{
"NDC": [
{
"NDCCode": "63459-404-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (63459-404-30) ",
"NDC11Code": "63459-0404-30",
"ProductNDC": "63459-404",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabitril",
"NonProprietaryName": "Tiagabine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20010401",
"EndMarketingDate": "20240430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020646",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "TIAGABINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100208",
"EndMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "GABITRIL (tiagabine hydrochloride) is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.",
"Description": "GABITRIL® (tiagabine HCl) is an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride, its molecular formula is C20H25NO2S2 HCl, and its molecular weight is 412.0. Tiagabine HCl is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base. The structural formula is."
},
{
"NDCCode": "63459-404-99",
"PackageDescription": "122881 TABLET, FILM COATED in 1 DRUM (63459-404-99) ",
"NDC11Code": "63459-0404-99",
"ProductNDC": "63459-404",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Tiagabine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20100208",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "TIAGABINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2026-09-25",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "08-FEB-10"
},
{
"NDCCode": "63459-101-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (63459-101-30) ",
"NDC11Code": "63459-0101-30",
"ProductNDC": "63459-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Provigil",
"NonProprietaryName": "Modafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990215",
"EndMarketingDate": "20260930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020717",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "MODAFINIL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110103",
"EndMarketingDatePackage": "20260930",
"SamplePackage": "N",
"IndicationAndUsage": "PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use. In OSA, PROVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with PROVIGIL for excessive sleepiness.",
"Description": "PROVIGIL (modafinil) is a wakefulness‑promoting agent for oral administration. Modafinil is a racemic compound. The chemical name for modafinil is 2‑[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Modafinil is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. PROVIGIL tablets contain 100 mg or 200 mg of modafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch."
},
{
"NDCCode": "63459-201-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (63459-201-30) ",
"NDC11Code": "63459-0201-30",
"ProductNDC": "63459-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Provigil",
"NonProprietaryName": "Modafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990215",
"EndMarketingDate": "20270831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020717",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "MODAFINIL",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110103",
"EndMarketingDatePackage": "20270831",
"SamplePackage": "N",
"IndicationAndUsage": "PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use. In OSA, PROVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with PROVIGIL for excessive sleepiness.",
"Description": "PROVIGIL (modafinil) is a wakefulness‑promoting agent for oral administration. Modafinil is a racemic compound. The chemical name for modafinil is 2‑[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Modafinil is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. PROVIGIL tablets contain 100 mg or 200 mg of modafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch."
},
{
"NDCCode": "63459-205-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (63459-205-30) ",
"NDC11Code": "63459-0205-30",
"ProductNDC": "63459-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nuvigil",
"NonProprietaryName": "Armodafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090526",
"EndMarketingDate": "20260331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021875",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "ARMODAFINIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110103",
"EndMarketingDatePackage": "20260331",
"SamplePackage": "N",
"IndicationAndUsage": "NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating NUVIGIL for excessive sleepiness.",
"Description": "NUVIGIL (armodafinil) is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. NUVIGIL tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch."
},
{
"NDCCode": "63459-215-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (63459-215-30) ",
"NDC11Code": "63459-0215-30",
"ProductNDC": "63459-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nuvigil",
"NonProprietaryName": "Armodafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090526",
"EndMarketingDate": "20280630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021875",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "ARMODAFINIL",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110103",
"EndMarketingDatePackage": "20280630",
"SamplePackage": "N",
"IndicationAndUsage": "NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating NUVIGIL for excessive sleepiness.",
"Description": "NUVIGIL (armodafinil) is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. NUVIGIL tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch."
},
{
"NDCCode": "63459-220-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (63459-220-30) ",
"NDC11Code": "63459-0220-30",
"ProductNDC": "63459-220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nuvigil",
"NonProprietaryName": "Armodafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140220",
"EndMarketingDate": "20260331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021875",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "ARMODAFINIL",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140220",
"EndMarketingDatePackage": "20260331",
"SamplePackage": "N",
"IndicationAndUsage": "NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating NUVIGIL for excessive sleepiness.",
"Description": "NUVIGIL (armodafinil) is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. NUVIGIL tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch."
},
{
"NDCCode": "63459-225-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (63459-225-30) ",
"NDC11Code": "63459-0225-30",
"ProductNDC": "63459-225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nuvigil",
"NonProprietaryName": "Armodafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090526",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021875",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "ARMODAFINIL",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110103",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating NUVIGIL for excessive sleepiness.",
"Description": "NUVIGIL (armodafinil) is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. NUVIGIL tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch."
},
{
"NDCCode": "63459-402-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (63459-402-30) ",
"NDC11Code": "63459-0402-30",
"ProductNDC": "63459-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabitril",
"NonProprietaryName": "Tiagabine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20010401",
"EndMarketingDate": "20240430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020646",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "TIAGABINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100208",
"EndMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "GABITRIL (tiagabine hydrochloride) is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.",
"Description": "GABITRIL® (tiagabine HCl) is an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride, its molecular formula is C20H25NO2S2 HCl, and its molecular weight is 412.0. Tiagabine HCl is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base. The structural formula is."
