{
"NDC": [
{
"NDCCode": "71800-631-08",
"PackageDescription": "8 TUBE in 1 CARTON (71800-631-08) > 30 g in 1 TUBE",
"NDC11Code": "71800-0631-08",
"ProductNDC": "71800-631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine And Tetracaine",
"NonProprietaryName": "Lidocaine And Tetracaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170503",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021717",
"LabelerName": "Innovida Pharmaceutique Corporation",
"SubstanceName": "LIDOCAINE; TETRACAINE",
"StrengthNumber": "70; 70",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180418",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine and tetracaine cream is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.",
"Description": "Lidocaine and tetracaine cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C 14H 22N 2O. The structural formula is:. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C 15H 24N 2O 2. The structural formula is:. Each gram of lidocaine and tetracaine cream contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum."
},
{
"NDCCode": "71800-054-08",
"PackageDescription": "24 TABLET in 1 BLISTER PACK (71800-054-08) ",
"NDC11Code": "71800-0054-08",
"ProductNDC": "71800-054",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pseudoephedrine Hcl",
"NonProprietaryName": "Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250210",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Innovida Pharmaeutique Corporation",
"SubstanceName": "PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250210",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies . temporarily restores freer breathing through the nose."
},
{
"NDCCode": "71800-631-04",
"PackageDescription": "4 TUBE in 1 CARTON (71800-631-04) > 30 g in 1 TUBE",
"NDC11Code": "71800-0631-04",
"ProductNDC": "71800-631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine And Tetracaine",
"NonProprietaryName": "Lidocaine And Tetracaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170503",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021717",
"LabelerName": "Innovida Pharmaceutique Corporation",
"SubstanceName": "LIDOCAINE; TETRACAINE",
"StrengthNumber": "70; 70",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180418",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine and tetracaine cream is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.",
"Description": "Lidocaine and tetracaine cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C 14H 22N 2O. The structural formula is:. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C 15H 24N 2O 2. The structural formula is:. Each gram of lidocaine and tetracaine cream contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum."
},
{
"NDCCode": "71800-631-15",
"PackageDescription": "1 TUBE in 1 CARTON (71800-631-15) > 30 g in 1 TUBE",
"NDC11Code": "71800-0631-15",
"ProductNDC": "71800-631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine And Tetracaine",
"NonProprietaryName": "Lidocaine And Tetracaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170503",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021717",
"LabelerName": "Innovida Pharmaceutique Corporation",
"SubstanceName": "LIDOCAINE; TETRACAINE",
"StrengthNumber": "70; 70",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20181211",
"SamplePackage": "N"
},
{
"NDCCode": "51316-631-08",
"PackageDescription": "1 BOTTLE in 1 CARTON (51316-631-08) / 237 mL in 1 BOTTLE",
"NDC11Code": "51316-0631-08",
"ProductNDC": "51316-631",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Severe Cough, Flu Plus Sore Throat",
"ProprietaryNameSuffix": "Honey",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20230217",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "CVS PHARMACY",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "650; 20",
"StrengthUnit": "mg/20mL; mg/20mL",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230217",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves these symptoms occurring with a cold or flu:cough due to minor throat and bronchial irritationminor aches and painssore throat painheadache, 2 temporarily reduces fever."
},
{
"NDCCode": "71919-631-08",
"PackageDescription": "30 mL in 1 VIAL, GLASS (71919-631-08) ",
"NDC11Code": "71919-0631-08",
"ProductNDC": "71919-631",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinapis Nigra",
"NonProprietaryName": "Black Mustard Seed",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20091028",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "BLACK MUSTARD SEED",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20091028",
"SamplePackage": "N",
"IndicationAndUsage": "Indications:. SINAPIS NIG Hoarseness."
},
{
"NDCCode": "0069-0274-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (0069-0274-30) / 30 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "00069-0274-30",
"ProductNDC": "0069-0274",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Velsipity",
"NonProprietaryName": "Etrasimod",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231019",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216956",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "ETRASIMOD ARGININE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231019",
"SamplePackage": "N",
"IndicationAndUsage": "VELSIPITY is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults.",
"Description": "VELSIPITY contains etrasimod, a sphingosine 1-phosphate (S1P) receptor modulator, supplied as etrasimod arginine. Etrasimod arginine is a white, off-white to light brown solid that is slightly soluble in water. The chemical name of etrasimod arginine is L-Arginine, (3R)-7-[[4-cyclopentyl-3-(trifluoromethyl)phenyl]methoxy]-1,2,3,4-tetrahydrocyclopent[b]indole-3-acetate (1:1) having a molecular formula of C32H40F3N5O5 and a molecular weight of 631.69 g/mol. The chemical structure of etrasimod arginine is. VELSIPITY is supplied for oral administration as 2 mg tablets. Each tablet contains 2 mg etrasimod (equivalent to 2.76 mg etrasimod arginine) and the following inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate, with a film coating containing FD&C blue #1/brilliant blue FCF aluminum lake, FD&C blue #2/indigo carmine aluminum lake, FD&C yellow #5/tartrazine aluminum lake, macrogol 4000 JP/PEG 3350, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide."
},
{
"NDCCode": "0074-0038-07",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0074-0038-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00074-0038-07",
"ProductNDC": "0074-0038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orilissa",
"NonProprietaryName": "Elagolix",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180723",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210450",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "ELAGOLIX SODIUM",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180723",
"SamplePackage": "Y",
"IndicationAndUsage": "ORILISSA is indicated for the management of moderate to severe pain associated with endometriosis. Limitations of Use:. Limit the duration of use based on the dose and coexisting condition (see Table 1) [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].",
"Description": "ORILISSA (elagolix) tablets for oral administration contain elagolix sodium, the sodium salt of the active moiety elagolix. Elagolix sodium is a nonpeptide small molecule, GnRH receptor antagonist. Elagolix sodium is chemically described as sodium 4-({(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2H)-yl]-1-phenylethyl}amino)butanoate. Elagolix sodium has a molecular formula of C32H29F5N3O5Na and a molecular weight of 653.58. Elagolix free acid has a molecular weight of 631.60. Elagolix sodium has the following structural formula:. Elagolix sodium is a white to off white to light yellow powder and is freely soluble in water. ORILISSA 150 mg tablets are light pink, oblong, film-coated tablets with “EL 150” debossed on one side. Each tablet contains 155.2 mg of elagolix sodium (equivalent to 150 mg of elagolix) as the active ingredient and the following inactive ingredients: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and carmine high tint. ORILISSA 200 mg tablets are light orange, oblong, film-coated tablets with “EL 200” debossed on one side. Each tablet contains 207.0 mg of elagolix sodium (equivalent to 200 mg of elagolix) as the active ingredient and the following inactive ingredients: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red."
