{
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"PackageDescription": "4 BLISTER PACK in 1 CARTON (58602-860-76) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
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"ProprietaryName": "Cetirizine Hydrochloride",
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"MarketingCategoryName": "ANDA",
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"LabelerName": "Aurohealth LLC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2021-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210212",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
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{
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"PackageDescription": "1 BOTTLE in 1 CARTON (49035-860-01) / 76.5 g in 1 BOTTLE",
"NDC11Code": "49035-0860-01",
"ProductNDC": "49035-860",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Pain Relieving Cream Lidocaine",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Wal-Mart Stores Inc",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180401",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor pain."
},
{
"NDCCode": "58602-701-76",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (58602-701-76) / 6 TABLET in 1 BLISTER PACK",
"NDC11Code": "58602-0701-76",
"ProductNDC": "58602-701",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loperamide Hydrochloride",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206548",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151215",
"SamplePackage": "N",
"IndicationAndUsage": "controls symptoms of diarrhea, including Travelers' Diarrhea."
},
{
"NDCCode": "58602-703-76",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (58602-703-76) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "58602-0703-76",
"ProductNDC": "58602-703",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230308",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212409",
"LabelerName": "Aurohealth LLC",
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"StrengthUnit": "mg/1; mg/1",
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"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230308",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyesitching of the nose or throatnasal congestion. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure . temporarily restores freer breathing through the nose."
},
{
"NDCCode": "58602-727-76",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (58602-727-76) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "58602-0727-76",
"ProductNDC": "58602-727",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loperamide Hydrochloride",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20251229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220372",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251229",
"SamplePackage": "N",
"IndicationAndUsage": "controls symptoms of diarrhea, including Travelers' Diarrhea."
},
{
"NDCCode": "58602-730-76",
"PackageDescription": "325 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-76) ",
"NDC11Code": "58602-0730-76",
"ProductNDC": "58602-730",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20161109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207229",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180811",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:minor pain of arthritis muscular achesbackachepremenstrual and menstrual crampsthe common coldheadache toothache. temporarily reduces fever."
},
{
"NDCCode": "58602-765-76",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (58602-765-76) / 6 TABLET, CHEWABLE in 1 BLISTER PACK",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Pain Relief",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20170913",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2023-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170913",
"SamplePackage": "N"
},
{
"NDCCode": "58602-766-76",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (58602-766-76) / 6 TABLET, CHEWABLE in 1 BLISTER PACK (58602-766-74) ",
"NDC11Code": "58602-0766-76",
"ProductNDC": "58602-766",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Pain Relief",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20170913",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170913",
"SamplePackage": "N"
},
{
"NDCCode": "58602-815-76",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (58602-815-76) / 6 TABLET in 1 BLISTER PACK",
"NDC11Code": "58602-0815-76",
"ProductNDC": "58602-815",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loperamide Hydrochloride And Simethicone",
"NonProprietaryName": "Loperamide Hydrochloride And Simethicone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211059",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE; DIMETHICONE",
"StrengthNumber": "2; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201214",
"SamplePackage": "N",
"IndicationAndUsage": "relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas."
},
{
"NDCCode": "58602-838-76",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (58602-838-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (58602-838-74) ",
"NDC11Code": "58602-0838-76",
"ProductNDC": "58602-838",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20200911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213557",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200911",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "58602-856-76",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (58602-856-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "58602-0856-76",
"ProductNDC": "58602-856",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20200911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213557",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200911",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "58602-862-76",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (58602-862-76) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "58602-0862-76",
"ProductNDC": "58602-862",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20210218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213557",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2021-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210218",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "58602-868-76",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (58602-868-76) / 6 TABLET in 1 BLISTER PACK",
"NDC11Code": "58602-0868-76",
"ProductNDC": "58602-868",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loperamide Hydrochloride And Simethicone",
"NonProprietaryName": "Loperamide Hydrochloride And Simethicone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211059",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE; DIMETHICONE",
"StrengthNumber": "2; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210224",
"SamplePackage": "N",
"IndicationAndUsage": "relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas."