},
{
"NDCCode": "63459-412-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (63459-412-30) ",
"NDC11Code": "63459-0412-30",
"ProductNDC": "63459-412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabitril",
"NonProprietaryName": "Tiagabine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20010401",
"EndMarketingDate": "20240430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020646",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "TIAGABINE HYDROCHLORIDE",
"StrengthNumber": "12",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100208",
"EndMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "GABITRIL (tiagabine hydrochloride) is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.",
"Description": "GABITRIL® (tiagabine HCl) is an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride, its molecular formula is C20H25NO2S2 HCl, and its molecular weight is 412.0. Tiagabine HCl is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base. The structural formula is."
},
{
"NDCCode": "63459-416-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (63459-416-30) ",
"NDC11Code": "63459-0416-30",
"ProductNDC": "63459-416",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabitril",
"NonProprietaryName": "Tiagabine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20010401",
"EndMarketingDate": "20240331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020646",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "TIAGABINE HYDROCHLORIDE",
"StrengthNumber": "16",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100208",
"EndMarketingDatePackage": "20240331",
"SamplePackage": "N",
"IndicationAndUsage": "GABITRIL (tiagabine hydrochloride) is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.",
"Description": "GABITRIL® (tiagabine HCl) is an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride, its molecular formula is C20H25NO2S2 HCl, and its molecular weight is 412.0. Tiagabine HCl is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base. The structural formula is."
},
{
"NDCCode": "63459-502-30",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (63459-502-30) / 1 LOZENGE in 1 BLISTER PACK (63459-502-01) ",
"NDC11Code": "63459-0502-30",
"ProductNDC": "63459-502",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Actiq",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL; TRANSMUCOSAL",
"StartMarketingDate": "19990120",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020747",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19990120",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "ACTIQ is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids when taking ACTIQ. Limitations of Use: 1 Not for use in opioid non-tolerant patients., 2 Not for use in the management of acute or postoperative pain, including headache/migraine and dental pain [see Contraindications (4)]., 3 As a part of the TIRF REMS, ACTIQ may be dispensed by outpatient pharmacies only to outpatients enrolled in the program [see Warnings and Precautions (5.7)]. For inpatient administration of ACTIQ, patient and prescriber enrollment are not required.",
"Description": "ACTIQ (fentanyl citrate) oral transmucosal lozenge is a solid formulation of fentanyl, an opioid agonist, intended for oral transmucosal administration. ACTIQ is formulated as a white to off-white solid drug matrix on a handle that is fracture resistant (ABS plastic) under normal conditions when used as directed. ACTIQ is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the ACTIQ unit to be removed from the mouth if signs of excessive opioid effects appear during administration. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. Inactive Ingredients: Hydrated dextrates, citric acid, dibasic sodium phosphate, artificial berry flavor, magnesium stearate, and edible glue (modified food starch and confectioner’s sugar)."
},
{
"NDCCode": "63459-504-30",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (63459-504-30) / 1 LOZENGE in 1 BLISTER PACK (63459-504-01) ",
"NDC11Code": "63459-0504-30",
"ProductNDC": "63459-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Actiq",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL; TRANSMUCOSAL",
"StartMarketingDate": "19990120",
"EndMarketingDate": "20250531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020747",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "400",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19990120",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "N",
"IndicationAndUsage": "ACTIQ is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids when taking ACTIQ. Limitations of Use: 1 Not for use in opioid non-tolerant patients., 2 Not for use in the management of acute or postoperative pain, including headache/migraine and dental pain [see Contraindications (4)]., 3 As a part of the TIRF REMS, ACTIQ may be dispensed by outpatient pharmacies only to outpatients enrolled in the program [see Warnings and Precautions (5.7)]. For inpatient administration of ACTIQ, patient and prescriber enrollment are not required.",
"Description": "ACTIQ (fentanyl citrate) oral transmucosal lozenge is a solid formulation of fentanyl, an opioid agonist, intended for oral transmucosal administration. ACTIQ is formulated as a white to off-white solid drug matrix on a handle that is fracture resistant (ABS plastic) under normal conditions when used as directed. ACTIQ is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the ACTIQ unit to be removed from the mouth if signs of excessive opioid effects appear during administration. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. Inactive Ingredients: Hydrated dextrates, citric acid, dibasic sodium phosphate, artificial berry flavor, magnesium stearate, and edible glue (modified food starch and confectioner’s sugar)."
},
{
"NDCCode": "63459-506-30",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (63459-506-30) / 1 LOZENGE in 1 BLISTER PACK (63459-506-01) ",
"NDC11Code": "63459-0506-30",
"ProductNDC": "63459-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Actiq",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL; TRANSMUCOSAL",
"StartMarketingDate": "19990120",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020747",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "600",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19990120",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "ACTIQ is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids when taking ACTIQ. Limitations of Use: 1 Not for use in opioid non-tolerant patients., 2 Not for use in the management of acute or postoperative pain, including headache/migraine and dental pain [see Contraindications (4)]., 3 As a part of the TIRF REMS, ACTIQ may be dispensed by outpatient pharmacies only to outpatients enrolled in the program [see Warnings and Precautions (5.7)]. For inpatient administration of ACTIQ, patient and prescriber enrollment are not required.",
"Description": "ACTIQ (fentanyl citrate) oral transmucosal lozenge is a solid formulation of fentanyl, an opioid agonist, intended for oral transmucosal administration. ACTIQ is formulated as a white to off-white solid drug matrix on a handle that is fracture resistant (ABS plastic) under normal conditions when used as directed. ACTIQ is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the ACTIQ unit to be removed from the mouth if signs of excessive opioid effects appear during administration. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. Inactive Ingredients: Hydrated dextrates, citric acid, dibasic sodium phosphate, artificial berry flavor, magnesium stearate, and edible glue (modified food starch and confectioner’s sugar)."
