{
"NDC": [
{
"NDCCode": "76187-860-00",
"PackageDescription": "1 TUBE in 1 CARTON (76187-860-00) / 50 mL in 1 TUBE",
"NDC11Code": "76187-0860-00",
"ProductNDC": "76187-860",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rejuvity Moisturizing Day Cream Broad Spectrum Spf 15 Sunscreen",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130523",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Isagenix International, LLC",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "10; 65",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "76187-762-02",
"PackageDescription": "1 TUBE in 1 PACKAGE (76187-762-02) / 60 mL in 1 TUBE",
"NDC11Code": "76187-0762-02",
"ProductNDC": "76187-762",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ageless Pain Relief",
"NonProprietaryName": "Methyl Salicylate, Menthol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110423",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Isagenix International, LLC",
"SubstanceName": "METHYL SALICYLATE; MENTHOL",
"StrengthNumber": "140; 70",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2023-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "Uses Temporarily receives the minor aches and pains of muscles and joints associated with: - simple backache - anthrics - strains - oruises - screms.",
"Description": "Ageless Pain Relief when applied topically provides temporary relef from joint pain associated with arthrits. Non-Allergenic Non-Sensinizing Non-Greasy, Stainless No Added Fragrance Quick Absorption Move Freely Ageless Pain Relief is a safe and effective non-narcotic topical pain relieving cream that can add in a wide variety of pain conditions including targeted. long-lastings relief from: - Joint pain - Muscle Pain - Simple Backache - Strains - Bruises exclusively formulated for and distributed by: Isagenix International, LLC 2225 S. Price Rd., Chandier.AZ 85286 3900956762-00 Item #20056."
},
{
"NDCCode": "55111-860-00",
"PackageDescription": "1 kg in 1 DRUM (55111-860-00) ",
"NDC11Code": "55111-0860-00",
"ProductNDC": "55111-860",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Dr.Reddy's Laboratories Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-01-10",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "23-MAR-15"
},
{
"NDCCode": "58657-860-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-01) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00) ",
"NDC11Code": "58657-0860-01",
"ProductNDC": "58657-860",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209781",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"Description": "Levetiracetam injection is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam injection, USP contains 100 mg of levetiracetam, USP per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection must be diluted prior to intravenous infusion [see Dosage and Administration (2.6)] ."
},
{
"NDCCode": "58657-860-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-10) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00) ",
"NDC11Code": "58657-0860-10",
"ProductNDC": "58657-860",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209781",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"Description": "Levetiracetam injection is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam injection, USP contains 100 mg of levetiracetam, USP per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection must be diluted prior to intravenous infusion [see Dosage and Administration (2.6)] ."
},
{
"NDCCode": "58657-860-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-25) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00) ",
"NDC11Code": "58657-0860-25",
"ProductNDC": "58657-860",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209781",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"Description": "Levetiracetam injection is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam injection, USP contains 100 mg of levetiracetam, USP per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection must be diluted prior to intravenous infusion [see Dosage and Administration (2.6)] ."
},
{
"NDCCode": "67457-860-50",
"PackageDescription": "10 VIAL in 1 CARTON (67457-860-50) > 5 mL in 1 VIAL (67457-860-00) ",
"NDC11Code": "67457-0860-50",
"ProductNDC": "67457-860",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190627",
"EndMarketingDate": "20211130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065506",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190627",
"EndMarketingDatePackage": "20211130",
"SamplePackage": "N"
},
{
"NDCCode": "69846-860-00",
"PackageDescription": "1 BOTTLE in 1 AMPULE (69846-860-00) / 236.5 mL in 1 BOTTLE",
"NDC11Code": "69846-0860-00",
"ProductNDC": "69846-860",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "S.t.37",
"NonProprietaryName": "Hexylresorcinol",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "19291120",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "NUMARK BRANDS, INC",
"SubstanceName": "HEXYLRESORCINOL",
"StrengthNumber": "1.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19291120",
"SamplePackage": "N",
"IndicationAndUsage": "Uses temporarily relieves: : 1 minor irritations of the mouth, 2 minor pain in the mouth, 3 sore mouth, 4 sore throat, 5 first aid to help prevent skin infection in minor cuts, scrapes, and burns."
},
{
"NDCCode": "71205-860-00",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-860-00) ",
"NDC11Code": "71205-0860-00",
"ProductNDC": "71205-860",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20211101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213247",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220506",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride extended-release tablets contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Its structural formula is. Metformin HCl is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: crospovidone, povidone (K-30, K-90), pregelatinised starch, magnesium stearate, sodium lauryl sulfate, hydroxypropyl cellulose, talc, cellulose acetate, polyethylene glycol (PEG 400, PEG 3350), triacetin, polyvinyl alcohol, titanium dioxide, black iron oxide, propylene glycol and hypromellose. FDA approved dissolution test specifications differ from the USP."
},
{
"NDCCode": "54868-0162-0",
"PackageDescription": "5 POUCH in 1 CARTON (54868-0162-0) > 1 PATCH in 1 POUCH > 72 [USP'U] in 1 PATCH",
"NDC11Code": "54868-0162-00",
"ProductNDC": "54868-0162",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20050714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076258",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "FENTANYL",
"StrengthNumber": "2.55",
"StrengthUnit": "mg/[USP'U]",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Fentanyl transdermal system is indicated for management of persistent, moderate to severe chronic pain that: : 1 requires continuous, around-the-clock opioid administration for an extended period of time, and, 2 cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.",
"Description": "Fentanyl transdermal system is a transdermal system providing continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72 hours. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n-octanol:water partition coefficient is 860:1. The pKa is 8.4."
},
{
"NDCCode": "54868-0244-0",
"PackageDescription": "5 POUCH in 1 CARTON (54868-0244-0) > 1 PATCH in 1 POUCH > 72 [USP'U] in 1 PATCH",
"NDC11Code": "54868-0244-00",
"ProductNDC": "54868-0244",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20050714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076258",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "FENTANYL",
"StrengthNumber": "5.1",
"StrengthUnit": "mg/[USP'U]",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Fentanyl transdermal system is indicated for management of persistent, moderate to severe chronic pain that: : 1 requires continuous, around-the-clock opioid administration for an extended period of time, and, 2 cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.",
"Description": "Fentanyl transdermal system is a transdermal system providing continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72 hours. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n-octanol:water partition coefficient is 860:1. The pKa is 8.4."
