{
"NDC": [
{
"NDCCode": "43596-0093-4",
"PackageDescription": "1 CONTAINER in 1 BOX (43596-0093-4) > 10 g in 1 CONTAINER (43596-0093-3) ",
"NDC11Code": "43596-0093-04",
"ProductNDC": "43596-0093",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Effet Parfait Long Lasting Compact Spf 15",
"ProprietaryNameSuffix": "Claire 4/beige",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180818",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".0575; .049",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180818",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "43596-0093-2",
"PackageDescription": "1 CONTAINER in 1 BOX (43596-0093-2) > 12 g in 1 CONTAINER (43596-0093-1) ",
"NDC11Code": "43596-0093-02",
"ProductNDC": "43596-0093",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Effet Parfait Long Lasting Compact Spf 15",
"ProprietaryNameSuffix": "Claire 4/beige",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180818",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".0575; .049",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180818",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "0093-3098-44",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (0093-3098-44) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-3098-19) ",
"NDC11Code": "00093-3098-44",
"ProductNDC": "0093-3098",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risedronate Sodium",
"NonProprietaryName": "Risedronate Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077132",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "RISEDRONATE SODIUM MONOHYDRATE",
"StrengthNumber": "35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150601",
"SamplePackage": "N",
"IndicationAndUsage": "Risedronate sodium tablets are a bisphosphonate indicated for: : 1 Treatment and prevention of postmenopausal osteoporosis (1.1), 2 Treatment to increase bone mass in men with osteoporosis (1.2) , 3 Treatment and prevention of glucocorticoid-induced osteoporosis (1.3) , 4 Treatment of Paget’s disease (1.4).",
"Description": "Risedronate sodium tablets, USP are a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each risedronate sodium tablet, USP for oral administration contains the equivalent of 5, 30, or 35 mg of anhydrous risedronate sodium, USP in the form of the monohydrate. The chemical name of risedronate sodium, USP is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium monohydrate, USP is the following. C7H10NO7P2NaH2O M.W. Monohydrate: 323.10 Anhydrous: 305.10. Risedronate sodium monohydrate, USP is a white to off-white powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive Ingredients. Colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized corn starch, sodium stearyl fumarate, and titanium dioxide. Additionally, the 5 mg tablets contain D&C yellow #10 lake, iron oxide yellow, and polysorbate 80; the 30 mg tablets contain polysorbate 80; and the 35 mg tablets contain FD&C yellow #6 aluminum lake, iron oxide yellow, iron oxide red, and polysorbate 80."
},
{
"NDCCode": "0093-3239-40",
"PackageDescription": "4 POUCH in 1 CARTON (0093-3239-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH",
"NDC11Code": "00093-3239-40",
"ProductNDC": "0093-3239",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20211227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204937",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "BUPRENORPHINE",
"StrengthNumber": "7.5",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211227",
"SamplePackage": "N",
"IndicationAndUsage": "Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "Buprenorphine is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the molecular formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Buprenorphine transdermal system is a square, tan-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a tan-colored web backing layer; (2) a separating layer over the buprenorphine-containing adhesive matrix; (3) the buprenorphine-containing adhesive matrix; and (4) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: levulinic acid, citric acid, and acrylate copolymer adhesive."
},
{
"NDCCode": "0093-3600-40",
"PackageDescription": "4 POUCH in 1 CARTON (0093-3600-40) > 1 PATCH in 1 POUCH (0093-3600-21) > 168 h in 1 PATCH",
"NDC11Code": "00093-3600-40",
"ProductNDC": "0093-3600",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20170530",
"EndMarketingDate": "20190331",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021306",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "BUPRENORPHINE",
"StrengthNumber": "5",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170530",
"EndMarketingDatePackage": "20190331",
"SamplePackage": "N"
},
{
"NDCCode": "0093-3601-40",
"PackageDescription": "4 POUCH in 1 CARTON (0093-3601-40) > 1 PATCH in 1 POUCH (0093-3601-21) > 168 h in 1 PATCH",
"NDC11Code": "00093-3601-40",
"ProductNDC": "0093-3601",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20170530",
"EndMarketingDate": "20190731",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021306",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "BUPRENORPHINE",
"StrengthNumber": "10",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170530",
"EndMarketingDatePackage": "20190731",
"SamplePackage": "N"
},
{
"NDCCode": "0093-3602-40",
"PackageDescription": "4 POUCH in 1 CARTON (0093-3602-40) > 1 PATCH in 1 POUCH (0093-3602-21) > 168 h in 1 PATCH",
"NDC11Code": "00093-3602-40",
"ProductNDC": "0093-3602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20170530",
"EndMarketingDate": "20190731",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021306",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "BUPRENORPHINE",
"StrengthNumber": "15",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170530",
"EndMarketingDatePackage": "20190731",
"SamplePackage": "N"
},
{
"NDCCode": "0093-3603-40",
"PackageDescription": "4 POUCH in 1 CARTON (0093-3603-40) > 1 PATCH in 1 POUCH (0093-3603-21) > 168 h in 1 PATCH",
"NDC11Code": "00093-3603-40",
"ProductNDC": "0093-3603",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20170530",
"EndMarketingDate": "20190731",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021306",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "BUPRENORPHINE",
"StrengthNumber": "20",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170530",
"EndMarketingDatePackage": "20190731",
"SamplePackage": "N"
},
{
"NDCCode": "0093-3656-40",
"PackageDescription": "4 POUCH in 1 CARTON (0093-3656-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH",
"NDC11Code": "00093-3656-40",
"ProductNDC": "0093-3656",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20181126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204937",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "BUPRENORPHINE",
"StrengthNumber": "5",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181126",
"SamplePackage": "N",
"IndicationAndUsage": "Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "Buprenorphine is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the molecular formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Buprenorphine transdermal system is a square, tan-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a tan-colored web backing layer; (2) a separating layer over the buprenorphine-containing adhesive matrix; (3) the buprenorphine-containing adhesive matrix; and (4) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: levulinic acid, citric acid, and acrylate copolymer adhesive."
