{
"NDC": [
{
"NDCCode": "68308-326-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (68308-326-10)",
"NDC11Code": "68308-0326-10",
"ProductNDC": "68308-326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fabb Tablets",
"NonProprietaryName": "Vitamins Tablets",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Midlothian Laboratories",
"SubstanceName": "PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": "25; 2.2; 1",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "68308-250-10",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68308-250-10) ",
"NDC11Code": "68308-0250-10",
"ProductNDC": "68308-250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin",
"NonProprietaryName": "Erythromycin",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20130729",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050536",
"LabelerName": "Mayne Pharma Inc.",
"SubstanceName": "ERYTHROMYCIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130729",
"SamplePackage": "N",
"IndicationAndUsage": "Erythromycin is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved) (see appropriate sulfonamide labeling for prescribing information). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes. Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Syphilis caused by Treponema pallidum: Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythromycin lactobionate for injection, USP followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.",
"Description": "Erythromycin delayed-release capsules, USP capsules contain enteric-coated pellets of erythromycin base for oral administration. Each erythromycin delayed-release capsules, USP contains 250 mg of erythromycin base. Also contains: lactose NF, povidone USP, and other ingredients. The capsule shell contains gelatin NF, titanium dioxide USP, FD&C Yellow #6, D&C Yellow #10 and FD&C Red #3. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids but it is the base which is microbiologically active. Erythromycin base is (3R *, 4S *, 5S *, 6R *, 7R *, 9R *, 11R *, 12R *, 13S *, 14R *)-4-[(2,6-Dideoxy-3-C-methyl- 3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6- trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-oxacyclo-tetradecane-2,10-dione."
},
{
"NDCCode": "68308-312-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (68308-312-10) ",
"NDC11Code": "68308-0312-10",
"ProductNDC": "68308-312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Aspirin, Caffeine, And Codeine Phosphate",
"NonProprietaryName": "Butalbital, Aspirin, Caffeine, And Codeine Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203335",
"LabelerName": "Mayne Pharma Inc.",
"SubstanceName": "ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE",
"StrengthNumber": "325; 50; 40; 30",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2022-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20151030",
"SamplePackage": "N"
},
{
"NDCCode": "68308-324-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (68308-324-10)",
"NDC11Code": "68308-0324-10",
"ProductNDC": "68308-324",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Folcaps",
"NonProprietaryName": "Vitamins Tablets",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Midlothian Laboratories",
"SubstanceName": "PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": "25; 2.2; 500",
"StrengthUnit": "mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "68308-325-10",
"PackageDescription": "60 TABLET in 1 BOTTLE (68308-325-10)",
"NDC11Code": "68308-0325-10",
"ProductNDC": "68308-325",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Foltabs 800",
"NonProprietaryName": "Vitamins Tablets",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"EndMarketingDate": "20190630",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Mayne Pharma Inc",
"SubstanceName": "PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": "115; 800; 115",
"StrengthUnit": "mg/1; ug/1; ug/1",
"Pharm_Classes": "Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-07-02",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "68308-405-47",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68308-405-47) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "68308-0405-47",
"ProductNDC": "68308-405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090177",
"LabelerName": "Mayne Pharma Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2020-08-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20081216",
"SamplePackage": "N"
},
{
"NDCCode": "68308-475-47",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68308-475-47) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "68308-0475-47",
"ProductNDC": "68308-475",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090177",
"LabelerName": "Mayne Pharma Inc.",
"SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "325; 7.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20081216",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and Acetaminophen Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains."
},
{
"NDCCode": "68308-480-47",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68308-480-47) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "68308-0480-47",
"ProductNDC": "68308-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090177",
"LabelerName": "Mayne Pharma Inc.",
"SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "325; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20081216",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and Acetaminophen Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains."
},
{
"NDCCode": "68308-505-47",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68308-505-47) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "68308-0505-47",
"ProductNDC": "68308-505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091313",
"LabelerName": "Mayne Pharma Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2020-05-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20110228",
"SamplePackage": "N"
},
{
"NDCCode": "68308-554-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (68308-554-10) ",
"NDC11Code": "68308-0554-10",
"ProductNDC": "68308-554",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zebutal",
"NonProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20131226",
"EndMarketingDate": "20231031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089007",
"LabelerName": "Mayne Pharma Inc.",
"SubstanceName": "ACETAMINOPHEN; BUTALBITAL; CAFFEINE",
"StrengthNumber": "325; 50; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131226",
"EndMarketingDatePackage": "20231031",
"SamplePackage": "N"
},
{
"NDCCode": "68308-570-30",
"PackageDescription": "3 BLISTER PACK in 1 BOX (68308-570-30) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-570-01) ",
"NDC11Code": "68308-0570-30",
"ProductNDC": "68308-570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20210921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212333",
"LabelerName": "Mayne Pharma",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2022-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210921",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.",
"Description": "Isotretinoin capsules, USP contain 10 mg, 20 mg or 30 mg of isotretinoin (a retinoid) in soft gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin USP, each capsule contains the following inactive ingredients: butylated hydroxyanisole, disodium edetate, hydrogenated vegetable oil Type I, hydrogenated vegetable oil Type II, soybean oil, vitamin E and yellow wax. The gelatin capsules contain the following: 1 10 mg – glycerin, iron oxide (yellow), sorbitol and titanium dioxide, 2 20 mg – glycerin, iron oxide (red), sorbitol and titanium dioxide, 3 30 mg – glycerin, iron oxide (red and yellow), ferrosoferric oxide, sorbitol and titanium dioxide."