},
{
"NDCCode": "0074-0038-28",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (0074-0038-28) / 7 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00074-0038-28",
"ProductNDC": "0074-0038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orilissa",
"NonProprietaryName": "Elagolix",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180723",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210450",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "ELAGOLIX SODIUM",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180723",
"SamplePackage": "N",
"IndicationAndUsage": "ORILISSA is indicated for the management of moderate to severe pain associated with endometriosis. Limitations of Use:. Limit the duration of use based on the dose and coexisting condition (see Table 1) [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].",
"Description": "ORILISSA (elagolix) tablets for oral administration contain elagolix sodium, the sodium salt of the active moiety elagolix. Elagolix sodium is a nonpeptide small molecule, GnRH receptor antagonist. Elagolix sodium is chemically described as sodium 4-({(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2H)-yl]-1-phenylethyl}amino)butanoate. Elagolix sodium has a molecular formula of C32H29F5N3O5Na and a molecular weight of 653.58. Elagolix free acid has a molecular weight of 631.60. Elagolix sodium has the following structural formula:. Elagolix sodium is a white to off white to light yellow powder and is freely soluble in water. ORILISSA 150 mg tablets are light pink, oblong, film-coated tablets with “EL 150” debossed on one side. Each tablet contains 155.2 mg of elagolix sodium (equivalent to 150 mg of elagolix) as the active ingredient and the following inactive ingredients: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and carmine high tint. ORILISSA 200 mg tablets are light orange, oblong, film-coated tablets with “EL 200” debossed on one side. Each tablet contains 207.0 mg of elagolix sodium (equivalent to 200 mg of elagolix) as the active ingredient and the following inactive ingredients: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red."
},
{
"NDCCode": "0074-0039-14",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0074-0039-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00074-0039-14",
"ProductNDC": "0074-0039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orilissa",
"NonProprietaryName": "Elagolix",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180723",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210450",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "ELAGOLIX SODIUM",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180723",
"SamplePackage": "Y",
"IndicationAndUsage": "ORILISSA is indicated for the management of moderate to severe pain associated with endometriosis. Limitations of Use:. Limit the duration of use based on the dose and coexisting condition (see Table 1) [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].",
"Description": "ORILISSA (elagolix) tablets for oral administration contain elagolix sodium, the sodium salt of the active moiety elagolix. Elagolix sodium is a nonpeptide small molecule, GnRH receptor antagonist. Elagolix sodium is chemically described as sodium 4-({(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2H)-yl]-1-phenylethyl}amino)butanoate. Elagolix sodium has a molecular formula of C32H29F5N3O5Na and a molecular weight of 653.58. Elagolix free acid has a molecular weight of 631.60. Elagolix sodium has the following structural formula:. Elagolix sodium is a white to off white to light yellow powder and is freely soluble in water. ORILISSA 150 mg tablets are light pink, oblong, film-coated tablets with “EL 150” debossed on one side. Each tablet contains 155.2 mg of elagolix sodium (equivalent to 150 mg of elagolix) as the active ingredient and the following inactive ingredients: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and carmine high tint. ORILISSA 200 mg tablets are light orange, oblong, film-coated tablets with “EL 200” debossed on one side. Each tablet contains 207.0 mg of elagolix sodium (equivalent to 200 mg of elagolix) as the active ingredient and the following inactive ingredients: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red."
},
{
"NDCCode": "0074-0039-56",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (0074-0039-56) / 14 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00074-0039-56",
"ProductNDC": "0074-0039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orilissa",
"NonProprietaryName": "Elagolix",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180723",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210450",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "ELAGOLIX SODIUM",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180723",
"SamplePackage": "N",
"IndicationAndUsage": "ORILISSA is indicated for the management of moderate to severe pain associated with endometriosis. Limitations of Use:. Limit the duration of use based on the dose and coexisting condition (see Table 1) [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].",
"Description": "ORILISSA (elagolix) tablets for oral administration contain elagolix sodium, the sodium salt of the active moiety elagolix. Elagolix sodium is a nonpeptide small molecule, GnRH receptor antagonist. Elagolix sodium is chemically described as sodium 4-({(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2H)-yl]-1-phenylethyl}amino)butanoate. Elagolix sodium has a molecular formula of C32H29F5N3O5Na and a molecular weight of 653.58. Elagolix free acid has a molecular weight of 631.60. Elagolix sodium has the following structural formula:. Elagolix sodium is a white to off white to light yellow powder and is freely soluble in water. ORILISSA 150 mg tablets are light pink, oblong, film-coated tablets with “EL 150” debossed on one side. Each tablet contains 155.2 mg of elagolix sodium (equivalent to 150 mg of elagolix) as the active ingredient and the following inactive ingredients: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and carmine high tint. ORILISSA 200 mg tablets are light orange, oblong, film-coated tablets with “EL 200” debossed on one side. Each tablet contains 207.0 mg of elagolix sodium (equivalent to 200 mg of elagolix) as the active ingredient and the following inactive ingredients: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red."
},
{
"NDCCode": "11084-631-20",
"PackageDescription": "2000 mL in 1 BOTTLE, PLASTIC (11084-631-20)",
"NDC11Code": "11084-0631-20",
"ProductNDC": "11084-631",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Astound Antibac",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130705",
"EndMarketingDate": "20200801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Deb USA, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".3",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-08-04",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "42858-631-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-631-01) ",
"NDC11Code": "42858-0631-01",
"ProductNDC": "42858-631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ms Contin",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170515",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019516",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170515",
"SamplePackage": "N",
"IndicationAndUsage": "MS CONTIN is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including MS CONTIN, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 MS CONTIN is not indicated as an as-needed (prn) analgesic.",
"Description": "MS CONTIN (morphine sulfate extended-release tablets) is for oral use and contains morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: cetostearyl alcohol, hydroxyethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, talc, and titanium dioxide. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). The 15 mg tablets also contain: FD&C Blue No. 2, lactose, polysorbate 80. The 30 mg tablets also contain: D&C Red No. 7, FD&C Blue No. 1, lactose, polysorbate 80. The 60 mg tablets also contain: D&C Red No. 30, D&C Yellow No. 10, hydroxypropyl cellulose, lactose. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is."
},
{
"NDCCode": "54860-631-01",
"PackageDescription": "2 BOTTLE, SPRAY in 1 BOX (54860-631-01) / 40 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "54860-0631-01",
"ProductNDC": "54860-631",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smart Care Hand Sanitizer With Glitter Silicone Case,2pk Vanilla Chai And Espresso",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260727",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Shenzhen Lantern Scicence Co.,Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260826",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and children 6 years and older Spray onto hands and rub together until dry. Recommended for repeated use. Children under 6 years of age Should be supervised when using this product."