},
{
"NDCCode": "54868-0287-0",
"PackageDescription": "5 POUCH in 1 CARTON (54868-0287-0) > 1 PATCH in 1 POUCH > 72 [USP'U] in 1 PATCH",
"NDC11Code": "54868-0287-00",
"ProductNDC": "54868-0287",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20050714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076258",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "FENTANYL",
"StrengthNumber": "7.65",
"StrengthUnit": "mg/[USP'U]",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Fentanyl transdermal system is indicated for management of persistent, moderate to severe chronic pain that: : 1 requires continuous, around-the-clock opioid administration for an extended period of time, and, 2 cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.",
"Description": "Fentanyl transdermal system is a transdermal system providing continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72 hours. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n-octanol:water partition coefficient is 860:1. The pKa is 8.4."
},
{
"NDCCode": "54868-1523-0",
"PackageDescription": "5 POUCH in 1 CARTON (54868-1523-0) > 1 PATCH in 1 POUCH > 72 [USP'U] in 1 PATCH",
"NDC11Code": "54868-1523-00",
"ProductNDC": "54868-1523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20050714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076258",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "FENTANYL",
"StrengthNumber": "10.2",
"StrengthUnit": "mg/[USP'U]",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Fentanyl transdermal system is indicated for management of persistent, moderate to severe chronic pain that: : 1 requires continuous, around-the-clock opioid administration for an extended period of time, and, 2 cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.",
"Description": "Fentanyl transdermal system is a transdermal system providing continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72 hours. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n-octanol:water partition coefficient is 860:1. The pKa is 8.4."
},
{
"NDCCode": "54868-5963-0",
"PackageDescription": "5 POUCH in 1 CARTON (54868-5963-0) > 1 PATCH in 1 POUCH > 72 [USP'U] in 1 PATCH",
"NDC11Code": "54868-5963-00",
"ProductNDC": "54868-5963",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20081118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076258",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "FENTANYL",
"StrengthNumber": "1.28",
"StrengthUnit": "mg/[USP'U]",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Fentanyl transdermal system is indicated for management of persistent, moderate to severe chronic pain that: : 1 requires continuous, around-the-clock opioid administration for an extended period of time, and, 2 cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.",
"Description": "Fentanyl transdermal system is a transdermal system providing continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72 hours. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n-octanol:water partition coefficient is 860:1. The pKa is 8.4."
},
{
"NDCCode": "76187-850-03",
"PackageDescription": "1 TUBE in 1 PACKAGE (76187-850-03) / 100 mL in 1 TUBE",
"NDC11Code": "76187-0850-03",
"ProductNDC": "76187-850",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Isa Sunguard Spf 30",
"NonProprietaryName": "Zinc Oxide, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110526",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Isagenix International, LLC",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
"StrengthNumber": "60; 23",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2023-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. Higher SPF gives more sunburn protection.",
"Description": "Rich in Aloe vera gel, green tea and chamomile, this long-lasting, water-resistant facial moisturizer provides optimal broad-spectrum protection from UVA and UVB rays. Manufactured for Isagenix International LLC, Distributed by Isagenix International LLC AZ 85286 USA. Isagenix International ULC, Mississauga, Ontario L4W 1G4 Canada 3900949.000-00 Item #40040."
},
{
"NDCCode": "0338-0104-04",
"PackageDescription": "12 BOTTLE, PLASTIC in 1 CARTON (0338-0104-04) / 1000 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00338-0104-04",
"ProductNDC": "0338-0104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ringers",
"NonProprietaryName": "Sodium Chloride, Calcium Chloride, Potassium Chloride,",
"DosageFormName": "IRRIGANT",
"RouteName": "IRRIGATION",
"StartMarketingDate": "19820219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018495",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "SODIUM CHLORIDE; CALCIUM CHLORIDE; POTASSIUM CHLORIDE",
"StrengthNumber": "860; 33; 30",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19820219",
"SamplePackage": "N",
"IndicationAndUsage": "Isotonic solution for irrigation only. Not for injection.",
"Description": "Ringer’s Irrigation, USP. Each 100 mL contains: 860 mg Sodium Chloride, USP, 33 mg Calcium Chloride, USP, 30 mg Potassium Chloride, USP. No antimicrobial agent has been added. pH 6.0 (5.0 to 7.5). Osmolarity 309 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle."
},
{
"NDCCode": "0363-0803-43",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (0363-0803-43) ",
"NDC11Code": "00363-0803-43",
"ProductNDC": "0363-0803",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Witch Hazel",
"NonProprietaryName": "Witch Hazel",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160623",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Walgreen Co.",
"SubstanceName": "WITCH HAZEL",
"StrengthNumber": "860",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160623",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of minor skin irritations due to: 1 insects bites, 2 minor cuts, 3 monor scrapes."
},
{
"NDCCode": "0378-9119-98",
"PackageDescription": "5 POUCH in 1 CARTON (0378-9119-98) / 1 PATCH in 1 POUCH (0378-9119-16) / 72 h in 1 PATCH",
"NDC11Code": "00378-9119-98",
"ProductNDC": "0378-9119",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20050131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076258",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "FENTANYL",
"StrengthNumber": "12",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050131",
"SamplePackage": "N",
"IndicationAndUsage": "Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "The system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 6.25 cm2). The composition per unit area of all transdermal system sizes is identical. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide. The structural formula is. Fentanyl transdermal system is a rectangular translucent system with rounded corners. “Fentanyl”, dosage strength and diagonal lines are printed in blue ink on each system. Each system is comprised of a polyester release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are. 1) a backing layer of translucent polyolefin film with blue print; 2) a drug-in-adhesive layer containing fentanyl as the active ingredient and dimethicone NF and silicone adhesive as inactive ingredients. Before use, a polyester release liner covering the drug-in-adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use."
