{
"NDC": [
{
"NDCCode": "59385-027-60",
"PackageDescription": "60 POUCH in 1 CARTON (59385-027-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-027-01) ",
"NDC11Code": "59385-0027-60",
"ProductNDC": "59385-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Belbuca",
"NonProprietaryName": "Buprenorphine Hydrochloride",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "BUCCAL",
"StartMarketingDate": "20170811",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207932",
"LabelerName": "BioDelivery Sciences International Inc",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "900",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170811",
"SamplePackage": "N",
"IndicationAndUsage": "BELBUCA 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.",
"Description": "BELBUCA is a buccal film that provides transmucosal delivery of buprenorphine, a partial opioid agonist. BELBUCA is a rectangular bi-layer, peppermint-flavored, buccal film with rounded corners, consisting of a white to off-white backing layer with strength identifier printed in black ink and a light yellow to yellow active mucoadhesive layer containing buprenorphine hydrochloride. The yellow side of the film is applied to the inside of the cheek where it adheres to the moist buccal mucosa to deliver the drug as the film dissolves. Buprenorphine hydrochloride USP is the active ingredient in BELBUCA. The chemical name of buprenorphine hydrochloride is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-, hydrochloride, [5α, 7α, (S)]. Its structural formula is as follows. The molecular weight of buprenorphine hydrochloride is 504.10; the empirical formula is C29H41NO4∙HCl. Buprenorphine hydrochloride occurs as a white or off-white crystalline powder. It is sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. The pKa is 8.5 for the amine function and 10.0 for the phenol function. Dosage strengths of BELBUCA are based on the active moiety, buprenorphine. BELBUCA is available as 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg buprenorphine per film. The strength of each film is dependent on the buprenorphine concentration in the formulation and the surface area of the film. Table 6 lists the dosage strength, equivalent amount of buprenorphine hydrochloride USP (active ingredient), unique identifier and film size for each strength. Each buccal film also contains carboxymethylcellulose sodium USP, citric acid anhydrous USP, hydroxyethylcellulose NF, hydroxypropylcellulose NF, methylparaben NF, monobasic sodium phosphate anhydrous USP, peppermint oil NF, polycarbophil USP, propylene glycol USP, propylparaben NF, sodium benzoate NF, sodium hydroxide NF, saccharin sodium NF, titanium dioxide USP, vitamin E acetate USP, yellow iron oxide, purified water USP, and TekPrint SW-9008 black ink (shellac NF, black iron oxide NF)."
},
{
"NDCCode": "59385-021-60",
"PackageDescription": "60 POUCH in 1 CARTON (59385-021-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-021-01) ",
"NDC11Code": "59385-0021-60",
"ProductNDC": "59385-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Belbuca",
"NonProprietaryName": "Buprenorphine Hydrochloride",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "BUCCAL",
"StartMarketingDate": "20170901",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207932",
"LabelerName": "BioDelivery Sciences International Inc",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170901",
"SamplePackage": "N",
"IndicationAndUsage": "BELBUCA 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.",
"Description": "BELBUCA is a buccal film that provides transmucosal delivery of buprenorphine, a partial opioid agonist. BELBUCA is a rectangular bi-layer, peppermint-flavored, buccal film with rounded corners, consisting of a white to off-white backing layer with strength identifier printed in black ink and a light yellow to yellow active mucoadhesive layer containing buprenorphine hydrochloride. The yellow side of the film is applied to the inside of the cheek where it adheres to the moist buccal mucosa to deliver the drug as the film dissolves. Buprenorphine hydrochloride USP is the active ingredient in BELBUCA. The chemical name of buprenorphine hydrochloride is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-, hydrochloride, [5α, 7α, (S)]. Its structural formula is as follows. The molecular weight of buprenorphine hydrochloride is 504.10; the empirical formula is C29H41NO4∙HCl. Buprenorphine hydrochloride occurs as a white or off-white crystalline powder. It is sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. The pKa is 8.5 for the amine function and 10.0 for the phenol function. Dosage strengths of BELBUCA are based on the active moiety, buprenorphine. BELBUCA is available as 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg buprenorphine per film. The strength of each film is dependent on the buprenorphine concentration in the formulation and the surface area of the film. Table 6 lists the dosage strength, equivalent amount of buprenorphine hydrochloride USP (active ingredient), unique identifier and film size for each strength. Each buccal film also contains carboxymethylcellulose sodium USP, citric acid anhydrous USP, hydroxyethylcellulose NF, hydroxypropylcellulose NF, methylparaben NF, monobasic sodium phosphate anhydrous USP, peppermint oil NF, polycarbophil USP, propylene glycol USP, propylparaben NF, sodium benzoate NF, sodium hydroxide NF, saccharin sodium NF, titanium dioxide USP, vitamin E acetate USP, yellow iron oxide, purified water USP, and TekPrint SW-9008 black ink (shellac NF, black iron oxide NF)."
},
{
"NDCCode": "59385-022-60",
"PackageDescription": "60 POUCH in 1 CARTON (59385-022-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-022-01) ",
"NDC11Code": "59385-0022-60",
"ProductNDC": "59385-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Belbuca",
"NonProprietaryName": "Buprenorphine Hydrochloride",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "BUCCAL",
"StartMarketingDate": "20171001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207932",
"LabelerName": "BioDelivery Sciences International Inc",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171001",
"SamplePackage": "N",
"IndicationAndUsage": "BELBUCA 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.",
"Description": "BELBUCA is a buccal film that provides transmucosal delivery of buprenorphine, a partial opioid agonist. BELBUCA is a rectangular bi-layer, peppermint-flavored, buccal film with rounded corners, consisting of a white to off-white backing layer with strength identifier printed in black ink and a light yellow to yellow active mucoadhesive layer containing buprenorphine hydrochloride. The yellow side of the film is applied to the inside of the cheek where it adheres to the moist buccal mucosa to deliver the drug as the film dissolves. Buprenorphine hydrochloride USP is the active ingredient in BELBUCA. The chemical name of buprenorphine hydrochloride is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-, hydrochloride, [5α, 7α, (S)]. Its structural formula is as follows. The molecular weight of buprenorphine hydrochloride is 504.10; the empirical formula is C29H41NO4∙HCl. Buprenorphine hydrochloride occurs as a white or off-white crystalline powder. It is sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. The pKa is 8.5 for the amine function and 10.0 for the phenol function. Dosage strengths of BELBUCA are based on the active moiety, buprenorphine. BELBUCA is available as 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg buprenorphine per film. The strength of each film is dependent on the buprenorphine concentration in the formulation and the surface area of the film. Table 6 lists the dosage strength, equivalent amount of buprenorphine hydrochloride USP (active ingredient), unique identifier and film size for each strength. Each buccal film also contains carboxymethylcellulose sodium USP, citric acid anhydrous USP, hydroxyethylcellulose NF, hydroxypropylcellulose NF, methylparaben NF, monobasic sodium phosphate anhydrous USP, peppermint oil NF, polycarbophil USP, propylene glycol USP, propylparaben NF, sodium benzoate NF, sodium hydroxide NF, saccharin sodium NF, titanium dioxide USP, vitamin E acetate USP, yellow iron oxide, purified water USP, and TekPrint SW-9008 black ink (shellac NF, black iron oxide NF)."
