleucine - Leucine - Retinol - Selenium - Sus Scrofa Capillary Tissue - Sus Scrofa Collagen - Sus Scrofa Placenta - Sus Scrofa Skin - Ubidecarenone - Ulva Lactuca Extract - Laminaria Digitata</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>ALPHA-TOCOPHEROL; LAMINARIA DIGITATA; BOTRYOGLOSSUM PLATYCARPUM; FUCUS SERRATUS; SUS SCROFA CAPILLARY TISSUE; UBIDECARENONE; SUS SCROFA COLLAGEN; FUCUS VESICULOSUS; ISOLEUCINE; ASCOPHYLLUM NODOSUM; LEUCINE; SUS SCROFA PLACENTA; RETINOL; ULVA LACTUCA EXTRACT; SELENIUM; SUS SCROFA SKIN</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve Take 15 minutes before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-061-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-061-20) > 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0061-20</NDC11Code>
<ProductNDC>17089-061</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti Age Face</ProprietaryName>
<NonProprietaryName>Asian Ginseng - Canakinumab - Eleuthero - Germanium Dioxide - Isoleucine - Leucine - Proline - Sus Scrofa Collagen - Sus Scrofa Skin - Valine - Witch Hazel -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<EndMarketingDate>20180701</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>SUS SCROFA COLLAGEN; GERMANIUM DIOXIDE; ASIAN GINSENG; HAMAMELIS VIRGINIANA LEAF; CANAKINUMAB; ISOLEUCINE; LEUCINE; PROLINE; ELEUTHERO; SUS SCROFA SKIN; VALINE</SubstanceName>
<StrengthNumber>4; 4; 3; 3; 5; 4; 4; 4; 3; 4; 9</StrengthNumber>
<StrengthUnit>[hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060523</StartMarketingDatePackage>
<EndMarketingDatePackage>20180701</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>17089-067-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-067-20) / 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0067-20</NDC11Code>
<ProductNDC>17089-067</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti Age Stress</ProprietaryName>
<NonProprietaryName>Acetylcysteine - Ballota Foetida - Epinephrine - Glutathione - Interferon Gamma-1b - Lenograstim - Lithium Carbonate - Melatonin - Penicillium Glabrum - Potassium Carbonate - Pummelo - Rhodotorula Rubra - Silver Nitrate - Strychnos Nux-vomica Seed - Sus Scrofa Cerebral Cortex - Sus Scrofa Stomach - Sus Scrofa Superior Gastric Plexus - Sus Scrofa Thalamus -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>MELATONIN; ACETYLCYSTEINE; STRYCHNOS NUX-VOMICA SEED; PENICILLIUM GLABRUM; RHODOTORULA RUBRA; SUS SCROFA STOMACH; SUS SCROFA SUPERIOR GASTRIC PLEXUS; SUS SCROFA THALAMUS; EPINEPHRINE; SILVER NITRATE; BALLOTA FOETIDA; PUMMELO; SUS SCROFA CEREBRAL CORTEX; POTASSIUM CARBONATE; LENOGRASTIM; GLUTATHIONE; INTERFERON GAMMA-1B; LITHIUM CARBONATE</SubstanceName>
<StrengthNumber>15; 4; 5; 8; 8; 7; 7; 7; 9; 9; 3; 3; 4; 9; 4; 4; 5; 8</StrengthNumber>
<StrengthUnit>[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Decreased Respiratory Secretion Viscosity [PE], Fungal Proteins [CS], Increased Glutathione Concentration [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Interferon gamma [EPC], Interferon-gamma [CS], Mood Stabilizer [EPC], Mucolytic [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Reduction Activity [MoA], Seed Storage Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve. Take 15 minutes before meals. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-068-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-068-20) / 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0068-20</NDC11Code>
<ProductNDC>17089-068</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti Age Vein</ProprietaryName>
<NonProprietaryName>Aconitum Napellus - Apis Mellifera - Arnica Montana - Arsenic Trioxide - Atropa Belladonna - Calcium Fluoride - Centella Asiatica - Cinchona Officinalis Bark - Cranberry - Horse Chestnut - Iron - Lachesis Muta Venom - Mercury - Pineapple - Pulsatilla Vulgaris - Sus Scrofa Artery - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Sus Scrofa Vein - Viscum Album Fruit - Witch Hazel -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; HORSE CHESTNUT; PINEAPPLE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; SUS SCROFA ARTERY; ATROPA BELLADONNA; CALCIUM FLUORIDE; CINCHONA OFFICINALIS BARK; IRON; WITCH HAZEL; CENTELLA ASIATICA; LACHESIS MUTA VENOM; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; MERCURY; CRANBERRY; PULSATILLA VULGARIS; SUS SCROFA VEIN; VISCUM ALBUM FRUIT</SubstanceName>