},
{
"NDCCode": "68308-571-30",
"PackageDescription": "3 BLISTER PACK in 1 BOX (68308-571-30) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-571-01) ",
"NDC11Code": "68308-0571-30",
"ProductNDC": "68308-571",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20210921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212333",
"LabelerName": "Mayne Pharma",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2022-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210921",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.",
"Description": "Isotretinoin capsules, USP contain 10 mg, 20 mg or 30 mg of isotretinoin (a retinoid) in soft gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin USP, each capsule contains the following inactive ingredients: butylated hydroxyanisole, disodium edetate, hydrogenated vegetable oil Type I, hydrogenated vegetable oil Type II, soybean oil, vitamin E and yellow wax. The gelatin capsules contain the following: 1 10 mg – glycerin, iron oxide (yellow), sorbitol and titanium dioxide, 2 20 mg – glycerin, iron oxide (red), sorbitol and titanium dioxide, 3 30 mg – glycerin, iron oxide (red and yellow), ferrosoferric oxide, sorbitol and titanium dioxide."
},
{
"NDCCode": "68308-573-30",
"PackageDescription": "3 BLISTER PACK in 1 BOX (68308-573-30) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-573-01) ",
"NDC11Code": "68308-0573-30",
"ProductNDC": "68308-573",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20210921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212333",
"LabelerName": "Mayne Pharma",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2022-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210921",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.",
"Description": "Isotretinoin capsules, USP contain 10 mg, 20 mg or 30 mg of isotretinoin (a retinoid) in soft gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin USP, each capsule contains the following inactive ingredients: butylated hydroxyanisole, disodium edetate, hydrogenated vegetable oil Type I, hydrogenated vegetable oil Type II, soybean oil, vitamin E and yellow wax. The gelatin capsules contain the following: 1 10 mg – glycerin, iron oxide (yellow), sorbitol and titanium dioxide, 2 20 mg – glycerin, iron oxide (red), sorbitol and titanium dioxide, 3 30 mg – glycerin, iron oxide (red and yellow), ferrosoferric oxide, sorbitol and titanium dioxide."
},
{
"NDCCode": "68308-575-30",
"PackageDescription": "3 BLISTER PACK in 1 BOX (68308-575-30) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-575-01) ",
"NDC11Code": "68308-0575-30",
"ProductNDC": "68308-575",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20210903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213571",
"LabelerName": "Mayne Pharma",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2022-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210903",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.",
"Description": "Isotretinoin capsules, USP contain 40 mg of isotretinoin (a retinoid) in soft gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin USP, each capsule contains the following inactive ingredients: butylated hydroxyanisole, disodium edetate, hydrogenated vegetable oil Type I, hydrogenated vegetable oil Type II, soybean oil, vitamin E and yellow wax. The gelatin capsules contain glycerin, iron oxide (red and yellow), ferrosoferric oxide, sorbitol and titanium dioxide. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. It is practically insoluble in water, soluble in chloroform and sparingly soluble in alcohol and in isopropyl alcohol. The structural formula is. Meets USP Dissolution Test 6."
},
{
"NDCCode": "68308-665-10",
"PackageDescription": "1 TUBE in 1 CARTON (68308-665-10) / 100 g in 1 TUBE",
"NDC11Code": "68308-0665-10",
"ProductNDC": "68308-665",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcitrol",
"NonProprietaryName": "Calcitriol",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230721",
"EndMarketingDate": "20260331",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022087",
"LabelerName": "Mayne Pharma Commercial LLC.",
"SubstanceName": "CALCITRIOL",
"StrengthNumber": "3",
"StrengthUnit": "ug/g",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230721",
"EndMarketingDatePackage": "20260331",
"SamplePackage": "N"
},
{
"NDCCode": "68308-710-10",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (68308-710-10) ",
"NDC11Code": "68308-0710-10",
"ProductNDC": "68308-710",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130708",
"EndMarketingDate": "20230630",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050795",
"LabelerName": "Mayne Pharma Commercial LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130708",
"EndMarketingDatePackage": "20230630",
"SamplePackage": "N",
"IndicationAndUsage": "Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: 1 Rickettsial infections (1.1), 2 Sexually transmitted infections (1.2), 3 Respiratory tract infections (1.3), 4 Specific bacterial infections (1.4), 5 Ophthalmic infections (1.5), 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8), 9 Prophylaxis of malaria (1.9).",
"Description": "Doxycycline hyclate delayed-release tablets, contain specially coated pellets of doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6- methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 50 mg, 75 mg, 80 mg, 100 mg, 150 mg or 200 mg (equivalent to doxycycline hyclate 57.7 mg, 86.6 mg, 92.3 mg, 115.4 mg, 173.1 mg or 230.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate; microcrystalline cellulose; sodium lauryl sulfate; sodium chloride; talc; anhydrous lactose; corn starch; crospovidone; magnesium stearate; cellulosic polymer coating. Each doxycycline hyclate delayed-release tablets 50 mg tablet contains 3 mg (0.131 mEq) of sodium, each doxycycline hyclate delayed-release tablets 75 mg tablet contains 4.5 mg (0.196 mEq) of sodium, each doxycycline hyclate delayed-release tablets 80 mg tablet contains 4.8 mg (0.209 mEq) of sodium, each doxycycline hyclate delayed-release tablets 100 mg tablet contains 6 mg (0.261 mEq) of sodium, each doxycycline hyclate delayed-release tablets 150 mg tablet contains 9 mg (0.392 mEq) of sodium, and each doxycycline hyclate delayed-release tablets 200 mg tablet contains 12 mg (0.522 mEq) of sodium."