},
{
"NDCCode": "62135-631-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (62135-631-90) ",
"NDC11Code": "62135-0631-90",
"ProductNDC": "62135-631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cimetidine",
"NonProprietaryName": "Cimetidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19940517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074329",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "CIMETIDINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230815",
"SamplePackage": "N",
"IndicationAndUsage": "Cimetidine tablets are indicated in. 1. Short-term treatment of active duodenal ulcer.Most patients heal within 4 weeks and there is rarely reason to use cimetidine tablets at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION: Duodenal Ulcer). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of cimetidine tablets and antacids is not recommended, since antacids have been reported to interfere with the absorption of cimetidine. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer.Patients have been maintained on continued treatment with cimetidine tablets 400 mg at bedtime for periods of up to 5 years. 3. Short-term treatment of active benign gastric ulcer.There is no information concerning usefulness of treatment periods of longer than 8 weeks. 4. Erosive gastroesophageal reflux (GERD).Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of lesions and control of symptoms. The use of cimetidine tablets beyond 12 weeks has not been established (see DOSAGE AND ADMINISTRATION: GERD). 5. The treatment of pathological hypersecretory conditions(i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas).",
"Description": "Cimetidine, USP is a histamine H 2-receptor antagonist. Chemically it is N\"-cyano- N-methyl- N'-[2-[[(5-methyl-1 H-imidazol-4-yl)methyl]thio]-ethyl]guanidine. Its structural formula is:. Cimetidine, USP contains an imidazole ring, and is chemically related to histamine. Cimetidine, USP has a bitter taste and characteristic odor. Solubility Characteristics. Cimetidine is soluble in alcohol, slightly soluble in water, very slightly soluble in chloroform and insoluble in ether. Each tablet, for oral administration, contains 200 mg, 300 mg, 400 mg or 800 mg cimetidine, USP. Inactive ingredients are: corn starch, hydroxypropylmethyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, povidone, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide."
},
{
"NDCCode": "63739-631-10",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-631-10) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "63739-0631-10",
"ProductNDC": "63739-631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070921",
"EndMarketingDate": "20210731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078226",
"LabelerName": "McKesson Corporation dba SKY Packaging",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140904",
"EndMarketingDatePackage": "20210731",
"SamplePackage": "N"
},
{
"NDCCode": "68428-631-03",
"PackageDescription": "75 PELLET in 1 VIAL, GLASS (68428-631-03) ",
"NDC11Code": "68428-0631-03",
"ProductNDC": "68428-631",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Selenium Metallicum",
"NonProprietaryName": "Selenium",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100409",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SELENIUM",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2023-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100409",
"SamplePackage": "N"
},
{
"NDCCode": "68428-631-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-631-05) ",
"NDC11Code": "68428-0631-05",
"ProductNDC": "68428-631",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Selenium Metallicum",
"NonProprietaryName": "Selenium",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100409",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SELENIUM",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2023-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100409",
"SamplePackage": "N"
},
{
"NDCCode": "68428-631-06",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (68428-631-06) ",
"NDC11Code": "68428-0631-06",
"ProductNDC": "68428-631",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Selenium Metallicum",
"NonProprietaryName": "Selenium",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100409",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SELENIUM",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2023-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100409",
"SamplePackage": "N"
},
{
"NDCCode": "68428-631-11",
"PackageDescription": "300 PELLET in 1 BOTTLE, GLASS (68428-631-11) ",
"NDC11Code": "68428-0631-11",
"ProductNDC": "68428-631",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Selenium Metallicum",
"NonProprietaryName": "Selenium",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100409",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SELENIUM",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2023-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100409",
"SamplePackage": "N"
},
{
"NDCCode": "68428-631-12",
"PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-631-12) ",
"NDC11Code": "68428-0631-12",
"ProductNDC": "68428-631",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Selenium Metallicum",
"NonProprietaryName": "Selenium",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100409",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SELENIUM",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2023-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100409",
"SamplePackage": "N"
},
{
"NDCCode": "69097-579-67",
"PackageDescription": "1 DOSE PACK in 1 CARTON (69097-579-67) / 1 GRANULE, FOR SOLUTION in 1 DOSE PACK",
"NDC11Code": "69097-0579-67",
"ProductNDC": "69097-579",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosfomycin Tromethamine",
"NonProprietaryName": "Fosfomycin Tromethamine",
"DosageFormName": "GRANULE, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20220126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211881",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "FOSFOMYCIN TROMETHAMINE",
"StrengthNumber": "3",
"StrengthUnit": "g/1",
"Status": "Active",
"LastUpdate": "2025-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220126",
"SamplePackage": "N",
"IndicationAndUsage": "Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin tromethamine granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine granules for oral solution, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.).",
"Description": "Fosfomycin tromethamine granules for oral solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: mandarin flavor, orange powder flavor, saccharin, and sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1R,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white or almost white, hygroscopic powder with a molecular weight of 259.19. Its empirical formula is C3H7O4P.C4H11NO3, and its chemical structure is as follows:."
},
{
"NDCCode": "69423-631-02",
"PackageDescription": "5 CANISTER in 1 CARTON (69423-631-02) / 59 g in 1 CANISTER",
"NDC11Code": "69423-0631-02",
"ProductNDC": "69423-631",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Secret Fresh Invisible",
"ProprietaryNameSuffix": "Antiperspirant/deodorant",
"NonProprietaryName": "Aluminum Zirconium Pentachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220103",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY",
"StrengthNumber": "18",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220103",
"EndMarketingDatePackage": "20260801",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm wetness."
},
{
"NDCCode": "70700-268-94",
"PackageDescription": "1 DOSE PACK in 1 CARTON (70700-268-94) / 1 POWDER in 1 DOSE PACK",
"NDC11Code": "70700-0268-94",
"ProductNDC": "70700-268",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosfomycin Tromethamine",
"NonProprietaryName": "Granules For Oral Solution",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20201006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212548",
"LabelerName": "XIROMED LLC",
"SubstanceName": "FOSFOMYCIN TROMETHAMINE",
"StrengthNumber": "3",
"StrengthUnit": "g/1",
"Status": "Active",
"LastUpdate": "2023-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201006",
"SamplePackage": "N",
"IndicationAndUsage": "Fosfomycin Tromethamine is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin Tromethamine is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with Fosfomycin Tromethamine, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.).",
"Description": "Fosfomycin Tromethamine Granules for Oral Solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: mandarin flavor, orange flavor, saccharin, and sucrose.The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1R,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white granular compound with a molecular weight of 259.2. Its empirical formula is C3H7O4P.C4H11NO3, and its chemical structure is as follows."