<StrengthNumber>10; 3; 3; 10; 10; 12; 4; 10; 8; 10; 10; 3; 3; 10; 7; 10; 3; 10; 4; 3</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Fruit Proteins [EXT], Fruit Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve. Take 15 minutes before meals. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-075-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-075-20) > 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0075-20</NDC11Code>
<ProductNDC>17089-075</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Omeosport</ProprietaryName>
<NonProprietaryName>.alpha.-ketoglutaric Acid - Aconitic Acid, Cis - Adenosine Triphosphate - Alpha Lipoic Acid - Ascorbic Acid - Asian Ginseng - Barium Cation - Beet - Cerous Oxalate Nonahydrate - Coenzyme A - Cysteine - Fumaric Acid - Lactic Acid, Dl - Magnesium Carbonate - Malic Acid - Manganese Phosphate, Dibasic - Pork - Pyridoxine Hydrochloride - Riboflavin - Sodium Diethyl Oxalacetate - Sodium Pyruvate - Succinic Acid - Sus Scrofa Adrenal Gland - Thiamine Hydrochloride - Sus Scrofa Embryo -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>ADENOSINE TRIPHOSPHATE; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ASCORBIC ACID; BARIUM OXALOSUCCINATE; BEET; CEROUS OXALATE NONAHYDRATE; ACONITIC ACID, (Z)-; COENZYME A; CYSTEINE; SUS SCROFA EMBRYO; FUMARIC ACID; ASIAN GINSENG; SUS SCROFA ADRENAL GLAND; LACTIC ACID; MAGNESIUM CARBONATE; MALIC ACID; MANGANESE PHOSPHATE, DIBASIC; PORK; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SUCCINIC ACID; THIAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8; 6; 6; 4; 6; 2; 6; 6; 6; 6; 6; 6; 3; 10; 8; 2; 6; 6; 6; 6; 6; 6; 6; 6; 4</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Magnetic Resonance Contrast Activity [MoA], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Paramagnetic Contrast Agent [EPC], Plant Proteins [CS], Vegetable Proteins [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: 1 Turn tube upside down and rotate cap to release pellets into cap., 2 Unscrew cap and without touching pellets tip them into the mouth under the tongue., 3 Allow to dissolve, 4 Take 15 minutes before meals. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-076-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-076-20) / 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0076-20</NDC11Code>
<ProductNDC>17089-076</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Citomix</ProprietaryName>
<NonProprietaryName>Aldesleukin - Binetrakin - Canakinumab - Centella Asiatica - Cranberry - Human Interleukin-6 (nonglycosylated) - Interferon Gamma-1b - Lenograstim - Pineapple - Sus Scrofa Bone Marrow - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Sus Scrofa Thymus -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>PINEAPPLE; LENOGRASTIM; CENTELLA ASIATICA; INTERFERON GAMMA-1B; CANAKINUMAB; ALDESLEUKIN; BINETRAKIN; HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED); SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA BONE MARROW; CRANBERRY; SUS SCROFA THYMUS</SubstanceName>
<StrengthNumber>3; 4; 3; 4; 5; 5; 4; 7; 4; 4; 3; 4</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Fruit Proteins [EXT], Fruit Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Lymphocyte Activation [PE], Increased Lymphocyte Cell Production [PE], Interferon gamma [EPC], Interferon-gamma [CS], Interleukin-2 [CS], Lymphocyte Growth Factor [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Immune support suring times of: : 1 Seasonal colds and flu.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-231-18</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BOX (17089-231-18) / 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>17089-0231-18</NDC11Code>
<ProductNDC>17089-231</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna-fem</ProprietaryName>