},
{
"NDCCode": "58602-869-76",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (58602-869-76) / 6 TABLET in 1 BLISTER PACK",
"NDC11Code": "58602-0869-76",
"ProductNDC": "58602-869",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loperamide Hydrochloride And Simethicone",
"NonProprietaryName": "Loperamide Hydrochloride And Simethicone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211059",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE; DIMETHICONE",
"StrengthNumber": "2; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210224",
"SamplePackage": "N",
"IndicationAndUsage": "relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas."
},
{
"NDCCode": "58602-870-76",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (58602-870-76) > 6 TABLET in 1 BLISTER PACK",
"NDC11Code": "58602-0870-76",
"ProductNDC": "58602-870",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loperamide Hydrochloride",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206548",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2022-03-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220322",
"SamplePackage": "N",
"IndicationAndUsage": "controls symptoms of diarrhea, including Travelers' Diarrhea."
},
{
"NDCCode": "58602-873-76",
"PackageDescription": "325 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-76) ",
"NDC11Code": "58602-0873-76",
"ProductNDC": "58602-873",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20211227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207229",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211227",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:muscular achesbackacheminor pain of arthritistoothachepremenstrual and menstrual crampheadachethe common cold. temporarily reduces fever."
},
{
"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",
"NonProprietaryName": "Fentanyl Transdermal",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20110209",
"EndMarketingDate": "20230930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077154",
"LabelerName": "SpecGx LLC",
"SubstanceName": "FENTANYL",
"StrengthNumber": "100",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2023-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110209",
"EndMarketingDatePackage": "20230930",
"SamplePackage": "N",
"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": "0406-9037-76",
"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",
"StrengthNumber": "37.5",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200228",
"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": "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",
"NonProprietaryName": "Fentanyl Transdermal",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20110209",
"EndMarketingDate": "20230930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077154",
"LabelerName": "SpecGx LLC",
"SubstanceName": "FENTANYL",
"StrengthNumber": "50",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2023-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110209",
"EndMarketingDatePackage": "20230930",
"SamplePackage": "N",
"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",
"MarketingCategoryName": "ANDA",
"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",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200228",
"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": "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]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200506",
"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": "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": "0406-9112-76",
"PackageDescription": "5 POUCH in 1 CARTON (0406-9112-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH",
"NDC11Code": "00406-9112-76",
"ProductNDC": "0406-9112",
"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": "12.5",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200506",
"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": "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": "0406-9125-76",
"PackageDescription": "5 POUCH in 1 CARTON (0406-9125-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH",
"NDC11Code": "00406-9125-76",
"ProductNDC": "0406-9125",
"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": "25",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200506",
"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": "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": "0406-9150-76",
"PackageDescription": "5 POUCH in 1 CARTON (0406-9150-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH",
"NDC11Code": "00406-9150-76",
"ProductNDC": "0406-9150",
"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": "50",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200506",
"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": "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": "0406-9175-76",
"PackageDescription": "5 POUCH in 1 CARTON (0406-9175-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH",
"NDC11Code": "00406-9175-76",
"ProductNDC": "0406-9175",
"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": "75",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200506",
"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": "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": "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."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
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<PackageDescription>4 BLISTER PACK in 1 CARTON (58602-860-76) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20210212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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</NDC>
<NDC>
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<ProductNDC>49035-860</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<LabelerName>Wal-Mart Stores Inc</LabelerName>
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<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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</NDC>
<NDC>
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<PackageDescription>4 BLISTER PACK in 1 CARTON (58602-701-76) / 6 TABLET in 1 BLISTER PACK</PackageDescription>
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<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>controls symptoms of diarrhea, including Travelers' Diarrhea.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>4 BLISTER PACK in 1 CARTON (58602-703-76) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>58602-703</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230308</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyesitching of the nose or throatnasal congestion. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure . temporarily restores freer breathing through the nose.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>4 BLISTER PACK in 1 CARTON (58602-727-76) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>58602-727</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loperamide Hydrochloride</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20251229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220372</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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</NDC>