},
{
"NDCCode": "70700-268-99",
"PackageDescription": "1 POWDER in 1 PACKET (70700-268-99) ",
"NDC11Code": "70700-0268-99",
"ProductNDC": "70700-268",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosfomycin Tromethamine",
"NonProprietaryName": "Granules For Oral Solution",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20201006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212548",
"LabelerName": "XIROMED LLC",
"SubstanceName": "FOSFOMYCIN TROMETHAMINE",
"StrengthNumber": "3",
"StrengthUnit": "g/1",
"Status": "Active",
"LastUpdate": "2023-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201006",
"SamplePackage": "N",
"IndicationAndUsage": "Fosfomycin Tromethamine is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin Tromethamine is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with Fosfomycin Tromethamine, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.).",
"Description": "Fosfomycin Tromethamine Granules for Oral Solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: mandarin flavor, orange flavor, saccharin, and sucrose.The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1R,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white granular compound with a molecular weight of 259.2. Its empirical formula is C3H7O4P.C4H11NO3, and its chemical structure is as follows."
},
{
"NDCCode": "71773-050-05",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (71773-050-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS",
"NDC11Code": "71773-0050-05",
"ProductNDC": "71773-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xerava",
"NonProprietaryName": "Eravacycline",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180910",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211109",
"LabelerName": "Tetraphase Pharmaceuticals, Inc.",
"SubstanceName": "ERAVACYCLINE DIHYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180910",
"SamplePackage": "N",
"IndicationAndUsage": "XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older. (1.1). Limitations of Use XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI). (1.1). To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.2).",
"Description": "XERAVA contains eravacycline, a synthetic tetracycline-class antibacterial agent for intravenous administration. Chemically, eravacycline is a C7-, C9-substituted sancycline derivative. The chemical name of eravacycline dihydrochloride is [(4S,4aS,5aR,12aS)-4-(dimethylamino)-7-fluoro-3,10,12,12a-tetrahydroxy-1,11-dioxo-9-[2‑(pyrrolidin-1-yl) acetamido]-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide] dihydrochloride. The molecular formula for eravacycline dihydrochloride is C27H31FN4O82HCl, and its molecular weight is 631.5. The following represents the chemical structure of eravacycline dihydrochloride. XERAVA is a sterile, preservative-free, yellow to orange, lyophilized powder in a glass single-dose vial for intravenous infusion after reconstitution and dilution. XERAVA is supplied in two (2) strengths as follows: : 1 Each 50 mg single-dose vial contains 50 mg of eravacycline (equivalent to 63.5 mg of eravacycline dihydrochloride) and the excipient, mannitol (150 mg). Sodium hydroxide and hydrochloric acid are used as needed for pH adjustment to 5.5 to 7.0., 2 Each 100 mg single-dose vial contains 100 mg of eravacycline (equivalent to 127 mg of eravacycline dihydrochloride) and the excipient, mannitol (150 mg). Sodium hydroxide and hydrochloric acid are used as needed for pH adjustment to 5.5 to 7.0."
},
{
"NDCCode": "71773-050-12",
"PackageDescription": "12 VIAL, GLASS in 1 CARTON (71773-050-12) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS",
"NDC11Code": "71773-0050-12",
"ProductNDC": "71773-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xerava",
"NonProprietaryName": "Eravacycline",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180910",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211109",
"LabelerName": "Tetraphase Pharmaceuticals, Inc.",
"SubstanceName": "ERAVACYCLINE DIHYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180910",
"SamplePackage": "N",
"IndicationAndUsage": "XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older. (1.1). Limitations of Use XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI). (1.1). To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.2).",
"Description": "XERAVA contains eravacycline, a synthetic tetracycline-class antibacterial agent for intravenous administration. Chemically, eravacycline is a C7-, C9-substituted sancycline derivative. The chemical name of eravacycline dihydrochloride is [(4S,4aS,5aR,12aS)-4-(dimethylamino)-7-fluoro-3,10,12,12a-tetrahydroxy-1,11-dioxo-9-[2‑(pyrrolidin-1-yl) acetamido]-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide] dihydrochloride. The molecular formula for eravacycline dihydrochloride is C27H31FN4O82HCl, and its molecular weight is 631.5. The following represents the chemical structure of eravacycline dihydrochloride. XERAVA is a sterile, preservative-free, yellow to orange, lyophilized powder in a glass single-dose vial for intravenous infusion after reconstitution and dilution. XERAVA is supplied in two (2) strengths as follows: : 1 Each 50 mg single-dose vial contains 50 mg of eravacycline (equivalent to 63.5 mg of eravacycline dihydrochloride) and the excipient, mannitol (150 mg). Sodium hydroxide and hydrochloric acid are used as needed for pH adjustment to 5.5 to 7.0., 2 Each 100 mg single-dose vial contains 100 mg of eravacycline (equivalent to 127 mg of eravacycline dihydrochloride) and the excipient, mannitol (150 mg). Sodium hydroxide and hydrochloric acid are used as needed for pH adjustment to 5.5 to 7.0."
},
{
"NDCCode": "71773-100-12",
"PackageDescription": "12 CARTON in 1 PACKAGE (71773-100-12) / 1 VIAL, GLASS in 1 CARTON (71773-100-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS",
"NDC11Code": "71773-0100-12",
"ProductNDC": "71773-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xerava",
"NonProprietaryName": "Eravacycline",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180910",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211109",
"LabelerName": "Tetraphase Pharmaceuticals, Inc.",
"SubstanceName": "ERAVACYCLINE DIHYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200914",
"SamplePackage": "N",
"IndicationAndUsage": "XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older. (1.1). Limitations of Use XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI). (1.1). To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.2).",
"Description": "XERAVA contains eravacycline, a synthetic tetracycline-class antibacterial agent for intravenous administration. Chemically, eravacycline is a C7-, C9-substituted sancycline derivative. The chemical name of eravacycline dihydrochloride is [(4S,4aS,5aR,12aS)-4-(dimethylamino)-7-fluoro-3,10,12,12a-tetrahydroxy-1,11-dioxo-9-[2‑(pyrrolidin-1-yl) acetamido]-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide] dihydrochloride. The molecular formula for eravacycline dihydrochloride is C27H31FN4O82HCl, and its molecular weight is 631.5. The following represents the chemical structure of eravacycline dihydrochloride. XERAVA is a sterile, preservative-free, yellow to orange, lyophilized powder in a glass single-dose vial for intravenous infusion after reconstitution and dilution. XERAVA is supplied in two (2) strengths as follows: : 1 Each 50 mg single-dose vial contains 50 mg of eravacycline (equivalent to 63.5 mg of eravacycline dihydrochloride) and the excipient, mannitol (150 mg). Sodium hydroxide and hydrochloric acid are used as needed for pH adjustment to 5.5 to 7.0., 2 Each 100 mg single-dose vial contains 100 mg of eravacycline (equivalent to 127 mg of eravacycline dihydrochloride) and the excipient, mannitol (150 mg). Sodium hydroxide and hydrochloric acid are used as needed for pH adjustment to 5.5 to 7.0."