},
{
"NDCCode": "0093-3657-40",
"PackageDescription": "4 POUCH in 1 CARTON (0093-3657-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH",
"NDC11Code": "00093-3657-40",
"ProductNDC": "0093-3657",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20181126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204937",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "BUPRENORPHINE",
"StrengthNumber": "10",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181126",
"SamplePackage": "N",
"IndicationAndUsage": "Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "Buprenorphine is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the molecular formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Buprenorphine transdermal system is a square, tan-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a tan-colored web backing layer; (2) a separating layer over the buprenorphine-containing adhesive matrix; (3) the buprenorphine-containing adhesive matrix; and (4) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: levulinic acid, citric acid, and acrylate copolymer adhesive."
},
{
"NDCCode": "0093-3658-40",
"PackageDescription": "4 POUCH in 1 CARTON (0093-3658-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH",
"NDC11Code": "00093-3658-40",
"ProductNDC": "0093-3658",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20181126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204937",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "BUPRENORPHINE",
"StrengthNumber": "15",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181126",
"SamplePackage": "N",
"IndicationAndUsage": "Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "Buprenorphine is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the molecular formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Buprenorphine transdermal system is a square, tan-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a tan-colored web backing layer; (2) a separating layer over the buprenorphine-containing adhesive matrix; (3) the buprenorphine-containing adhesive matrix; and (4) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: levulinic acid, citric acid, and acrylate copolymer adhesive."
},
{
"NDCCode": "0093-3659-40",
"PackageDescription": "4 POUCH in 1 CARTON (0093-3659-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH",
"NDC11Code": "00093-3659-40",
"ProductNDC": "0093-3659",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20181126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204937",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "BUPRENORPHINE",
"StrengthNumber": "20",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181126",
"SamplePackage": "N",
"IndicationAndUsage": "Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "Buprenorphine is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the molecular formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Buprenorphine transdermal system is a square, tan-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a tan-colored web backing layer; (2) a separating layer over the buprenorphine-containing adhesive matrix; (3) the buprenorphine-containing adhesive matrix; and (4) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: levulinic acid, citric acid, and acrylate copolymer adhesive."
},
{
"NDCCode": "0093-3750-28",
"PackageDescription": "7 POUCH in 1 CARTON (0093-3750-28) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE",
"NDC11Code": "00093-3750-28",
"ProductNDC": "0093-3750",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobramycin",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200915",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210915",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "TOBRAMYCIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200915",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "Tobramycin inhalation solution is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].",
"Description": "Tobramycin inhalation solution, USP is a sterile, clear, colorless to yellow, non-pyrogenic, aqueous solution with pH and salinity adjusted. Tobramycin inhalation solution, USP is administered by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is C18H37N5O9 and the molecular weight is 467.51. Tobramycin, USP is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine. The structural formula for tobramycin, USP is. Each single-dose 4 mL ampule of tobramycin inhalation solution, USP contains one 300 mg dose of tobramycin, USP with sodium chloride and trisodium citrate dihydrate in sterile water for injection. Sulfuric acid and sodium hydroxide are used, as needed, to adjust the pH to 5.0. Nitrogen is used for sparging and filling. The formulation contains no preservatives."
},
{
"NDCCode": "0093-3750-63",
"PackageDescription": "14 POUCH in 1 CARTON (0093-3750-63) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE",
"NDC11Code": "00093-3750-63",
"ProductNDC": "0093-3750",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobramycin",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200915",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210915",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "TOBRAMYCIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200915",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "Tobramycin inhalation solution is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].",
"Description": "Tobramycin inhalation solution, USP is a sterile, clear, colorless to yellow, non-pyrogenic, aqueous solution with pH and salinity adjusted. Tobramycin inhalation solution, USP is administered by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is C18H37N5O9 and the molecular weight is 467.51. Tobramycin, USP is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine. The structural formula for tobramycin, USP is. Each single-dose 4 mL ampule of tobramycin inhalation solution, USP contains one 300 mg dose of tobramycin, USP with sodium chloride and trisodium citrate dihydrate in sterile water for injection. Sulfuric acid and sodium hydroxide are used, as needed, to adjust the pH to 5.0. Nitrogen is used for sparging and filling. The formulation contains no preservatives."
