{
"NDC": [
{
"NDCCode": "59088-816-24",
"PackageDescription": "24 TUBE in 1 KIT (59088-816-24) / 7 g in 1 TUBE (59088-816-01) ",
"NDC11Code": "59088-0816-24",
"ProductNDC": "59088-816",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hcl - Hydrocortisone Acetate",
"NonProprietaryName": "Lidocaine Hcl And Hydrocortisone Acetate",
"DosageFormName": "CREAM",
"RouteName": "RECTAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
"StrengthNumber": "20; 20",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110701",
"EndMarketingDatePackage": "20260103",
"SamplePackage": "N",
"IndicationAndUsage": "Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.",
"Description": "Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure: Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. INGREDIENTS: PharmaPure Rx Lidocaine HCl 2% - Hydrocortisone Acetate 2% Cream. Each gram contains Lidocaine HCl 20 mg, Hydrocortisone Acetate 20 mg. ACTIVE INGREDIENTS. LIDOCAINE HCl 2% HYDROCORTISONE ACETATE 2%."
},
{
"NDCCode": "59088-816-01",
"PackageDescription": "7 g in 1 TUBE (59088-816-01) ",
"NDC11Code": "59088-0816-01",
"ProductNDC": "59088-816",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hcl - Hydrocortisone Acetate",
"NonProprietaryName": "Lidocaine Hcl And Hydrocortisone Acetate",
"DosageFormName": "CREAM",
"RouteName": "RECTAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
"StrengthNumber": "20; 20",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110701",
"SamplePackage": "N",
"IndicationAndUsage": "Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.",
"Description": "Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure: Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. INGREDIENTS: PharmaPure Rx Lidocaine HCl 2% - Hydrocortisone Acetate 2% Cream. Each gram contains Lidocaine HCl 20 mg, Hydrocortisone Acetate 20 mg. ACTIVE INGREDIENTS. LIDOCAINE HCl 2% HYDROCORTISONE ACETATE 2%."
},
{
"NDCCode": "43269-816-24",
"PackageDescription": "709 mL in 1 BOTTLE, PUMP (43269-816-24)",
"NDC11Code": "43269-0816-24",
"ProductNDC": "43269-816",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Iced Vanilla Antibacterial Foaming Hand Wash",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120830",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "SJ Creations, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".2",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2018-12-13",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "71179-816-24",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (71179-816-24) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "71179-0816-24",
"ProductNDC": "71179-816",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naproxen Sodium And Pseudoephedrine Hydrochloride Cold And Sinus",
"NonProprietaryName": "Naproxen Sodium And Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211360",
"LabelerName": "VESPYR BRANDS LLC",
"SubstanceName": "NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "220; 120",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240807",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these cold, sinus, and flu symptoms: : 1 sinus pressure, 2 minor body aches and pains, 3 headache, 4 nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose), 5 fever."
},
{
"NDCCode": "59088-736-00",
"PackageDescription": "1 KIT in 1 CARTON (59088-736-00) * 24 CAPSULE in 1 BOTTLE (50436-0384-9) * 1 TUBE in 1 CARTON (59088-594-03) > 28.3 g in 1 TUBE",
"NDC11Code": "59088-0736-00",
"ProductNDC": "59088-736",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gpl Pak",
"NonProprietaryName": "Gabapentin, Lidocaine Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20190426",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2020-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190426",
"SamplePackage": "N"
},
{
"NDCCode": "59088-738-00",
"PackageDescription": "1 KIT in 1 CARTON (59088-738-00) * 1 g in 1 POUCH (0591-3525-11) * 24 CAPSULE in 1 BOTTLE (50436-0384-9) ",
"NDC11Code": "59088-0738-00",
"ProductNDC": "59088-738",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabacaine",
"NonProprietaryName": "Gabapentin, Lidocaine",
"DosageFormName": "KIT",
"StartMarketingDate": "20190503",
"EndMarketingDate": "20210327",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2021-03-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190503",
"EndMarketingDatePackage": "20210327",
"SamplePackage": "N"
},
{
"NDCCode": "59088-739-00",
"PackageDescription": "1 KIT in 1 CARTON (59088-739-00) * 1 TUBE in 1 CARTON (0591-2070-30) > 30 g in 1 TUBE * 24 CAPSULE in 1 BOTTLE (50436-0384-9) ",
"NDC11Code": "59088-0739-00",
"ProductNDC": "59088-739",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prilopentin",
"NonProprietaryName": "Gabapentin, Lidocaine And Prilocaine",
"DosageFormName": "KIT",
"StartMarketingDate": "20190819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204989",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2020-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190819",
"SamplePackage": "N"
},
{
"NDCCode": "59088-743-00",
"PackageDescription": "1 KIT in 1 CARTON (59088-743-00) * 24 CAPSULE in 1 BOTTLE (50436-0384-9) * 1 TUBE in 1 CARTON (59088-594-03) > 28.3 g in 1 TUBE",
"NDC11Code": "59088-0743-00",
"ProductNDC": "59088-743",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lido Gb-300",
"NonProprietaryName": "Gabapentin, Lidocaine Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20190508",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2020-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190508",
"SamplePackage": "N"
},
{
"NDCCode": "59088-747-00",
"PackageDescription": "1 KIT in 1 CARTON (59088-747-00) * 24 CAPSULE in 1 BOTTLE * 1 TUBE in 1 CARTON (59088-371-07) > 85 g in 1 TUBE",
"NDC11Code": "59088-0747-00",
"ProductNDC": "59088-747",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapal",
"NonProprietaryName": "Gabapentin, Lidocaine Hydrochloride",
"DosageFormName": "KIT",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20200125",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2020-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200201",
"SamplePackage": "N"
},
{
"NDCCode": "59088-749-00",
"PackageDescription": "1 KIT in 1 CARTON (59088-749-00) * 1 TUBE in 1 CARTON (59088-371-07) > 85 g in 1 TUBE * 24 CAPSULE in 1 BOTTLE (50436-0383-4) ",
"NDC11Code": "59088-0749-00",
"ProductNDC": "59088-749",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidotin",
"NonProprietaryName": "Gabapentin, Lidocaine Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20200302",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2020-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200302",
"SamplePackage": "N"
},
{
"NDCCode": "59088-765-00",
"PackageDescription": "1 KIT in 1 CARTON (59088-765-00) * 24 CAPSULE in 1 BOTTLE (50436-0384-9) * 1 TUBE in 1 CARTON (52565-007-30) > 30 g in 1 TUBE",
"NDC11Code": "59088-0765-00",
"ProductNDC": "59088-765",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prilopentin -ii",
"NonProprietaryName": "Gabapentin, Lidocaine And Prilocaine",
"DosageFormName": "KIT",
"StartMarketingDate": "20200702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204989",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2020-11-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200702",
"SamplePackage": "N"
},
{
"NDCCode": "11084-816-09",
"PackageDescription": "25 mL in 1 APPLICATOR (11084-816-09) ",
"NDC11Code": "11084-0816-09",
"ProductNDC": "11084-816",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bactoshield Chg",
"NonProprietaryName": "Chlorhexidine Gluconate",
"DosageFormName": "SPONGE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019822",
"LabelerName": "Deb USA, Inc.",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180831",
"SamplePackage": "N"
},
{
"NDCCode": "24208-816-05",
"PackageDescription": "1 BOTTLE, DISPENSING in 1 CARTON (24208-816-05) > 5 mL in 1 BOTTLE, DISPENSING",
"NDC11Code": "24208-0816-05",
"ProductNDC": "24208-816",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timoptic-xe",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20160531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020330",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2022-05-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160531",
"SamplePackage": "N",
"IndicationAndUsage": "TIMOPTIC-XE Sterile Ophthalmic Gel Forming Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "TIMOPTIC-XE® (timolol maleate ophthalmic gel forming solution) is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is: 1 25°."