},
{
"NDCCode": "63459-508-30",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (63459-508-30) / 1 LOZENGE in 1 BLISTER PACK (63459-508-01) ",
"NDC11Code": "63459-0508-30",
"ProductNDC": "63459-508",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Actiq",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL; TRANSMUCOSAL",
"StartMarketingDate": "19990120",
"EndMarketingDate": "20240630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020747",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "800",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19990120",
"EndMarketingDatePackage": "20240630",
"SamplePackage": "N",
"IndicationAndUsage": "ACTIQ is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids when taking ACTIQ. Limitations of Use: 1 Not for use in opioid non-tolerant patients., 2 Not for use in the management of acute or postoperative pain, including headache/migraine and dental pain [see Contraindications (4)]., 3 As a part of the TIRF REMS, ACTIQ may be dispensed by outpatient pharmacies only to outpatients enrolled in the program [see Warnings and Precautions (5.7)]. For inpatient administration of ACTIQ, patient and prescriber enrollment are not required.",
"Description": "ACTIQ (fentanyl citrate) oral transmucosal lozenge is a solid formulation of fentanyl, an opioid agonist, intended for oral transmucosal administration. ACTIQ is formulated as a white to off-white solid drug matrix on a handle that is fracture resistant (ABS plastic) under normal conditions when used as directed. ACTIQ is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the ACTIQ unit to be removed from the mouth if signs of excessive opioid effects appear during administration. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. Inactive Ingredients: Hydrated dextrates, citric acid, dibasic sodium phosphate, artificial berry flavor, magnesium stearate, and edible glue (modified food starch and confectioner’s sugar)."
},
{
"NDCCode": "63459-512-30",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (63459-512-30) / 1 LOZENGE in 1 BLISTER PACK (63459-512-01) ",
"NDC11Code": "63459-0512-30",
"ProductNDC": "63459-512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Actiq",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL; TRANSMUCOSAL",
"StartMarketingDate": "19990120",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020747",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "1200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19990120",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "ACTIQ is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids when taking ACTIQ. Limitations of Use: 1 Not for use in opioid non-tolerant patients., 2 Not for use in the management of acute or postoperative pain, including headache/migraine and dental pain [see Contraindications (4)]., 3 As a part of the TIRF REMS, ACTIQ may be dispensed by outpatient pharmacies only to outpatients enrolled in the program [see Warnings and Precautions (5.7)]. For inpatient administration of ACTIQ, patient and prescriber enrollment are not required.",
"Description": "ACTIQ (fentanyl citrate) oral transmucosal lozenge is a solid formulation of fentanyl, an opioid agonist, intended for oral transmucosal administration. ACTIQ is formulated as a white to off-white solid drug matrix on a handle that is fracture resistant (ABS plastic) under normal conditions when used as directed. ACTIQ is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the ACTIQ unit to be removed from the mouth if signs of excessive opioid effects appear during administration. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. Inactive Ingredients: Hydrated dextrates, citric acid, dibasic sodium phosphate, artificial berry flavor, magnesium stearate, and edible glue (modified food starch and confectioner’s sugar)."
},
{
"NDCCode": "63459-516-30",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (63459-516-30) / 1 LOZENGE in 1 BLISTER PACK (63459-516-01) ",
"NDC11Code": "63459-0516-30",
"ProductNDC": "63459-516",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Actiq",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL; TRANSMUCOSAL",
"StartMarketingDate": "19990120",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020747",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "1600",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2023-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19990120",
"SamplePackage": "N"
},
{
"NDCCode": "13537-404-01",
"PackageDescription": "1 BOTTLE in 1 BOX (13537-404-01) > 30 mL in 1 BOTTLE (13537-404-02)",
"NDC11Code": "13537-0404-01",
"ProductNDC": "13537-404",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel",
"ProprietaryNameSuffix": "Dermo Clarite Clarifying And Moisturizing With Spf 30",
"NonProprietaryName": "Avobenzone, Ensulizole, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111213",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation Ltd.",
"SubstanceName": "AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": ".03; .03; .05; .05; .06",
"StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16781-404-60",
"PackageDescription": "1 KIT in 1 CARTON (16781-404-60) * 60 CAPSULE in 1 BOTTLE * 30 SWAB in 1 PACKET",
"NDC11Code": "16781-0404-60",
"ProductNDC": "16781-404",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocin",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20130617",
"EndMarketingDate": "20160131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050649",
"LabelerName": "Onset Dermatologics, LLC",
"Status": "Deprecated",
"LastUpdate": "2015-09-04"
},
{
"NDCCode": "21695-404-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (21695-404-30)",
"NDC11Code": "21695-0404-30",
"ProductNDC": "21695-404",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19991220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074984",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5 H)one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride is formulated as a once-a-day extended release capsule containing either 120 mg, 180 mg, 240 mg, or 300 mg diltiazem hydrochloride. Each diltiazem extended-release capsule, for oral administration, contains the following inactive ingredients. 120 mg — ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, black iron oxide, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. 180 mg — ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, D&C yellow #10, FD&C blue #1, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. 240 mg — ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, D&C yellow #10, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. 300 mg— ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, black iron oxide, D&C yellow #10, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. This drug product conforms to USP Drug release test #11."