},
{
"NDCCode": "59385-023-60",
"PackageDescription": "60 POUCH in 1 CARTON (59385-023-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-023-01) ",
"NDC11Code": "59385-0023-60",
"ProductNDC": "59385-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Belbuca",
"NonProprietaryName": "Buprenorphine Hydrochloride",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "BUCCAL",
"StartMarketingDate": "20170901",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207932",
"LabelerName": "BioDelivery Sciences International Inc",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170901",
"SamplePackage": "N",
"IndicationAndUsage": "BELBUCA 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.",
"Description": "BELBUCA is a buccal film that provides transmucosal delivery of buprenorphine, a partial opioid agonist. BELBUCA is a rectangular bi-layer, peppermint-flavored, buccal film with rounded corners, consisting of a white to off-white backing layer with strength identifier printed in black ink and a light yellow to yellow active mucoadhesive layer containing buprenorphine hydrochloride. The yellow side of the film is applied to the inside of the cheek where it adheres to the moist buccal mucosa to deliver the drug as the film dissolves. Buprenorphine hydrochloride USP is the active ingredient in BELBUCA. The chemical name of buprenorphine hydrochloride is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-, hydrochloride, [5α, 7α, (S)]. Its structural formula is as follows. The molecular weight of buprenorphine hydrochloride is 504.10; the empirical formula is C29H41NO4∙HCl. Buprenorphine hydrochloride occurs as a white or off-white crystalline powder. It is sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. The pKa is 8.5 for the amine function and 10.0 for the phenol function. Dosage strengths of BELBUCA are based on the active moiety, buprenorphine. BELBUCA is available as 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg buprenorphine per film. The strength of each film is dependent on the buprenorphine concentration in the formulation and the surface area of the film. Table 6 lists the dosage strength, equivalent amount of buprenorphine hydrochloride USP (active ingredient), unique identifier and film size for each strength. Each buccal film also contains carboxymethylcellulose sodium USP, citric acid anhydrous USP, hydroxyethylcellulose NF, hydroxypropylcellulose NF, methylparaben NF, monobasic sodium phosphate anhydrous USP, peppermint oil NF, polycarbophil USP, propylene glycol USP, propylparaben NF, sodium benzoate NF, sodium hydroxide NF, saccharin sodium NF, titanium dioxide USP, vitamin E acetate USP, yellow iron oxide, purified water USP, and TekPrint SW-9008 black ink (shellac NF, black iron oxide NF)."
},
{
"NDCCode": "59385-024-60",
"PackageDescription": "60 POUCH in 1 CARTON (59385-024-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-024-01) ",
"NDC11Code": "59385-0024-60",
"ProductNDC": "59385-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Belbuca",
"NonProprietaryName": "Buprenorphine Hydrochloride",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "BUCCAL",
"StartMarketingDate": "20170821",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207932",
"LabelerName": "BioDelivery Sciences International Inc",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "450",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170821",
"SamplePackage": "N",
"IndicationAndUsage": "BELBUCA 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.",
"Description": "BELBUCA is a buccal film that provides transmucosal delivery of buprenorphine, a partial opioid agonist. BELBUCA is a rectangular bi-layer, peppermint-flavored, buccal film with rounded corners, consisting of a white to off-white backing layer with strength identifier printed in black ink and a light yellow to yellow active mucoadhesive layer containing buprenorphine hydrochloride. The yellow side of the film is applied to the inside of the cheek where it adheres to the moist buccal mucosa to deliver the drug as the film dissolves. Buprenorphine hydrochloride USP is the active ingredient in BELBUCA. The chemical name of buprenorphine hydrochloride is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-, hydrochloride, [5α, 7α, (S)]. Its structural formula is as follows. The molecular weight of buprenorphine hydrochloride is 504.10; the empirical formula is C29H41NO4∙HCl. Buprenorphine hydrochloride occurs as a white or off-white crystalline powder. It is sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. The pKa is 8.5 for the amine function and 10.0 for the phenol function. Dosage strengths of BELBUCA are based on the active moiety, buprenorphine. BELBUCA is available as 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg buprenorphine per film. The strength of each film is dependent on the buprenorphine concentration in the formulation and the surface area of the film. Table 6 lists the dosage strength, equivalent amount of buprenorphine hydrochloride USP (active ingredient), unique identifier and film size for each strength. Each buccal film also contains carboxymethylcellulose sodium USP, citric acid anhydrous USP, hydroxyethylcellulose NF, hydroxypropylcellulose NF, methylparaben NF, monobasic sodium phosphate anhydrous USP, peppermint oil NF, polycarbophil USP, propylene glycol USP, propylparaben NF, sodium benzoate NF, sodium hydroxide NF, saccharin sodium NF, titanium dioxide USP, vitamin E acetate USP, yellow iron oxide, purified water USP, and TekPrint SW-9008 black ink (shellac NF, black iron oxide NF)."
},
{
"NDCCode": "59385-025-60",
"PackageDescription": "60 POUCH in 1 CARTON (59385-025-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-025-01) ",
"NDC11Code": "59385-0025-60",
"ProductNDC": "59385-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Belbuca",
"NonProprietaryName": "Buprenorphine Hydrochloride",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "BUCCAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207932",
"LabelerName": "BioDelivery Sciences International Inc",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "600",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170824",
"SamplePackage": "N",
"IndicationAndUsage": "BELBUCA 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.",
"Description": "BELBUCA is a buccal film that provides transmucosal delivery of buprenorphine, a partial opioid agonist. BELBUCA is a rectangular bi-layer, peppermint-flavored, buccal film with rounded corners, consisting of a white to off-white backing layer with strength identifier printed in black ink and a light yellow to yellow active mucoadhesive layer containing buprenorphine hydrochloride. The yellow side of the film is applied to the inside of the cheek where it adheres to the moist buccal mucosa to deliver the drug as the film dissolves. Buprenorphine hydrochloride USP is the active ingredient in BELBUCA. The chemical name of buprenorphine hydrochloride is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-, hydrochloride, [5α, 7α, (S)]. Its structural formula is as follows. The molecular weight of buprenorphine hydrochloride is 504.10; the empirical formula is C29H41NO4∙HCl. Buprenorphine hydrochloride occurs as a white or off-white crystalline powder. It is sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. The pKa is 8.5 for the amine function and 10.0 for the phenol function. Dosage strengths of BELBUCA are based on the active moiety, buprenorphine. BELBUCA is available as 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg buprenorphine per film. The strength of each film is dependent on the buprenorphine concentration in the formulation and the surface area of the film. Table 6 lists the dosage strength, equivalent amount of buprenorphine hydrochloride USP (active ingredient), unique identifier and film size for each strength. Each buccal film also contains carboxymethylcellulose sodium USP, citric acid anhydrous USP, hydroxyethylcellulose NF, hydroxypropylcellulose NF, methylparaben NF, monobasic sodium phosphate anhydrous USP, peppermint oil NF, polycarbophil USP, propylene glycol USP, propylparaben NF, sodium benzoate NF, sodium hydroxide NF, saccharin sodium NF, titanium dioxide USP, vitamin E acetate USP, yellow iron oxide, purified water USP, and TekPrint SW-9008 black ink (shellac NF, black iron oxide NF)."