},
{
"NDCCode": "45802-816-01",
"PackageDescription": "1 TUBE in 1 CARTON (45802-816-01) / 100 g in 1 TUBE",
"NDC11Code": "45802-0816-01",
"ProductNDC": "45802-816",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"NonProprietaryName": "Calcipotriene, Betamethasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200174",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "CALCIPOTRIENE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "50; .643",
"StrengthUnit": "ug/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200130",
"SamplePackage": "N",
"IndicationAndUsage": "Calcipotriene and Betamethasone Dipropionate Ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.",
"Description": "Calcipotriene and Betamethasone Dipropionate Ointment, 0.005%/0.064% contains calcipotriene and betamethasone dipropionate. It is intended for topical use only. Calcipotriene is a synthetic vitamin D3 analogue. Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1 (alpha),3(beta),24-triol, with the empirical formula C27H40O3, a molecular weight of 412.3, and the following structural formula. Calcipotriene is a white to almost white crystalline compound. Betamethasone dipropionate is a synthetic corticosteroid. Betamethasone dipropionate has the chemical name 9-fluoro-11(beta),17,21-trihydroxy-16(beta)-methylpregna-1, 4-diene-3,20-dione17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to almost white odorless powder. Each gram of Calcipotriene and Betamethasone Dipropionate Ointment contains 50.00 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in an off-white to yellow paraffin ointment base of mineral oil, PPG-15 stearyl ether, dl-alpha tocopherol and white petrolatum."
},
{
"NDCCode": "45802-816-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-816-96) / 60 g in 1 TUBE",
"NDC11Code": "45802-0816-96",
"ProductNDC": "45802-816",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"NonProprietaryName": "Calcipotriene, Betamethasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200174",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "CALCIPOTRIENE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "50; .643",
"StrengthUnit": "ug/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200130",
"SamplePackage": "N",
"IndicationAndUsage": "Calcipotriene and Betamethasone Dipropionate Ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.",
"Description": "Calcipotriene and Betamethasone Dipropionate Ointment, 0.005%/0.064% contains calcipotriene and betamethasone dipropionate. It is intended for topical use only. Calcipotriene is a synthetic vitamin D3 analogue. Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1 (alpha),3(beta),24-triol, with the empirical formula C27H40O3, a molecular weight of 412.3, and the following structural formula. Calcipotriene is a white to almost white crystalline compound. Betamethasone dipropionate is a synthetic corticosteroid. Betamethasone dipropionate has the chemical name 9-fluoro-11(beta),17,21-trihydroxy-16(beta)-methylpregna-1, 4-diene-3,20-dione17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to almost white odorless powder. Each gram of Calcipotriene and Betamethasone Dipropionate Ointment contains 50.00 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in an off-white to yellow paraffin ointment base of mineral oil, PPG-15 stearyl ether, dl-alpha tocopherol and white petrolatum."
},
{
"NDCCode": "46708-816-31",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-816-31) ",
"NDC11Code": "46708-0816-31",
"ProductNDC": "46708-816",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218587",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride, USP is 1,5-Benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. Its molecular formula is C22H26N2O4SHCl and its molecular weight is 450.98. Its structural formula is as follows. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, formic acid, methanol and water, sparingly soluble in dehydrated ethanol and insoluble in ether. Diltiazem hydrochloride extended-release capsules, USP contain 120 mg or 180 mg or 240 mg diltiazem hydrochloride and are formulated for the controlled release of diltiazem hydrochloride over a 24-hour period. Inactive Ingredients: Diltiazem hydrochloride extended-release capsules, USP contain lactose monohydrate, hypromellose, colloidal silicon dioxide and magnesium stearate. The 120 mg, 180 mg and 240 mg capsule shells contain FD&C Blue 1, FD&C Red 3, FD&C Red 40, titanium dioxide and gelatin. Additionally, 120 mg capsule shell contains FD&C Yellow 6, 180 mg and 240 mg capsule shell contains D&C Red 33. The capsules are printed with edible ink containing shellac, iron oxide black and potassium hydroxide. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "46708-816-71",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-816-71) ",
"NDC11Code": "46708-0816-71",
"ProductNDC": "46708-816",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218587",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride, USP is 1,5-Benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. Its molecular formula is C22H26N2O4SHCl and its molecular weight is 450.98. Its structural formula is as follows. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, formic acid, methanol and water, sparingly soluble in dehydrated ethanol and insoluble in ether. Diltiazem hydrochloride extended-release capsules, USP contain 120 mg or 180 mg or 240 mg diltiazem hydrochloride and are formulated for the controlled release of diltiazem hydrochloride over a 24-hour period. Inactive Ingredients: Diltiazem hydrochloride extended-release capsules, USP contain lactose monohydrate, hypromellose, colloidal silicon dioxide and magnesium stearate. The 120 mg, 180 mg and 240 mg capsule shells contain FD&C Blue 1, FD&C Red 3, FD&C Red 40, titanium dioxide and gelatin. Additionally, 120 mg capsule shell contains FD&C Yellow 6, 180 mg and 240 mg capsule shell contains D&C Red 33. The capsules are printed with edible ink containing shellac, iron oxide black and potassium hydroxide. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "46708-816-91",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-816-91) ",
"NDC11Code": "46708-0816-91",
"ProductNDC": "46708-816",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218587",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride, USP is 1,5-Benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. Its molecular formula is C22H26N2O4SHCl and its molecular weight is 450.98. Its structural formula is as follows. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, formic acid, methanol and water, sparingly soluble in dehydrated ethanol and insoluble in ether. Diltiazem hydrochloride extended-release capsules, USP contain 120 mg or 180 mg or 240 mg diltiazem hydrochloride and are formulated for the controlled release of diltiazem hydrochloride over a 24-hour period. Inactive Ingredients: Diltiazem hydrochloride extended-release capsules, USP contain lactose monohydrate, hypromellose, colloidal silicon dioxide and magnesium stearate. The 120 mg, 180 mg and 240 mg capsule shells contain FD&C Blue 1, FD&C Red 3, FD&C Red 40, titanium dioxide and gelatin. Additionally, 120 mg capsule shell contains FD&C Yellow 6, 180 mg and 240 mg capsule shell contains D&C Red 33. The capsules are printed with edible ink containing shellac, iron oxide black and potassium hydroxide. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "52125-816-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (52125-816-02)",
"NDC11Code": "52125-0816-02",
"ProductNDC": "52125-816",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202764",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Postherpetic Neuralgia. Gabapentin tablets USP are indicated for the management of postherpetic neuralgia in adults. Epilepsy. Gabapentin tablets USP are indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin tablets USP are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years.",
"Description": "Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. Each tablet for oral administration contains the following inactive ingredients: Mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium Stearate and Aquarius® BP18114 Cool Vanilla. Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. This product (Gabapentin Tablets, USP 600 mg and 800 mg) meets the USP Dissolution Test 1."