},
{
"NDCCode": "24236-404-02",
"PackageDescription": "30 CAPSULE in 1 BLISTER PACK (24236-404-02)",
"NDC11Code": "24236-0404-02",
"ProductNDC": "24236-404",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracycline Hydrochloride",
"NonProprietaryName": "Tetracycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20111213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA060704",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "37000-404-30",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (37000-404-30) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "37000-0404-30",
"ProductNDC": "37000-404",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vicks Qlearquil",
"ProprietaryNameSuffix": "All Day And All Night 24 Hour Allergy Relief",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140301",
"EndMarketingDate": "20180701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076301",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-07-02",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "43063-404-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (43063-404-30) ",
"NDC11Code": "43063-0404-30",
"ProductNDC": "43063-404",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100621",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078477",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130619",
"SamplePackage": "N"
},
{
"NDCCode": "43547-404-03",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (43547-404-03) ",
"NDC11Code": "43547-0404-03",
"ProductNDC": "43547-404",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040377",
"LabelerName": "Solco Healthcare U.S., LLC",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20020104",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine hydrochloride tablets [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage."
},
{
"NDCCode": "45865-404-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (45865-404-30) ",
"NDC11Code": "45865-0404-30",
"ProductNDC": "45865-404",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075483",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Enalapril maleate is indicated for the treatment of hypertension. Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.",
"Description": "Enalapril maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[ N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, ( Z)-2-butenedioate salt (1:1). Its molecular formula is, C 20H 28N 2O 5●C 4H 4O 4, and its structural formula is:. Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin converting enzyme inhibitor. Enalapril maleate is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: hypromellose, anhydrous lactose, corn starch, stearic acid and talc. The 10 mg and 20 mg tablets also contain iron oxides."
},
{
"NDCCode": "46708-404-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (46708-404-30) ",
"NDC11Code": "46708-0404-30",
"ProductNDC": "46708-404",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nadolol",
"NonProprietaryName": "Nadolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230608",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211763",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "NADOLOL",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-15",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Angina Pectoris. Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Hypertension. Nadolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nadolol tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Nadolol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.",
"Description": "Nadolol, USP is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5,6,7,8-tetrahydro-cis-6,7-dihydroxy-1- naphthyl)oxy]-2-propanol. Structural formula. C17H27NO4 MW 309.40. Nadolol, USP is a white to off-white powder. It is freely soluble in alcohol and in methanol, soluble in water at pH 2, slightly soluble in chloroform, in methylene chloride, in isopropyl alcohol, and in water (between pH 7 and pH 10); insoluble in acetone, in benzene, in ether, in hexane, and in trichloroethane. Each tablet for oral administration contains 20 mg, 40 mg, or 80 mg of nadolol, USP and the following inactive ingredients: povidone K-30, corn starch, microcrystalline cellulose, citric acid monohydrate, FD&C Blue No. 2 Aluminum Lake, and magnesium stearate."
},
{
"NDCCode": "47593-404-30",
"PackageDescription": "207 mL in 1 BOTTLE, PLASTIC (47593-404-30)",
"NDC11Code": "47593-0404-30",
"ProductNDC": "47593-404",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Digisan E Foam Hand Sanitizer",
"NonProprietaryName": "Antiseptic Handwash",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20031104",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Ecolab Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2017-06-21"
},
{
"NDCCode": "49349-404-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (49349-404-02)",
"NDC11Code": "49349-0404-02",
"ProductNDC": "49349-404",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Reliever Plus",
"NonProprietaryName": "Acetaminophen, Aspirin And Caffeine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161117",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-05-02"
},
{
"NDCCode": "49643-404-30",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49643-404-30) ",
"NDC11Code": "49643-0404-30",
"ProductNDC": "49643-404",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Gambels Oak Pollen",
"NonProprietaryName": "Quercus Gambelii",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "QUERCUS GAMBELII POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
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"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "51346-404-02",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (51346-404-02) > 30 mL in 1 BOTTLE, PUMP (51346-404-01)",
"NDC11Code": "51346-0404-02",
"ProductNDC": "51346-404",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Provence Air Skin Fit Foundation Ginger Beige C02",
"NonProprietaryName": "Titanium Dioxide, Octinoxate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "NATURE REPUBLIC CO., LTD.",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "3.24; .9; .57",
"StrengthUnit": "g/30mL; g/30mL; g/30mL",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"ProductNdcExcludeFlag": "N",
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}
]
}
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<IndicationAndUsage>GABITRIL (tiagabine hydrochloride) is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.</IndicationAndUsage>
<Description>GABITRIL® (tiagabine HCl) is an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride, its molecular formula is C20H25NO2S2 HCl, and its molecular weight is 412.0. Tiagabine HCl is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base. The structural formula is.</Description>
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<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