},
{
"NDCCode": "75936-631-02",
"PackageDescription": "1 TUBE in 1 BOX (75936-631-02) / 35 mL in 1 TUBE (75936-631-01) ",
"NDC11Code": "75936-0631-02",
"ProductNDC": "75936-631",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Protectint 34c",
"NonProprietaryName": "Homosalate, Octisalate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231122",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Supergoop, LLC",
"SubstanceName": "HOMOSALATE; ZINC OXIDE; OCTISALATE",
"StrengthNumber": "7; 13.58; 5",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231122",
"SamplePackage": "N",
"IndicationAndUsage": "Stop use and ask a doctor if rash occurs."
},
{
"NDCCode": "78900-631-10",
"PackageDescription": "474 mL in 1 BOTTLE, PUMP (78900-631-10) ",
"NDC11Code": "78900-0631-10",
"ProductNDC": "78900-631",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201026",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Innovative Tool and design",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201026",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>71800-631-08</NDCCode>
<PackageDescription>8 TUBE in 1 CARTON (71800-631-08) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>71800-0631-08</NDC11Code>
<ProductNDC>71800-631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine And Tetracaine</ProprietaryName>
<NonProprietaryName>Lidocaine And Tetracaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170503</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021717</ApplicationNumber>
<LabelerName>Innovida Pharmaceutique Corporation</LabelerName>
<SubstanceName>LIDOCAINE; TETRACAINE</SubstanceName>
<StrengthNumber>70; 70</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine and tetracaine cream is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.</IndicationAndUsage>
<Description>Lidocaine and tetracaine cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C 14H 22N 2O. The structural formula is:. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C 15H 24N 2O 2. The structural formula is:. Each gram of lidocaine and tetracaine cream contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>71800-054-08</NDCCode>
<PackageDescription>24 TABLET in 1 BLISTER PACK (71800-054-08) </PackageDescription>
<NDC11Code>71800-0054-08</NDC11Code>
<ProductNDC>71800-054</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pseudoephedrine Hcl</ProprietaryName>
<NonProprietaryName>Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250210</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Innovida Pharmaeutique Corporation</LabelerName>
<SubstanceName>PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies . temporarily restores freer breathing through the nose.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71800-631-04</NDCCode>
<PackageDescription>4 TUBE in 1 CARTON (71800-631-04) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>71800-0631-04</NDC11Code>
<ProductNDC>71800-631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine And Tetracaine</ProprietaryName>
<NonProprietaryName>Lidocaine And Tetracaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170503</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021717</ApplicationNumber>
<LabelerName>Innovida Pharmaceutique Corporation</LabelerName>
<SubstanceName>LIDOCAINE; TETRACAINE</SubstanceName>
<StrengthNumber>70; 70</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine and tetracaine cream is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.</IndicationAndUsage>
<Description>Lidocaine and tetracaine cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C 14H 22N 2O. The structural formula is:. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C 15H 24N 2O 2. The structural formula is:. Each gram of lidocaine and tetracaine cream contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>71800-631-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (71800-631-15) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>71800-0631-15</NDC11Code>
<ProductNDC>71800-631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine And Tetracaine</ProprietaryName>
<NonProprietaryName>Lidocaine And Tetracaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170503</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021717</ApplicationNumber>
<LabelerName>Innovida Pharmaceutique Corporation</LabelerName>
<SubstanceName>LIDOCAINE; TETRACAINE</SubstanceName>
<StrengthNumber>70; 70</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51316-631-08</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (51316-631-08) / 237 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>51316-0631-08</NDC11Code>
<ProductNDC>51316-631</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Severe Cough, Flu Plus Sore Throat</ProprietaryName>
<ProprietaryNameSuffix>Honey</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230217</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>CVS PHARMACY</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>650; 20</StrengthNumber>
<StrengthUnit>mg/20mL; mg/20mL</StrengthUnit>
<Pharm_Classes>Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves these symptoms occurring with a cold or flu:cough due to minor throat and bronchial irritationminor aches and painssore throat painheadache, 2 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-631-08</NDCCode>
<PackageDescription>30 mL in 1 VIAL, GLASS (71919-631-08) </PackageDescription>
<NDC11Code>71919-0631-08</NDC11Code>
<ProductNDC>71919-631</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinapis Nigra</ProprietaryName>
<NonProprietaryName>Black Mustard Seed</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091028</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>BLACK MUSTARD SEED</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications:. SINAPIS NIG Hoarseness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0069-0274-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0069-0274-30) / 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00069-0274-30</NDC11Code>
<ProductNDC>0069-0274</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Velsipity</ProprietaryName>
<NonProprietaryName>Etrasimod</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231019</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216956</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>ETRASIMOD ARGININE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VELSIPITY is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults.</IndicationAndUsage>
<Description>VELSIPITY contains etrasimod, a sphingosine 1-phosphate (S1P) receptor modulator, supplied as etrasimod arginine. Etrasimod arginine is a white, off-white to light brown solid that is slightly soluble in water. The chemical name of etrasimod arginine is L-Arginine, (3R)-7-[[4-cyclopentyl-3-(trifluoromethyl)phenyl]methoxy]-1,2,3,4-tetrahydrocyclopent[b]indole-3-acetate (1:1) having a molecular formula of C32H40F3N5O5 and a molecular weight of 631.69 g/mol. The chemical structure of etrasimod arginine is. VELSIPITY is supplied for oral administration as 2 mg tablets. Each tablet contains 2 mg etrasimod (equivalent to 2.76 mg etrasimod arginine) and the following inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate, with a film coating containing FD&C blue #1/brilliant blue FCF aluminum lake, FD&C blue #2/indigo carmine aluminum lake, FD&C yellow #5/tartrazine aluminum lake, macrogol 4000 JP/PEG 3350, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0074-0038-07</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0074-0038-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00074-0038-07</NDC11Code>
<ProductNDC>0074-0038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Orilissa</ProprietaryName>
<NonProprietaryName>Elagolix</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180723</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210450</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>ELAGOLIX SODIUM</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180723</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ORILISSA is indicated for the management of moderate to severe pain associated with endometriosis. Limitations of Use:. Limit the duration of use based on the dose and coexisting condition (see Table 1) [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>ORILISSA (elagolix) tablets for oral administration contain elagolix sodium, the sodium salt of the active moiety elagolix. Elagolix sodium is a nonpeptide small molecule, GnRH receptor antagonist. Elagolix sodium is chemically described as sodium 4-({(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2H)-yl]-1-phenylethyl}amino)butanoate. Elagolix sodium has a molecular formula of C32H29F5N3O5Na and a molecular weight of 653.58. Elagolix free acid has a molecular weight of 631.60. Elagolix sodium has the following structural formula:. Elagolix sodium is a white to off white to light yellow powder and is freely soluble in water. ORILISSA 150 mg tablets are light pink, oblong, film-coated tablets with “EL 150” debossed on one side. Each tablet contains 155.2 mg of elagolix sodium (equivalent to 150 mg of elagolix) as the active ingredient and the following inactive ingredients: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and carmine high tint. ORILISSA 200 mg tablets are light orange, oblong, film-coated tablets with “EL 200” debossed on one side. Each tablet contains 207.0 mg of elagolix sodium (equivalent to 200 mg of elagolix) as the active ingredient and the following inactive ingredients: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>0074-0038-28</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (0074-0038-28) / 7 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00074-0038-28</NDC11Code>