<NonProprietaryName>Adenosinum Ciclophosphoricum - Lilium Tigrinum - Melatonin - Sus Scrofa Adrenal Gland - Sus Scrofa Corpus Luteum - Sus Scrofa Hypothalamus - Sus Scrofa Ovary - Sus Scrofa Pancreas - Sus Scrofa Pineal Gland - Sus Scrofa Pituitary Gland - Sus Scrofa Thymus - Thyroid -</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA CORPUS LUTEUM; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA HYPOTHALAMUS; LILIUM LANCIFOLIUM BULB; MELATONIN; SUS SCROFA OVARY; SUS SCROFA PANCREAS; SUS SCROFA PINEAL GLAND; SUS SCROFA THYMUS; THYROID</SubstanceName>
<StrengthNumber>6; 30; 30; 30; 30; 6; 200; 6; 30; 30; 30; 6</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Take 15 minutes before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-233-18</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BOX (17089-233-18) > 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>17089-0233-18</NDC11Code>
<ProductNDC>17089-233</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna-male</ProprietaryName>
<NonProprietaryName>Adenosinum Ciclophosphoricum - Melatonin - Phosphorus - Sus Scrofa Adrenal Gland - Sus Scrofa Hypothalamus - Sus Scrofa Pancreas - Sus Scrofa Pineal Gland - Sus Scrofa Pituitary Gland - Sus Scrofa Testicle - Sus Scrofa Thymus - Thyroid - Turnera Diffusa Top -</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>ADENOSINE CYCLIC PHOSPHATE; TURNERA DIFFUSA LEAFY TWIG; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA HYPOTHALAMUS; MELATONIN; SUS SCROFA TESTICLE; SUS SCROFA PANCREAS; PHOSPHORUS; SUS SCROFA PINEAL GLAND; SUS SCROFA THYMUS; THYROID</SubstanceName>
<StrengthNumber>6; 6; 30; 30; 30; 30; 30; 30; 6; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2019-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Take 15 minutes before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-235-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-235-20) > 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0235-20</NDC11Code>
<ProductNDC>17089-235</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna-tonsils</ProprietaryName>
<NonProprietaryName>Angelica Sinensis Root - Binetrakin - Interleukin-3 - Lenograstim - Melatonin - Reishi - Shiitake Mushroom - Sus Scrofa Blood - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Sus Scrofa Spleen - Interleukin-11 -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>ANGELICA SINENSIS ROOT; SUS SCROFA BLOOD; LENOGRASTIM; INTERLEUKIN-11; INTERLEUKIN-3; BINETRAKIN; SHIITAKE MUSHROOM; REISHI; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; MELATONIN; SUS SCROFA SPLEEN</SubstanceName>
<StrengthNumber>3; 7; 4; 5; 5; 4; 8; 8; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2019-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve Take 15 minutes before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-237-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-237-20) > 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0237-20</NDC11Code>
<ProductNDC>17089-237</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna-react</ProprietaryName>
<NonProprietaryName>Angelica Sinensis Root - Arnica Montana - Asian Ginseng - Echinacea Angustifolia - Fomitopsis Pinicola Fruiting Body - Interferon Gamma-1b - Paeonia Officinalis Root - Pork Liver - Reishi - Silybum Marianum Seed - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Turmeric -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>TURMERIC; ANGELICA SINENSIS ROOT; ARNICA MONTANA; SILYBUM MARIANUM SEED; ECHINACEA ANGUSTIFOLIA; ASIAN GINSENG; PORK LIVER; INTERFERON GAMMA-1B; REISHI; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; PAEONIA OFFICINALIS ROOT; FOMITOPSIS PINICOLA FRUITING BODY</SubstanceName>
<StrengthNumber>3; 3; 4; 3; 3; 1; 4; 4; 8; 4; 3; 8</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Interferon gamma [EPC], Interferon-gamma [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions:. Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve Take 15 minutes before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-242-18</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BOX (17089-242-18) > 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>17089-0242-18</NDC11Code>
<ProductNDC>17089-242</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna-addict 1</ProprietaryName>