},
{
"NDCCode": "0378-9121-98",
"PackageDescription": "5 POUCH in 1 CARTON (0378-9121-98) / 1 PATCH in 1 POUCH (0378-9121-16) / 72 h in 1 PATCH",
"NDC11Code": "00378-9121-98",
"ProductNDC": "0378-9121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20050131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076258",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "FENTANYL",
"StrengthNumber": "25",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050131",
"SamplePackage": "N",
"IndicationAndUsage": "Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "The system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 6.25 cm2). The composition per unit area of all transdermal system sizes is identical. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide. The structural formula is. Fentanyl transdermal system is a rectangular translucent system with rounded corners. “Fentanyl”, dosage strength and diagonal lines are printed in blue ink on each system. Each system is comprised of a polyester release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are. 1) a backing layer of translucent polyolefin film with blue print; 2) a drug-in-adhesive layer containing fentanyl as the active ingredient and dimethicone NF and silicone adhesive as inactive ingredients. Before use, a polyester release liner covering the drug-in-adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use."
},
{
"NDCCode": "0378-9122-98",
"PackageDescription": "5 POUCH in 1 CARTON (0378-9122-98) / 1 PATCH in 1 POUCH (0378-9122-16) / 72 h in 1 PATCH",
"NDC11Code": "00378-9122-98",
"ProductNDC": "0378-9122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20050131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076258",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "FENTANYL",
"StrengthNumber": "50",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050131",
"SamplePackage": "N",
"IndicationAndUsage": "Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "The system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 6.25 cm2). The composition per unit area of all transdermal system sizes is identical. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide. The structural formula is. Fentanyl transdermal system is a rectangular translucent system with rounded corners. “Fentanyl”, dosage strength and diagonal lines are printed in blue ink on each system. Each system is comprised of a polyester release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are. 1) a backing layer of translucent polyolefin film with blue print; 2) a drug-in-adhesive layer containing fentanyl as the active ingredient and dimethicone NF and silicone adhesive as inactive ingredients. Before use, a polyester release liner covering the drug-in-adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use."
},
{
"NDCCode": "0378-9123-98",
"PackageDescription": "5 POUCH in 1 CARTON (0378-9123-98) / 1 PATCH in 1 POUCH (0378-9123-16) / 72 h in 1 PATCH",
"NDC11Code": "00378-9123-98",
"ProductNDC": "0378-9123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20050131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076258",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "FENTANYL",
"StrengthNumber": "75",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050131",
"SamplePackage": "N",
"IndicationAndUsage": "Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "The system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 6.25 cm2). The composition per unit area of all transdermal system sizes is identical. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide. The structural formula is. Fentanyl transdermal system is a rectangular translucent system with rounded corners. “Fentanyl”, dosage strength and diagonal lines are printed in blue ink on each system. Each system is comprised of a polyester release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are. 1) a backing layer of translucent polyolefin film with blue print; 2) a drug-in-adhesive layer containing fentanyl as the active ingredient and dimethicone NF and silicone adhesive as inactive ingredients. Before use, a polyester release liner covering the drug-in-adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use."
},
{
"NDCCode": "0378-9124-98",
"PackageDescription": "5 POUCH in 1 CARTON (0378-9124-98) / 1 PATCH in 1 POUCH (0378-9124-16) / 72 h in 1 PATCH",
"NDC11Code": "00378-9124-98",
"ProductNDC": "0378-9124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20050131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076258",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "FENTANYL",
"StrengthNumber": "100",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050131",
"SamplePackage": "N",
"IndicationAndUsage": "Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "The system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 6.25 cm2). The composition per unit area of all transdermal system sizes is identical. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide. The structural formula is. Fentanyl transdermal system is a rectangular translucent system with rounded corners. “Fentanyl”, dosage strength and diagonal lines are printed in blue ink on each system. Each system is comprised of a polyester release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are. 1) a backing layer of translucent polyolefin film with blue print; 2) a drug-in-adhesive layer containing fentanyl as the active ingredient and dimethicone NF and silicone adhesive as inactive ingredients. Before use, a polyester release liner covering the drug-in-adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use."
},
{
"NDCCode": "0378-9125-98",
"PackageDescription": "5 POUCH in 1 CARTON (0378-9125-98) / 1 PATCH in 1 POUCH (0378-9125-16) / 72 h in 1 PATCH",
"NDC11Code": "00378-9125-98",
"ProductNDC": "0378-9125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20150226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076258",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "FENTANYL",
"StrengthNumber": "37.5",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150226",
"SamplePackage": "N",
"IndicationAndUsage": "Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "The system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 6.25 cm2). The composition per unit area of all transdermal system sizes is identical. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide. The structural formula is. Fentanyl transdermal system is a rectangular translucent system with rounded corners. “Fentanyl”, dosage strength and diagonal lines are printed in blue ink on each system. Each system is comprised of a polyester release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are. 1) a backing layer of translucent polyolefin film with blue print; 2) a drug-in-adhesive layer containing fentanyl as the active ingredient and dimethicone NF and silicone adhesive as inactive ingredients. Before use, a polyester release liner covering the drug-in-adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use."
},
{
"NDCCode": "0378-9126-98",
"PackageDescription": "5 POUCH in 1 CARTON (0378-9126-98) / 1 PATCH in 1 POUCH (0378-9126-16) / 72 h in 1 PATCH",
"NDC11Code": "00378-9126-98",
"ProductNDC": "0378-9126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20150226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076258",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "FENTANYL",
"StrengthNumber": "62.5",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150226",
"SamplePackage": "N",
"IndicationAndUsage": "Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "The system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 6.25 cm2). The composition per unit area of all transdermal system sizes is identical. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide. The structural formula is. Fentanyl transdermal system is a rectangular translucent system with rounded corners. “Fentanyl”, dosage strength and diagonal lines are printed in blue ink on each system. Each system is comprised of a polyester release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are. 1) a backing layer of translucent polyolefin film with blue print; 2) a drug-in-adhesive layer containing fentanyl as the active ingredient and dimethicone NF and silicone adhesive as inactive ingredients. Before use, a polyester release liner covering the drug-in-adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use."