},
{
"NDCCode": "54868-5975-0",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (54868-5975-0) > 1 LOZENGE in 1 BLISTER PACK",
"NDC11Code": "54868-5975-00",
"ProductNDC": "54868-5975",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Citrate",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL; TRANSMUCOSAL",
"StartMarketingDate": "20081219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020747",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "400",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oral Transmucosal Fentanyl Citrate (OTFC) is indicated only for the management of breakthrough cancer pain in patients 16 and older with malignancies 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 around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking OTFC. This product must not be used in opioid non-tolerant patients because life-threatening respiratory depression and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, OTFC is contraindicated in the management of acute or postoperative pain. OTFC is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.",
"Description": "OTFC (oral transmucosal fentanyl citrate) is a solid formulation of fentanyl citrate, a potent opioid analgesic, intended for oral transmucosal administration. OTFC 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. OTFC is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the OTFC 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": "54868-6025-0",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (54868-6025-0) > 1 LOZENGE in 1 BLISTER PACK",
"NDC11Code": "54868-6025-00",
"ProductNDC": "54868-6025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Citrate",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL; TRANSMUCOSAL",
"StartMarketingDate": "20090424",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020747",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oral Transmucosal Fentanyl Citrate (OTFC) is indicated only for the management of breakthrough cancer pain in patients 16 and older with malignancies 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 around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking OTFC. This product must not be used in opioid non-tolerant patients because life-threatening respiratory depression and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, OTFC is contraindicated in the management of acute or postoperative pain. OTFC is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.",
"Description": "OTFC (oral transmucosal fentanyl citrate) is a solid formulation of fentanyl citrate, a potent opioid analgesic, intended for oral transmucosal administration. OTFC 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. OTFC is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the OTFC 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": "54868-6026-0",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (54868-6026-0) > 1 LOZENGE in 1 BLISTER PACK",
"NDC11Code": "54868-6026-00",
"ProductNDC": "54868-6026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Citrate",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL; TRANSMUCOSAL",
"StartMarketingDate": "20090424",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020747",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "600",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oral Transmucosal Fentanyl Citrate (OTFC) is indicated only for the management of breakthrough cancer pain in patients 16 and older with malignancies 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 around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking OTFC. This product must not be used in opioid non-tolerant patients because life-threatening respiratory depression and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, OTFC is contraindicated in the management of acute or postoperative pain. OTFC is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.",
"Description": "OTFC (oral transmucosal fentanyl citrate) is a solid formulation of fentanyl citrate, a potent opioid analgesic, intended for oral transmucosal administration. OTFC 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. OTFC is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the OTFC 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": "54868-6027-0",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (54868-6027-0) > 1 LOZENGE in 1 BLISTER PACK",
"NDC11Code": "54868-6027-00",
"ProductNDC": "54868-6027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Citrate",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL; TRANSMUCOSAL",
"StartMarketingDate": "20090424",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020747",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "800",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oral Transmucosal Fentanyl Citrate (OTFC) is indicated only for the management of breakthrough cancer pain in patients 16 and older with malignancies 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 around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking OTFC. This product must not be used in opioid non-tolerant patients because life-threatening respiratory depression and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, OTFC is contraindicated in the management of acute or postoperative pain. OTFC is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.",
"Description": "OTFC (oral transmucosal fentanyl citrate) is a solid formulation of fentanyl citrate, a potent opioid analgesic, intended for oral transmucosal administration. OTFC 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. OTFC is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the OTFC 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": "54868-6037-0",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (54868-6037-0) > 1 LOZENGE in 1 BLISTER PACK",
"NDC11Code": "54868-6037-00",
"ProductNDC": "54868-6037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Citrate",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL; TRANSMUCOSAL",
"StartMarketingDate": "20090605",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020747",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "1200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oral Transmucosal Fentanyl Citrate (OTFC) is indicated only for the management of breakthrough cancer pain in patients 16 and older with malignancies 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 around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking OTFC. This product must not be used in opioid non-tolerant patients because life-threatening respiratory depression and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, OTFC is contraindicated in the management of acute or postoperative pain. OTFC is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.",
"Description": "OTFC (oral transmucosal fentanyl citrate) is a solid formulation of fentanyl citrate, a potent opioid analgesic, intended for oral transmucosal administration. OTFC 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. OTFC is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the OTFC 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": "60687-816-32",
"PackageDescription": "20 BLISTER PACK in 1 CARTON (60687-816-32) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (60687-816-33) ",
"NDC11Code": "60687-0816-32",
"ProductNDC": "60687-816",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lubiprostone",
"NonProprietaryName": "Lubiprostone",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260318",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209920",
"LabelerName": "American Health Packaging",
"SubstanceName": "LUBIPROSTONE",
"StrengthNumber": "8",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260318",
"SamplePackage": "N",
"IndicationAndUsage": "Lubiprostone capsules are a chloride channel activator indicated for the treatment of: 1 chronic idiopathic constipation (CIC) in adults. (1.1), 2 opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. (1.2)Limitations of Use: Effectiveness of lubiprostone capsules in the treatment of OIC in patients taking diphenylheptane opioids (e.g., methadone) has not been established. (1.2, 7.1), 3 irritable bowel syndrome with constipation (IBS-C) in women ≥18 years old. (1.3).",
"Description": "Lubiprostone is a chloride channel activator for oral use. The chemical name for lubiprostone is (–)-7-[(2 R,4a R,5 R,7a R)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[ b]pyran-5-yl]heptanoic acid. The molecular formula of lubiprostone is C 20H 32F 2O 5 with a molecular weight of 390.47 and a chemical structure as follows:. Lubiprostone drug substance occurs as off-white to white crystalline powder, is very soluble in ether and ethanol, and is practically insoluble in hexane and water. Lubiprostone capsules are available as imprinted, oval, soft gelatin capsules in two strengths. Pink capsules contain 8 mcg of lubiprostone and the following inactive ingredients: black iron oxide, ferric oxide red, gelatin, hypromellose, lecithin, medium-chain triglycerides, propylene glycol, purified water, sorbitol sorbitan solution, and titanium dioxide. Orange capsules contain 24 mcg of lubiprostone and the following inactive ingredients: black iron oxide, D&C Yellow No. 10, FD&C Red No. 40, gelatin, hypromellose, lecithin, medium-chain triglycerides, propylene glycol, purified water, and sorbitol sorbitan solution."