},
{
"NDCCode": "68308-715-10",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (68308-715-10) ",
"NDC11Code": "68308-0715-10",
"ProductNDC": "68308-715",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130708",
"EndMarketingDate": "20240731",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050795",
"LabelerName": "Mayne Pharma Commercial LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130708",
"EndMarketingDatePackage": "20240731",
"SamplePackage": "N",
"IndicationAndUsage": "Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: 1 Rickettsial infections (1.1), 2 Sexually transmitted infections (1.2), 3 Respiratory tract infections (1.3), 4 Specific bacterial infections (1.4), 5 Ophthalmic infections (1.5), 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8), 9 Prophylaxis of malaria (1.9).",
"Description": "Doxycycline hyclate delayed-release tablets, contain specially coated pellets of doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6- methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 50 mg, 75 mg, 80 mg, 100 mg, 150 mg or 200 mg (equivalent to doxycycline hyclate 57.7 mg, 86.6 mg, 92.3 mg, 115.4 mg, 173.1 mg or 230.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate; microcrystalline cellulose; sodium lauryl sulfate; sodium chloride; talc; anhydrous lactose; corn starch; crospovidone; magnesium stearate; cellulosic polymer coating. Each doxycycline hyclate delayed-release tablets 50 mg tablet contains 3 mg (0.131 mEq) of sodium, each doxycycline hyclate delayed-release tablets 75 mg tablet contains 4.5 mg (0.196 mEq) of sodium, each doxycycline hyclate delayed-release tablets 80 mg tablet contains 4.8 mg (0.209 mEq) of sodium, each doxycycline hyclate delayed-release tablets 100 mg tablet contains 6 mg (0.261 mEq) of sodium, each doxycycline hyclate delayed-release tablets 150 mg tablet contains 9 mg (0.392 mEq) of sodium, and each doxycycline hyclate delayed-release tablets 200 mg tablet contains 12 mg (0.522 mEq) of sodium."
},
{
"NDCCode": "68308-781-30",
"PackageDescription": "3 BLISTER PACK in 1 BOX (68308-781-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-781-01) ",
"NDC11Code": "68308-0781-30",
"ProductNDC": "68308-781",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20120501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076485",
"LabelerName": "Mayne Pharma",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231201",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. \"Severe,\" by definition, 2means \"many\" as opposed to \"few or several\" nodules. Because of significant adverse effects associated with its use, isotretinoin capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, isotretinoin capsules are indicated only for those patients who are not pregnant, because isotretinoin capsules can cause life-threatening birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off isotretinoin capsules. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).",
"Description": "Isotretinoin, a retinoid, is available as isotretinoin capsules in 10-mg, 20-mg, 30-mg and 40-mg soft gelatin capsules for oral administration. Each capsule contains yellow wax, butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil, tocopherol, and soybean oil. Gelatin capsules contain gelatin, glycerin and non-crystallizing sorbitol solution, with the following dye systems: 10 mg - ferric oxide (yellow) and titanium dioxide; 20 mg - titanium dioxide; 30 mg - titanium dioxide and ferric oxide (red); 40 mg - FD&C Yellow No. 6 and titanium dioxide. The edible imprinting ink for all the capsules contains: shellac glaze, dehydrated alcohol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide. Meets USP Dissolution Test 6. Chemically, isotretinoin is 13- cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. The structural formula is:."
},
{
"NDCCode": "68308-782-30",
"PackageDescription": "3 BLISTER PACK in 1 BOX (68308-782-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-782-01) ",
"NDC11Code": "68308-0782-30",
"ProductNDC": "68308-782",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20120501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076485",
"LabelerName": "Mayne Pharma",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231201",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. \"Severe,\" by definition, 2means \"many\" as opposed to \"few or several\" nodules. Because of significant adverse effects associated with its use, isotretinoin capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, isotretinoin capsules are indicated only for those patients who are not pregnant, because isotretinoin capsules can cause life-threatening birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off isotretinoin capsules. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).",
"Description": "Isotretinoin, a retinoid, is available as isotretinoin capsules in 10-mg, 20-mg, 30-mg and 40-mg soft gelatin capsules for oral administration. Each capsule contains yellow wax, butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil, tocopherol, and soybean oil. Gelatin capsules contain gelatin, glycerin and non-crystallizing sorbitol solution, with the following dye systems: 10 mg - ferric oxide (yellow) and titanium dioxide; 20 mg - titanium dioxide; 30 mg - titanium dioxide and ferric oxide (red); 40 mg - FD&C Yellow No. 6 and titanium dioxide. The edible imprinting ink for all the capsules contains: shellac glaze, dehydrated alcohol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide. Meets USP Dissolution Test 6. Chemically, isotretinoin is 13- cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. The structural formula is:."