<NDC>
<NDCCode>58602-730-76</NDCCode>
<PackageDescription>325 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-76) </PackageDescription>
<NDC11Code>58602-0730-76</NDC11Code>
<ProductNDC>58602-730</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
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<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207229</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:minor pain of arthritis muscular achesbackachepremenstrual and menstrual crampsthe common coldheadache toothache. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58602-765-76</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (58602-765-76) / 6 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>58602-0765-76</NDC11Code>
<ProductNDC>58602-765</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Pain Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-11-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
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<PackageDescription>4 BLISTER PACK in 1 CARTON (58602-766-76) / 6 TABLET, CHEWABLE in 1 BLISTER PACK (58602-766-74) </PackageDescription>
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<ProductNDC>58602-766</ProductNDC>
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<ProprietaryName>Childrens Pain Relief</ProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58602-815-76</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (58602-815-76) / 6 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>58602-0815-76</NDC11Code>
<ProductNDC>58602-815</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loperamide Hydrochloride And Simethicone</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride And Simethicone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211059</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE; DIMETHICONE</SubstanceName>
<StrengthNumber>2; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58602-838-76</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (58602-838-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (58602-838-74) </PackageDescription>
<NDC11Code>58602-0838-76</NDC11Code>
<ProductNDC>58602-838</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213557</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58602-856-76</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (58602-856-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>58602-0856-76</NDC11Code>
<ProductNDC>58602-856</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213557</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58602-862-76</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (58602-862-76) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>58602-0862-76</NDC11Code>
<ProductNDC>58602-862</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213557</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58602-868-76</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (58602-868-76) / 6 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>58602-0868-76</NDC11Code>
<ProductNDC>58602-868</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loperamide Hydrochloride And Simethicone</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride And Simethicone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211059</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE; DIMETHICONE</SubstanceName>
<StrengthNumber>2; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58602-869-76</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (58602-869-76) / 6 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>58602-0869-76</NDC11Code>
<ProductNDC>58602-869</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loperamide Hydrochloride And Simethicone</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride And Simethicone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211059</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE; DIMETHICONE</SubstanceName>
<StrengthNumber>2; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58602-870-76</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (58602-870-76) > 6 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>58602-0870-76</NDC11Code>
<ProductNDC>58602-870</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loperamide Hydrochloride</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206548</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-03-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>controls symptoms of diarrhea, including Travelers' Diarrhea.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58602-873-76</NDCCode>
<PackageDescription>325 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-76) </PackageDescription>
<NDC11Code>58602-0873-76</NDC11Code>
<ProductNDC>58602-873</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207229</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:muscular achesbackacheminor pain of arthritistoothachepremenstrual and menstrual crampheadachethe common cold. temporarily reduces fever.</IndicationAndUsage>
</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>
<NDC>
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<PackageDescription>5 POUCH in 1 CARTON (0406-9112-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH</PackageDescription>
<NDC11Code>00406-9112-76</NDC11Code>
<ProductNDC>0406-9112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<StartMarketingDate>20200506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077154</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
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<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>
<NDC>
<NDCCode>0406-9125-76</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (0406-9125-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH</PackageDescription>
<NDC11Code>00406-9125-76</NDC11Code>
<ProductNDC>0406-9125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Transdermal</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077154</ApplicationNumber>
<LabelerName>SpecGx LLC</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>2026-05-05</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>
<NDC>
<NDCCode>0406-9150-76</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (0406-9150-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH</PackageDescription>
<NDC11Code>00406-9150-76</NDC11Code>
<ProductNDC>0406-9150</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>50</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-05</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>
<NDC>
<NDCCode>0406-9175-76</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (0406-9175-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH</PackageDescription>
<NDC11Code>00406-9175-76</NDC11Code>
<ProductNDC>0406-9175</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>75</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-05</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>
<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>
</NDCList>