},
{
"NDCCode": "62332-816-31",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-816-31) ",
"NDC11Code": "62332-0816-31",
"ProductNDC": "62332-816",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218587",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride, USP is 1,5-Benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. Its molecular formula is C22H26N2O4SHCl and its molecular weight is 450.98. Its structural formula is as follows. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, formic acid, methanol and water, sparingly soluble in dehydrated ethanol and insoluble in ether. Diltiazem hydrochloride extended-release capsules, USP contain 120 mg or 180 mg or 240 mg diltiazem hydrochloride and are formulated for the controlled release of diltiazem hydrochloride over a 24-hour period. Inactive Ingredients: Diltiazem hydrochloride extended-release capsules, USP contain lactose monohydrate, hypromellose, colloidal silicon dioxide and magnesium stearate. The 120 mg, 180 mg and 240 mg capsule shells contain FD&C Blue 1, FD&C Red 3, FD&C Red 40, titanium dioxide and gelatin. Additionally, 120 mg capsule shell contains FD&C Yellow 6, 180 mg and 240 mg capsule shell contains D&C Red 33. The capsules are printed with edible ink containing shellac, iron oxide black and potassium hydroxide. For oral administration. Meets USP Dissolution Test 32."
},
{
"NDCCode": "62332-816-71",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-816-71) ",
"NDC11Code": "62332-0816-71",
"ProductNDC": "62332-816",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218587",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride, USP is 1,5-Benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. Its molecular formula is C22H26N2O4SHCl and its molecular weight is 450.98. Its structural formula is as follows. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, formic acid, methanol and water, sparingly soluble in dehydrated ethanol and insoluble in ether. Diltiazem hydrochloride extended-release capsules, USP contain 120 mg or 180 mg or 240 mg diltiazem hydrochloride and are formulated for the controlled release of diltiazem hydrochloride over a 24-hour period. Inactive Ingredients: Diltiazem hydrochloride extended-release capsules, USP contain lactose monohydrate, hypromellose, colloidal silicon dioxide and magnesium stearate. The 120 mg, 180 mg and 240 mg capsule shells contain FD&C Blue 1, FD&C Red 3, FD&C Red 40, titanium dioxide and gelatin. Additionally, 120 mg capsule shell contains FD&C Yellow 6, 180 mg and 240 mg capsule shell contains D&C Red 33. The capsules are printed with edible ink containing shellac, iron oxide black and potassium hydroxide. For oral administration. Meets USP Dissolution Test 32."
},
{
"NDCCode": "62332-816-91",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-816-91) ",
"NDC11Code": "62332-0816-91",
"ProductNDC": "62332-816",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218587",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride, USP is 1,5-Benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. Its molecular formula is C22H26N2O4SHCl and its molecular weight is 450.98. Its structural formula is as follows. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, formic acid, methanol and water, sparingly soluble in dehydrated ethanol and insoluble in ether. Diltiazem hydrochloride extended-release capsules, USP contain 120 mg or 180 mg or 240 mg diltiazem hydrochloride and are formulated for the controlled release of diltiazem hydrochloride over a 24-hour period. Inactive Ingredients: Diltiazem hydrochloride extended-release capsules, USP contain lactose monohydrate, hypromellose, colloidal silicon dioxide and magnesium stearate. The 120 mg, 180 mg and 240 mg capsule shells contain FD&C Blue 1, FD&C Red 3, FD&C Red 40, titanium dioxide and gelatin. Additionally, 120 mg capsule shell contains FD&C Yellow 6, 180 mg and 240 mg capsule shell contains D&C Red 33. The capsules are printed with edible ink containing shellac, iron oxide black and potassium hydroxide. For oral administration. Meets USP Dissolution Test 32."
},
{
"NDCCode": "83457-817-02",
"PackageDescription": "2 KIT in 1 CARTON (83457-817-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (83457-816-01) / .1 mL in 1 SYRINGE * 1 mL in 1 PACKET (83457-927-01) ",
"NDC11Code": "83457-0817-02",
"ProductNDC": "83457-817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humira",
"NonProprietaryName": "Adalimumab",
"DosageFormName": "KIT",
"StartMarketingDate": "20240214",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125057",
"LabelerName": "Cordavis Limited",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240214",
"SamplePackage": "N",
"IndicationAndUsage": "HUMIRA is a tumor necrosis factor (TNF) blocker indicated for: : 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1) , 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2) , 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3) , 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8) , 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9) .",
"Description": "Adalimumab is a tumor necrosis factor blocker. Adalimumab is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 mg), and Water for Injection, USP. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP."