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<NDC>
<NDCCode>63459-101-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (63459-101-30) </PackageDescription>
<NDC11Code>63459-0101-30</NDC11Code>
<ProductNDC>63459-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Provigil</ProprietaryName>
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<LabelerName>Cephalon, LLC</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110103</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use. In OSA, PROVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with PROVIGIL for excessive sleepiness.</IndicationAndUsage>
<Description>PROVIGIL (modafinil) is a wakefulness‑promoting agent for oral administration. Modafinil is a racemic compound. The chemical name for modafinil is 2‑[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Modafinil is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. PROVIGIL tablets contain 100 mg or 200 mg of modafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>63459-201-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (63459-201-30) </PackageDescription>
<NDC11Code>63459-0201-30</NDC11Code>
<ProductNDC>63459-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Provigil</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>19990215</StartMarketingDate>
<EndMarketingDate>20270831</EndMarketingDate>
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<LabelerName>Cephalon, LLC</LabelerName>
<SubstanceName>MODAFINIL</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110103</StartMarketingDatePackage>
<EndMarketingDatePackage>20270831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use. In OSA, PROVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with PROVIGIL for excessive sleepiness.</IndicationAndUsage>
<Description>PROVIGIL (modafinil) is a wakefulness‑promoting agent for oral administration. Modafinil is a racemic compound. The chemical name for modafinil is 2‑[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Modafinil is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. PROVIGIL tablets contain 100 mg or 200 mg of modafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>63459-205-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (63459-205-30) </PackageDescription>
<NDC11Code>63459-0205-30</NDC11Code>
<ProductNDC>63459-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nuvigil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
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<EndMarketingDate>20260331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
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<LabelerName>Cephalon, LLC</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110103</StartMarketingDatePackage>
<EndMarketingDatePackage>20260331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating NUVIGIL for excessive sleepiness.</IndicationAndUsage>
<Description>NUVIGIL (armodafinil) is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. NUVIGIL tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>63459-215-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (63459-215-30) </PackageDescription>
<NDC11Code>63459-0215-30</NDC11Code>
<ProductNDC>63459-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nuvigil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090526</StartMarketingDate>
<EndMarketingDate>20280630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021875</ApplicationNumber>
<LabelerName>Cephalon, LLC</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110103</StartMarketingDatePackage>
<EndMarketingDatePackage>20280630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating NUVIGIL for excessive sleepiness.</IndicationAndUsage>
<Description>NUVIGIL (armodafinil) is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. NUVIGIL tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>63459-220-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (63459-220-30) </PackageDescription>
<NDC11Code>63459-0220-30</NDC11Code>
<ProductNDC>63459-220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nuvigil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140220</StartMarketingDate>
<EndMarketingDate>20260331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
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<LabelerName>Cephalon, LLC</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140220</StartMarketingDatePackage>
<EndMarketingDatePackage>20260331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating NUVIGIL for excessive sleepiness.</IndicationAndUsage>
<Description>NUVIGIL (armodafinil) is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. NUVIGIL tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>63459-225-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (63459-225-30) </PackageDescription>
<NDC11Code>63459-0225-30</NDC11Code>
<ProductNDC>63459-225</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nuvigil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090526</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021875</ApplicationNumber>
<LabelerName>Cephalon, LLC</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110103</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating NUVIGIL for excessive sleepiness.</IndicationAndUsage>
<Description>NUVIGIL (armodafinil) is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. NUVIGIL tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>63459-402-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (63459-402-30) </PackageDescription>
<NDC11Code>63459-0402-30</NDC11Code>
<ProductNDC>63459-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabitril</ProprietaryName>
<NonProprietaryName>Tiagabine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010401</StartMarketingDate>
<EndMarketingDate>20240430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020646</ApplicationNumber>
<LabelerName>Cephalon, LLC</LabelerName>
<SubstanceName>TIAGABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100208</StartMarketingDatePackage>
<EndMarketingDatePackage>20240430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GABITRIL (tiagabine hydrochloride) is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.</IndicationAndUsage>
<Description>GABITRIL® (tiagabine HCl) is an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride, its molecular formula is C20H25NO2S2 HCl, and its molecular weight is 412.0. Tiagabine HCl is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>63459-412-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (63459-412-30) </PackageDescription>
<NDC11Code>63459-0412-30</NDC11Code>
<ProductNDC>63459-412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabitril</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
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<StartMarketingDate>20010401</StartMarketingDate>
<EndMarketingDate>20240430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020646</ApplicationNumber>
<LabelerName>Cephalon, LLC</LabelerName>