},
{
"NDCCode": "0093-4000-62",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (0093-4000-62) / 1 KIT in 1 BLISTER PACK (0093-4000-28) * 24 TABLET in 1 BLISTER PACK (0093-3634-11) * 4 TABLET in 1 BLISTER PACK (0093-3622-22) ",
"NDC11Code": "00093-4000-62",
"ProductNDC": "0093-4000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vestura",
"NonProprietaryName": "Drospirenone And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20210302",
"EndMarketingDate": "20260531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078833",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Deprecated",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210302",
"EndMarketingDatePackage": "20260531",
"SamplePackage": "N",
"IndicationAndUsage": "Vestura is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2), 3 Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3).",
"Description": "Vestura® (drospirenone and ethinyl estradiol) tablets, USP provides an oral contraceptive regimen consisting of 24 pink active uncoated tablets each containing 3 mg of drospirenone, USP and 0.02 mg of ethinyl estradiol, USP (stabilized using vitamin E and an enhanced processing technique) and 4 peach inert uncoated tablets. The inactive ingredients in the pink tablets are lactose monohydrate, corn starch, pregelatinized corn starch, magnesium stearate, and FD&C Red #40. The peach inert uncoated tablets contain lactose anhydrous, microcrystalline cellulose, FD&C Yellow #6, and magnesium stearate. Drospirenone, USP (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3’,4’,6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16]cyclopenta[a]phenanthrene-17,2’(5H)-furan]-3,5’(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3. Ethinyl estradiol, USP (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows."
},
{
"NDCCode": "0093-4145-64",
"PackageDescription": "6 POUCH in 1 CARTON (0093-4145-64) > 4 VIAL, SINGLE-DOSE in 1 POUCH (0093-4145-04) > 3 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00093-4145-64",
"ProductNDC": "0093-4145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levalbuterol",
"NonProprietaryName": "Levalbuterol",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20130429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090297",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
"StrengthNumber": ".31",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20130429",
"EndMarketingDatePackage": "20190630",
"SamplePackage": "N"
},
{
"NDCCode": "0093-4146-64",
"PackageDescription": "6 POUCH in 1 CARTON (0093-4146-64) > 4 VIAL, SINGLE-DOSE in 1 POUCH (0093-4146-04) > 3 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00093-4146-64",
"ProductNDC": "0093-4146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levalbuterol",
"NonProprietaryName": "Levalbuterol",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20130429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090297",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
"StrengthNumber": ".63",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20130429",
"EndMarketingDatePackage": "20191231",
"SamplePackage": "N"
},
{
"NDCCode": "0093-4148-64",
"PackageDescription": "6 POUCH in 1 CARTON (0093-4148-64) > 4 VIAL, SINGLE-DOSE in 1 POUCH (0093-4148-04) > 3 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00093-4148-64",
"ProductNDC": "0093-4148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levalbuterol",
"NonProprietaryName": "Levalbuterol",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20130429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090297",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20130429",
"EndMarketingDatePackage": "20190331",
"SamplePackage": "N"
},
{
"NDCCode": "0093-5171-44",
"PackageDescription": "4 BLISTER PACK in 1 BOX (0093-5171-44) > 1 TABLET in 1 BLISTER PACK (0093-5171-19)",
"NDC11Code": "00093-5171-44",
"ProductNDC": "0093-5171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080206",
"EndMarketingDate": "20180531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075710",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-06-01",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "0093-5172-44",
"PackageDescription": "4 BLISTER PACK in 1 BOX (0093-5172-44) > 1 TABLET in 1 BLISTER PACK (0093-5172-19)",
"NDC11Code": "00093-5172-44",
"ProductNDC": "0093-5172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080206",
"EndMarketingDate": "20171231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075710",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0093-5509-44",
"PackageDescription": "4 BLISTER PACK in 1 BOX, UNIT-DOSE (0093-5509-44) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0093-5509-19)",
"NDC11Code": "00093-5509-44",
"ProductNDC": "0093-5509",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risedronate Sodium",
"NonProprietaryName": "Risedronate Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203217",
"LabelerName": "Teva Pharmaceuticals USA Inc",
"SubstanceName": "RISEDRONATE SODIUM MONOHYDRATE",
"StrengthNumber": "35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-11-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0093-6139-32",
"PackageDescription": "2 SYRINGE, PLASTIC in 1 PACKAGE (0093-6139-32) > 4 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "00093-6139-32",
"ProductNDC": "0093-6139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diazepam",
"NonProprietaryName": "Diazepam",
"DosageFormName": "GEL",
"RouteName": "RECTAL",
"StartMarketingDate": "20100903",
"EndMarketingDate": "20210930",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020648",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "DIAZEPAM",
"StrengthNumber": "20",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2021-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100903",
"EndMarketingDatePackage": "20210930",
"SamplePackage": "N"
},
{
"NDCCode": "0093-8210-62",
"PackageDescription": "3 POUCH in 1 CARTON (0093-8210-62) / 1 BLISTER PACK in 1 POUCH (0093-8210-28) / 1 KIT in 1 BLISTER PACK * 24 TABLET, CHEWABLE in 1 BLISTER PACK (0093-3476-38) * 4 TABLET in 1 BLISTER PACK (0093-3525-44) ",
"NDC11Code": "00093-8210-62",
"ProductNDC": "0093-8210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finzala",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20220804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210087",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220804",
"SamplePackage": "N",
"IndicationAndUsage": "Finzala is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. .",
"Description": "Finzala® (norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/20 mcg and ferrous fumarate tablets) provide an oral contraceptive regimen consisting of 24 white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below: 1 24 white, round, flat-faced, beveled-edge, unscored tablets each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. , 2 4 brown, round, flat-faced, beveled-edge, unscored tablets each containing 75 mg ferrous fumarate, USP."