},
{
"NDCCode": "59385-026-60",
"PackageDescription": "60 POUCH in 1 CARTON (59385-026-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-026-01) ",
"NDC11Code": "59385-0026-60",
"ProductNDC": "59385-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Belbuca",
"NonProprietaryName": "Buprenorphine Hydrochloride",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "BUCCAL",
"StartMarketingDate": "20171001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207932",
"LabelerName": "BioDelivery Sciences International Inc",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171001",
"SamplePackage": "N",
"IndicationAndUsage": "BELBUCA 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.",
"Description": "BELBUCA is a buccal film that provides transmucosal delivery of buprenorphine, a partial opioid agonist. BELBUCA is a rectangular bi-layer, peppermint-flavored, buccal film with rounded corners, consisting of a white to off-white backing layer with strength identifier printed in black ink and a light yellow to yellow active mucoadhesive layer containing buprenorphine hydrochloride. The yellow side of the film is applied to the inside of the cheek where it adheres to the moist buccal mucosa to deliver the drug as the film dissolves. Buprenorphine hydrochloride USP is the active ingredient in BELBUCA. The chemical name of buprenorphine hydrochloride is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-, hydrochloride, [5α, 7α, (S)]. Its structural formula is as follows. The molecular weight of buprenorphine hydrochloride is 504.10; the empirical formula is C29H41NO4∙HCl. Buprenorphine hydrochloride occurs as a white or off-white crystalline powder. It is sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. The pKa is 8.5 for the amine function and 10.0 for the phenol function. Dosage strengths of BELBUCA are based on the active moiety, buprenorphine. BELBUCA is available as 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg buprenorphine per film. The strength of each film is dependent on the buprenorphine concentration in the formulation and the surface area of the film. Table 6 lists the dosage strength, equivalent amount of buprenorphine hydrochloride USP (active ingredient), unique identifier and film size for each strength. Each buccal film also contains carboxymethylcellulose sodium USP, citric acid anhydrous USP, hydroxyethylcellulose NF, hydroxypropylcellulose NF, methylparaben NF, monobasic sodium phosphate anhydrous USP, peppermint oil NF, polycarbophil USP, propylene glycol USP, propylparaben NF, sodium benzoate NF, sodium hydroxide NF, saccharin sodium NF, titanium dioxide USP, vitamin E acetate USP, yellow iron oxide, purified water USP, and TekPrint SW-9008 black ink (shellac NF, black iron oxide NF)."
},
{
"NDCCode": "12634-027-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (12634-027-60)",
"NDC11Code": "12634-0027-60",
"ProductNDC": "12634-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram Hydrobromide",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078216",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"IndicationAndUsage": "Citalopram HBr is indicated for the treatment of depression. The efficacy of citalopram HBr in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Citalopram HBr, USP is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram HBr is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram HBr, USP occurs as a fine, white to off-white powder.Citalopram HBr is sparingly soluble in water and soluble in ethanol. Citalopram hydrobromide is available only in tablet dosage form. Citalopram hydrobromide 10 mg tablets are film-coated, round shaped tablets containing citalopram HBr in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram HBr in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch, and titanium dioxide."
},
{
"NDCCode": "16590-027-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (16590-027-60)",
"NDC11Code": "16590-0027-60",
"ProductNDC": "16590-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19910918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072828",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen USP is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The structural formula is represented below. BACLOFEN STRUCTURE IIMAGE. Baclofen Tablets USP 10 mg and 20 mg contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and starch (corn)."
},
{
"NDCCode": "21922-027-07",
"PackageDescription": "1 TUBE in 1 CARTON (21922-027-07) / 60 g in 1 TUBE",
"NDC11Code": "21922-0027-07",
"ProductNDC": "21922-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Phosphate",
"NonProprietaryName": "Clindamycin Phosphate Gel Usp, 1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212438",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210315",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin phosphate gel USP, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).",
"Description": "Clindamycin phosphate gel USP, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The gel contains allantoin, carbopol 974 P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. The structural formula is represented below. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1 methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo-α-D- galacto octopyranoside 2-(dihydrogen phosphate)."
},
{
"NDCCode": "33261-027-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (33261-027-60)",
"NDC11Code": "33261-0027-60",
"ProductNDC": "33261-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram Hydrobromide",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078216",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Citalopram HBr is indicated for the treatment of depression. The efficacy of citalopram HBr in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Citalopram HBr is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram HBr is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram HBr, USP occurs as a fine, white to off-white powder.Citalopram HBr is sparingly soluble in water and soluble in ethanol. Citalopram hydrobromide is available as tablets. Citalopram hydrobromide 10 mg tablets are film-coated, round shaped tablets containing citalopram HBr in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram HBr in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, starch, croscarmellose sodium, copovidone, magnesium stearate, hypromellose, titanium dioxide, ferric oxide red, ferric oxide yellow, glycerin, and polyethylene glycol."
},
{
"NDCCode": "42858-027-06",
"PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-027-06)",
"NDC11Code": "42858-0027-06",
"ProductNDC": "42858-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Palladone",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20040924",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021044",
"LabelerName": "Rhodes Pharmaceuticals L.P.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "16",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2014-09-12"
},
{
"NDCCode": "43353-027-53",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-027-53) ",
"NDC11Code": "43353-0027-53",
"ProductNDC": "43353-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078281",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150429",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for.",
"Description": "The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S × 1.5 H2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each Pantoprazole Sodium Delayed-Release Tablet contains 45.1 mg or 22.55 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, talc, titanium dioxide, and triethyl citrate. The 20 mg tablet also contains black iron oxide, isopropyl alcohol, and propylene glycol. Pantoprazole Sodium Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 4."
},
{
"NDCCode": "43353-027-60",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-027-60) ",
"NDC11Code": "43353-0027-60",
"ProductNDC": "43353-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078281",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160419",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for.",
"Description": "The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S × 1.5 H2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each Pantoprazole Sodium Delayed-Release Tablet contains 45.1 mg or 22.55 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, talc, titanium dioxide, and triethyl citrate. The 20 mg tablet also contains black iron oxide, isopropyl alcohol, and propylene glycol. Pantoprazole Sodium Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 4."
},
{
"NDCCode": "43744-027-60",
"PackageDescription": "750 g in 1 DRUM (43744-027-60)",
"NDC11Code": "43744-0027-60",
"ProductNDC": "43744-027",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Aluminum Hydroxide Dried Gel",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110307",
"EndMarketingDate": "20110308",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "ALUMINUM HYDROXIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20110308"
},
{
"NDCCode": "49035-027-60",
"PackageDescription": "160 LOZENGE in 1 BAG (49035-027-60) ",
"NDC11Code": "49035-0027-60",
"ProductNDC": "49035-027",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Honey Lemon Cough Drops",
"NonProprietaryName": "Menthol",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20160427",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Walmart Stores Inc.",
"SubstanceName": "MENTHOL",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160427",
"SamplePackage": "N",
"IndicationAndUsage": "Uses temporarily relieves. cough as may occur with a cold. occasional minor irritation and sore throat."
},
{
"NDCCode": "52565-027-59",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (52565-027-59) > 60 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "52565-0027-59",
"ProductNDC": "52565-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin",
"NonProprietaryName": "Erythromycin",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208100",
"LabelerName": "Teligent Pharma, Inc.",
"SubstanceName": "ERYTHROMYCIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"IndicationAndUsage": "Erythromycin Topical Solution is indicated for the topical treatment of acne vulgaris.",
"Description": "Erythromycin Topical Solution contains erythromycin for topical dermatologic use. Erythromycin is a macrolide antibiotic produced from a strain of Saccaropolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids. Chemically, erythromycin is: (3R*,4S*,5S*,6R*,7R*,9R*,11R*, 12R*,13S*,14R*)-4-[(2,6-Dideoxy-3-C- methyl-3-O-methyl-α-L-ribo-hexopyranosyl)-oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. It has the following structural formula:. Erythromycin is a white or slightly yellow crystalline powder that is very soluble in water, freely soluble in alcohols, acetone, chloroform, acetonitrile, ethyl acetate, and moderately soluble in ether, ethylene dichloride and amyl acetate. Each mL of Erythromycin Topical Solution USP 2% contains 20 mg of erythromycin base in a vehicle consisting of alcohol (71.5%), propylene glycol, and citric acid."