},
{
"NDCCode": "0378-9127-98",
"PackageDescription": "5 POUCH in 1 CARTON (0378-9127-98) / 1 PATCH in 1 POUCH (0378-9127-16) / 72 h in 1 PATCH",
"NDC11Code": "00378-9127-98",
"ProductNDC": "0378-9127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20150226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076258",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "FENTANYL",
"StrengthNumber": "87.5",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150226",
"SamplePackage": "N",
"IndicationAndUsage": "Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "The system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 6.25 cm2). The composition per unit area of all transdermal system sizes is identical. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide. The structural formula is. Fentanyl transdermal system is a rectangular translucent system with rounded corners. “Fentanyl”, dosage strength and diagonal lines are printed in blue ink on each system. Each system is comprised of a polyester release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are. 1) a backing layer of translucent polyolefin film with blue print; 2) a drug-in-adhesive layer containing fentanyl as the active ingredient and dimethicone NF and silicone adhesive as inactive ingredients. Before use, a polyester release liner covering the drug-in-adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use."
},
{
"NDCCode": "0406-9000-76",
"PackageDescription": "5 POUCH in 1 CARTON (0406-9000-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH",
"NDC11Code": "00406-9000-76",
"ProductNDC": "0406-9000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Transdermal",
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"IndicationAndUsage": "Fentanyl transdermal system is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1)], reserve fentanyl transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "Fentanyl transdermal system contains fentanyl, an opioid agonist, available as a patch for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hr per 7.8 cm2). The composition per unit area of all system sizes is identical. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. Fentanyl transdermal systems are a rectangular, opaque patch with rounded corners: 1 12 mcg/hr: Fentanyl Transdermal System 12 mcg/hr printed in green, 2 25 mcg/hr: Fentanyl Transdermal System 25 mcg/hr printed in green, 3 37.5 mcg/hr: Fentanyl Transdermal System 37.5 mcg/hr printed in green, 4 50 mcg/hr: Fentanyl Transdermal System 50 mcg/hr printed in green, 5 62.5 mcg/hr: Fentanyl Transdermal System 62.5 mcg/hr printed in green, 6 75 mcg/hr: Fentanyl Transdermal System 75 mcg/hr printed in green, 7 100 mcg/hr: Fentanyl Transdermal System 100 mcg/hr printed in green."
},
{
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"PackageDescription": "5 POUCH in 1 CARTON (0406-9037-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH",
"NDC11Code": "00406-9037-76",
"ProductNDC": "0406-9037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Transdermal",
"NonProprietaryName": "Fentanyl Transdermal",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20200228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077154",
"LabelerName": "SpecGx LLC",
"SubstanceName": "FENTANYL",
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"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
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"LastUpdate": "2026-05-05",
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"IndicationAndUsage": "Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid-tolerant patients that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "Fentanyl transdermal system contains fentanyl, an opioid agonist, available as a patch for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hr per 7.8 cm2). The composition per unit area of all system sizes is identical. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. Fentanyl transdermal systems are a rectangular, opaque patch with rounded corners: 1 12 mcg/hr: Fentanyl Transdermal System 12 mcg/hr printed in green, 2 25 mcg/hr: Fentanyl Transdermal System 25 mcg/hr printed in green, 3 37.5 mcg/hr: Fentanyl Transdermal System 37.5 mcg/hr printed in green, 4 50 mcg/hr: Fentanyl Transdermal System 50 mcg/hr printed in green, 5 62.5 mcg/hr: Fentanyl Transdermal System 62.5 mcg/hr printed in green, 6 75 mcg/hr: Fentanyl Transdermal System 75 mcg/hr printed in green, 7 100 mcg/hr: Fentanyl Transdermal System 100 mcg/hr printed in green."
},
{
"NDCCode": "0406-9050-76",
"PackageDescription": "5 POUCH in 1 CARTON (0406-9050-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH",
"NDC11Code": "00406-9050-76",
"ProductNDC": "0406-9050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Transdermal",
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"DosageFormName": "PATCH, EXTENDED RELEASE",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077154",
"LabelerName": "SpecGx LLC",
"SubstanceName": "FENTANYL",
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"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
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"IndicationAndUsage": "Fentanyl transdermal system is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1)], reserve fentanyl transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "Fentanyl transdermal system contains fentanyl, an opioid agonist, available as a patch for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hr per 7.8 cm2). The composition per unit area of all system sizes is identical. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. Fentanyl transdermal systems are a rectangular, opaque patch with rounded corners: 1 12 mcg/hr: Fentanyl Transdermal System 12 mcg/hr printed in green, 2 25 mcg/hr: Fentanyl Transdermal System 25 mcg/hr printed in green, 3 37.5 mcg/hr: Fentanyl Transdermal System 37.5 mcg/hr printed in green, 4 50 mcg/hr: Fentanyl Transdermal System 50 mcg/hr printed in green, 5 62.5 mcg/hr: Fentanyl Transdermal System 62.5 mcg/hr printed in green, 6 75 mcg/hr: Fentanyl Transdermal System 75 mcg/hr printed in green, 7 100 mcg/hr: Fentanyl Transdermal System 100 mcg/hr printed in green."
},
{
"NDCCode": "0406-9062-76",
"PackageDescription": "5 POUCH in 1 CARTON (0406-9062-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH",
"NDC11Code": "00406-9062-76",
"ProductNDC": "0406-9062",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Transdermal",
"NonProprietaryName": "Fentanyl Transdermal",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20200228",
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"ApplicationNumber": "ANDA077154",
"LabelerName": "SpecGx LLC",
"SubstanceName": "FENTANYL",
"StrengthNumber": "62.5",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid-tolerant patients that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "Fentanyl transdermal system contains fentanyl, an opioid agonist, available as a patch for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hr per 7.8 cm2). The composition per unit area of all system sizes is identical. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. Fentanyl transdermal systems are a rectangular, opaque patch with rounded corners: 1 12 mcg/hr: Fentanyl Transdermal System 12 mcg/hr printed in green, 2 25 mcg/hr: Fentanyl Transdermal System 25 mcg/hr printed in green, 3 37.5 mcg/hr: Fentanyl Transdermal System 37.5 mcg/hr printed in green, 4 50 mcg/hr: Fentanyl Transdermal System 50 mcg/hr printed in green, 5 62.5 mcg/hr: Fentanyl Transdermal System 62.5 mcg/hr printed in green, 6 75 mcg/hr: Fentanyl Transdermal System 75 mcg/hr printed in green, 7 100 mcg/hr: Fentanyl Transdermal System 100 mcg/hr printed in green."