},
{
"NDCCode": "0642-0093-01",
"PackageDescription": "1 BLISTER PACK in 1 BOX (0642-0093-01) > 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "00642-0093-01",
"ProductNDC": "0642-0093",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitafol",
"ProprietaryNameSuffix": "Ultra",
"NonProprietaryName": "Doconexent, Niacinamide, .alpha.-tocopherol Acetate, Dl-, Cholecalciferol, .beta.-carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, And Levomefolate Calcium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20130923",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Exeltis USA, Inc.",
"SubstanceName": "DOCONEXENT; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; .BETA.-CAROTENE; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON; ZINC OXIDE; CUPRIC OXIDE; POTASSIUM IODIDE; MAGNESIUM OXIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM",
"StrengthNumber": "200; 15; 20; 1000; 1100; 30; 1.6; 1.8; 2.5; 12; 29; 25; 2; 150; 20; .4; .6",
"StrengthUnit": "mg/1; mg/1; [iU]/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin D [CS],Vitamin D [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-04-25",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0642-0093-03",
"PackageDescription": "1 BLISTER PACK in 1 BOX (0642-0093-03) / 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "00642-0093-03",
"ProductNDC": "0642-0093",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitafol",
"ProprietaryNameSuffix": "Ultra",
"NonProprietaryName": "Doconexent, Niacinamide, .alpha.-tocopherol Acetate, Dl-, Cholecalciferol, .beta.-carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, And Levomefolate Calcium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20130923",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Exeltis USA, Inc.",
"SubstanceName": "DOCONEXENT; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; BETA CAROTENE; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON; ZINC OXIDE; CUPRIC OXIDE; POTASSIUM IODIDE; MAGNESIUM OXIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM",
"StrengthNumber": "200; 15; 9; 25; 330; 30; 1.6; 1.8; 2.5; 12; 29; 25; 2; 150; 20; 680; 1020",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Folate Analog [EPC], Folic Acid [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130923",
"SamplePackage": "N",
"IndicationAndUsage": "Vitafol ® Ultra provides vitamin, mineral, and DHA supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.*. Vitafol ® Ultra does not contain fish, fish oils, fish proteins or fish byproducts.",
"Description": "Amount per Capsule. Other Ingredients. Gelatin (Bovine), Glycerin, Soybean Oil, Yellow Beeswax, Sorbitol, Purified Water, Soy Lecithin, Microcrystalline Cellulose, Mannitol, FD&C Blue #1, Ethyl Vanillin. Titanium Dioxide (color). May contain: Sunflower Oil, Olive Oil. Contains: Soy."
},
{
"NDCCode": "10210-0093-1",
"PackageDescription": "1 KIT in 1 KIT (10210-0093-1) * 5 g in 1 TUBE (10210-0068-1) * 5 g in 1 TUBE (10210-0071-1) * 5 g in 1 TUBE (10210-0070-1) * 5 g in 1 TUBE (10210-0069-1) * 5 g in 1 TUBE (10210-0072-1) * 4.25 g in 1 CYLINDER (10210-0033-1) * 4.25 g in 1 CYLINDER (10210-0031-1) * 4.25 g in 1 CYLINDER (10210-0028-1) ",
"NDC11Code": "10210-0093-01",
"ProductNDC": "10210-0093",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Carmex Variety Pack Daily Care Moisturizing Lip Balm Spf 15",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Carma Laboratories, Inc.",
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"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250401",
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},
{
"NDCCode": "11014-0093-1",
"PackageDescription": "2 POUCH in 1 CARTON (11014-0093-1) > 4 VIAL, SINGLE-DOSE in 1 POUCH > 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "11014-0093-01",
"ProductNDC": "11014-0093",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Arformoterol Tartrate",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20070401",
"EndMarketingDate": "20180322",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Catalent Pharma Solutions, LLC",
"SubstanceName": "ARFORMOTEROL TARTRATE",
"StrengthNumber": "15",
"StrengthUnit": "ug/2mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20180322"
},
{
"NDCCode": "11014-0093-3",
"PackageDescription": "15 POUCH in 1 CARTON (11014-0093-3) > 4 VIAL, SINGLE-DOSE in 1 POUCH > 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "11014-0093-03",
"ProductNDC": "11014-0093",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Arformoterol Tartrate",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20070401",
"EndMarketingDate": "20180322",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Catalent Pharma Solutions, LLC",
"SubstanceName": "ARFORMOTEROL TARTRATE",
"StrengthNumber": "15",
"StrengthUnit": "ug/2mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20180322"
},
{
"NDCCode": "13630-0093-4",
"PackageDescription": "177 mL in 1 CAN (13630-0093-4) ",
"NDC11Code": "13630-0093-04",
"ProductNDC": "13630-0093",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aloe Up",
"ProprietaryNameSuffix": "Broad Spectrum Spf 50",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate And Octocrylene",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150825",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Prime Packaging Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "24; 120; 40; 22",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150825",
"SamplePackage": "N"
},
{
"NDCCode": "15631-0093-4",
"PackageDescription": "2500 PELLET in 1 PACKAGE (15631-0093-4) ",
"NDC11Code": "15631-0093-04",
"ProductNDC": "15631-0093",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcarea Carbonica",
"NonProprietaryName": "Calcarea Carbonica",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151002",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "OYSTER SHELL CALCIUM CARBONATE, CRUDE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Active",
"LastUpdate": "2021-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>43596-0093-4</NDCCode>
<PackageDescription>1 CONTAINER in 1 BOX (43596-0093-4) > 10 g in 1 CONTAINER (43596-0093-3) </PackageDescription>
<NDC11Code>43596-0093-04</NDC11Code>
<ProductNDC>43596-0093</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Effet Parfait Long Lasting Compact Spf 15</ProprietaryName>
<ProprietaryNameSuffix>Claire 4/beige</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180818</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.0575; .049</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43596-0093-2</NDCCode>