},
{
"NDCCode": "54304-027-01",
"PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (54304-027-01) ",
"NDC11Code": "54304-0027-01",
"ProductNDC": "54304-027",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Secret Plus Hand Sanitizer",
"ProprietaryNameSuffix": "01",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200425",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Zhejiang Meizhiyuan Cosmetics Co., Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70.4",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200425",
"SamplePackage": "N"
},
{
"NDCCode": "59726-027-60",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (59726-027-60) > 60 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "59726-0027-60",
"ProductNDC": "59726-027",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief Dm",
"NonProprietaryName": "Guaifenesin, Dextromethorphan Hbr",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140731",
"EndMarketingDate": "20191231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "P & L Development, LLC",
"SubstanceName": "GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "400; 20",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140731",
"EndMarketingDatePackage": "20191231",
"SamplePackage": "N"
},
{
"NDCCode": "61919-027-90",
"PackageDescription": "90 BOTTLE in 1 BOTTLE (61919-027-90) / 60 BOTTLE in 1 BOTTLE (61919-027-60) / 30 TABLET in 1 BOTTLE (61919-027-30) ",
"NDC11Code": "61919-0027-90",
"ProductNDC": "61919-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072235",
"LabelerName": "Direct Rx",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-02-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150101",
"SamplePackage": "N"
},
{
"NDCCode": "65862-027-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (65862-027-60) ",
"NDC11Code": "65862-0027-60",
"ProductNDC": "65862-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nevirapine",
"NonProprietaryName": "Nevirapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120522",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077521",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "NEVIRAPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120522",
"SamplePackage": "N",
"IndicationAndUsage": "Nevirapine tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1, 14.2)]. Limitations of Use. Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablets is not recommended to be initiated, unless the benefit outweighs the risk, in: : 1 adult females with CD4+ cell counts greater than 250 cells/mm3 or , 2 adult males with CD4+ cell counts greater than 400 cells/mm3[see Warnings and Precautions (5.1)].",
"Description": "Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Nevirapine is structurally a member of the dipyridodiazepinone chemical class of compounds.The chemical name of nevirapine is 11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido [3,2-b:2',3'-e][1,4] diazepin-6-one. Nevirapine USP is a white to off-white crystalline powder with the molecular weight of 266.30 and the molecular formula C15H14N4O. Nevirapine has the following structural formula. Nevirapine tablets, USP are for oral administration. Each tablet contains 200 mg of nevirapine and the inactive ingredients microcrystalline cellulose, lactose monohydrate, povidone, sodium starch glycolate, colloidal silicon dioxide, and magnesium stearate."
},
{
"NDCCode": "67046-027-60",
"PackageDescription": "60 TABLET in 1 BLISTER PACK (67046-027-60)",
"NDC11Code": "67046-0027-60",
"ProductNDC": "67046-027",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Acetaminophen",
"NonProprietaryName": "Extra Strength Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100802",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "temporarily reduces fever . temporarily relieves minor aches and pains due to: headache muscular aches the common cold minor pain of arthritis backache toothache premenstrual and menstrual cramps ."
},
{
"NDCCode": "67046-027-62",
"PackageDescription": "60 TABLET in 1 BLISTER PACK (67046-027-62)",
"NDC11Code": "67046-0027-62",
"ProductNDC": "67046-027",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Acetaminophen",
"NonProprietaryName": "Extra Strength Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100802",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "temporarily reduces fever . temporarily relieves minor aches and pains due to: headache muscular aches the common cold minor pain of arthritis backache toothache premenstrual and menstrual cramps ."
},
{
"NDCCode": "69539-027-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (69539-027-60) ",
"NDC11Code": "69539-0027-60",
"ProductNDC": "69539-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204921",
"LabelerName": "MSN LABORATORIES PRIVATE LIMITED",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2022-04-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220319",
"SamplePackage": "N"
},
{
"NDCCode": "70157-027-01",
"PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (70157-027-01) ",
"NDC11Code": "70157-0027-01",
"ProductNDC": "70157-027",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Standard Procedure Spf 50 Sunscreen Face And Body",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250530",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Baxter Laboratories",
"SubstanceName": "AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE",
"StrengthNumber": "3; 5; 10; 8",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250530",
"SamplePackage": "N",
"IndicationAndUsage": "Stop use and ask a doctor if rash occurs."
},
{
"NDCCode": "71205-027-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71205-027-60) ",
"NDC11Code": "71205-0027-60",
"ProductNDC": "71205-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204590",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180501",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib capsules are indicated.",
"Description": "Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure:. Celecoxib USP is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib USP is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range.The inactive ingredients in celecoxib capsules include: gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, hydroxypropyl cellulose, crospovidone and titanium dioxide. The imprinting ink of capsule shell of the 50 mg capsule contains the following inactive ingredients: shellac, propylene glycol, sodium hydroxide, titanium dioxide, povidone and FD&C Red#40 Aluminum Lake- E129. The imprinting ink of capsule shell of the 100 mg capsule contains the following inactive ingredients: shellac, propylene glycol, strong ammonia solution and FD&C Blue#2 Aluminum Lake-E132. The imprinting ink of capsule shell of the 200 mg capsule contains the following inactive ingredients: shellac, propylene glycol, strong ammonia solution and yellow iron oxide. The imprinting ink of capsule shell of the 400 mg capsule contains the following inactive ingredients: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide, FD&C Blue#1 Aluminum Lake- E133 and FD&C Yellow#5 Aluminum Lake-E102."
},
{
"NDCCode": "72789-027-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (72789-027-60) ",
"NDC11Code": "72789-0027-60",
"ProductNDC": "72789-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010416",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075805",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191211",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidine tablets are indicated in adult and pediatric patients 40 kg and above for the treatment of. active duodenal ulcer (DU). active gastric ulcer(GU). symptomatic non-erosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. Famotidine tablets are indicated in adults for the: treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine neoplasias). reduction of the risk of duodenal ulcer recurrence.",
"Description": "The active ingredient in Famotidine tablets is a histamine-2 (H2) receptor antagonist. Famotidine is N’-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C 8H 15N 7O 2S 3and its molecular weight is 337.43. Its structural formula is:. Each Famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (modified corn starch), sodium starch glycolate, talc, titanium dioxide and triacetin. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol."
},
{
"NDCCode": "72888-027-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (72888-027-60) ",
"NDC11Code": "72888-0027-60",
"ProductNDC": "72888-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211029",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078625",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211029",
"SamplePackage": "N",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs Lamotrigine’s. Its chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pK aof 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine tablets, USP are supplied for oral administration as 25 mg, 100 mg, 150 mg and 200 mg tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "73152-027-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (73152-027-60) ",
"NDC11Code": "73152-0027-60",
"ProductNDC": "73152-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartarate",
"NonProprietaryName": "Tolterodine Tartarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210775",
"LabelerName": "Athem LLC",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200803",
"SamplePackage": "N",
"IndicationAndUsage": "Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.",
"Description": "Tolterodine tartrate tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). The empirical formula of tolterodine tartrate is C 26H 37NO 7, and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below:. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Each tolterodine tartrate tablet, for oral administration contains 1 or 2 mg of tolterodine tartrate. The inactive ingredients are colloidal silicone dioxide, dibasic calcium phosphate dihydrate, cellulose microcrystalline, magnesium stearate, sodium starch glycolate (pH 3.0 to 5.0), Opadry White Y-1-7000."