},
{
"NDCCode": "0406-9100-76",
"PackageDescription": "5 POUCH in 1 CARTON (0406-9100-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH",
"NDC11Code": "00406-9100-76",
"ProductNDC": "0406-9100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Transdermal",
"NonProprietaryName": "Fentanyl Transdermal",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20200506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077154",
"LabelerName": "SpecGx LLC",
"SubstanceName": "FENTANYL",
"StrengthNumber": "100",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
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"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid-tolerant patients that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "Fentanyl transdermal system contains fentanyl, an opioid agonist, available as a patch for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hr per 7.8 cm2). The composition per unit area of all system sizes is identical. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. Fentanyl transdermal systems are a rectangular, opaque patch with rounded corners: 1 12 mcg/hr: Fentanyl Transdermal System 12 mcg/hr printed in green, 2 25 mcg/hr: Fentanyl Transdermal System 25 mcg/hr printed in green, 3 37.5 mcg/hr: Fentanyl Transdermal System 37.5 mcg/hr printed in green, 4 50 mcg/hr: Fentanyl Transdermal System 50 mcg/hr printed in green, 5 62.5 mcg/hr: Fentanyl Transdermal System 62.5 mcg/hr printed in green, 6 75 mcg/hr: Fentanyl Transdermal System 75 mcg/hr printed in green, 7 100 mcg/hr: Fentanyl Transdermal System 100 mcg/hr printed in green."
}
]
}
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<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
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<SamplePackage>N</SamplePackage>
<Description>Levetiracetam injection is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam injection, USP contains 100 mg of levetiracetam, USP per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection must be diluted prior to intravenous infusion [see Dosage and Administration (2.6)] .</Description>
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<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Levetiracetam injection is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam injection, USP contains 100 mg of levetiracetam, USP per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection must be diluted prior to intravenous infusion [see Dosage and Administration (2.6)] .</Description>
</NDC>
<NDC>
<NDCCode>58657-860-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-25) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00) </PackageDescription>
<NDC11Code>58657-0860-25</NDC11Code>
<ProductNDC>58657-860</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209781</ApplicationNumber>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Levetiracetam injection is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam injection, USP contains 100 mg of levetiracetam, USP per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection must be diluted prior to intravenous infusion [see Dosage and Administration (2.6)] .</Description>
</NDC>
<NDC>
<NDCCode>67457-860-50</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (67457-860-50) > 5 mL in 1 VIAL (67457-860-00) </PackageDescription>
<NDC11Code>67457-0860-50</NDC11Code>
<ProductNDC>67457-860</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190627</StartMarketingDate>
<EndMarketingDate>20211130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065506</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190627</StartMarketingDatePackage>
<EndMarketingDatePackage>20211130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69846-860-00</NDCCode>
<PackageDescription>1 BOTTLE in 1 AMPULE (69846-860-00) / 236.5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>69846-0860-00</NDC11Code>
<ProductNDC>69846-860</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>S.t.37</ProprietaryName>
<NonProprietaryName>Hexylresorcinol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>19291120</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>NUMARK BRANDS, INC</LabelerName>
<SubstanceName>HEXYLRESORCINOL</SubstanceName>
<StrengthNumber>1.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19291120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses temporarily relieves: : 1 minor irritations of the mouth, 2 minor pain in the mouth, 3 sore mouth, 4 sore throat, 5 first aid to help prevent skin infection in minor cuts, scrapes, and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71205-860-00</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-860-00) </PackageDescription>
<NDC11Code>71205-0860-00</NDC11Code>
<ProductNDC>71205-860</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213247</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride extended-release tablets contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Its structural formula is. Metformin HCl is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: crospovidone, povidone (K-30, K-90), pregelatinised starch, magnesium stearate, sodium lauryl sulfate, hydroxypropyl cellulose, talc, cellulose acetate, polyethylene glycol (PEG 400, PEG 3350), triacetin, polyvinyl alcohol, titanium dioxide, black iron oxide, propylene glycol and hypromellose. FDA approved dissolution test specifications differ from the USP.</Description>
</NDC>
<NDC>
<NDCCode>54868-0162-0</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (54868-0162-0) > 1 PATCH in 1 POUCH > 72 [USP'U] in 1 PATCH</PackageDescription>
<NDC11Code>54868-0162-00</NDC11Code>
<ProductNDC>54868-0162</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20050714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076258</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>2.55</StrengthNumber>
<StrengthUnit>mg/[USP'U]</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Fentanyl transdermal system is indicated for management of persistent, moderate to severe chronic pain that: : 1 requires continuous, around-the-clock opioid administration for an extended period of time, and, 2 cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.</IndicationAndUsage>
<Description>Fentanyl transdermal system is a transdermal system providing continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72 hours. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n-octanol:water partition coefficient is 860:1. The pKa is 8.4.</Description>
</NDC>
<NDC>
<NDCCode>54868-0244-0</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (54868-0244-0) > 1 PATCH in 1 POUCH > 72 [USP'U] in 1 PATCH</PackageDescription>
<NDC11Code>54868-0244-00</NDC11Code>
<ProductNDC>54868-0244</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20050714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076258</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>5.1</StrengthNumber>
<StrengthUnit>mg/[USP'U]</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Fentanyl transdermal system is indicated for management of persistent, moderate to severe chronic pain that: : 1 requires continuous, around-the-clock opioid administration for an extended period of time, and, 2 cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.</IndicationAndUsage>
<Description>Fentanyl transdermal system is a transdermal system providing continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72 hours. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n-octanol:water partition coefficient is 860:1. The pKa is 8.4.</Description>
</NDC>
<NDC>
<NDCCode>54868-0287-0</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (54868-0287-0) > 1 PATCH in 1 POUCH > 72 [USP'U] in 1 PATCH</PackageDescription>
<NDC11Code>54868-0287-00</NDC11Code>
<ProductNDC>54868-0287</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20050714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076258</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>7.65</StrengthNumber>