<PackageDescription>1 CONTAINER in 1 BOX (43596-0093-2) > 12 g in 1 CONTAINER (43596-0093-1) </PackageDescription>
<NDC11Code>43596-0093-02</NDC11Code>
<ProductNDC>43596-0093</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Effet Parfait Long Lasting Compact Spf 15</ProprietaryName>
<ProprietaryNameSuffix>Claire 4/beige</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180818</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.0575; .049</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0093-3098-44</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (0093-3098-44) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-3098-19) </PackageDescription>
<NDC11Code>00093-3098-44</NDC11Code>
<ProductNDC>0093-3098</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risedronate Sodium</ProprietaryName>
<NonProprietaryName>Risedronate Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077132</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>RISEDRONATE SODIUM MONOHYDRATE</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risedronate sodium tablets are a bisphosphonate indicated for: : 1 Treatment and prevention of postmenopausal osteoporosis (1.1), 2 Treatment to increase bone mass in men with osteoporosis (1.2) , 3 Treatment and prevention of glucocorticoid-induced osteoporosis (1.3) , 4 Treatment of Paget’s disease (1.4).</IndicationAndUsage>
<Description>Risedronate sodium tablets, USP are a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each risedronate sodium tablet, USP for oral administration contains the equivalent of 5, 30, or 35 mg of anhydrous risedronate sodium, USP in the form of the monohydrate. The chemical name of risedronate sodium, USP is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium monohydrate, USP is the following. C7H10NO7P2NaH2O M.W. Monohydrate: 323.10 Anhydrous: 305.10. Risedronate sodium monohydrate, USP is a white to off-white powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive Ingredients. Colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized corn starch, sodium stearyl fumarate, and titanium dioxide. Additionally, the 5 mg tablets contain D&C yellow #10 lake, iron oxide yellow, and polysorbate 80; the 30 mg tablets contain polysorbate 80; and the 35 mg tablets contain FD&C yellow #6 aluminum lake, iron oxide yellow, iron oxide red, and polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>0093-3239-40</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (0093-3239-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH</PackageDescription>
<NDC11Code>00093-3239-40</NDC11Code>
<ProductNDC>0093-3239</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine</ProprietaryName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20211227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204937</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Buprenorphine is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the molecular formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Buprenorphine transdermal system is a square, tan-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a tan-colored web backing layer; (2) a separating layer over the buprenorphine-containing adhesive matrix; (3) the buprenorphine-containing adhesive matrix; and (4) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: levulinic acid, citric acid, and acrylate copolymer adhesive.</Description>
</NDC>
<NDC>
<NDCCode>0093-3600-40</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (0093-3600-40) > 1 PATCH in 1 POUCH (0093-3600-21) > 168 h in 1 PATCH</PackageDescription>
<NDC11Code>00093-3600-40</NDC11Code>
<ProductNDC>0093-3600</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine</ProprietaryName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<EndMarketingDate>20190331</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021306</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<EndMarketingDatePackage>20190331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0093-3601-40</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (0093-3601-40) > 1 PATCH in 1 POUCH (0093-3601-21) > 168 h in 1 PATCH</PackageDescription>
<NDC11Code>00093-3601-40</NDC11Code>
<ProductNDC>0093-3601</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine</ProprietaryName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<EndMarketingDate>20190731</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021306</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<EndMarketingDatePackage>20190731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0093-3602-40</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (0093-3602-40) > 1 PATCH in 1 POUCH (0093-3602-21) > 168 h in 1 PATCH</PackageDescription>
<NDC11Code>00093-3602-40</NDC11Code>
<ProductNDC>0093-3602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine</ProprietaryName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<EndMarketingDate>20190731</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021306</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<EndMarketingDatePackage>20190731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0093-3603-40</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (0093-3603-40) > 1 PATCH in 1 POUCH (0093-3603-21) > 168 h in 1 PATCH</PackageDescription>
<NDC11Code>00093-3603-40</NDC11Code>
<ProductNDC>0093-3603</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine</ProprietaryName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<EndMarketingDate>20190731</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021306</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<EndMarketingDatePackage>20190731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0093-3656-40</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (0093-3656-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH</PackageDescription>
<NDC11Code>00093-3656-40</NDC11Code>
<ProductNDC>0093-3656</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine</ProprietaryName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20181126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204937</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Buprenorphine is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the molecular formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Buprenorphine transdermal system is a square, tan-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a tan-colored web backing layer; (2) a separating layer over the buprenorphine-containing adhesive matrix; (3) the buprenorphine-containing adhesive matrix; and (4) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: levulinic acid, citric acid, and acrylate copolymer adhesive.</Description>