},
{
"NDCCode": "73905-027-01",
"PackageDescription": "60 mL in 1 BOTTLE (73905-027-01) ",
"NDC11Code": "73905-0027-01",
"ProductNDC": "73905-027",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200320",
"EndMarketingDate": "20240423",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200320",
"EndMarketingDatePackage": "20240423",
"SamplePackage": "Y"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>59385-027-60</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (59385-027-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-027-01) </PackageDescription>
<NDC11Code>59385-0027-60</NDC11Code>
<ProductNDC>59385-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Belbuca</ProprietaryName>
<NonProprietaryName>Buprenorphine Hydrochloride</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>BUCCAL</RouteName>
<StartMarketingDate>20170811</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207932</ApplicationNumber>
<LabelerName>BioDelivery Sciences International Inc</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>900</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BELBUCA 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.</IndicationAndUsage>
<Description>BELBUCA is a buccal film that provides transmucosal delivery of buprenorphine, a partial opioid agonist. BELBUCA is a rectangular bi-layer, peppermint-flavored, buccal film with rounded corners, consisting of a white to off-white backing layer with strength identifier printed in black ink and a light yellow to yellow active mucoadhesive layer containing buprenorphine hydrochloride. The yellow side of the film is applied to the inside of the cheek where it adheres to the moist buccal mucosa to deliver the drug as the film dissolves. Buprenorphine hydrochloride USP is the active ingredient in BELBUCA. The chemical name of buprenorphine hydrochloride is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-, hydrochloride, [5α, 7α, (S)]. Its structural formula is as follows. The molecular weight of buprenorphine hydrochloride is 504.10; the empirical formula is C29H41NO4∙HCl. Buprenorphine hydrochloride occurs as a white or off-white crystalline powder. It is sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. The pKa is 8.5 for the amine function and 10.0 for the phenol function. Dosage strengths of BELBUCA are based on the active moiety, buprenorphine. BELBUCA is available as 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg buprenorphine per film. The strength of each film is dependent on the buprenorphine concentration in the formulation and the surface area of the film. Table 6 lists the dosage strength, equivalent amount of buprenorphine hydrochloride USP (active ingredient), unique identifier and film size for each strength. Each buccal film also contains carboxymethylcellulose sodium USP, citric acid anhydrous USP, hydroxyethylcellulose NF, hydroxypropylcellulose NF, methylparaben NF, monobasic sodium phosphate anhydrous USP, peppermint oil NF, polycarbophil USP, propylene glycol USP, propylparaben NF, sodium benzoate NF, sodium hydroxide NF, saccharin sodium NF, titanium dioxide USP, vitamin E acetate USP, yellow iron oxide, purified water USP, and TekPrint SW-9008 black ink (shellac NF, black iron oxide NF).</Description>
</NDC>
<NDC>
<NDCCode>59385-021-60</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (59385-021-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-021-01) </PackageDescription>
<NDC11Code>59385-0021-60</NDC11Code>
<ProductNDC>59385-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Belbuca</ProprietaryName>
<NonProprietaryName>Buprenorphine Hydrochloride</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>BUCCAL</RouteName>
<StartMarketingDate>20170901</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207932</ApplicationNumber>
<LabelerName>BioDelivery Sciences International Inc</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BELBUCA 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.</IndicationAndUsage>
<Description>BELBUCA is a buccal film that provides transmucosal delivery of buprenorphine, a partial opioid agonist. BELBUCA is a rectangular bi-layer, peppermint-flavored, buccal film with rounded corners, consisting of a white to off-white backing layer with strength identifier printed in black ink and a light yellow to yellow active mucoadhesive layer containing buprenorphine hydrochloride. The yellow side of the film is applied to the inside of the cheek where it adheres to the moist buccal mucosa to deliver the drug as the film dissolves. Buprenorphine hydrochloride USP is the active ingredient in BELBUCA. The chemical name of buprenorphine hydrochloride is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-, hydrochloride, [5α, 7α, (S)]. Its structural formula is as follows. The molecular weight of buprenorphine hydrochloride is 504.10; the empirical formula is C29H41NO4∙HCl. Buprenorphine hydrochloride occurs as a white or off-white crystalline powder. It is sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. The pKa is 8.5 for the amine function and 10.0 for the phenol function. Dosage strengths of BELBUCA are based on the active moiety, buprenorphine. BELBUCA is available as 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg buprenorphine per film. The strength of each film is dependent on the buprenorphine concentration in the formulation and the surface area of the film. Table 6 lists the dosage strength, equivalent amount of buprenorphine hydrochloride USP (active ingredient), unique identifier and film size for each strength. Each buccal film also contains carboxymethylcellulose sodium USP, citric acid anhydrous USP, hydroxyethylcellulose NF, hydroxypropylcellulose NF, methylparaben NF, monobasic sodium phosphate anhydrous USP, peppermint oil NF, polycarbophil USP, propylene glycol USP, propylparaben NF, sodium benzoate NF, sodium hydroxide NF, saccharin sodium NF, titanium dioxide USP, vitamin E acetate USP, yellow iron oxide, purified water USP, and TekPrint SW-9008 black ink (shellac NF, black iron oxide NF).</Description>
</NDC>
<NDC>
<NDCCode>59385-022-60</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (59385-022-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-022-01) </PackageDescription>
<NDC11Code>59385-0022-60</NDC11Code>
<ProductNDC>59385-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Belbuca</ProprietaryName>
<NonProprietaryName>Buprenorphine Hydrochloride</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>BUCCAL</RouteName>
<StartMarketingDate>20171001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207932</ApplicationNumber>
<LabelerName>BioDelivery Sciences International Inc</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BELBUCA 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.</IndicationAndUsage>
<Description>BELBUCA is a buccal film that provides transmucosal delivery of buprenorphine, a partial opioid agonist. BELBUCA is a rectangular bi-layer, peppermint-flavored, buccal film with rounded corners, consisting of a white to off-white backing layer with strength identifier printed in black ink and a light yellow to yellow active mucoadhesive layer containing buprenorphine hydrochloride. The yellow side of the film is applied to the inside of the cheek where it adheres to the moist buccal mucosa to deliver the drug as the film dissolves. Buprenorphine hydrochloride USP is the active ingredient in BELBUCA. The chemical name of buprenorphine hydrochloride is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-, hydrochloride, [5α, 7α, (S)]. Its structural formula is as follows. The molecular weight of buprenorphine hydrochloride is 504.10; the empirical formula is C29H41NO4∙HCl. Buprenorphine hydrochloride occurs as a white or off-white crystalline powder. It is sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. The pKa is 8.5 for the amine function and 10.0 for the phenol function. Dosage strengths of BELBUCA are based on the active moiety, buprenorphine. BELBUCA is available as 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg buprenorphine per film. The strength of each film is dependent on the buprenorphine concentration in the formulation and the surface area of the film. Table 6 lists the dosage strength, equivalent amount of buprenorphine hydrochloride USP (active ingredient), unique identifier and film size for each strength. Each buccal film also contains carboxymethylcellulose sodium USP, citric acid anhydrous USP, hydroxyethylcellulose NF, hydroxypropylcellulose NF, methylparaben NF, monobasic sodium phosphate anhydrous USP, peppermint oil NF, polycarbophil USP, propylene glycol USP, propylparaben NF, sodium benzoate NF, sodium hydroxide NF, saccharin sodium NF, titanium dioxide USP, vitamin E acetate USP, yellow iron oxide, purified water USP, and TekPrint SW-9008 black ink (shellac NF, black iron oxide NF).</Description>
</NDC>
<NDC>
<NDCCode>59385-023-60</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (59385-023-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-023-01) </PackageDescription>
<NDC11Code>59385-0023-60</NDC11Code>
<ProductNDC>59385-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Belbuca</ProprietaryName>
<NonProprietaryName>Buprenorphine Hydrochloride</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>BUCCAL</RouteName>
<StartMarketingDate>20170901</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207932</ApplicationNumber>
<LabelerName>BioDelivery Sciences International Inc</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BELBUCA 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.</IndicationAndUsage>