<StrengthUnit>mg/[USP'U]</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Fentanyl transdermal system is indicated for management of persistent, moderate to severe chronic pain that: : 1 requires continuous, around-the-clock opioid administration for an extended period of time, and, 2 cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.</IndicationAndUsage>
<Description>Fentanyl transdermal system is a transdermal system providing continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72 hours. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n-octanol:water partition coefficient is 860:1. The pKa is 8.4.</Description>
</NDC>
<NDC>
<NDCCode>54868-1523-0</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (54868-1523-0) > 1 PATCH in 1 POUCH > 72 [USP'U] in 1 PATCH</PackageDescription>
<NDC11Code>54868-1523-00</NDC11Code>
<ProductNDC>54868-1523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20050714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076258</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>10.2</StrengthNumber>
<StrengthUnit>mg/[USP'U]</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Fentanyl transdermal system is indicated for management of persistent, moderate to severe chronic pain that: : 1 requires continuous, around-the-clock opioid administration for an extended period of time, and, 2 cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.</IndicationAndUsage>
<Description>Fentanyl transdermal system is a transdermal system providing continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72 hours. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n-octanol:water partition coefficient is 860:1. The pKa is 8.4.</Description>
</NDC>
<NDC>
<NDCCode>54868-5963-0</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (54868-5963-0) > 1 PATCH in 1 POUCH > 72 [USP'U] in 1 PATCH</PackageDescription>
<NDC11Code>54868-5963-00</NDC11Code>
<ProductNDC>54868-5963</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20081118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076258</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>1.28</StrengthNumber>
<StrengthUnit>mg/[USP'U]</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Fentanyl transdermal system is indicated for management of persistent, moderate to severe chronic pain that: : 1 requires continuous, around-the-clock opioid administration for an extended period of time, and, 2 cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.</IndicationAndUsage>
<Description>Fentanyl transdermal system is a transdermal system providing continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72 hours. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n-octanol:water partition coefficient is 860:1. The pKa is 8.4.</Description>
</NDC>
<NDC>
<NDCCode>76187-850-03</NDCCode>
<PackageDescription>1 TUBE in 1 PACKAGE (76187-850-03) / 100 mL in 1 TUBE</PackageDescription>
<NDC11Code>76187-0850-03</NDC11Code>
<ProductNDC>76187-850</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Isa Sunguard Spf 30</ProprietaryName>
<NonProprietaryName>Zinc Oxide, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110526</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Isagenix International, LLC</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>60; 23</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. Higher SPF gives more sunburn protection.</IndicationAndUsage>
<Description>Rich in Aloe vera gel, green tea and chamomile, this long-lasting, water-resistant facial moisturizer provides optimal broad-spectrum protection from UVA and UVB rays. Manufactured for Isagenix International LLC, Distributed by Isagenix International LLC AZ 85286 USA. Isagenix International ULC, Mississauga, Ontario L4W 1G4 Canada 3900949.000-00 Item #40040.</Description>
</NDC>
<NDC>
<NDCCode>0338-0104-04</NDCCode>
<PackageDescription>12 BOTTLE, PLASTIC in 1 CARTON (0338-0104-04) / 1000 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00338-0104-04</NDC11Code>
<ProductNDC>0338-0104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ringers</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Calcium Chloride, Potassium Chloride,</NonProprietaryName>
<DosageFormName>IRRIGANT</DosageFormName>
<RouteName>IRRIGATION</RouteName>
<StartMarketingDate>19820219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018495</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>SODIUM CHLORIDE; CALCIUM CHLORIDE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>860; 33; 30</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19820219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isotonic solution for irrigation only. Not for injection.</IndicationAndUsage>
<Description>Ringer’s Irrigation, USP. Each 100 mL contains: 860 mg Sodium Chloride, USP, 33 mg Calcium Chloride, USP, 30 mg Potassium Chloride, USP. No antimicrobial agent has been added. pH 6.0 (5.0 to 7.5). Osmolarity 309 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle.</Description>
</NDC>
<NDC>
<NDCCode>0363-0803-43</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (0363-0803-43) </PackageDescription>
<NDC11Code>00363-0803-43</NDC11Code>
<ProductNDC>0363-0803</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Witch Hazel</ProprietaryName>
<NonProprietaryName>Witch Hazel</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160623</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Walgreen Co.</LabelerName>
<SubstanceName>WITCH HAZEL</SubstanceName>
<StrengthNumber>860</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of minor skin irritations due to: 1 insects bites, 2 minor cuts, 3 monor scrapes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0378-9119-98</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (0378-9119-98) / 1 PATCH in 1 POUCH (0378-9119-16) / 72 h in 1 PATCH</PackageDescription>
<NDC11Code>00378-9119-98</NDC11Code>
<ProductNDC>0378-9119</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20050131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076258</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>The system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 6.25 cm2). The composition per unit area of all transdermal system sizes is identical. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide. The structural formula is. Fentanyl transdermal system is a rectangular translucent system with rounded corners. “Fentanyl”, dosage strength and diagonal lines are printed in blue ink on each system. Each system is comprised of a polyester release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are. 1) a backing layer of translucent polyolefin film with blue print; 2) a drug-in-adhesive layer containing fentanyl as the active ingredient and dimethicone NF and silicone adhesive as inactive ingredients. Before use, a polyester release liner covering the drug-in-adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use.</Description>
</NDC>
<NDC>
<NDCCode>0378-9121-98</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (0378-9121-98) / 1 PATCH in 1 POUCH (0378-9121-16) / 72 h in 1 PATCH</PackageDescription>
<NDC11Code>00378-9121-98</NDC11Code>
<ProductNDC>0378-9121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20050131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076258</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>The system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 6.25 cm2). The composition per unit area of all transdermal system sizes is identical. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide. The structural formula is. Fentanyl transdermal system is a rectangular translucent system with rounded corners. “Fentanyl”, dosage strength and diagonal lines are printed in blue ink on each system. Each system is comprised of a polyester release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are. 1) a backing layer of translucent polyolefin film with blue print; 2) a drug-in-adhesive layer containing fentanyl as the active ingredient and dimethicone NF and silicone adhesive as inactive ingredients. Before use, a polyester release liner covering the drug-in-adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use.</Description>