},
{
"NDCCode": "59088-008-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-008-54) ",
"NDC11Code": "59088-0008-54",
"ProductNDC": "59088-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finazol",
"NonProprietaryName": "Ferrous Fumarate, Folate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241011",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC CITRATE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON",
"StrengthNumber": "1500; 200; 10; 45; 3.25; 3.35; 22.5; 6; 1000; 26; 100; 15; 100; 18; 25; 50; 30; 30; 1; .75; 37.5; 25; 24.5; 25",
"StrengthUnit": "ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241011",
"SamplePackage": "N",
"IndicationAndUsage": "Finazol is indicated for iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. Also, for conditions in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.",
"Description": "Full Prescribing Information: DESCRIPTION: Active Ingredients: Each caplet contains: Vitamin A (as Retinyl Acetate) ……………………………….....1500 mcg RAE Vitamin C (as Ascorbic Acid) ….…..….…………………….……….....200 mg Vitamin D3 (as Cholecalciferol) ….…………………………....10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) ………………………….....45 mg Thiamin (as Thiamine Mononitrate) …..…..…………………………...3.25 mg Riboflavin (as Vitamin B2) …..…..…..…..………………………….…3.35 mg Niacin (as Niacinamide)……………………………………………..…22.5 mg Vitamin B6 (as Pyridoxine HCl)……………………………………………6 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) …………………1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)……………………………………..26 mcg Biotin………………………………………………………………….100 mcg Pantothenic Acid (as Calcium Pantothenate)………………………….....15 mg Calcium (as Calcium Carbonate)………………………………………..100 mg Iron (as Ferrous Fumarate)……………………………………………....18 mg Iodine (as Potassium Iodide)…………………………………………...25 mcg Magnesium (as Magnesium Oxide)……………………………………...50 mg Zinc (as Zinc Citrate)……………………………………………………..30 mg Selenium (as Selenomethionine)….…………………………………….30 mcg Copper (as Copper Oxide)………………………………………………....1 mg Manganese (as Manganese Sulfate)…………………………………...0.75 mg Chromium (as Chromium Polynicotinate)…………………………….37.5 mcg Molybdenum (as Sodium Molybdate)…………………………………..25 mcg Potassium (as Potassium Chloride) ……………………………….…..24.5 mg Boron (as Boron Citrate)……………………………………..…………25 mcg. Other Ingredients: Crospovidone, Dextrin, Dextrose Monohydrate, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Purified Stearic Acid, Silicon Dioxide, Sodium Carboxymethylcellulose, Titanium Dioxide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>59088-816-24</NDCCode>
<PackageDescription>24 TUBE in 1 KIT (59088-816-24) / 7 g in 1 TUBE (59088-816-01) </PackageDescription>
<NDC11Code>59088-0816-24</NDC11Code>
<ProductNDC>59088-816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl - Hydrocortisone Acetate</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl And Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>20; 20</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110701</StartMarketingDatePackage>
<EndMarketingDatePackage>20260103</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.</IndicationAndUsage>
<Description>Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure: Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. INGREDIENTS: PharmaPure Rx Lidocaine HCl 2% - Hydrocortisone Acetate 2% Cream. Each gram contains Lidocaine HCl 20 mg, Hydrocortisone Acetate 20 mg. ACTIVE INGREDIENTS. LIDOCAINE HCl 2% HYDROCORTISONE ACETATE 2%.</Description>
</NDC>
<NDC>
<NDCCode>59088-816-01</NDCCode>
<PackageDescription>7 g in 1 TUBE (59088-816-01) </PackageDescription>
<NDC11Code>59088-0816-01</NDC11Code>
<ProductNDC>59088-816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl - Hydrocortisone Acetate</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl And Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>20; 20</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.</IndicationAndUsage>
<Description>Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure: Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. INGREDIENTS: PharmaPure Rx Lidocaine HCl 2% - Hydrocortisone Acetate 2% Cream. Each gram contains Lidocaine HCl 20 mg, Hydrocortisone Acetate 20 mg. ACTIVE INGREDIENTS. LIDOCAINE HCl 2% HYDROCORTISONE ACETATE 2%.</Description>
</NDC>
<NDC>
<NDCCode>43269-816-24</NDCCode>
<PackageDescription>709 mL in 1 BOTTLE, PUMP (43269-816-24)</PackageDescription>
<NDC11Code>43269-0816-24</NDC11Code>
<ProductNDC>43269-816</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Iced Vanilla Antibacterial Foaming Hand Wash</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120830</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>SJ Creations, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-13</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71179-816-24</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (71179-816-24) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>71179-0816-24</NDC11Code>
<ProductNDC>71179-816</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium And Pseudoephedrine Hydrochloride Cold And Sinus</ProprietaryName>
<NonProprietaryName>Naproxen Sodium And Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211360</ApplicationNumber>
<LabelerName>VESPYR BRANDS LLC</LabelerName>
<SubstanceName>NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>220; 120</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these cold, sinus, and flu symptoms: : 1 sinus pressure, 2 minor body aches and pains, 3 headache, 4 nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose), 5 fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-736-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (59088-736-00) * 24 CAPSULE in 1 BOTTLE (50436-0384-9) * 1 TUBE in 1 CARTON (59088-594-03) > 28.3 g in 1 TUBE</PackageDescription>
<NDC11Code>59088-0736-00</NDC11Code>
<ProductNDC>59088-736</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gpl Pak</ProprietaryName>
<NonProprietaryName>Gabapentin, Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20190426</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-738-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (59088-738-00) * 1 g in 1 POUCH (0591-3525-11) * 24 CAPSULE in 1 BOTTLE (50436-0384-9) </PackageDescription>
<NDC11Code>59088-0738-00</NDC11Code>
<ProductNDC>59088-738</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabacaine</ProprietaryName>
<NonProprietaryName>Gabapentin, Lidocaine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20190503</StartMarketingDate>
<EndMarketingDate>20210327</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2021-03-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190503</StartMarketingDatePackage>
<EndMarketingDatePackage>20210327</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-739-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (59088-739-00) * 1 TUBE in 1 CARTON (0591-2070-30) > 30 g in 1 TUBE * 24 CAPSULE in 1 BOTTLE (50436-0384-9) </PackageDescription>
<NDC11Code>59088-0739-00</NDC11Code>
<ProductNDC>59088-739</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prilopentin</ProprietaryName>
<NonProprietaryName>Gabapentin, Lidocaine And Prilocaine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20190819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204989</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-743-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (59088-743-00) * 24 CAPSULE in 1 BOTTLE (50436-0384-9) * 1 TUBE in 1 CARTON (59088-594-03) > 28.3 g in 1 TUBE</PackageDescription>
<NDC11Code>59088-0743-00</NDC11Code>
<ProductNDC>59088-743</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lido Gb-300</ProprietaryName>
<NonProprietaryName>Gabapentin, Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20190508</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-747-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (59088-747-00) * 24 CAPSULE in 1 BOTTLE * 1 TUBE in 1 CARTON (59088-371-07) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>59088-0747-00</NDC11Code>
<ProductNDC>59088-747</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapal</ProprietaryName>
<NonProprietaryName>Gabapentin, Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20200125</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-749-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (59088-749-00) * 1 TUBE in 1 CARTON (59088-371-07) > 85 g in 1 TUBE * 24 CAPSULE in 1 BOTTLE (50436-0383-4) </PackageDescription>
<NDC11Code>59088-0749-00</NDC11Code>
<ProductNDC>59088-749</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidotin</ProprietaryName>
<NonProprietaryName>Gabapentin, Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20200302</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-765-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (59088-765-00) * 24 CAPSULE in 1 BOTTLE (50436-0384-9) * 1 TUBE in 1 CARTON (52565-007-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>59088-0765-00</NDC11Code>
<ProductNDC>59088-765</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prilopentin -ii</ProprietaryName>
<NonProprietaryName>Gabapentin, Lidocaine And Prilocaine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20200702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204989</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-11-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200702</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11084-816-09</NDCCode>
<PackageDescription>25 mL in 1 APPLICATOR (11084-816-09) </PackageDescription>