<Description>BELBUCA is a buccal film that provides transmucosal delivery of buprenorphine, a partial opioid agonist. BELBUCA is a rectangular bi-layer, peppermint-flavored, buccal film with rounded corners, consisting of a white to off-white backing layer with strength identifier printed in black ink and a light yellow to yellow active mucoadhesive layer containing buprenorphine hydrochloride. The yellow side of the film is applied to the inside of the cheek where it adheres to the moist buccal mucosa to deliver the drug as the film dissolves. Buprenorphine hydrochloride USP is the active ingredient in BELBUCA. The chemical name of buprenorphine hydrochloride is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-, hydrochloride, [5α, 7α, (S)]. Its structural formula is as follows. The molecular weight of buprenorphine hydrochloride is 504.10; the empirical formula is C29H41NO4∙HCl. Buprenorphine hydrochloride occurs as a white or off-white crystalline powder. It is sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. The pKa is 8.5 for the amine function and 10.0 for the phenol function. Dosage strengths of BELBUCA are based on the active moiety, buprenorphine. BELBUCA is available as 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg buprenorphine per film. The strength of each film is dependent on the buprenorphine concentration in the formulation and the surface area of the film. Table 6 lists the dosage strength, equivalent amount of buprenorphine hydrochloride USP (active ingredient), unique identifier and film size for each strength. Each buccal film also contains carboxymethylcellulose sodium USP, citric acid anhydrous USP, hydroxyethylcellulose NF, hydroxypropylcellulose NF, methylparaben NF, monobasic sodium phosphate anhydrous USP, peppermint oil NF, polycarbophil USP, propylene glycol USP, propylparaben NF, sodium benzoate NF, sodium hydroxide NF, saccharin sodium NF, titanium dioxide USP, vitamin E acetate USP, yellow iron oxide, purified water USP, and TekPrint SW-9008 black ink (shellac NF, black iron oxide NF).</Description>
</NDC>
<NDC>
<NDCCode>59385-024-60</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (59385-024-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-024-01) </PackageDescription>
<NDC11Code>59385-0024-60</NDC11Code>
<ProductNDC>59385-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Belbuca</ProprietaryName>
<NonProprietaryName>Buprenorphine Hydrochloride</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>BUCCAL</RouteName>
<StartMarketingDate>20170821</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207932</ApplicationNumber>
<LabelerName>BioDelivery Sciences International Inc</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>450</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BELBUCA 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.</IndicationAndUsage>
<Description>BELBUCA is a buccal film that provides transmucosal delivery of buprenorphine, a partial opioid agonist. BELBUCA is a rectangular bi-layer, peppermint-flavored, buccal film with rounded corners, consisting of a white to off-white backing layer with strength identifier printed in black ink and a light yellow to yellow active mucoadhesive layer containing buprenorphine hydrochloride. The yellow side of the film is applied to the inside of the cheek where it adheres to the moist buccal mucosa to deliver the drug as the film dissolves. Buprenorphine hydrochloride USP is the active ingredient in BELBUCA. The chemical name of buprenorphine hydrochloride is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-, hydrochloride, [5α, 7α, (S)]. Its structural formula is as follows. The molecular weight of buprenorphine hydrochloride is 504.10; the empirical formula is C29H41NO4∙HCl. Buprenorphine hydrochloride occurs as a white or off-white crystalline powder. It is sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. The pKa is 8.5 for the amine function and 10.0 for the phenol function. Dosage strengths of BELBUCA are based on the active moiety, buprenorphine. BELBUCA is available as 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg buprenorphine per film. The strength of each film is dependent on the buprenorphine concentration in the formulation and the surface area of the film. Table 6 lists the dosage strength, equivalent amount of buprenorphine hydrochloride USP (active ingredient), unique identifier and film size for each strength. Each buccal film also contains carboxymethylcellulose sodium USP, citric acid anhydrous USP, hydroxyethylcellulose NF, hydroxypropylcellulose NF, methylparaben NF, monobasic sodium phosphate anhydrous USP, peppermint oil NF, polycarbophil USP, propylene glycol USP, propylparaben NF, sodium benzoate NF, sodium hydroxide NF, saccharin sodium NF, titanium dioxide USP, vitamin E acetate USP, yellow iron oxide, purified water USP, and TekPrint SW-9008 black ink (shellac NF, black iron oxide NF).</Description>
</NDC>
<NDC>
<NDCCode>59385-025-60</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (59385-025-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-025-01) </PackageDescription>
<NDC11Code>59385-0025-60</NDC11Code>
<ProductNDC>59385-025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Belbuca</ProprietaryName>
<NonProprietaryName>Buprenorphine Hydrochloride</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>BUCCAL</RouteName>
<StartMarketingDate>20170824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207932</ApplicationNumber>
<LabelerName>BioDelivery Sciences International Inc</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BELBUCA 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.</IndicationAndUsage>
<Description>BELBUCA is a buccal film that provides transmucosal delivery of buprenorphine, a partial opioid agonist. BELBUCA is a rectangular bi-layer, peppermint-flavored, buccal film with rounded corners, consisting of a white to off-white backing layer with strength identifier printed in black ink and a light yellow to yellow active mucoadhesive layer containing buprenorphine hydrochloride. The yellow side of the film is applied to the inside of the cheek where it adheres to the moist buccal mucosa to deliver the drug as the film dissolves. Buprenorphine hydrochloride USP is the active ingredient in BELBUCA. The chemical name of buprenorphine hydrochloride is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-, hydrochloride, [5α, 7α, (S)]. Its structural formula is as follows. The molecular weight of buprenorphine hydrochloride is 504.10; the empirical formula is C29H41NO4∙HCl. Buprenorphine hydrochloride occurs as a white or off-white crystalline powder. It is sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. The pKa is 8.5 for the amine function and 10.0 for the phenol function. Dosage strengths of BELBUCA are based on the active moiety, buprenorphine. BELBUCA is available as 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg buprenorphine per film. The strength of each film is dependent on the buprenorphine concentration in the formulation and the surface area of the film. Table 6 lists the dosage strength, equivalent amount of buprenorphine hydrochloride USP (active ingredient), unique identifier and film size for each strength. Each buccal film also contains carboxymethylcellulose sodium USP, citric acid anhydrous USP, hydroxyethylcellulose NF, hydroxypropylcellulose NF, methylparaben NF, monobasic sodium phosphate anhydrous USP, peppermint oil NF, polycarbophil USP, propylene glycol USP, propylparaben NF, sodium benzoate NF, sodium hydroxide NF, saccharin sodium NF, titanium dioxide USP, vitamin E acetate USP, yellow iron oxide, purified water USP, and TekPrint SW-9008 black ink (shellac NF, black iron oxide NF).</Description>
</NDC>
<NDC>
<NDCCode>59385-026-60</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (59385-026-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-026-01) </PackageDescription>
<NDC11Code>59385-0026-60</NDC11Code>
<ProductNDC>59385-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Belbuca</ProprietaryName>
<NonProprietaryName>Buprenorphine Hydrochloride</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>BUCCAL</RouteName>
<StartMarketingDate>20171001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207932</ApplicationNumber>
<LabelerName>BioDelivery Sciences International Inc</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BELBUCA 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.</IndicationAndUsage>
<Description>BELBUCA is a buccal film that provides transmucosal delivery of buprenorphine, a partial opioid agonist. BELBUCA is a rectangular bi-layer, peppermint-flavored, buccal film with rounded corners, consisting of a white to off-white backing layer with strength identifier printed in black ink and a light yellow to yellow active mucoadhesive layer containing buprenorphine hydrochloride. The yellow side of the film is applied to the inside of the cheek where it adheres to the moist buccal mucosa to deliver the drug as the film dissolves. Buprenorphine hydrochloride USP is the active ingredient in BELBUCA. The chemical name of buprenorphine hydrochloride is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-, hydrochloride, [5α, 7α, (S)]. Its structural formula is as follows. The molecular weight of buprenorphine hydrochloride is 504.10; the empirical formula is C29H41NO4∙HCl. Buprenorphine hydrochloride occurs as a white or off-white crystalline powder. It is sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. The pKa is 8.5 for the amine function and 10.0 for the phenol function. Dosage strengths of BELBUCA are based on the active moiety, buprenorphine. BELBUCA is available as 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg buprenorphine per film. The strength of each film is dependent on the buprenorphine concentration in the formulation and the surface area of the film. Table 6 lists the dosage strength, equivalent amount of buprenorphine hydrochloride USP (active ingredient), unique identifier and film size for each strength. Each buccal film also contains carboxymethylcellulose sodium USP, citric acid anhydrous USP, hydroxyethylcellulose NF, hydroxypropylcellulose NF, methylparaben NF, monobasic sodium phosphate anhydrous USP, peppermint oil NF, polycarbophil USP, propylene glycol USP, propylparaben NF, sodium benzoate NF, sodium hydroxide NF, saccharin sodium NF, titanium dioxide USP, vitamin E acetate USP, yellow iron oxide, purified water USP, and TekPrint SW-9008 black ink (shellac NF, black iron oxide NF).</Description>