</NDC>
<NDC>
<NDCCode>0093-3657-40</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (0093-3657-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH</PackageDescription>
<NDC11Code>00093-3657-40</NDC11Code>
<ProductNDC>0093-3657</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine</ProprietaryName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20181126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204937</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Buprenorphine is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the molecular formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Buprenorphine transdermal system is a square, tan-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a tan-colored web backing layer; (2) a separating layer over the buprenorphine-containing adhesive matrix; (3) the buprenorphine-containing adhesive matrix; and (4) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: levulinic acid, citric acid, and acrylate copolymer adhesive.</Description>
</NDC>
<NDC>
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<PackageDescription>4 POUCH in 1 CARTON (0093-3658-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH</PackageDescription>
<NDC11Code>00093-3658-40</NDC11Code>
<ProductNDC>0093-3658</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine</ProprietaryName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20181126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204937</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Buprenorphine is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the molecular formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Buprenorphine transdermal system is a square, tan-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a tan-colored web backing layer; (2) a separating layer over the buprenorphine-containing adhesive matrix; (3) the buprenorphine-containing adhesive matrix; and (4) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: levulinic acid, citric acid, and acrylate copolymer adhesive.</Description>
</NDC>
<NDC>
<NDCCode>0093-3659-40</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (0093-3659-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH</PackageDescription>
<NDC11Code>00093-3659-40</NDC11Code>
<ProductNDC>0093-3659</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine</ProprietaryName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20181126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204937</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Buprenorphine is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the molecular formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Buprenorphine transdermal system is a square, tan-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a tan-colored web backing layer; (2) a separating layer over the buprenorphine-containing adhesive matrix; (3) the buprenorphine-containing adhesive matrix; and (4) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: levulinic acid, citric acid, and acrylate copolymer adhesive.</Description>
</NDC>
<NDC>
<NDCCode>0093-3750-28</NDCCode>
<PackageDescription>7 POUCH in 1 CARTON (0093-3750-28) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE</PackageDescription>
<NDC11Code>00093-3750-28</NDC11Code>
<ProductNDC>0093-3750</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobramycin</ProprietaryName>
<NonProprietaryName>Tobramycin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210915</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>TOBRAMYCIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tobramycin inhalation solution is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Tobramycin inhalation solution, USP is a sterile, clear, colorless to yellow, non-pyrogenic, aqueous solution with pH and salinity adjusted. Tobramycin inhalation solution, USP is administered by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is C18H37N5O9 and the molecular weight is 467.51. Tobramycin, USP is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine. The structural formula for tobramycin, USP is. Each single-dose 4 mL ampule of tobramycin inhalation solution, USP contains one 300 mg dose of tobramycin, USP with sodium chloride and trisodium citrate dihydrate in sterile water for injection. Sulfuric acid and sodium hydroxide are used, as needed, to adjust the pH to 5.0. Nitrogen is used for sparging and filling. The formulation contains no preservatives.</Description>
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<NDC>
<NDCCode>0093-3750-63</NDCCode>
<PackageDescription>14 POUCH in 1 CARTON (0093-3750-63) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE</PackageDescription>
<NDC11Code>00093-3750-63</NDC11Code>
<ProductNDC>0093-3750</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobramycin</ProprietaryName>
<NonProprietaryName>Tobramycin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210915</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>TOBRAMYCIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tobramycin inhalation solution is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Tobramycin inhalation solution, USP is a sterile, clear, colorless to yellow, non-pyrogenic, aqueous solution with pH and salinity adjusted. Tobramycin inhalation solution, USP is administered by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is C18H37N5O9 and the molecular weight is 467.51. Tobramycin, USP is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine. The structural formula for tobramycin, USP is. Each single-dose 4 mL ampule of tobramycin inhalation solution, USP contains one 300 mg dose of tobramycin, USP with sodium chloride and trisodium citrate dihydrate in sterile water for injection. Sulfuric acid and sodium hydroxide are used, as needed, to adjust the pH to 5.0. Nitrogen is used for sparging and filling. The formulation contains no preservatives.</Description>
</NDC>
<NDC>
<NDCCode>0093-4000-62</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (0093-4000-62) / 1 KIT in 1 BLISTER PACK (0093-4000-28) * 24 TABLET in 1 BLISTER PACK (0093-3634-11) * 4 TABLET in 1 BLISTER PACK (0093-3622-22) </PackageDescription>
<NDC11Code>00093-4000-62</NDC11Code>
<ProductNDC>0093-4000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vestura</ProprietaryName>