<NDC11Code>11084-0816-09</NDC11Code>
<ProductNDC>11084-816</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bactoshield Chg</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate</NonProprietaryName>
<DosageFormName>SPONGE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180831</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019822</ApplicationNumber>
<LabelerName>Deb USA, Inc.</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24208-816-05</NDCCode>
<PackageDescription>1 BOTTLE, DISPENSING in 1 CARTON (24208-816-05) > 5 mL in 1 BOTTLE, DISPENSING</PackageDescription>
<NDC11Code>24208-0816-05</NDC11Code>
<ProductNDC>24208-816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timoptic-xe</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20160531</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020330</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-05-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TIMOPTIC-XE Sterile Ophthalmic Gel Forming Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>TIMOPTIC-XE® (timolol maleate ophthalmic gel forming solution) is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is: 1 25°.</Description>
</NDC>
<NDC>
<NDCCode>45802-816-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-816-01) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0816-01</NDC11Code>
<ProductNDC>45802-816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcipotriene And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Calcipotriene, Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200174</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>CALCIPOTRIENE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>50; .643</StrengthNumber>
<StrengthUnit>ug/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcipotriene and Betamethasone Dipropionate Ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.</IndicationAndUsage>
<Description>Calcipotriene and Betamethasone Dipropionate Ointment, 0.005%/0.064% contains calcipotriene and betamethasone dipropionate. It is intended for topical use only. Calcipotriene is a synthetic vitamin D3 analogue. Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1 (alpha),3(beta),24-triol, with the empirical formula C27H40O3, a molecular weight of 412.3, and the following structural formula. Calcipotriene is a white to almost white crystalline compound. Betamethasone dipropionate is a synthetic corticosteroid. Betamethasone dipropionate has the chemical name 9-fluoro-11(beta),17,21-trihydroxy-16(beta)-methylpregna-1, 4-diene-3,20-dione17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to almost white odorless powder. Each gram of Calcipotriene and Betamethasone Dipropionate Ointment contains 50.00 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in an off-white to yellow paraffin ointment base of mineral oil, PPG-15 stearyl ether, dl-alpha tocopherol and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>45802-816-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-816-96) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0816-96</NDC11Code>
<ProductNDC>45802-816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcipotriene And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Calcipotriene, Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200174</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>CALCIPOTRIENE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>50; .643</StrengthNumber>
<StrengthUnit>ug/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcipotriene and Betamethasone Dipropionate Ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.</IndicationAndUsage>
<Description>Calcipotriene and Betamethasone Dipropionate Ointment, 0.005%/0.064% contains calcipotriene and betamethasone dipropionate. It is intended for topical use only. Calcipotriene is a synthetic vitamin D3 analogue. Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1 (alpha),3(beta),24-triol, with the empirical formula C27H40O3, a molecular weight of 412.3, and the following structural formula. Calcipotriene is a white to almost white crystalline compound. Betamethasone dipropionate is a synthetic corticosteroid. Betamethasone dipropionate has the chemical name 9-fluoro-11(beta),17,21-trihydroxy-16(beta)-methylpregna-1, 4-diene-3,20-dione17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to almost white odorless powder. Each gram of Calcipotriene and Betamethasone Dipropionate Ointment contains 50.00 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in an off-white to yellow paraffin ointment base of mineral oil, PPG-15 stearyl ether, dl-alpha tocopherol and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>46708-816-31</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-816-31) </PackageDescription>
<NDC11Code>46708-0816-31</NDC11Code>
<ProductNDC>46708-816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218587</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina.</IndicationAndUsage>
<Description>Diltiazem hydrochloride, USP is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride, USP is 1,5-Benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. Its molecular formula is C22H26N2O4SHCl and its molecular weight is 450.98. Its structural formula is as follows. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, formic acid, methanol and water, sparingly soluble in dehydrated ethanol and insoluble in ether. Diltiazem hydrochloride extended-release capsules, USP contain 120 mg or 180 mg or 240 mg diltiazem hydrochloride and are formulated for the controlled release of diltiazem hydrochloride over a 24-hour period. Inactive Ingredients: Diltiazem hydrochloride extended-release capsules, USP contain lactose monohydrate, hypromellose, colloidal silicon dioxide and magnesium stearate. The 120 mg, 180 mg and 240 mg capsule shells contain FD&C Blue 1, FD&C Red 3, FD&C Red 40, titanium dioxide and gelatin. Additionally, 120 mg capsule shell contains FD&C Yellow 6, 180 mg and 240 mg capsule shell contains D&C Red 33. The capsules are printed with edible ink containing shellac, iron oxide black and potassium hydroxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>46708-816-71</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-816-71) </PackageDescription>
<NDC11Code>46708-0816-71</NDC11Code>
<ProductNDC>46708-816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218587</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina.</IndicationAndUsage>
<Description>Diltiazem hydrochloride, USP is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride, USP is 1,5-Benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. Its molecular formula is C22H26N2O4SHCl and its molecular weight is 450.98. Its structural formula is as follows. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, formic acid, methanol and water, sparingly soluble in dehydrated ethanol and insoluble in ether. Diltiazem hydrochloride extended-release capsules, USP contain 120 mg or 180 mg or 240 mg diltiazem hydrochloride and are formulated for the controlled release of diltiazem hydrochloride over a 24-hour period. Inactive Ingredients: Diltiazem hydrochloride extended-release capsules, USP contain lactose monohydrate, hypromellose, colloidal silicon dioxide and magnesium stearate. The 120 mg, 180 mg and 240 mg capsule shells contain FD&C Blue 1, FD&C Red 3, FD&C Red 40, titanium dioxide and gelatin. Additionally, 120 mg capsule shell contains FD&C Yellow 6, 180 mg and 240 mg capsule shell contains D&C Red 33. The capsules are printed with edible ink containing shellac, iron oxide black and potassium hydroxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>46708-816-91</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-816-91) </PackageDescription>
<NDC11Code>46708-0816-91</NDC11Code>
<ProductNDC>46708-816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218587</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina.</IndicationAndUsage>
<Description>Diltiazem hydrochloride, USP is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride, USP is 1,5-Benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. Its molecular formula is C22H26N2O4SHCl and its molecular weight is 450.98. Its structural formula is as follows. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, formic acid, methanol and water, sparingly soluble in dehydrated ethanol and insoluble in ether. Diltiazem hydrochloride extended-release capsules, USP contain 120 mg or 180 mg or 240 mg diltiazem hydrochloride and are formulated for the controlled release of diltiazem hydrochloride over a 24-hour period. Inactive Ingredients: Diltiazem hydrochloride extended-release capsules, USP contain lactose monohydrate, hypromellose, colloidal silicon dioxide and magnesium stearate. The 120 mg, 180 mg and 240 mg capsule shells contain FD&C Blue 1, FD&C Red 3, FD&C Red 40, titanium dioxide and gelatin. Additionally, 120 mg capsule shell contains FD&C Yellow 6, 180 mg and 240 mg capsule shell contains D&C Red 33. The capsules are printed with edible ink containing shellac, iron oxide black and potassium hydroxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>52125-816-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (52125-816-02)</PackageDescription>
<NDC11Code>52125-0816-02</NDC11Code>