<SubstanceName>TIAGABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100208</StartMarketingDatePackage>
<EndMarketingDatePackage>20240430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GABITRIL (tiagabine hydrochloride) is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.</IndicationAndUsage>
<Description>GABITRIL® (tiagabine HCl) is an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride, its molecular formula is C20H25NO2S2 HCl, and its molecular weight is 412.0. Tiagabine HCl is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>63459-416-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (63459-416-30) </PackageDescription>
<NDC11Code>63459-0416-30</NDC11Code>
<ProductNDC>63459-416</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabitril</ProprietaryName>
<NonProprietaryName>Tiagabine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010401</StartMarketingDate>
<EndMarketingDate>20240331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020646</ApplicationNumber>
<LabelerName>Cephalon, LLC</LabelerName>
<SubstanceName>TIAGABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100208</StartMarketingDatePackage>
<EndMarketingDatePackage>20240331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GABITRIL (tiagabine hydrochloride) is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.</IndicationAndUsage>
<Description>GABITRIL® (tiagabine HCl) is an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride, its molecular formula is C20H25NO2S2 HCl, and its molecular weight is 412.0. Tiagabine HCl is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>63459-502-30</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (63459-502-30) / 1 LOZENGE in 1 BLISTER PACK (63459-502-01) </PackageDescription>
<NDC11Code>63459-0502-30</NDC11Code>
<ProductNDC>63459-502</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Actiq</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL; TRANSMUCOSAL</RouteName>
<StartMarketingDate>19990120</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020747</ApplicationNumber>
<LabelerName>Cephalon, LLC</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19990120</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ACTIQ is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids when taking ACTIQ. Limitations of Use: 1 Not for use in opioid non-tolerant patients., 2 Not for use in the management of acute or postoperative pain, including headache/migraine and dental pain [see Contraindications (4)]., 3 As a part of the TIRF REMS, ACTIQ may be dispensed by outpatient pharmacies only to outpatients enrolled in the program [see Warnings and Precautions (5.7)]. For inpatient administration of ACTIQ, patient and prescriber enrollment are not required.</IndicationAndUsage>
<Description>ACTIQ (fentanyl citrate) oral transmucosal lozenge is a solid formulation of fentanyl, an opioid agonist, intended for oral transmucosal administration. ACTIQ is formulated as a white to off-white solid drug matrix on a handle that is fracture resistant (ABS plastic) under normal conditions when used as directed. ACTIQ is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the ACTIQ unit to be removed from the mouth if signs of excessive opioid effects appear during administration. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. Inactive Ingredients: Hydrated dextrates, citric acid, dibasic sodium phosphate, artificial berry flavor, magnesium stearate, and edible glue (modified food starch and confectioner’s sugar).</Description>
</NDC>
<NDC>
<NDCCode>63459-504-30</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (63459-504-30) / 1 LOZENGE in 1 BLISTER PACK (63459-504-01) </PackageDescription>
<NDC11Code>63459-0504-30</NDC11Code>
<ProductNDC>63459-504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Actiq</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL; TRANSMUCOSAL</RouteName>
<StartMarketingDate>19990120</StartMarketingDate>
<EndMarketingDate>20250531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020747</ApplicationNumber>
<LabelerName>Cephalon, LLC</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19990120</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ACTIQ is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids when taking ACTIQ. Limitations of Use: 1 Not for use in opioid non-tolerant patients., 2 Not for use in the management of acute or postoperative pain, including headache/migraine and dental pain [see Contraindications (4)]., 3 As a part of the TIRF REMS, ACTIQ may be dispensed by outpatient pharmacies only to outpatients enrolled in the program [see Warnings and Precautions (5.7)]. For inpatient administration of ACTIQ, patient and prescriber enrollment are not required.</IndicationAndUsage>
<Description>ACTIQ (fentanyl citrate) oral transmucosal lozenge is a solid formulation of fentanyl, an opioid agonist, intended for oral transmucosal administration. ACTIQ is formulated as a white to off-white solid drug matrix on a handle that is fracture resistant (ABS plastic) under normal conditions when used as directed. ACTIQ is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the ACTIQ unit to be removed from the mouth if signs of excessive opioid effects appear during administration. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. Inactive Ingredients: Hydrated dextrates, citric acid, dibasic sodium phosphate, artificial berry flavor, magnesium stearate, and edible glue (modified food starch and confectioner’s sugar).</Description>
</NDC>
<NDC>
<NDCCode>63459-506-30</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (63459-506-30) / 1 LOZENGE in 1 BLISTER PACK (63459-506-01) </PackageDescription>
<NDC11Code>63459-0506-30</NDC11Code>
<ProductNDC>63459-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Actiq</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL; TRANSMUCOSAL</RouteName>
<StartMarketingDate>19990120</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020747</ApplicationNumber>
<LabelerName>Cephalon, LLC</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19990120</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ACTIQ is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids when taking ACTIQ. Limitations of Use: 1 Not for use in opioid non-tolerant patients., 2 Not for use in the management of acute or postoperative pain, including headache/migraine and dental pain [see Contraindications (4)]., 3 As a part of the TIRF REMS, ACTIQ may be dispensed by outpatient pharmacies only to outpatients enrolled in the program [see Warnings and Precautions (5.7)]. For inpatient administration of ACTIQ, patient and prescriber enrollment are not required.</IndicationAndUsage>