<NonProprietaryName>Drospirenone And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210302</StartMarketingDate>
<EndMarketingDate>20260531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078833</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210302</StartMarketingDatePackage>
<EndMarketingDatePackage>20260531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vestura is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2), 3 Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3).</IndicationAndUsage>
<Description>Vestura® (drospirenone and ethinyl estradiol) tablets, USP provides an oral contraceptive regimen consisting of 24 pink active uncoated tablets each containing 3 mg of drospirenone, USP and 0.02 mg of ethinyl estradiol, USP (stabilized using vitamin E and an enhanced processing technique) and 4 peach inert uncoated tablets. The inactive ingredients in the pink tablets are lactose monohydrate, corn starch, pregelatinized corn starch, magnesium stearate, and FD&C Red #40. The peach inert uncoated tablets contain lactose anhydrous, microcrystalline cellulose, FD&C Yellow #6, and magnesium stearate. Drospirenone, USP (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3’,4’,6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16]cyclopenta[a]phenanthrene-17,2’(5H)-furan]-3,5’(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3. Ethinyl estradiol, USP (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows.</Description>
</NDC>
<NDC>
<NDCCode>0093-4145-64</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0093-4145-64) > 4 VIAL, SINGLE-DOSE in 1 POUCH (0093-4145-04) > 3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00093-4145-64</NDC11Code>
<ProductNDC>0093-4145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levalbuterol</ProprietaryName>
<NonProprietaryName>Levalbuterol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20130429</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090297</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>LEVALBUTEROL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.31</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130429</StartMarketingDatePackage>
<EndMarketingDatePackage>20190630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0093-4146-64</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0093-4146-64) > 4 VIAL, SINGLE-DOSE in 1 POUCH (0093-4146-04) > 3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00093-4146-64</NDC11Code>
<ProductNDC>0093-4146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levalbuterol</ProprietaryName>
<NonProprietaryName>Levalbuterol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20130429</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090297</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>LEVALBUTEROL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.63</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130429</StartMarketingDatePackage>
<EndMarketingDatePackage>20191231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0093-4148-64</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0093-4148-64) > 4 VIAL, SINGLE-DOSE in 1 POUCH (0093-4148-04) > 3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00093-4148-64</NDC11Code>
<ProductNDC>0093-4148</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levalbuterol</ProprietaryName>
<NonProprietaryName>Levalbuterol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20130429</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090297</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>LEVALBUTEROL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130429</StartMarketingDatePackage>
<EndMarketingDatePackage>20190331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>0093-5171-44</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 BOX (0093-5171-44) > 1 TABLET in 1 BLISTER PACK (0093-5171-19)</PackageDescription>
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<ProductNDC>0093-5171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080206</StartMarketingDate>
<EndMarketingDate>20180531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075710</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-06-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>0093-5172-44</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 BOX (0093-5172-44) > 1 TABLET in 1 BLISTER PACK (0093-5172-19)</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080206</StartMarketingDate>
<EndMarketingDate>20171231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075710</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0093-5509-44</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 BOX, UNIT-DOSE (0093-5509-44) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0093-5509-19)</PackageDescription>
<NDC11Code>00093-5509-44</NDC11Code>
<ProductNDC>0093-5509</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risedronate Sodium</ProprietaryName>
<NonProprietaryName>Risedronate Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203217</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA Inc</LabelerName>
<SubstanceName>RISEDRONATE SODIUM MONOHYDRATE</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0093-6139-32</NDCCode>
<PackageDescription>2 SYRINGE, PLASTIC in 1 PACKAGE (0093-6139-32) > 4 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>00093-6139-32</NDC11Code>
<ProductNDC>0093-6139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diazepam</ProprietaryName>
<NonProprietaryName>Diazepam</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20100903</StartMarketingDate>
<EndMarketingDate>20210930</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020648</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>DIAZEPAM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100903</StartMarketingDatePackage>
<EndMarketingDatePackage>20210930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>0093-8210-62</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (0093-8210-62) / 1 BLISTER PACK in 1 POUCH (0093-8210-28) / 1 KIT in 1 BLISTER PACK * 24 TABLET, CHEWABLE in 1 BLISTER PACK (0093-3476-38) * 4 TABLET in 1 BLISTER PACK (0093-3525-44) </PackageDescription>
<NDC11Code>00093-8210-62</NDC11Code>
<ProductNDC>0093-8210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Finzala</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20220804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210087</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Finzala is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. .</IndicationAndUsage>