},
{
"NDCCode": "68308-783-30",
"PackageDescription": "3 BLISTER PACK in 1 BOX (68308-783-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-783-01) ",
"NDC11Code": "68308-0783-30",
"ProductNDC": "68308-783",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20120501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076485",
"LabelerName": "Mayne Pharma",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231201",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. \"Severe,\" by definition, 2means \"many\" as opposed to \"few or several\" nodules. Because of significant adverse effects associated with its use, isotretinoin capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, isotretinoin capsules are indicated only for those patients who are not pregnant, because isotretinoin capsules can cause life-threatening birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off isotretinoin capsules. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).",
"Description": "Isotretinoin, a retinoid, is available as isotretinoin capsules in 10-mg, 20-mg, 30-mg and 40-mg soft gelatin capsules for oral administration. Each capsule contains yellow wax, butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil, tocopherol, and soybean oil. Gelatin capsules contain gelatin, glycerin and non-crystallizing sorbitol solution, with the following dye systems: 10 mg - ferric oxide (yellow) and titanium dioxide; 20 mg - titanium dioxide; 30 mg - titanium dioxide and ferric oxide (red); 40 mg - FD&C Yellow No. 6 and titanium dioxide. The edible imprinting ink for all the capsules contains: shellac glaze, dehydrated alcohol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide. Meets USP Dissolution Test 6. Chemically, isotretinoin is 13- cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. The structural formula is:."
},
{
"NDCCode": "68308-784-30",
"PackageDescription": "3 BLISTER PACK in 1 BOX (68308-784-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-784-01) ",
"NDC11Code": "68308-0784-30",
"ProductNDC": "68308-784",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20120501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076485",
"LabelerName": "Mayne Pharma",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231201",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. \"Severe,\" by definition, 2means \"many\" as opposed to \"few or several\" nodules. Because of significant adverse effects associated with its use, isotretinoin capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, isotretinoin capsules are indicated only for those patients who are not pregnant, because isotretinoin capsules can cause life-threatening birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off isotretinoin capsules. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).",
"Description": "Isotretinoin, a retinoid, is available as isotretinoin capsules in 10-mg, 20-mg, 30-mg and 40-mg soft gelatin capsules for oral administration. Each capsule contains yellow wax, butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil, tocopherol, and soybean oil. Gelatin capsules contain gelatin, glycerin and non-crystallizing sorbitol solution, with the following dye systems: 10 mg - ferric oxide (yellow) and titanium dioxide; 20 mg - titanium dioxide; 30 mg - titanium dioxide and ferric oxide (red); 40 mg - FD&C Yellow No. 6 and titanium dioxide. The edible imprinting ink for all the capsules contains: shellac glaze, dehydrated alcohol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide. Meets USP Dissolution Test 6. Chemically, isotretinoin is 13- cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. The structural formula is:."
},
{
"NDCCode": "10122-326-10",
"PackageDescription": "10 CARTON in 1 BOX (10122-326-10) > 1 BAG in 1 CARTON (10122-326-01) > 200 mL in 1 BAG",
"NDC11Code": "10122-0326-10",
"ProductNDC": "10122-326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cardene Iv",
"NonProprietaryName": "Nicardipine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19920130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019734",
"LabelerName": "Chiesi USA, Inc.",
"SubstanceName": "NICARDIPINE HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-03-30",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "10695-326-80",
"PackageDescription": "10 kg in 1 CONTAINER (10695-326-80) ",
"NDC11Code": "10695-0326-80",
"ProductNDC": "10695-326",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Glycine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Willow Birch Pharma, LLC",
"SubstanceName": "GLYCINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-17",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "15-DEC-25"
},
{
"NDCCode": "15127-326-10",
"PackageDescription": "296 mL in 1 BOTTLE, GLASS (15127-326-10) ",
"NDC11Code": "15127-0326-10",
"ProductNDC": "15127-326",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Magnesium Citrate",
"ProprietaryNameSuffix": "Cherry",
"NonProprietaryName": "Magnesium Citrate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20061003",
"EndMarketingDate": "20191231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Select Brand Dist.",
"SubstanceName": "MAGNESIUM CITRATE",
"StrengthNumber": "1.745",
"StrengthUnit": "g/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20061003",
"EndMarketingDatePackage": "20191231",
"SamplePackage": "N"
},
{
"NDCCode": "16590-326-10",
"PackageDescription": "10 TABLET in 1 BOTTLE, PLASTIC (16590-326-10)",
"NDC11Code": "16590-0326-10",
"ProductNDC": "16590-326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19740226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083677",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions: 1 Endocrine disordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer , 2 Rheumatic disordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis , 3 Collagen diseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis , 4 Dermatologic diseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis , 5 Allergic statesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisSerum sicknessBronchial asthmaContact dermatitisAtopic dermatitisDrug hypersensitivity reactions , 6 Ophthalmic diseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic conjunctivitisKeratitisAllergic corneal marginal ulcersHerpes zoster ophthalmicusIritis and iridocyclitisChorioretinitisAnterior segment inflammationDiffuse posterior uveitis and choroiditisOptic neuritisSympathetic ophthalmia , 7 Respiratory diseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis , 8 Hematologic disordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia , 9 Neoplastic diseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood , 10 Edematous statesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus , 11 Gastrointestinal diseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 Nervous SystemAcute exacerbations of multiple sclerosis , 13 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The molecular formula for prednisone is C21H26O5. Chemically, it is 17, 21-dihydroxypregna-1, 4-diene-3,11,20-trione and has the following structural formula. Prednisone is a white to practically white, odorless, crystalline powder and has a molecular weight of 358.44. It melts at about 230°C with some decomposition. Prednisone is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 1 mg, 2.5 mg, 5 mg, 10 mg, or 20 mg of prednisone. Inactive ingredients:1 mg: anhydrous lactose, corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.