<Description>ACTIQ (fentanyl citrate) oral transmucosal lozenge is a solid formulation of fentanyl, an opioid agonist, intended for oral transmucosal administration. ACTIQ is formulated as a white to off-white solid drug matrix on a handle that is fracture resistant (ABS plastic) under normal conditions when used as directed. ACTIQ is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the ACTIQ unit to be removed from the mouth if signs of excessive opioid effects appear during administration. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. Inactive Ingredients: Hydrated dextrates, citric acid, dibasic sodium phosphate, artificial berry flavor, magnesium stearate, and edible glue (modified food starch and confectioner’s sugar).</Description>
</NDC>
<NDC>
<NDCCode>63459-508-30</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (63459-508-30) / 1 LOZENGE in 1 BLISTER PACK (63459-508-01) </PackageDescription>
<NDC11Code>63459-0508-30</NDC11Code>
<ProductNDC>63459-508</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Actiq</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL; TRANSMUCOSAL</RouteName>
<StartMarketingDate>19990120</StartMarketingDate>
<EndMarketingDate>20240630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020747</ApplicationNumber>
<LabelerName>Cephalon, LLC</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19990120</StartMarketingDatePackage>
<EndMarketingDatePackage>20240630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ACTIQ is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids when taking ACTIQ. Limitations of Use: 1 Not for use in opioid non-tolerant patients., 2 Not for use in the management of acute or postoperative pain, including headache/migraine and dental pain [see Contraindications (4)]., 3 As a part of the TIRF REMS, ACTIQ may be dispensed by outpatient pharmacies only to outpatients enrolled in the program [see Warnings and Precautions (5.7)]. For inpatient administration of ACTIQ, patient and prescriber enrollment are not required.</IndicationAndUsage>
<Description>ACTIQ (fentanyl citrate) oral transmucosal lozenge is a solid formulation of fentanyl, an opioid agonist, intended for oral transmucosal administration. ACTIQ is formulated as a white to off-white solid drug matrix on a handle that is fracture resistant (ABS plastic) under normal conditions when used as directed. ACTIQ is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the ACTIQ unit to be removed from the mouth if signs of excessive opioid effects appear during administration. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. Inactive Ingredients: Hydrated dextrates, citric acid, dibasic sodium phosphate, artificial berry flavor, magnesium stearate, and edible glue (modified food starch and confectioner’s sugar).</Description>
</NDC>
<NDC>
<NDCCode>63459-512-30</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (63459-512-30) / 1 LOZENGE in 1 BLISTER PACK (63459-512-01) </PackageDescription>
<NDC11Code>63459-0512-30</NDC11Code>
<ProductNDC>63459-512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Actiq</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL; TRANSMUCOSAL</RouteName>
<StartMarketingDate>19990120</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020747</ApplicationNumber>
<LabelerName>Cephalon, LLC</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19990120</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ACTIQ is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids when taking ACTIQ. Limitations of Use: 1 Not for use in opioid non-tolerant patients., 2 Not for use in the management of acute or postoperative pain, including headache/migraine and dental pain [see Contraindications (4)]., 3 As a part of the TIRF REMS, ACTIQ may be dispensed by outpatient pharmacies only to outpatients enrolled in the program [see Warnings and Precautions (5.7)]. For inpatient administration of ACTIQ, patient and prescriber enrollment are not required.</IndicationAndUsage>
<Description>ACTIQ (fentanyl citrate) oral transmucosal lozenge is a solid formulation of fentanyl, an opioid agonist, intended for oral transmucosal administration. ACTIQ is formulated as a white to off-white solid drug matrix on a handle that is fracture resistant (ABS plastic) under normal conditions when used as directed. ACTIQ is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the ACTIQ unit to be removed from the mouth if signs of excessive opioid effects appear during administration. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. Inactive Ingredients: Hydrated dextrates, citric acid, dibasic sodium phosphate, artificial berry flavor, magnesium stearate, and edible glue (modified food starch and confectioner’s sugar).</Description>
</NDC>
<NDC>
<NDCCode>63459-516-30</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (63459-516-30) / 1 LOZENGE in 1 BLISTER PACK (63459-516-01) </PackageDescription>
<NDC11Code>63459-0516-30</NDC11Code>
<ProductNDC>63459-516</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Actiq</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL; TRANSMUCOSAL</RouteName>
<StartMarketingDate>19990120</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020747</ApplicationNumber>
<LabelerName>Cephalon, LLC</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>1600</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13537-404-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (13537-404-01) > 30 mL in 1 BOTTLE (13537-404-02)</PackageDescription>
<NDC11Code>13537-0404-01</NDC11Code>
<ProductNDC>13537-404</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel</ProprietaryName>
<ProprietaryNameSuffix>Dermo Clarite Clarifying And Moisturizing With Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Ensulizole, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation Ltd.</LabelerName>
<SubstanceName>AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>.03; .03; .05; .05; .06</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL; g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16781-404-60</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (16781-404-60) * 60 CAPSULE in 1 BOTTLE * 30 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>16781-0404-60</NDC11Code>
<ProductNDC>16781-404</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocin</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130617</StartMarketingDate>
<EndMarketingDate>20160131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050649</ApplicationNumber>
<LabelerName>Onset Dermatologics, LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2015-09-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>21695-404-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (21695-404-30)</PackageDescription>
<NDC11Code>21695-0404-30</NDC11Code>