<Description>Finzala® (norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/20 mcg and ferrous fumarate tablets) provide an oral contraceptive regimen consisting of 24 white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below: 1 24 white, round, flat-faced, beveled-edge, unscored tablets each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. , 2 4 brown, round, flat-faced, beveled-edge, unscored tablets each containing 75 mg ferrous fumarate, USP.</Description>
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<NDC>
<NDCCode>0642-0093-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX (0642-0093-01) > 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00642-0093-01</NDC11Code>
<ProductNDC>0642-0093</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitafol</ProprietaryName>
<ProprietaryNameSuffix>Ultra</ProprietaryNameSuffix>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20130923</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Exeltis USA, Inc.</LabelerName>
<SubstanceName>DOCONEXENT; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; .BETA.-CAROTENE; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON; ZINC OXIDE; CUPRIC OXIDE; POTASSIUM IODIDE; MAGNESIUM OXIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM</SubstanceName>
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<StrengthUnit>mg/1; mg/1; [iU]/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin D [CS],Vitamin D [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-25</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0642-0093-03</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX (0642-0093-03) / 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00642-0093-03</NDC11Code>
<ProductNDC>0642-0093</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitafol</ProprietaryName>
<ProprietaryNameSuffix>Ultra</ProprietaryNameSuffix>
<NonProprietaryName>Doconexent, Niacinamide, .alpha.-tocopherol Acetate, Dl-, Cholecalciferol, .beta.-carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, And Levomefolate Calcium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130923</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Exeltis USA, Inc.</LabelerName>
<SubstanceName>DOCONEXENT; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; BETA CAROTENE; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON; ZINC OXIDE; CUPRIC OXIDE; POTASSIUM IODIDE; MAGNESIUM OXIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM</SubstanceName>
<StrengthNumber>200; 15; 9; 25; 330; 30; 1.6; 1.8; 2.5; 12; 29; 25; 2; 150; 20; 680; 1020</StrengthNumber>
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<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Folate Analog [EPC], Folic Acid [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vitafol ® Ultra provides vitamin, mineral, and DHA supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.*. Vitafol ® Ultra does not contain fish, fish oils, fish proteins or fish byproducts.</IndicationAndUsage>
<Description>Amount per Capsule. Other Ingredients. Gelatin (Bovine), Glycerin, Soybean Oil, Yellow Beeswax, Sorbitol, Purified Water, Soy Lecithin, Microcrystalline Cellulose, Mannitol, FD&C Blue #1, Ethyl Vanillin. Titanium Dioxide (color). May contain: Sunflower Oil, Olive Oil. Contains: Soy.</Description>
</NDC>
<NDC>
<NDCCode>10210-0093-1</NDCCode>
<PackageDescription>1 KIT in 1 KIT (10210-0093-1) * 5 g in 1 TUBE (10210-0068-1) * 5 g in 1 TUBE (10210-0071-1) * 5 g in 1 TUBE (10210-0070-1) * 5 g in 1 TUBE (10210-0069-1) * 5 g in 1 TUBE (10210-0072-1) * 4.25 g in 1 CYLINDER (10210-0033-1) * 4.25 g in 1 CYLINDER (10210-0031-1) * 4.25 g in 1 CYLINDER (10210-0028-1) </PackageDescription>
<NDC11Code>10210-0093-01</NDC11Code>
<ProductNDC>10210-0093</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Carmex Variety Pack Daily Care Moisturizing Lip Balm Spf 15</ProprietaryName>
<NonProprietaryName>Octinoxate, Oxybenzone, Homosalate, Octocrylene, Octisalate, Avobenzone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Carma Laboratories, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11014-0093-1</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (11014-0093-1) > 4 VIAL, SINGLE-DOSE in 1 POUCH > 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>11014-0093-01</NDC11Code>
<ProductNDC>11014-0093</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Arformoterol Tartrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20070401</StartMarketingDate>
<EndMarketingDate>20180322</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
<SubstanceName>ARFORMOTEROL TARTRATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>ug/2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20180322</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11014-0093-3</NDCCode>
<PackageDescription>15 POUCH in 1 CARTON (11014-0093-3) > 4 VIAL, SINGLE-DOSE in 1 POUCH > 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>11014-0093-03</NDC11Code>
<ProductNDC>11014-0093</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Arformoterol Tartrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20070401</StartMarketingDate>
<EndMarketingDate>20180322</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
<SubstanceName>ARFORMOTEROL TARTRATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>ug/2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20180322</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13630-0093-4</NDCCode>
<PackageDescription>177 mL in 1 CAN (13630-0093-4) </PackageDescription>
<NDC11Code>13630-0093-04</NDC11Code>
<ProductNDC>13630-0093</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aloe Up</ProprietaryName>
<ProprietaryNameSuffix>Broad Spectrum Spf 50</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate And Octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150825</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Prime Packaging Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>24; 120; 40; 22</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>15631-0093-4</NDCCode>
<PackageDescription>2500 PELLET in 1 PACKAGE (15631-0093-4) </PackageDescription>
<NDC11Code>15631-0093-04</NDC11Code>
<ProductNDC>15631-0093</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calcarea Carbonica</ProprietaryName>
<NonProprietaryName>Calcarea Carbonica</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151002</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>OYSTER SHELL CALCIUM CARBONATE, CRUDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
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