<ProductNDC>0074-0038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Orilissa</ProprietaryName>
<NonProprietaryName>Elagolix</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180723</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210450</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>ELAGOLIX SODIUM</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ORILISSA is indicated for the management of moderate to severe pain associated with endometriosis. Limitations of Use:. Limit the duration of use based on the dose and coexisting condition (see Table 1) [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>ORILISSA (elagolix) tablets for oral administration contain elagolix sodium, the sodium salt of the active moiety elagolix. Elagolix sodium is a nonpeptide small molecule, GnRH receptor antagonist. Elagolix sodium is chemically described as sodium 4-({(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2H)-yl]-1-phenylethyl}amino)butanoate. Elagolix sodium has a molecular formula of C32H29F5N3O5Na and a molecular weight of 653.58. Elagolix free acid has a molecular weight of 631.60. Elagolix sodium has the following structural formula:. Elagolix sodium is a white to off white to light yellow powder and is freely soluble in water. ORILISSA 150 mg tablets are light pink, oblong, film-coated tablets with “EL 150” debossed on one side. Each tablet contains 155.2 mg of elagolix sodium (equivalent to 150 mg of elagolix) as the active ingredient and the following inactive ingredients: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and carmine high tint. ORILISSA 200 mg tablets are light orange, oblong, film-coated tablets with “EL 200” debossed on one side. Each tablet contains 207.0 mg of elagolix sodium (equivalent to 200 mg of elagolix) as the active ingredient and the following inactive ingredients: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>0074-0039-14</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0074-0039-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00074-0039-14</NDC11Code>
<ProductNDC>0074-0039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Orilissa</ProprietaryName>
<NonProprietaryName>Elagolix</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180723</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210450</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>ELAGOLIX SODIUM</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180723</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ORILISSA is indicated for the management of moderate to severe pain associated with endometriosis. Limitations of Use:. Limit the duration of use based on the dose and coexisting condition (see Table 1) [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>ORILISSA (elagolix) tablets for oral administration contain elagolix sodium, the sodium salt of the active moiety elagolix. Elagolix sodium is a nonpeptide small molecule, GnRH receptor antagonist. Elagolix sodium is chemically described as sodium 4-({(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2H)-yl]-1-phenylethyl}amino)butanoate. Elagolix sodium has a molecular formula of C32H29F5N3O5Na and a molecular weight of 653.58. Elagolix free acid has a molecular weight of 631.60. Elagolix sodium has the following structural formula:. Elagolix sodium is a white to off white to light yellow powder and is freely soluble in water. ORILISSA 150 mg tablets are light pink, oblong, film-coated tablets with “EL 150” debossed on one side. Each tablet contains 155.2 mg of elagolix sodium (equivalent to 150 mg of elagolix) as the active ingredient and the following inactive ingredients: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and carmine high tint. ORILISSA 200 mg tablets are light orange, oblong, film-coated tablets with “EL 200” debossed on one side. Each tablet contains 207.0 mg of elagolix sodium (equivalent to 200 mg of elagolix) as the active ingredient and the following inactive ingredients: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>0074-0039-56</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (0074-0039-56) / 14 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00074-0039-56</NDC11Code>
<ProductNDC>0074-0039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Orilissa</ProprietaryName>
<NonProprietaryName>Elagolix</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180723</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210450</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>ELAGOLIX SODIUM</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ORILISSA is indicated for the management of moderate to severe pain associated with endometriosis. Limitations of Use:. Limit the duration of use based on the dose and coexisting condition (see Table 1) [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>ORILISSA (elagolix) tablets for oral administration contain elagolix sodium, the sodium salt of the active moiety elagolix. Elagolix sodium is a nonpeptide small molecule, GnRH receptor antagonist. Elagolix sodium is chemically described as sodium 4-({(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2H)-yl]-1-phenylethyl}amino)butanoate. Elagolix sodium has a molecular formula of C32H29F5N3O5Na and a molecular weight of 653.58. Elagolix free acid has a molecular weight of 631.60. Elagolix sodium has the following structural formula:. Elagolix sodium is a white to off white to light yellow powder and is freely soluble in water. ORILISSA 150 mg tablets are light pink, oblong, film-coated tablets with “EL 150” debossed on one side. Each tablet contains 155.2 mg of elagolix sodium (equivalent to 150 mg of elagolix) as the active ingredient and the following inactive ingredients: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and carmine high tint. ORILISSA 200 mg tablets are light orange, oblong, film-coated tablets with “EL 200” debossed on one side. Each tablet contains 207.0 mg of elagolix sodium (equivalent to 200 mg of elagolix) as the active ingredient and the following inactive ingredients: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>11084-631-20</NDCCode>
<PackageDescription>2000 mL in 1 BOTTLE, PLASTIC (11084-631-20)</PackageDescription>
<NDC11Code>11084-0631-20</NDC11Code>
<ProductNDC>11084-631</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Astound Antibac</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130705</StartMarketingDate>
<EndMarketingDate>20200801</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Deb USA, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>42858-631-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-631-01) </PackageDescription>
<NDC11Code>42858-0631-01</NDC11Code>
<ProductNDC>42858-631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ms Contin</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170515</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019516</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MS CONTIN is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including MS CONTIN, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 MS CONTIN is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>MS CONTIN (morphine sulfate extended-release tablets) is for oral use and contains morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: cetostearyl alcohol, hydroxyethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, talc, and titanium dioxide. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). The 15 mg tablets also contain: FD&C Blue No. 2, lactose, polysorbate 80. The 30 mg tablets also contain: D&C Red No. 7, FD&C Blue No. 1, lactose, polysorbate 80. The 60 mg tablets also contain: D&C Red No. 30, D&C Yellow No. 10, hydroxypropyl cellulose, lactose. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>54860-631-01</NDCCode>
<PackageDescription>2 BOTTLE, SPRAY in 1 BOX (54860-631-01) / 40 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>54860-0631-01</NDC11Code>