|2.5 mg: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc.5 mg: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc.10 mg: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc.20 mg: anhydrous lactose, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "19355-326-01",
"PackageDescription": "10 mL in 1 BOTTLE, PLASTIC (19355-326-01) ",
"NDC11Code": "19355-0326-01",
"ProductNDC": "19355-326",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prismatic Protectant Spf50",
"NonProprietaryName": "Zinc Oxide, Titanium Dioxide, Octinoxate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "PhytogenX, Inc.",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE",
"StrengthNumber": "190; 33; 75",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190301",
"SamplePackage": "N"
},
{
"NDCCode": "23155-326-31",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (23155-326-31) / 10 mL in 1 VIAL, GLASS",
"NDC11Code": "23155-0326-31",
"ProductNDC": "23155-326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibutilide Fumarate",
"NonProprietaryName": "Ibutilide Fumarate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204146",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "IBUTILIDE FUMARATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240401",
"SamplePackage": "N",
"IndicationAndUsage": "Ibutilide fumarate injection is indicated for the rapid conversion of atrial fibrillation or atrial flutter of recent onset to sinus rhythm. Patients with atrial arrhythmias of longer duration are less likely to respond to ibutilide fumarate. The effectiveness of ibutilide has not been determined in patients with arrhythmias of more than 90 days in duration.LIFE-THREATENING ARRHYTHMIAS—APPROPRIATE TREATMENT ENVIRONMENT Ibutilide fumarate can cause potentially fatal arrhythmias, particularly sustained polymorphic ventricular tachycardia, usually in association with QT prolongation (torsades de pointes), but sometimes without documented QT prolongation. In registration studies, these arrhythmias, which require cardioversion, occurred in 1.7% of treated patients during, or within a number of hours of, use of Ibutilide fumarate. These arrhythmias can be reversed if treated promptly (see WARNINGS, Proarrhythmia). It is essential that Ibutilide fumarate be administered in a setting of continuous ECG monitoring and by personnel trained in identification and treatment of acute ventricular arrhythmias, particularly polymorphic ventricular tachycardia. Patients with atrial fibrillation of more than 2 to 3 days’ duration must be adequately anticoagulated, generally for at least 2 weeks. CHOICE OF PATIENTS Patients with chronic atrial fibrillation have a strong tendency to revert after conversion to sinus rhythm (see CLINICAL STUDIES) and treatments to maintain sinus rhythm carry risks. Patients to be treated with Ibutilide fumarate , therefore, should be carefully selected such that the expected benefits of maintaining sinus rhythm outweigh the immediate risks of Ibutilide fumarate , and the risks of maintenance therapy, and are likely to offer an advantage compared with alternative management.",
"Description": "Ibutilide Fumarate Injection is an antiarrhythmic drug with predominantly class III (cardiac action potential prolongation) properties according to the Vaughan Williams Classification. Each milliliter of Ibutilide Fumarate Injection contains 0.1 mg of ibutilide fumarate, USP (equivalent to 0.087 mg ibutilide free base), 0.189 mg sodium acetate trihydrate, USP, 8.90 mg sodium chloride, USP, hydrochloric acid NF and/or sodium hydroxide NF to adjust pH to approximately 4.6, and Water for Injection, USP. Ibutilide Fumarate Injection is an isotonic, clear, colorless, sterile aqueous solution. Ibutilide fumarate has one chiral center, and exists as a racemate of the (+) and (−) enantiomers. The chemical name for ibutilide fumarate is Methanesulfonamide, N-{4-{4-(ethylheptylamino)-1-hydroxybutyl} phenyl}, (+) (−), (E)-2-butenedioate (1:0.5) (hemifumarate salt) Its molecular formula is C22H38N2O5S, and its molecular weight is 442.62. Ibutilide fumarate is a white to off-white powder with an aqueous solubility of over 100 mg/mL at pH 7 or lower.The structural formula is represented below."
},
{
"NDCCode": "41520-326-10",
"PackageDescription": "296 mL in 1 BOTTLE, GLASS (41520-326-10) ",
"NDC11Code": "41520-0326-10",
"ProductNDC": "41520-326",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Magnesium Citrate",
"NonProprietaryName": "Magnesium Citrate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150531",
"EndMarketingDate": "20231229",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Care One (American Sales Company)",
"SubstanceName": "MAGNESIUM CITRATE",
"StrengthNumber": "1.745",
"StrengthUnit": "g/29.6mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150531",
"EndMarketingDatePackage": "20231229",
"SamplePackage": "N"
},
{
"NDCCode": "43063-326-10",
"PackageDescription": "10 TABLET in 1 BOTTLE, PLASTIC (43063-326-10) ",
"NDC11Code": "43063-0326-10",
"ProductNDC": "43063-326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077253",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20110520",
"SamplePackage": "N"
},
{
"NDCCode": "48433-326-10",
"PackageDescription": "100 POUCH in 1 BOX, UNIT-DOSE (48433-326-10) > 1 TABLET, FILM COATED in 1 POUCH (48433-326-01)",
"NDC11Code": "48433-0326-10",
"ProductNDC": "48433-326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075978",
"LabelerName": "Safecor Health, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. C4H11N5HCl M.W. 165.63. Metformin hydrochloride is a white to off-white crystalline compound. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, polyethylene glycol, povidone and titanium dioxide."