</NDC>
<NDC>
<NDCCode>12634-027-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (12634-027-60)</PackageDescription>
<NDC11Code>12634-0027-60</NDC11Code>
<ProductNDC>12634-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram Hydrobromide</ProprietaryName>
<NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078216</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Citalopram HBr is indicated for the treatment of depression. The efficacy of citalopram HBr in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Citalopram HBr, USP is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram HBr is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram HBr, USP occurs as a fine, white to off-white powder.Citalopram HBr is sparingly soluble in water and soluble in ethanol. Citalopram hydrobromide is available only in tablet dosage form. Citalopram hydrobromide 10 mg tablets are film-coated, round shaped tablets containing citalopram HBr in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram HBr in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>16590-027-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (16590-027-60)</PackageDescription>
<NDC11Code>16590-0027-60</NDC11Code>
<ProductNDC>16590-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19910918</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072828</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen USP is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The structural formula is represented below. BACLOFEN STRUCTURE IIMAGE. Baclofen Tablets USP 10 mg and 20 mg contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and starch (corn).</Description>
</NDC>
<NDC>
<NDCCode>21922-027-07</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-027-07) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0027-07</NDC11Code>
<ProductNDC>21922-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Phosphate</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate Gel Usp, 1%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212438</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin phosphate gel USP, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).</IndicationAndUsage>
<Description>Clindamycin phosphate gel USP, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The gel contains allantoin, carbopol 974 P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. The structural formula is represented below. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1 methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo-α-D- galacto octopyranoside 2-(dihydrogen phosphate).</Description>
</NDC>
<NDC>
<NDCCode>33261-027-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (33261-027-60)</PackageDescription>
<NDC11Code>33261-0027-60</NDC11Code>
<ProductNDC>33261-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram Hydrobromide</ProprietaryName>
<NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078216</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Citalopram HBr is indicated for the treatment of depression. The efficacy of citalopram HBr in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Citalopram HBr is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram HBr is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram HBr, USP occurs as a fine, white to off-white powder.Citalopram HBr is sparingly soluble in water and soluble in ethanol. Citalopram hydrobromide is available as tablets. Citalopram hydrobromide 10 mg tablets are film-coated, round shaped tablets containing citalopram HBr in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram HBr in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, starch, croscarmellose sodium, copovidone, magnesium stearate, hypromellose, titanium dioxide, ferric oxide red, ferric oxide yellow, glycerin, and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>42858-027-06</NDCCode>
<PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-027-06)</PackageDescription>
<NDC11Code>42858-0027-06</NDC11Code>
<ProductNDC>42858-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Palladone</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040924</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021044</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals L.P.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-09-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>43353-027-53</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-027-53) </PackageDescription>
<NDC11Code>43353-0027-53</NDC11Code>
<ProductNDC>43353-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078281</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for.</IndicationAndUsage>
<Description>The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S × 1.5 H2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each Pantoprazole Sodium Delayed-Release Tablet contains 45.1 mg or 22.55 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, talc, titanium dioxide, and triethyl citrate. The 20 mg tablet also contains black iron oxide, isopropyl alcohol, and propylene glycol. Pantoprazole Sodium Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 4.</Description>
</NDC>
<NDC>
<NDCCode>43353-027-60</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-027-60) </PackageDescription>
<NDC11Code>43353-0027-60</NDC11Code>
<ProductNDC>43353-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078281</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for.</IndicationAndUsage>
<Description>The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S × 1.5 H2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each Pantoprazole Sodium Delayed-Release Tablet contains 45.1 mg or 22.55 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, talc, titanium dioxide, and triethyl citrate. The 20 mg tablet also contains black iron oxide, isopropyl alcohol, and propylene glycol. Pantoprazole Sodium Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 4.</Description>
</NDC>
<NDC>
<NDCCode>43744-027-60</NDCCode>
<PackageDescription>750 g in 1 DRUM (43744-027-60)</PackageDescription>
<NDC11Code>43744-0027-60</NDC11Code>
<ProductNDC>43744-027</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Aluminum Hydroxide Dried Gel</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110307</StartMarketingDate>
<EndMarketingDate>20110308</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>ALUMINUM HYDROXIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20110308</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49035-027-60</NDCCode>
<PackageDescription>160 LOZENGE in 1 BAG (49035-027-60) </PackageDescription>
<NDC11Code>49035-0027-60</NDC11Code>
<ProductNDC>49035-027</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Honey Lemon Cough Drops</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160427</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Walmart Stores Inc.</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses temporarily relieves. cough as may occur with a cold. occasional minor irritation and sore throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52565-027-59</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (52565-027-59) > 60 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>52565-0027-59</NDC11Code>
<ProductNDC>52565-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin</ProprietaryName>
<NonProprietaryName>Erythromycin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208100</ApplicationNumber>
<LabelerName>Teligent Pharma, Inc.</LabelerName>
<SubstanceName>ERYTHROMYCIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Erythromycin Topical Solution is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Erythromycin Topical Solution contains erythromycin for topical dermatologic use. Erythromycin is a macrolide antibiotic produced from a strain of Saccaropolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids. Chemically, erythromycin is: (3R*,4S*,5S*,6R*,7R*,9R*,11R*, 12R*,13S*,14R*)-4-[(2,6-Dideoxy-3-C- methyl-3-O-methyl-α-L-ribo-hexopyranosyl)-oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. It has the following structural formula:. Erythromycin is a white or slightly yellow crystalline powder that is very soluble in water, freely soluble in alcohols, acetone, chloroform, acetonitrile, ethyl acetate, and moderately soluble in ether, ethylene dichloride and amyl acetate. Each mL of Erythromycin Topical Solution USP 2% contains 20 mg of erythromycin base in a vehicle consisting of alcohol (71.5%), propylene glycol, and citric acid.</Description>
</NDC>
<NDC>
<NDCCode>54304-027-01</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, PLASTIC (54304-027-01) </PackageDescription>
<NDC11Code>54304-0027-01</NDC11Code>
<ProductNDC>54304-027</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Secret Plus Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>01</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200425</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Zhejiang Meizhiyuan Cosmetics Co., Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70.4</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59726-027-60</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (59726-027-60) > 60 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>59726-0027-60</NDC11Code>