</NDC>
<NDC>
<NDCCode>0378-9122-98</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (0378-9122-98) / 1 PATCH in 1 POUCH (0378-9122-16) / 72 h in 1 PATCH</PackageDescription>
<NDC11Code>00378-9122-98</NDC11Code>
<ProductNDC>0378-9122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20050131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076258</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>The system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 6.25 cm2). The composition per unit area of all transdermal system sizes is identical. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide. The structural formula is. Fentanyl transdermal system is a rectangular translucent system with rounded corners. “Fentanyl”, dosage strength and diagonal lines are printed in blue ink on each system. Each system is comprised of a polyester release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are. 1) a backing layer of translucent polyolefin film with blue print; 2) a drug-in-adhesive layer containing fentanyl as the active ingredient and dimethicone NF and silicone adhesive as inactive ingredients. Before use, a polyester release liner covering the drug-in-adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use.</Description>
</NDC>
<NDC>
<NDCCode>0378-9123-98</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (0378-9123-98) / 1 PATCH in 1 POUCH (0378-9123-16) / 72 h in 1 PATCH</PackageDescription>
<NDC11Code>00378-9123-98</NDC11Code>
<ProductNDC>0378-9123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20050131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076258</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>The system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 6.25 cm2). The composition per unit area of all transdermal system sizes is identical. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide. The structural formula is. Fentanyl transdermal system is a rectangular translucent system with rounded corners. “Fentanyl”, dosage strength and diagonal lines are printed in blue ink on each system. Each system is comprised of a polyester release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are. 1) a backing layer of translucent polyolefin film with blue print; 2) a drug-in-adhesive layer containing fentanyl as the active ingredient and dimethicone NF and silicone adhesive as inactive ingredients. Before use, a polyester release liner covering the drug-in-adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use.</Description>
</NDC>
<NDC>
<NDCCode>0378-9124-98</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (0378-9124-98) / 1 PATCH in 1 POUCH (0378-9124-16) / 72 h in 1 PATCH</PackageDescription>
<NDC11Code>00378-9124-98</NDC11Code>
<ProductNDC>0378-9124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20050131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076258</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>The system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 6.25 cm2). The composition per unit area of all transdermal system sizes is identical. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide. The structural formula is. Fentanyl transdermal system is a rectangular translucent system with rounded corners. “Fentanyl”, dosage strength and diagonal lines are printed in blue ink on each system. Each system is comprised of a polyester release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are. 1) a backing layer of translucent polyolefin film with blue print; 2) a drug-in-adhesive layer containing fentanyl as the active ingredient and dimethicone NF and silicone adhesive as inactive ingredients. Before use, a polyester release liner covering the drug-in-adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use.</Description>
</NDC>
<NDC>
<NDCCode>0378-9125-98</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (0378-9125-98) / 1 PATCH in 1 POUCH (0378-9125-16) / 72 h in 1 PATCH</PackageDescription>
<NDC11Code>00378-9125-98</NDC11Code>
<ProductNDC>0378-9125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20150226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076258</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>The system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 6.25 cm2). The composition per unit area of all transdermal system sizes is identical. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide. The structural formula is. Fentanyl transdermal system is a rectangular translucent system with rounded corners. “Fentanyl”, dosage strength and diagonal lines are printed in blue ink on each system. Each system is comprised of a polyester release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are. 1) a backing layer of translucent polyolefin film with blue print; 2) a drug-in-adhesive layer containing fentanyl as the active ingredient and dimethicone NF and silicone adhesive as inactive ingredients. Before use, a polyester release liner covering the drug-in-adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use.</Description>
</NDC>
<NDC>
<NDCCode>0378-9126-98</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (0378-9126-98) / 1 PATCH in 1 POUCH (0378-9126-16) / 72 h in 1 PATCH</PackageDescription>
<NDC11Code>00378-9126-98</NDC11Code>
<ProductNDC>0378-9126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20150226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076258</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>62.5</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>The system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 6.25 cm2). The composition per unit area of all transdermal system sizes is identical. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide. The structural formula is. Fentanyl transdermal system is a rectangular translucent system with rounded corners. “Fentanyl”, dosage strength and diagonal lines are printed in blue ink on each system. Each system is comprised of a polyester release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are. 1) a backing layer of translucent polyolefin film with blue print; 2) a drug-in-adhesive layer containing fentanyl as the active ingredient and dimethicone NF and silicone adhesive as inactive ingredients. Before use, a polyester release liner covering the drug-in-adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use.</Description>
</NDC>
<NDC>
<NDCCode>0378-9127-98</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (0378-9127-98) / 1 PATCH in 1 POUCH (0378-9127-16) / 72 h in 1 PATCH</PackageDescription>
<NDC11Code>00378-9127-98</NDC11Code>
<ProductNDC>0378-9127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20150226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076258</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>87.5</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>The system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 6.25 cm2). The composition per unit area of all transdermal system sizes is identical. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide. The structural formula is. Fentanyl transdermal system is a rectangular translucent system with rounded corners. “Fentanyl”, dosage strength and diagonal lines are printed in blue ink on each system. Each system is comprised of a polyester release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are. 1) a backing layer of translucent polyolefin film with blue print; 2) a drug-in-adhesive layer containing fentanyl as the active ingredient and dimethicone NF and silicone adhesive as inactive ingredients. Before use, a polyester release liner covering the drug-in-adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use.</Description>
</NDC>
<NDC>