}
]
}
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<NDC>
<NDCCode>68308-326-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68308-326-10)</PackageDescription>
<NDC11Code>68308-0326-10</NDC11Code>
<ProductNDC>68308-326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fabb Tablets</ProprietaryName>
<NonProprietaryName>Vitamins Tablets</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Midlothian Laboratories</LabelerName>
<SubstanceName>PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>25; 2.2; 1</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68308-250-10</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68308-250-10) </PackageDescription>
<NDC11Code>68308-0250-10</NDC11Code>
<ProductNDC>68308-250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin</ProprietaryName>
<NonProprietaryName>Erythromycin</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130729</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050536</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<SubstanceName>ERYTHROMYCIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Erythromycin is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved) (see appropriate sulfonamide labeling for prescribing information). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes. Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Syphilis caused by Treponema pallidum: Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythromycin lactobionate for injection, USP followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.</IndicationAndUsage>
<Description>Erythromycin delayed-release capsules, USP capsules contain enteric-coated pellets of erythromycin base for oral administration. Each erythromycin delayed-release capsules, USP contains 250 mg of erythromycin base. Also contains: lactose NF, povidone USP, and other ingredients. The capsule shell contains gelatin NF, titanium dioxide USP, FD&C Yellow #6, D&C Yellow #10 and FD&C Red #3. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids but it is the base which is microbiologically active. Erythromycin base is (3R *, 4S *, 5S *, 6R *, 7R *, 9R *, 11R *, 12R *, 13S *, 14R *)-4-[(2,6-Dideoxy-3-C-methyl- 3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6- trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-oxacyclo-tetradecane-2,10-dione.</Description>
</NDC>
<NDC>
<NDCCode>68308-312-10</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (68308-312-10) </PackageDescription>
<NDC11Code>68308-0312-10</NDC11Code>
<ProductNDC>68308-312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Aspirin, Caffeine, And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Butalbital, Aspirin, Caffeine, And Codeine Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203335</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<SubstanceName>ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>325; 50; 40; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68308-324-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68308-324-10)</PackageDescription>
<NDC11Code>68308-0324-10</NDC11Code>
<ProductNDC>68308-324</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Folcaps</ProprietaryName>
<NonProprietaryName>Vitamins Tablets</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Midlothian Laboratories</LabelerName>
<SubstanceName>PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>25; 2.2; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68308-325-10</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68308-325-10)</PackageDescription>
<NDC11Code>68308-0325-10</NDC11Code>
<ProductNDC>68308-325</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Foltabs 800</ProprietaryName>
<NonProprietaryName>Vitamins Tablets</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<EndMarketingDate>20190630</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Mayne Pharma Inc</LabelerName>
<SubstanceName>PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>115; 800; 115</StrengthNumber>
<StrengthUnit>mg/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-07-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>68308-405-47</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68308-405-47) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68308-0405-47</NDC11Code>
<ProductNDC>68308-405</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090177</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-08-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68308-475-47</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68308-475-47) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68308-0475-47</NDC11Code>
<ProductNDC>68308-475</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090177</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 7.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and Acetaminophen Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains.</Description>
</NDC>
<NDC>
<NDCCode>68308-480-47</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68308-480-47) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68308-0480-47</NDC11Code>
<ProductNDC>68308-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090177</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and Acetaminophen Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains.</Description>
</NDC>
<NDC>
<NDCCode>68308-505-47</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68308-505-47) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68308-0505-47</NDC11Code>
<ProductNDC>68308-505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091313</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-05-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68308-554-10</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (68308-554-10) </PackageDescription>
<NDC11Code>68308-0554-10</NDC11Code>
<ProductNDC>68308-554</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zebutal</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen And Caffeine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131226</StartMarketingDate>
<EndMarketingDate>20231031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089007</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; BUTALBITAL; CAFFEINE</SubstanceName>
<StrengthNumber>325; 50; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131226</StartMarketingDatePackage>
<EndMarketingDatePackage>20231031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68308-570-30</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 BOX (68308-570-30) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-570-01) </PackageDescription>
<NDC11Code>68308-0570-30</NDC11Code>
<ProductNDC>68308-570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isotretinoin</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212333</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.</IndicationAndUsage>
<Description>Isotretinoin capsules, USP contain 10 mg, 20 mg or 30 mg of isotretinoin (a retinoid) in soft gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin USP, each capsule contains the following inactive ingredients: butylated hydroxyanisole, disodium edetate, hydrogenated vegetable oil Type I, hydrogenated vegetable oil Type II, soybean oil, vitamin E and yellow wax. The gelatin capsules contain the following: 1 10 mg – glycerin, iron oxide (yellow), sorbitol and titanium dioxide, 2 20 mg – glycerin, iron oxide (red), sorbitol and titanium dioxide, 3 30 mg – glycerin, iron oxide (red and yellow), ferrosoferric oxide, sorbitol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68308-571-30</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 BOX (68308-571-30) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-571-01) </PackageDescription>