<ProductNDC>52125-816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202764</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</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>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Postherpetic Neuralgia. Gabapentin tablets USP are indicated for the management of postherpetic neuralgia in adults. Epilepsy. Gabapentin tablets USP are indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin tablets USP are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years.</IndicationAndUsage>
<Description>Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. Each tablet for oral administration contains the following inactive ingredients: Mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium Stearate and Aquarius® BP18114 Cool Vanilla. Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. This product (Gabapentin Tablets, USP 600 mg and 800 mg) meets the USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>54868-5975-0</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (54868-5975-0) > 1 LOZENGE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>54868-5975-00</NDC11Code>
<ProductNDC>54868-5975</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Citrate</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL; TRANSMUCOSAL</RouteName>
<StartMarketingDate>20081219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020747</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</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>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oral Transmucosal Fentanyl Citrate (OTFC) is indicated only for the management of breakthrough cancer pain in patients 16 and older with malignancies 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 around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking OTFC. This product must not be used in opioid non-tolerant patients because life-threatening respiratory depression and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, OTFC is contraindicated in the management of acute or postoperative pain. OTFC is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.</IndicationAndUsage>
<Description>OTFC (oral transmucosal fentanyl citrate) is a solid formulation of fentanyl citrate, a potent opioid analgesic, intended for oral transmucosal administration. OTFC 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. OTFC is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the OTFC 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>54868-6025-0</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (54868-6025-0) > 1 LOZENGE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>54868-6025-00</NDC11Code>
<ProductNDC>54868-6025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Citrate</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL; TRANSMUCOSAL</RouteName>
<StartMarketingDate>20090424</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020747</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</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>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oral Transmucosal Fentanyl Citrate (OTFC) is indicated only for the management of breakthrough cancer pain in patients 16 and older with malignancies 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 around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking OTFC. This product must not be used in opioid non-tolerant patients because life-threatening respiratory depression and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, OTFC is contraindicated in the management of acute or postoperative pain. OTFC is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.</IndicationAndUsage>
<Description>OTFC (oral transmucosal fentanyl citrate) is a solid formulation of fentanyl citrate, a potent opioid analgesic, intended for oral transmucosal administration. OTFC 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. OTFC is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the OTFC 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>54868-6026-0</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (54868-6026-0) > 1 LOZENGE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>54868-6026-00</NDC11Code>
<ProductNDC>54868-6026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Citrate</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL; TRANSMUCOSAL</RouteName>
<StartMarketingDate>20090424</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020747</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</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>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oral Transmucosal Fentanyl Citrate (OTFC) is indicated only for the management of breakthrough cancer pain in patients 16 and older with malignancies 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 around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking OTFC. This product must not be used in opioid non-tolerant patients because life-threatening respiratory depression and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, OTFC is contraindicated in the management of acute or postoperative pain. OTFC is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.</IndicationAndUsage>
<Description>OTFC (oral transmucosal fentanyl citrate) is a solid formulation of fentanyl citrate, a potent opioid analgesic, intended for oral transmucosal administration. OTFC 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. OTFC is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the OTFC 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>54868-6027-0</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (54868-6027-0) > 1 LOZENGE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>54868-6027-00</NDC11Code>
<ProductNDC>54868-6027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Citrate</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL; TRANSMUCOSAL</RouteName>
<StartMarketingDate>20090424</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020747</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</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>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oral Transmucosal Fentanyl Citrate (OTFC) is indicated only for the management of breakthrough cancer pain in patients 16 and older with malignancies 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 around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking OTFC. This product must not be used in opioid non-tolerant patients because life-threatening respiratory depression and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, OTFC is contraindicated in the management of acute or postoperative pain. OTFC is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.</IndicationAndUsage>
<Description>OTFC (oral transmucosal fentanyl citrate) is a solid formulation of fentanyl citrate, a potent opioid analgesic, intended for oral transmucosal administration. OTFC 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. OTFC is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the OTFC 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>54868-6037-0</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (54868-6037-0) > 1 LOZENGE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>54868-6037-00</NDC11Code>
<ProductNDC>54868-6037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Citrate</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL; TRANSMUCOSAL</RouteName>
<StartMarketingDate>20090605</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020747</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</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>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oral Transmucosal Fentanyl Citrate (OTFC) is indicated only for the management of breakthrough cancer pain in patients 16 and older with malignancies 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 around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking OTFC. This product must not be used in opioid non-tolerant patients because life-threatening respiratory depression and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, OTFC is contraindicated in the management of acute or postoperative pain. OTFC is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.</IndicationAndUsage>
<Description>OTFC (oral transmucosal fentanyl citrate) is a solid formulation of fentanyl citrate, a potent opioid analgesic, intended for oral transmucosal administration. OTFC 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. OTFC is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the OTFC 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>60687-816-32</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 CARTON (60687-816-32) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (60687-816-33) </PackageDescription>
<NDC11Code>60687-0816-32</NDC11Code>
<ProductNDC>60687-816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lubiprostone</ProprietaryName>
<NonProprietaryName>Lubiprostone</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260318</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209920</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>LUBIPROSTONE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260318</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lubiprostone capsules are a chloride channel activator indicated for the treatment of: 1 chronic idiopathic constipation (CIC) in adults. (1.1), 2 opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. (1.2)Limitations of Use: Effectiveness of lubiprostone capsules in the treatment of OIC in patients taking diphenylheptane opioids (e.g., methadone) has not been established. (1.2, 7.1), 3 irritable bowel syndrome with constipation (IBS-C) in women ≥18 years old. (1.3).</IndicationAndUsage>