<ProductNDC>21695-404</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19991220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074984</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5 H)one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride is formulated as a once-a-day extended release capsule containing either 120 mg, 180 mg, 240 mg, or 300 mg diltiazem hydrochloride. Each diltiazem extended-release capsule, for oral administration, contains the following inactive ingredients. 120 mg — ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, black iron oxide, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. 180 mg — ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, D&C yellow #10, FD&C blue #1, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. 240 mg — ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, D&C yellow #10, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. 300 mg— ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, black iron oxide, D&C yellow #10, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. This drug product conforms to USP Drug release test #11.</Description>
</NDC>
<NDC>
<NDCCode>24236-404-02</NDCCode>
<PackageDescription>30 CAPSULE in 1 BLISTER PACK (24236-404-02)</PackageDescription>
<NDC11Code>24236-0404-02</NDC11Code>
<ProductNDC>24236-404</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA060704</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>37000-404-30</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (37000-404-30) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>37000-0404-30</NDC11Code>
<ProductNDC>37000-404</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vicks Qlearquil</ProprietaryName>
<ProprietaryNameSuffix>All Day And All Night 24 Hour Allergy Relief</ProprietaryNameSuffix>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140301</StartMarketingDate>
<EndMarketingDate>20180701</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076301</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>43063-404-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (43063-404-30) </PackageDescription>
<NDC11Code>43063-0404-30</NDC11Code>
<ProductNDC>43063-404</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100621</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078477</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43547-404-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (43547-404-03) </PackageDescription>
<NDC11Code>43547-0404-03</NDC11Code>
<ProductNDC>43547-404</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040377</ApplicationNumber>
<LabelerName>Solco Healthcare U.S., LLC</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine hydrochloride tablets [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.</Description>
</NDC>
<NDC>
<NDCCode>45865-404-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (45865-404-30) </PackageDescription>
<NDC11Code>45865-0404-30</NDC11Code>
<ProductNDC>45865-404</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enalapril Maleate</ProprietaryName>
<NonProprietaryName>Enalapril Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075483</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>ENALAPRIL MALEATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enalapril maleate is indicated for the treatment of hypertension. Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.</IndicationAndUsage>
<Description>Enalapril maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[ N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, ( Z)-2-butenedioate salt (1:1). Its molecular formula is, C 20H 28N 2O 5●C 4H 4O 4, and its structural formula is:. Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin converting enzyme inhibitor. Enalapril maleate is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: hypromellose, anhydrous lactose, corn starch, stearic acid and talc. The 10 mg and 20 mg tablets also contain iron oxides.</Description>
</NDC>
<NDC>
<NDCCode>46708-404-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (46708-404-30) </PackageDescription>
<NDC11Code>46708-0404-30</NDC11Code>
<ProductNDC>46708-404</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nadolol</ProprietaryName>
<NonProprietaryName>Nadolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230608</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211763</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>NADOLOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Angina Pectoris. Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Hypertension. Nadolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nadolol tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Nadolol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.</IndicationAndUsage>
<Description>Nadolol, USP is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5,6,7,8-tetrahydro-cis-6,7-dihydroxy-1- naphthyl)oxy]-2-propanol. Structural formula. C17H27NO4 MW 309.40. Nadolol, USP is a white to off-white powder. It is freely soluble in alcohol and in methanol, soluble in water at pH 2, slightly soluble in chloroform, in methylene chloride, in isopropyl alcohol, and in water (between pH 7 and pH 10); insoluble in acetone, in benzene, in ether, in hexane, and in trichloroethane. Each tablet for oral administration contains 20 mg, 40 mg, or 80 mg of nadolol, USP and the following inactive ingredients: povidone K-30, corn starch, microcrystalline cellulose, citric acid monohydrate, FD&C Blue No. 2 Aluminum Lake, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>47593-404-30</NDCCode>
<PackageDescription>207 mL in 1 BOTTLE, PLASTIC (47593-404-30)</PackageDescription>
<NDC11Code>47593-0404-30</NDC11Code>
<ProductNDC>47593-404</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Digisan E Foam Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Antiseptic Handwash</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20031104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Ecolab Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-06-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>49349-404-02</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (49349-404-02)</PackageDescription>
<NDC11Code>49349-0404-02</NDC11Code>
<ProductNDC>49349-404</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Reliever Plus</ProprietaryName>
<NonProprietaryName>Acetaminophen, Aspirin And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161117</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-05-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>49643-404-30</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49643-404-30) </PackageDescription>
<NDC11Code>49643-0404-30</NDC11Code>
<ProductNDC>49643-404</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Gambels Oak Pollen</ProprietaryName>
<NonProprietaryName>Quercus Gambelii</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>QUERCUS GAMBELII POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>51346-404-02</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (51346-404-02) > 30 mL in 1 BOTTLE, PUMP (51346-404-01)</PackageDescription>
<NDC11Code>51346-0404-02</NDC11Code>
<ProductNDC>51346-404</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Provence Air Skin Fit Foundation Ginger Beige C02</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>3.24; .9; .57</StrengthNumber>
<StrengthUnit>g/30mL; g/30mL; g/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>