<ProductNDC>59726-027</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus Relief Dm</ProprietaryName>
<NonProprietaryName>Guaifenesin, Dextromethorphan Hbr</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140731</StartMarketingDate>
<EndMarketingDate>20191231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>P & L Development, LLC</LabelerName>
<SubstanceName>GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>400; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140731</StartMarketingDatePackage>
<EndMarketingDatePackage>20191231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61919-027-90</NDCCode>
<PackageDescription>90 BOTTLE in 1 BOTTLE (61919-027-90) / 60 BOTTLE in 1 BOTTLE (61919-027-60) / 30 TABLET in 1 BOTTLE (61919-027-30) </PackageDescription>
<NDC11Code>61919-0027-90</NDC11Code>
<ProductNDC>61919-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072235</ApplicationNumber>
<LabelerName>Direct Rx</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-02-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65862-027-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (65862-027-60) </PackageDescription>
<NDC11Code>65862-0027-60</NDC11Code>
<ProductNDC>65862-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nevirapine</ProprietaryName>
<NonProprietaryName>Nevirapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120522</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077521</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>NEVIRAPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nevirapine tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1, 14.2)]. Limitations of Use. Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablets is not recommended to be initiated, unless the benefit outweighs the risk, in: : 1 adult females with CD4+ cell counts greater than 250 cells/mm3 or , 2 adult males with CD4+ cell counts greater than 400 cells/mm3[see Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Nevirapine is structurally a member of the dipyridodiazepinone chemical class of compounds.The chemical name of nevirapine is 11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido [3,2-b:2',3'-e][1,4] diazepin-6-one. Nevirapine USP is a white to off-white crystalline powder with the molecular weight of 266.30 and the molecular formula C15H14N4O. Nevirapine has the following structural formula. Nevirapine tablets, USP are for oral administration. Each tablet contains 200 mg of nevirapine and the inactive ingredients microcrystalline cellulose, lactose monohydrate, povidone, sodium starch glycolate, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>67046-027-60</NDCCode>
<PackageDescription>60 TABLET in 1 BLISTER PACK (67046-027-60)</PackageDescription>
<NDC11Code>67046-0027-60</NDC11Code>
<ProductNDC>67046-027</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Acetaminophen</ProprietaryName>
<NonProprietaryName>Extra Strength Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100802</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporarily reduces fever . temporarily relieves minor aches and pains due to: headache muscular aches the common cold minor pain of arthritis backache toothache premenstrual and menstrual cramps .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67046-027-62</NDCCode>
<PackageDescription>60 TABLET in 1 BLISTER PACK (67046-027-62)</PackageDescription>
<NDC11Code>67046-0027-62</NDC11Code>
<ProductNDC>67046-027</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Acetaminophen</ProprietaryName>
<NonProprietaryName>Extra Strength Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100802</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporarily reduces fever . temporarily relieves minor aches and pains due to: headache muscular aches the common cold minor pain of arthritis backache toothache premenstrual and menstrual cramps .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69539-027-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (69539-027-60) </PackageDescription>
<NDC11Code>69539-0027-60</NDC11Code>
<ProductNDC>69539-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220319</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204921</ApplicationNumber>
<LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2022-04-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70157-027-01</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, PLASTIC (70157-027-01) </PackageDescription>
<NDC11Code>70157-0027-01</NDC11Code>
<ProductNDC>70157-027</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Standard Procedure Spf 50 Sunscreen Face And Body</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250530</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Baxter Laboratories</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 5; 10; 8</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71205-027-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71205-027-60) </PackageDescription>
<NDC11Code>71205-0027-60</NDC11Code>
<ProductNDC>71205-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204590</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib capsules are indicated.</IndicationAndUsage>
<Description>Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure:. Celecoxib USP is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib USP is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range.The inactive ingredients in celecoxib capsules include: gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, hydroxypropyl cellulose, crospovidone and titanium dioxide. The imprinting ink of capsule shell of the 50 mg capsule contains the following inactive ingredients: shellac, propylene glycol, sodium hydroxide, titanium dioxide, povidone and FD&C Red#40 Aluminum Lake- E129. The imprinting ink of capsule shell of the 100 mg capsule contains the following inactive ingredients: shellac, propylene glycol, strong ammonia solution and FD&C Blue#2 Aluminum Lake-E132. The imprinting ink of capsule shell of the 200 mg capsule contains the following inactive ingredients: shellac, propylene glycol, strong ammonia solution and yellow iron oxide. The imprinting ink of capsule shell of the 400 mg capsule contains the following inactive ingredients: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide, FD&C Blue#1 Aluminum Lake- E133 and FD&C Yellow#5 Aluminum Lake-E102.</Description>
</NDC>
<NDC>
<NDCCode>72789-027-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (72789-027-60) </PackageDescription>
<NDC11Code>72789-0027-60</NDC11Code>
<ProductNDC>72789-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010416</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075805</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidine tablets are indicated in adult and pediatric patients 40 kg and above for the treatment of. active duodenal ulcer (DU). active gastric ulcer(GU). symptomatic non-erosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. Famotidine tablets are indicated in adults for the: treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine neoplasias). reduction of the risk of duodenal ulcer recurrence.</IndicationAndUsage>
<Description>The active ingredient in Famotidine tablets is a histamine-2 (H2) receptor antagonist. Famotidine is N’-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C 8H 15N 7O 2S 3and its molecular weight is 337.43. Its structural formula is:. Each Famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (modified corn starch), sodium starch glycolate, talc, titanium dioxide and triacetin. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>72888-027-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (72888-027-60) </PackageDescription>
<NDC11Code>72888-0027-60</NDC11Code>
<ProductNDC>72888-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211029</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078625</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs Lamotrigine’s. Its chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pK aof 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine tablets, USP are supplied for oral administration as 25 mg, 100 mg, 150 mg and 200 mg tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>73152-027-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (73152-027-60) </PackageDescription>
<NDC11Code>73152-0027-60</NDC11Code>
<ProductNDC>73152-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolterodine Tartarate</ProprietaryName>
<NonProprietaryName>Tolterodine Tartarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210775</ApplicationNumber>
<LabelerName>Athem LLC</LabelerName>
<SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.</IndicationAndUsage>
<Description>Tolterodine tartrate tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). The empirical formula of tolterodine tartrate is C 26H 37NO 7, and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below:. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Each tolterodine tartrate tablet, for oral administration contains 1 or 2 mg of tolterodine tartrate. The inactive ingredients are colloidal silicone dioxide, dibasic calcium phosphate dihydrate, cellulose microcrystalline, magnesium stearate, sodium starch glycolate (pH 3.0 to 5.0), Opadry White Y-1-7000.</Description>
</NDC>
<NDC>
<NDCCode>73905-027-01</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (73905-027-01) </PackageDescription>
<NDC11Code>73905-0027-01</NDC11Code>
<ProductNDC>73905-027</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200320</StartMarketingDate>
<EndMarketingDate>20240423</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200320</StartMarketingDatePackage>
<EndMarketingDatePackage>20240423</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
</NDCList>