<Description>Lubiprostone is a chloride channel activator for oral use. The chemical name for lubiprostone is (–)-7-[(2 R,4a R,5 R,7a R)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[ b]pyran-5-yl]heptanoic acid. The molecular formula of lubiprostone is C 20H 32F 2O 5 with a molecular weight of 390.47 and a chemical structure as follows:. Lubiprostone drug substance occurs as off-white to white crystalline powder, is very soluble in ether and ethanol, and is practically insoluble in hexane and water. Lubiprostone capsules are available as imprinted, oval, soft gelatin capsules in two strengths. Pink capsules contain 8 mcg of lubiprostone and the following inactive ingredients: black iron oxide, ferric oxide red, gelatin, hypromellose, lecithin, medium-chain triglycerides, propylene glycol, purified water, sorbitol sorbitan solution, and titanium dioxide. Orange capsules contain 24 mcg of lubiprostone and the following inactive ingredients: black iron oxide, D&C Yellow No. 10, FD&C Red No. 40, gelatin, hypromellose, lecithin, medium-chain triglycerides, propylene glycol, purified water, and sorbitol sorbitan solution.</Description>
</NDC>
<NDC>
<NDCCode>62332-816-31</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-816-31) </PackageDescription>
<NDC11Code>62332-0816-31</NDC11Code>
<ProductNDC>62332-816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218587</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina.</IndicationAndUsage>
<Description>Diltiazem hydrochloride, USP is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride, USP is 1,5-Benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. Its molecular formula is C22H26N2O4SHCl and its molecular weight is 450.98. Its structural formula is as follows. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, formic acid, methanol and water, sparingly soluble in dehydrated ethanol and insoluble in ether. Diltiazem hydrochloride extended-release capsules, USP contain 120 mg or 180 mg or 240 mg diltiazem hydrochloride and are formulated for the controlled release of diltiazem hydrochloride over a 24-hour period. Inactive Ingredients: Diltiazem hydrochloride extended-release capsules, USP contain lactose monohydrate, hypromellose, colloidal silicon dioxide and magnesium stearate. The 120 mg, 180 mg and 240 mg capsule shells contain FD&C Blue 1, FD&C Red 3, FD&C Red 40, titanium dioxide and gelatin. Additionally, 120 mg capsule shell contains FD&C Yellow 6, 180 mg and 240 mg capsule shell contains D&C Red 33. The capsules are printed with edible ink containing shellac, iron oxide black and potassium hydroxide. For oral administration. Meets USP Dissolution Test 32.</Description>
</NDC>
<NDC>
<NDCCode>62332-816-71</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-816-71) </PackageDescription>
<NDC11Code>62332-0816-71</NDC11Code>
<ProductNDC>62332-816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218587</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina.</IndicationAndUsage>
<Description>Diltiazem hydrochloride, USP is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride, USP is 1,5-Benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. Its molecular formula is C22H26N2O4SHCl and its molecular weight is 450.98. Its structural formula is as follows. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, formic acid, methanol and water, sparingly soluble in dehydrated ethanol and insoluble in ether. Diltiazem hydrochloride extended-release capsules, USP contain 120 mg or 180 mg or 240 mg diltiazem hydrochloride and are formulated for the controlled release of diltiazem hydrochloride over a 24-hour period. Inactive Ingredients: Diltiazem hydrochloride extended-release capsules, USP contain lactose monohydrate, hypromellose, colloidal silicon dioxide and magnesium stearate. The 120 mg, 180 mg and 240 mg capsule shells contain FD&C Blue 1, FD&C Red 3, FD&C Red 40, titanium dioxide and gelatin. Additionally, 120 mg capsule shell contains FD&C Yellow 6, 180 mg and 240 mg capsule shell contains D&C Red 33. The capsules are printed with edible ink containing shellac, iron oxide black and potassium hydroxide. For oral administration. Meets USP Dissolution Test 32.</Description>
</NDC>
<NDC>
<NDCCode>62332-816-91</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-816-91) </PackageDescription>
<NDC11Code>62332-0816-91</NDC11Code>
<ProductNDC>62332-816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218587</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina.</IndicationAndUsage>
<Description>Diltiazem hydrochloride, USP is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride, USP is 1,5-Benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. Its molecular formula is C22H26N2O4SHCl and its molecular weight is 450.98. Its structural formula is as follows. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, formic acid, methanol and water, sparingly soluble in dehydrated ethanol and insoluble in ether. Diltiazem hydrochloride extended-release capsules, USP contain 120 mg or 180 mg or 240 mg diltiazem hydrochloride and are formulated for the controlled release of diltiazem hydrochloride over a 24-hour period. Inactive Ingredients: Diltiazem hydrochloride extended-release capsules, USP contain lactose monohydrate, hypromellose, colloidal silicon dioxide and magnesium stearate. The 120 mg, 180 mg and 240 mg capsule shells contain FD&C Blue 1, FD&C Red 3, FD&C Red 40, titanium dioxide and gelatin. Additionally, 120 mg capsule shell contains FD&C Yellow 6, 180 mg and 240 mg capsule shell contains D&C Red 33. The capsules are printed with edible ink containing shellac, iron oxide black and potassium hydroxide. For oral administration. Meets USP Dissolution Test 32.</Description>
</NDC>
<NDC>
<NDCCode>83457-817-02</NDCCode>
<PackageDescription>2 KIT in 1 CARTON (83457-817-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (83457-816-01) / .1 mL in 1 SYRINGE * 1 mL in 1 PACKET (83457-927-01) </PackageDescription>
<NDC11Code>83457-0817-02</NDC11Code>
<ProductNDC>83457-817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Humira</ProprietaryName>
<NonProprietaryName>Adalimumab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240214</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125057</ApplicationNumber>
<LabelerName>Cordavis Limited</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HUMIRA is a tumor necrosis factor (TNF) blocker indicated for: : 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1) , 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2) , 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3) , 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8) , 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9) .</IndicationAndUsage>
<Description>Adalimumab is a tumor necrosis factor blocker. Adalimumab is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 mg), and Water for Injection, USP. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>59088-008-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-008-54) </PackageDescription>
<NDC11Code>59088-0008-54</NDC11Code>
<ProductNDC>59088-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Finazol</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241011</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC CITRATE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON</SubstanceName>
<StrengthNumber>1500; 200; 10; 45; 3.25; 3.35; 22.5; 6; 1000; 26; 100; 15; 100; 18; 25; 50; 30; 30; 1; .75; 37.5; 25; 24.5; 25</StrengthNumber>
<StrengthUnit>ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Finazol is indicated for iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. Also, for conditions in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.</IndicationAndUsage>
<Description>Full Prescribing Information: DESCRIPTION: Active Ingredients: Each caplet contains: Vitamin A (as Retinyl Acetate) ……………………………….....1500 mcg RAE Vitamin C (as Ascorbic Acid) ….…..….…………………….……….....200 mg Vitamin D3 (as Cholecalciferol) ….…………………………....10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) ………………………….....45 mg Thiamin (as Thiamine Mononitrate) …..…..…………………………...3.25 mg Riboflavin (as Vitamin B2) …..…..…..…..………………………….…3.35 mg Niacin (as Niacinamide)……………………………………………..…22.5 mg Vitamin B6 (as Pyridoxine HCl)……………………………………………6 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) …………………1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)……………………………………..26 mcg Biotin………………………………………………………………….100 mcg Pantothenic Acid (as Calcium Pantothenate)………………………….....15 mg Calcium (as Calcium Carbonate)………………………………………..100 mg Iron (as Ferrous Fumarate)……………………………………………....18 mg Iodine (as Potassium Iodide)…………………………………………...25 mcg Magnesium (as Magnesium Oxide)……………………………………...50 mg Zinc (as Zinc Citrate)……………………………………………………..30 mg Selenium (as Selenomethionine)….…………………………………….30 mcg Copper (as Copper Oxide)………………………………………………....1 mg Manganese (as Manganese Sulfate)…………………………………...0.75 mg Chromium (as Chromium Polynicotinate)…………………………….37.5 mcg Molybdenum (as Sodium Molybdate)…………………………………..25 mcg Potassium (as Potassium Chloride) ……………………………….…..24.5 mg Boron (as Boron Citrate)……………………………………..…………25 mcg. Other Ingredients: Crospovidone, Dextrin, Dextrose Monohydrate, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Purified Stearic Acid, Silicon Dioxide, Sodium Carboxymethylcellulose, Titanium Dioxide.</Description>
</NDC>
</NDCList>