<NDC11Code>68308-0571-30</NDC11Code>
<ProductNDC>68308-571</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isotretinoin</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212333</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.</IndicationAndUsage>
<Description>Isotretinoin capsules, USP contain 10 mg, 20 mg or 30 mg of isotretinoin (a retinoid) in soft gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin USP, each capsule contains the following inactive ingredients: butylated hydroxyanisole, disodium edetate, hydrogenated vegetable oil Type I, hydrogenated vegetable oil Type II, soybean oil, vitamin E and yellow wax. The gelatin capsules contain the following: 1 10 mg – glycerin, iron oxide (yellow), sorbitol and titanium dioxide, 2 20 mg – glycerin, iron oxide (red), sorbitol and titanium dioxide, 3 30 mg – glycerin, iron oxide (red and yellow), ferrosoferric oxide, sorbitol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68308-573-30</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 BOX (68308-573-30) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-573-01) </PackageDescription>
<NDC11Code>68308-0573-30</NDC11Code>
<ProductNDC>68308-573</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isotretinoin</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212333</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.</IndicationAndUsage>
<Description>Isotretinoin capsules, USP contain 10 mg, 20 mg or 30 mg of isotretinoin (a retinoid) in soft gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin USP, each capsule contains the following inactive ingredients: butylated hydroxyanisole, disodium edetate, hydrogenated vegetable oil Type I, hydrogenated vegetable oil Type II, soybean oil, vitamin E and yellow wax. The gelatin capsules contain the following: 1 10 mg – glycerin, iron oxide (yellow), sorbitol and titanium dioxide, 2 20 mg – glycerin, iron oxide (red), sorbitol and titanium dioxide, 3 30 mg – glycerin, iron oxide (red and yellow), ferrosoferric oxide, sorbitol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68308-575-30</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 BOX (68308-575-30) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-575-01) </PackageDescription>
<NDC11Code>68308-0575-30</NDC11Code>
<ProductNDC>68308-575</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isotretinoin</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210903</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213571</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.</IndicationAndUsage>
<Description>Isotretinoin capsules, USP contain 40 mg of isotretinoin (a retinoid) in soft gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin USP, each capsule contains the following inactive ingredients: butylated hydroxyanisole, disodium edetate, hydrogenated vegetable oil Type I, hydrogenated vegetable oil Type II, soybean oil, vitamin E and yellow wax. The gelatin capsules contain glycerin, iron oxide (red and yellow), ferrosoferric oxide, sorbitol and titanium dioxide. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. It is practically insoluble in water, soluble in chloroform and sparingly soluble in alcohol and in isopropyl alcohol. The structural formula is. Meets USP Dissolution Test 6.</Description>
</NDC>
<NDC>
<NDCCode>68308-665-10</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68308-665-10) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>68308-0665-10</NDC11Code>
<ProductNDC>68308-665</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcitrol</ProprietaryName>
<NonProprietaryName>Calcitriol</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230721</StartMarketingDate>
<EndMarketingDate>20260331</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022087</ApplicationNumber>
<LabelerName>Mayne Pharma Commercial LLC.</LabelerName>
<SubstanceName>CALCITRIOL</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>ug/g</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230721</StartMarketingDatePackage>
<EndMarketingDatePackage>20260331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68308-710-10</NDCCode>
<PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE (68308-710-10) </PackageDescription>
<NDC11Code>68308-0710-10</NDC11Code>
<ProductNDC>68308-710</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130708</StartMarketingDate>
<EndMarketingDate>20230630</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050795</ApplicationNumber>
<LabelerName>Mayne Pharma Commercial LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130708</StartMarketingDatePackage>
<EndMarketingDatePackage>20230630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: 1 Rickettsial infections (1.1), 2 Sexually transmitted infections (1.2), 3 Respiratory tract infections (1.3), 4 Specific bacterial infections (1.4), 5 Ophthalmic infections (1.5), 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8), 9 Prophylaxis of malaria (1.9).</IndicationAndUsage>
<Description>Doxycycline hyclate delayed-release tablets, contain specially coated pellets of doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6- methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 50 mg, 75 mg, 80 mg, 100 mg, 150 mg or 200 mg (equivalent to doxycycline hyclate 57.7 mg, 86.6 mg, 92.3 mg, 115.4 mg, 173.1 mg or 230.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate; microcrystalline cellulose; sodium lauryl sulfate; sodium chloride; talc; anhydrous lactose; corn starch; crospovidone; magnesium stearate; cellulosic polymer coating. Each doxycycline hyclate delayed-release tablets 50 mg tablet contains 3 mg (0.131 mEq) of sodium, each doxycycline hyclate delayed-release tablets 75 mg tablet contains 4.5 mg (0.196 mEq) of sodium, each doxycycline hyclate delayed-release tablets 80 mg tablet contains 4.8 mg (0.209 mEq) of sodium, each doxycycline hyclate delayed-release tablets 100 mg tablet contains 6 mg (0.261 mEq) of sodium, each doxycycline hyclate delayed-release tablets 150 mg tablet contains 9 mg (0.392 mEq) of sodium, and each doxycycline hyclate delayed-release tablets 200 mg tablet contains 12 mg (0.522 mEq) of sodium.</Description>
</NDC>
<NDC>
<NDCCode>68308-715-10</NDCCode>
<PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE (68308-715-10) </PackageDescription>
<NDC11Code>68308-0715-10</NDC11Code>
<ProductNDC>68308-715</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130708</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050795</ApplicationNumber>
<LabelerName>Mayne Pharma Commercial LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130708</StartMarketingDatePackage>
<EndMarketingDatePackage>20240731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: 1 Rickettsial infections (1.1), 2 Sexually transmitted infections (1.2), 3 Respiratory tract infections (1.3), 4 Specific bacterial infections (1.4), 5 Ophthalmic infections (1.5), 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8), 9 Prophylaxis of malaria (1.9).</IndicationAndUsage>