<NDCCode>0406-9000-76</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (0406-9000-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH</PackageDescription>
<NDC11Code>00406-9000-76</NDC11Code>
<ProductNDC>0406-9000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Transdermal</ProprietaryName>
<NonProprietaryName>Fentanyl Transdermal</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20110209</StartMarketingDate>
<EndMarketingDate>20230930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077154</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110209</StartMarketingDatePackage>
<EndMarketingDatePackage>20230930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl transdermal system is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1)], reserve fentanyl transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Fentanyl transdermal system contains fentanyl, an opioid agonist, available as a patch for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hr per 7.8 cm2). The composition per unit area of all system sizes is identical. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. Fentanyl transdermal systems are a rectangular, opaque patch with rounded corners: 1 12 mcg/hr: Fentanyl Transdermal System 12 mcg/hr printed in green, 2 25 mcg/hr: Fentanyl Transdermal System 25 mcg/hr printed in green, 3 37.5 mcg/hr: Fentanyl Transdermal System 37.5 mcg/hr printed in green, 4 50 mcg/hr: Fentanyl Transdermal System 50 mcg/hr printed in green, 5 62.5 mcg/hr: Fentanyl Transdermal System 62.5 mcg/hr printed in green, 6 75 mcg/hr: Fentanyl Transdermal System 75 mcg/hr printed in green, 7 100 mcg/hr: Fentanyl Transdermal System 100 mcg/hr printed in green.</Description>
</NDC>
<NDC>
<NDCCode>0406-9037-76</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (0406-9037-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH</PackageDescription>
<NDC11Code>00406-9037-76</NDC11Code>
<ProductNDC>0406-9037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Transdermal</ProprietaryName>
<NonProprietaryName>Fentanyl Transdermal</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20200228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077154</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid-tolerant patients that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Fentanyl transdermal system contains fentanyl, an opioid agonist, available as a patch for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hr per 7.8 cm2). The composition per unit area of all system sizes is identical. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. Fentanyl transdermal systems are a rectangular, opaque patch with rounded corners: 1 12 mcg/hr: Fentanyl Transdermal System 12 mcg/hr printed in green, 2 25 mcg/hr: Fentanyl Transdermal System 25 mcg/hr printed in green, 3 37.5 mcg/hr: Fentanyl Transdermal System 37.5 mcg/hr printed in green, 4 50 mcg/hr: Fentanyl Transdermal System 50 mcg/hr printed in green, 5 62.5 mcg/hr: Fentanyl Transdermal System 62.5 mcg/hr printed in green, 6 75 mcg/hr: Fentanyl Transdermal System 75 mcg/hr printed in green, 7 100 mcg/hr: Fentanyl Transdermal System 100 mcg/hr printed in green.</Description>
</NDC>
<NDC>
<NDCCode>0406-9050-76</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (0406-9050-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH</PackageDescription>
<NDC11Code>00406-9050-76</NDC11Code>
<ProductNDC>0406-9050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Transdermal</ProprietaryName>
<NonProprietaryName>Fentanyl Transdermal</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20110209</StartMarketingDate>
<EndMarketingDate>20230930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077154</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110209</StartMarketingDatePackage>
<EndMarketingDatePackage>20230930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl transdermal system is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1)], reserve fentanyl transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Fentanyl transdermal system contains fentanyl, an opioid agonist, available as a patch for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hr per 7.8 cm2). The composition per unit area of all system sizes is identical. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. Fentanyl transdermal systems are a rectangular, opaque patch with rounded corners: 1 12 mcg/hr: Fentanyl Transdermal System 12 mcg/hr printed in green, 2 25 mcg/hr: Fentanyl Transdermal System 25 mcg/hr printed in green, 3 37.5 mcg/hr: Fentanyl Transdermal System 37.5 mcg/hr printed in green, 4 50 mcg/hr: Fentanyl Transdermal System 50 mcg/hr printed in green, 5 62.5 mcg/hr: Fentanyl Transdermal System 62.5 mcg/hr printed in green, 6 75 mcg/hr: Fentanyl Transdermal System 75 mcg/hr printed in green, 7 100 mcg/hr: Fentanyl Transdermal System 100 mcg/hr printed in green.</Description>
</NDC>
<NDC>
<NDCCode>0406-9062-76</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (0406-9062-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH</PackageDescription>
<NDC11Code>00406-9062-76</NDC11Code>
<ProductNDC>0406-9062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Transdermal</ProprietaryName>
<NonProprietaryName>Fentanyl Transdermal</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20200228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077154</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>62.5</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid-tolerant patients that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Fentanyl transdermal system contains fentanyl, an opioid agonist, available as a patch for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hr per 7.8 cm2). The composition per unit area of all system sizes is identical. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. Fentanyl transdermal systems are a rectangular, opaque patch with rounded corners: 1 12 mcg/hr: Fentanyl Transdermal System 12 mcg/hr printed in green, 2 25 mcg/hr: Fentanyl Transdermal System 25 mcg/hr printed in green, 3 37.5 mcg/hr: Fentanyl Transdermal System 37.5 mcg/hr printed in green, 4 50 mcg/hr: Fentanyl Transdermal System 50 mcg/hr printed in green, 5 62.5 mcg/hr: Fentanyl Transdermal System 62.5 mcg/hr printed in green, 6 75 mcg/hr: Fentanyl Transdermal System 75 mcg/hr printed in green, 7 100 mcg/hr: Fentanyl Transdermal System 100 mcg/hr printed in green.</Description>
</NDC>
<NDC>
<NDCCode>0406-9100-76</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (0406-9100-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH</PackageDescription>
<NDC11Code>00406-9100-76</NDC11Code>
<ProductNDC>0406-9100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Transdermal</ProprietaryName>
<NonProprietaryName>Fentanyl Transdermal</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20200506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077154</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid-tolerant patients that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 fentanyl 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 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Fentanyl transdermal system contains fentanyl, an opioid agonist, available as a patch for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hr per 7.8 cm2). The composition per unit area of all system sizes is identical. The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. Fentanyl transdermal systems are a rectangular, opaque patch with rounded corners: 1 12 mcg/hr: Fentanyl Transdermal System 12 mcg/hr printed in green, 2 25 mcg/hr: Fentanyl Transdermal System 25 mcg/hr printed in green, 3 37.5 mcg/hr: Fentanyl Transdermal System 37.5 mcg/hr printed in green, 4 50 mcg/hr: Fentanyl Transdermal System 50 mcg/hr printed in green, 5 62.5 mcg/hr: Fentanyl Transdermal System 62.5 mcg/hr printed in green, 6 75 mcg/hr: Fentanyl Transdermal System 75 mcg/hr printed in green, 7 100 mcg/hr: Fentanyl Transdermal System 100 mcg/hr printed in green.</Description>
</NDC>
</NDCList>