<ProductNDC>54860-631</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smart Care Hand Sanitizer With Glitter Silicone Case,2pk Vanilla Chai And Espresso</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260727</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Shenzhen Lantern Scicence Co.,Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and children 6 years and older Spray onto hands and rub together until dry. Recommended for repeated use. Children under 6 years of age Should be supervised when using this product.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62135-631-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (62135-631-90) </PackageDescription>
<NDC11Code>62135-0631-90</NDC11Code>
<ProductNDC>62135-631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cimetidine</ProprietaryName>
<NonProprietaryName>Cimetidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074329</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>CIMETIDINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cimetidine tablets are indicated in. 1. Short-term treatment of active duodenal ulcer.Most patients heal within 4 weeks and there is rarely reason to use cimetidine tablets at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION: Duodenal Ulcer). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of cimetidine tablets and antacids is not recommended, since antacids have been reported to interfere with the absorption of cimetidine. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer.Patients have been maintained on continued treatment with cimetidine tablets 400 mg at bedtime for periods of up to 5 years. 3. Short-term treatment of active benign gastric ulcer.There is no information concerning usefulness of treatment periods of longer than 8 weeks. 4. Erosive gastroesophageal reflux (GERD).Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of lesions and control of symptoms. The use of cimetidine tablets beyond 12 weeks has not been established (see DOSAGE AND ADMINISTRATION: GERD). 5. The treatment of pathological hypersecretory conditions(i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas).</IndicationAndUsage>
<Description>Cimetidine, USP is a histamine H 2-receptor antagonist. Chemically it is N"-cyano- N-methyl- N'-[2-[[(5-methyl-1 H-imidazol-4-yl)methyl]thio]-ethyl]guanidine. Its structural formula is:. Cimetidine, USP contains an imidazole ring, and is chemically related to histamine. Cimetidine, USP has a bitter taste and characteristic odor. Solubility Characteristics. Cimetidine is soluble in alcohol, slightly soluble in water, very slightly soluble in chloroform and insoluble in ether. Each tablet, for oral administration, contains 200 mg, 300 mg, 400 mg or 800 mg cimetidine, USP. Inactive ingredients are: corn starch, hydroxypropylmethyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, povidone, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63739-631-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-631-10) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63739-0631-10</NDC11Code>
<ProductNDC>63739-631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070921</StartMarketingDate>
<EndMarketingDate>20210731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078226</ApplicationNumber>
<LabelerName>McKesson Corporation dba SKY Packaging</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140904</StartMarketingDatePackage>
<EndMarketingDatePackage>20210731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68428-631-03</NDCCode>
<PackageDescription>75 PELLET in 1 VIAL, GLASS (68428-631-03) </PackageDescription>
<NDC11Code>68428-0631-03</NDC11Code>
<ProductNDC>68428-631</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Selenium Metallicum</ProprietaryName>
<NonProprietaryName>Selenium</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100409</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SELENIUM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68428-631-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-631-05) </PackageDescription>
<NDC11Code>68428-0631-05</NDC11Code>
<ProductNDC>68428-631</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Selenium Metallicum</ProprietaryName>
<NonProprietaryName>Selenium</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100409</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SELENIUM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68428-631-06</NDCCode>
<PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (68428-631-06) </PackageDescription>
<NDC11Code>68428-0631-06</NDC11Code>
<ProductNDC>68428-631</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Selenium Metallicum</ProprietaryName>
<NonProprietaryName>Selenium</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100409</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SELENIUM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68428-631-11</NDCCode>
<PackageDescription>300 PELLET in 1 BOTTLE, GLASS (68428-631-11) </PackageDescription>
<NDC11Code>68428-0631-11</NDC11Code>
<ProductNDC>68428-631</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Selenium Metallicum</ProprietaryName>
<NonProprietaryName>Selenium</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100409</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SELENIUM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68428-631-12</NDCCode>
<PackageDescription>600 PELLET in 1 BOTTLE, GLASS (68428-631-12) </PackageDescription>
<NDC11Code>68428-0631-12</NDC11Code>
<ProductNDC>68428-631</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Selenium Metallicum</ProprietaryName>
<NonProprietaryName>Selenium</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100409</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SELENIUM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69097-579-67</NDCCode>
<PackageDescription>1 DOSE PACK in 1 CARTON (69097-579-67) / 1 GRANULE, FOR SOLUTION in 1 DOSE PACK</PackageDescription>
<NDC11Code>69097-0579-67</NDC11Code>
<ProductNDC>69097-579</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosfomycin Tromethamine</ProprietaryName>
<NonProprietaryName>Fosfomycin Tromethamine</NonProprietaryName>
<DosageFormName>GRANULE, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211881</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>FOSFOMYCIN TROMETHAMINE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin tromethamine granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine granules for oral solution, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.).</IndicationAndUsage>
<Description>Fosfomycin tromethamine granules for oral solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: mandarin flavor, orange powder flavor, saccharin, and sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1R,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white or almost white, hygroscopic powder with a molecular weight of 259.19. Its empirical formula is C3H7O4P.C4H11NO3, and its chemical structure is as follows:.</Description>
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<NDC>
<NDCCode>69423-631-02</NDCCode>
<PackageDescription>5 CANISTER in 1 CARTON (69423-631-02) / 59 g in 1 CANISTER</PackageDescription>
<NDC11Code>69423-0631-02</NDC11Code>
<ProductNDC>69423-631</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Secret Fresh Invisible</ProprietaryName>
<ProprietaryNameSuffix>Antiperspirant/deodorant</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Pentachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220103</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220103</StartMarketingDatePackage>
<EndMarketingDatePackage>20260801</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70700-268-94</NDCCode>
<PackageDescription>1 DOSE PACK in 1 CARTON (70700-268-94) / 1 POWDER in 1 DOSE PACK</PackageDescription>
<NDC11Code>70700-0268-94</NDC11Code>
<ProductNDC>70700-268</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosfomycin Tromethamine</ProprietaryName>
<NonProprietaryName>Granules For Oral Solution</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212548</ApplicationNumber>
<LabelerName>XIROMED LLC</LabelerName>
<SubstanceName>FOSFOMYCIN TROMETHAMINE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosfomycin Tromethamine is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin Tromethamine is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with Fosfomycin Tromethamine, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.).</IndicationAndUsage>
<Description>Fosfomycin Tromethamine Granules for Oral Solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: mandarin flavor, orange flavor, saccharin, and sucrose.The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1R,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white granular compound with a molecular weight of 259.2. Its empirical formula is C3H7O4P.C4H11NO3, and its chemical structure is as follows.</Description>