<NonProprietaryName>Caffeine - Chelidonium Majus - Dieffenbachia Seguine - Juniper - Matricaria Recutita - Nicotine - Papaver Rhoeas Flower - Plantago Major - Scrophularia Nodosa - Sodium Chloride - Strychnos Nux-vomica Seed - Sugarcane - Tobacco Leaf -</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<EndMarketingDate>20210228</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>CAFFEINE; DIEFFENBACHIA SEGUINE; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; JUNIPER; SODIUM CHLORIDE; NICOTINE; STRYCHNOS NUX-VOMICA SEED; PAPAVER RHOEAS FLOWER; PLANTAGO MAJOR; SUGARCANE; SCROPHULARIA NODOSA; TOBACCO LEAF</SubstanceName>
<StrengthNumber>6; 4; 1; 1; 1; 9; 6; 9; 12; 1; 6; 1; 6</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060523</StartMarketingDatePackage>
<EndMarketingDatePackage>20210228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>17089-243-18</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BOX (17089-243-18) > 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>17089-0243-18</NDC11Code>
<ProductNDC>17089-243</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna-addict 2</ProprietaryName>
<NonProprietaryName>Asian Ginseng - Avena Sativa Flowering Top - Black Currant - Matricaria Recutita - Eleuthero - Eschscholzia Californica - Hops - Hypericum Perforatum - Passiflora Incarnata Top - Potassium Phosphate,</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>AVENA SATIVA FLOWERING TOP; BLACK CURRANT; MATRICARIA RECUTITA; ESCHSCHOLZIA CALIFORNICA; ASIAN GINSENG; HOPS; HYPERICUM PERFORATUM; POTASSIUM PHOSPHATE, DIBASIC; PASSIFLORA INCARNATA TOP; PULSATILLA VULGARIS; PULSATILLA VULGARIS; PULSATILLA VULGARIS; ELEUTHERO; STEVIA LEAF; VALERIAN</SubstanceName>
<StrengthNumber>1; 1; 3; 1; 2; 1; 3; 8; 1; 6; 9; 12; 1; 1; 1</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-04-11</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>17089-251-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-251-20) > 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0251-20</NDC11Code>
<ProductNDC>17089-251</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna-virus</ProprietaryName>
<NonProprietaryName>Aldesleukin - Everlasting Extract - Fomitopsis Pinicola Fruiting Body - Interferon Gamma-1b - Melatonin - Metenkefalin - Reishi - Rice - Serotonin - Soybean - Sus Scrofa Blood - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Sus Scrofa Spleen -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>ALDESLEUKIN; EVERLASTING EXTRACT; FOMITOPSIS PINICOLA FRUITING BODY; INTERFERON GAMMA-1B; METENKEFALIN; REISHI; BROWN RICE; SEROTONIN; SOYBEAN; SUS SCROFA BLOOD; SUS SCROFA SPLEEN; MELATONIN; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE</SubstanceName>
<StrengthNumber>5; 3; 8; 3; 4; 8; 3; 6; 3; 4; 4; 15; 7</StrengthNumber>
<StrengthUnit>[hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Lymphocyte Activation [PE], Increased Lymphocyte Cell Production [PE], Interferon gamma [EPC], Interferon-gamma [CS], Interleukin-2 [CS], Lymphocyte Growth Factor [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve. Take 15 minutes before meals. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17089-259-18</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BOX (17089-259-18) > 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>17089-0259-18</NDC11Code>
<ProductNDC>17089-259</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Osteobios</ProprietaryName>
<NonProprietaryName>Calcitonin Human - Calcium Carbonate - Calcium Fluoride - Calcium Phosphate - Isoleucine - Leucine - Lysine - Methionine - Phenylalanine - Sus Scrofa Bone - Sus Scrofa Parathyroid Gland - Threonine - Tryptophan - Valine -</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>CALCITONIN HUMAN; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; CALCIUM CARBONATE; CALCIUM FLUORIDE; CALCIUM PHOSPHATE; SUS SCROFA BONE; SUS SCROFA PARATHYROID GLAND</SubstanceName>
<StrengthNumber>6; 3; 3; 3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Calcium [CS], Cations, Divalent [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Take 15 minutes before meals.</IndicationAndUsage>
</NDC>
</NDCList>