</NDC>
<NDC>
<NDCCode>70700-268-99</NDCCode>
<PackageDescription>1 POWDER in 1 PACKET (70700-268-99) </PackageDescription>
<NDC11Code>70700-0268-99</NDC11Code>
<ProductNDC>70700-268</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosfomycin Tromethamine</ProprietaryName>
<NonProprietaryName>Granules For Oral Solution</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212548</ApplicationNumber>
<LabelerName>XIROMED LLC</LabelerName>
<SubstanceName>FOSFOMYCIN TROMETHAMINE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosfomycin Tromethamine is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin Tromethamine is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with Fosfomycin Tromethamine, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.).</IndicationAndUsage>
<Description>Fosfomycin Tromethamine Granules for Oral Solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: mandarin flavor, orange flavor, saccharin, and sucrose.The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1R,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white granular compound with a molecular weight of 259.2. Its empirical formula is C3H7O4P.C4H11NO3, and its chemical structure is as follows.</Description>
</NDC>
<NDC>
<NDCCode>71773-050-05</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (71773-050-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>71773-0050-05</NDC11Code>
<ProductNDC>71773-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xerava</ProprietaryName>
<NonProprietaryName>Eravacycline</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180910</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211109</ApplicationNumber>
<LabelerName>Tetraphase Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ERAVACYCLINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older. (1.1). Limitations of Use XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI). (1.1). To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.2).</IndicationAndUsage>
<Description>XERAVA contains eravacycline, a synthetic tetracycline-class antibacterial agent for intravenous administration. Chemically, eravacycline is a C7-, C9-substituted sancycline derivative. The chemical name of eravacycline dihydrochloride is [(4S,4aS,5aR,12aS)-4-(dimethylamino)-7-fluoro-3,10,12,12a-tetrahydroxy-1,11-dioxo-9-[2‑(pyrrolidin-1-yl) acetamido]-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide] dihydrochloride. The molecular formula for eravacycline dihydrochloride is C27H31FN4O82HCl, and its molecular weight is 631.5. The following represents the chemical structure of eravacycline dihydrochloride. XERAVA is a sterile, preservative-free, yellow to orange, lyophilized powder in a glass single-dose vial for intravenous infusion after reconstitution and dilution. XERAVA is supplied in two (2) strengths as follows: : 1 Each 50 mg single-dose vial contains 50 mg of eravacycline (equivalent to 63.5 mg of eravacycline dihydrochloride) and the excipient, mannitol (150 mg). Sodium hydroxide and hydrochloric acid are used as needed for pH adjustment to 5.5 to 7.0., 2 Each 100 mg single-dose vial contains 100 mg of eravacycline (equivalent to 127 mg of eravacycline dihydrochloride) and the excipient, mannitol (150 mg). Sodium hydroxide and hydrochloric acid are used as needed for pH adjustment to 5.5 to 7.0.</Description>
</NDC>
<NDC>
<NDCCode>71773-050-12</NDCCode>
<PackageDescription>12 VIAL, GLASS in 1 CARTON (71773-050-12) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>71773-0050-12</NDC11Code>
<ProductNDC>71773-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xerava</ProprietaryName>
<NonProprietaryName>Eravacycline</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180910</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211109</ApplicationNumber>
<LabelerName>Tetraphase Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ERAVACYCLINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older. (1.1). Limitations of Use XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI). (1.1). To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.2).</IndicationAndUsage>
<Description>XERAVA contains eravacycline, a synthetic tetracycline-class antibacterial agent for intravenous administration. Chemically, eravacycline is a C7-, C9-substituted sancycline derivative. The chemical name of eravacycline dihydrochloride is [(4S,4aS,5aR,12aS)-4-(dimethylamino)-7-fluoro-3,10,12,12a-tetrahydroxy-1,11-dioxo-9-[2‑(pyrrolidin-1-yl) acetamido]-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide] dihydrochloride. The molecular formula for eravacycline dihydrochloride is C27H31FN4O82HCl, and its molecular weight is 631.5. The following represents the chemical structure of eravacycline dihydrochloride. XERAVA is a sterile, preservative-free, yellow to orange, lyophilized powder in a glass single-dose vial for intravenous infusion after reconstitution and dilution. XERAVA is supplied in two (2) strengths as follows: : 1 Each 50 mg single-dose vial contains 50 mg of eravacycline (equivalent to 63.5 mg of eravacycline dihydrochloride) and the excipient, mannitol (150 mg). Sodium hydroxide and hydrochloric acid are used as needed for pH adjustment to 5.5 to 7.0., 2 Each 100 mg single-dose vial contains 100 mg of eravacycline (equivalent to 127 mg of eravacycline dihydrochloride) and the excipient, mannitol (150 mg). Sodium hydroxide and hydrochloric acid are used as needed for pH adjustment to 5.5 to 7.0.</Description>
</NDC>
<NDC>
<NDCCode>71773-100-12</NDCCode>
<PackageDescription>12 CARTON in 1 PACKAGE (71773-100-12) / 1 VIAL, GLASS in 1 CARTON (71773-100-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>71773-0100-12</NDC11Code>
<ProductNDC>71773-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xerava</ProprietaryName>
<NonProprietaryName>Eravacycline</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180910</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211109</ApplicationNumber>
<LabelerName>Tetraphase Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ERAVACYCLINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older. (1.1). Limitations of Use XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI). (1.1). To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.2).</IndicationAndUsage>
<Description>XERAVA contains eravacycline, a synthetic tetracycline-class antibacterial agent for intravenous administration. Chemically, eravacycline is a C7-, C9-substituted sancycline derivative. The chemical name of eravacycline dihydrochloride is [(4S,4aS,5aR,12aS)-4-(dimethylamino)-7-fluoro-3,10,12,12a-tetrahydroxy-1,11-dioxo-9-[2‑(pyrrolidin-1-yl) acetamido]-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide] dihydrochloride. The molecular formula for eravacycline dihydrochloride is C27H31FN4O82HCl, and its molecular weight is 631.5. The following represents the chemical structure of eravacycline dihydrochloride. XERAVA is a sterile, preservative-free, yellow to orange, lyophilized powder in a glass single-dose vial for intravenous infusion after reconstitution and dilution. XERAVA is supplied in two (2) strengths as follows: : 1 Each 50 mg single-dose vial contains 50 mg of eravacycline (equivalent to 63.5 mg of eravacycline dihydrochloride) and the excipient, mannitol (150 mg). Sodium hydroxide and hydrochloric acid are used as needed for pH adjustment to 5.5 to 7.0., 2 Each 100 mg single-dose vial contains 100 mg of eravacycline (equivalent to 127 mg of eravacycline dihydrochloride) and the excipient, mannitol (150 mg). Sodium hydroxide and hydrochloric acid are used as needed for pH adjustment to 5.5 to 7.0.</Description>
</NDC>
<NDC>
<NDCCode>75936-631-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (75936-631-02) / 35 mL in 1 TUBE (75936-631-01) </PackageDescription>
<NDC11Code>75936-0631-02</NDC11Code>
<ProductNDC>75936-631</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Protectint 34c</ProprietaryName>
<NonProprietaryName>Homosalate, Octisalate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231122</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Supergoop, LLC</LabelerName>
<SubstanceName>HOMOSALATE; ZINC OXIDE; OCTISALATE</SubstanceName>
<StrengthNumber>7; 13.58; 5</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>78900-631-10</NDCCode>
<PackageDescription>474 mL in 1 BOTTLE, PUMP (78900-631-10) </PackageDescription>
<NDC11Code>78900-0631-10</NDC11Code>
<ProductNDC>78900-631</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201026</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Innovative Tool and design</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
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