<Description>Doxycycline hyclate delayed-release tablets, contain specially coated pellets of doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6- methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 50 mg, 75 mg, 80 mg, 100 mg, 150 mg or 200 mg (equivalent to doxycycline hyclate 57.7 mg, 86.6 mg, 92.3 mg, 115.4 mg, 173.1 mg or 230.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate; microcrystalline cellulose; sodium lauryl sulfate; sodium chloride; talc; anhydrous lactose; corn starch; crospovidone; magnesium stearate; cellulosic polymer coating. Each doxycycline hyclate delayed-release tablets 50 mg tablet contains 3 mg (0.131 mEq) of sodium, each doxycycline hyclate delayed-release tablets 75 mg tablet contains 4.5 mg (0.196 mEq) of sodium, each doxycycline hyclate delayed-release tablets 80 mg tablet contains 4.8 mg (0.209 mEq) of sodium, each doxycycline hyclate delayed-release tablets 100 mg tablet contains 6 mg (0.261 mEq) of sodium, each doxycycline hyclate delayed-release tablets 150 mg tablet contains 9 mg (0.392 mEq) of sodium, and each doxycycline hyclate delayed-release tablets 200 mg tablet contains 12 mg (0.522 mEq) of sodium.</Description>
</NDC>
<NDC>
<NDCCode>68308-781-30</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 BOX (68308-781-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-781-01) </PackageDescription>
<NDC11Code>68308-0781-30</NDC11Code>
<ProductNDC>68308-781</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isotretinoin</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076485</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<IndicationAndUsage>Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, 2means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with its use, isotretinoin capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, isotretinoin capsules are indicated only for those patients who are not pregnant, because isotretinoin capsules can cause life-threatening birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off isotretinoin capsules. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).</IndicationAndUsage>
<Description>Isotretinoin, a retinoid, is available as isotretinoin capsules in 10-mg, 20-mg, 30-mg and 40-mg soft gelatin capsules for oral administration. Each capsule contains yellow wax, butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil, tocopherol, and soybean oil. Gelatin capsules contain gelatin, glycerin and non-crystallizing sorbitol solution, with the following dye systems: 10 mg - ferric oxide (yellow) and titanium dioxide; 20 mg - titanium dioxide; 30 mg - titanium dioxide and ferric oxide (red); 40 mg - FD&C Yellow No. 6 and titanium dioxide. The edible imprinting ink for all the capsules contains: shellac glaze, dehydrated alcohol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide. Meets USP Dissolution Test 6. Chemically, isotretinoin is 13- cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. The structural formula is:.</Description>
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<IndicationAndUsage>Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, 2means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with its use, isotretinoin capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, isotretinoin capsules are indicated only for those patients who are not pregnant, because isotretinoin capsules can cause life-threatening birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off isotretinoin capsules. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).</IndicationAndUsage>
<Description>Isotretinoin, a retinoid, is available as isotretinoin capsules in 10-mg, 20-mg, 30-mg and 40-mg soft gelatin capsules for oral administration. Each capsule contains yellow wax, butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil, tocopherol, and soybean oil. Gelatin capsules contain gelatin, glycerin and non-crystallizing sorbitol solution, with the following dye systems: 10 mg - ferric oxide (yellow) and titanium dioxide; 20 mg - titanium dioxide; 30 mg - titanium dioxide and ferric oxide (red); 40 mg - FD&C Yellow No. 6 and titanium dioxide. The edible imprinting ink for all the capsules contains: shellac glaze, dehydrated alcohol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide. Meets USP Dissolution Test 6. Chemically, isotretinoin is 13- cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. The structural formula is:.</Description>
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<IndicationAndUsage>Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, 2means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with its use, isotretinoin capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, isotretinoin capsules are indicated only for those patients who are not pregnant, because isotretinoin capsules can cause life-threatening birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off isotretinoin capsules. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).</IndicationAndUsage>
<Description>Isotretinoin, a retinoid, is available as isotretinoin capsules in 10-mg, 20-mg, 30-mg and 40-mg soft gelatin capsules for oral administration. Each capsule contains yellow wax, butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil, tocopherol, and soybean oil. Gelatin capsules contain gelatin, glycerin and non-crystallizing sorbitol solution, with the following dye systems: 10 mg - ferric oxide (yellow) and titanium dioxide; 20 mg - titanium dioxide; 30 mg - titanium dioxide and ferric oxide (red); 40 mg - FD&C Yellow No. 6 and titanium dioxide. The edible imprinting ink for all the capsules contains: shellac glaze, dehydrated alcohol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide. Meets USP Dissolution Test 6. Chemically, isotretinoin is 13- cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. The structural formula is:.</Description>
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<NDC>
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<ProductNDC>68308-784</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isotretinoin</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076485</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, 2means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with its use, isotretinoin capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, isotretinoin capsules are indicated only for those patients who are not pregnant, because isotretinoin capsules can cause life-threatening birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off isotretinoin capsules. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).</IndicationAndUsage>
<Description>Isotretinoin, a retinoid, is available as isotretinoin capsules in 10-mg, 20-mg, 30-mg and 40-mg soft gelatin capsules for oral administration. Each capsule contains yellow wax, butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil, tocopherol, and soybean oil. Gelatin capsules contain gelatin, glycerin and non-crystallizing sorbitol solution, with the following dye systems: 10 mg - ferric oxide (yellow) and titanium dioxide; 20 mg - titanium dioxide; 30 mg - titanium dioxide and ferric oxide (red); 40 mg - FD&C Yellow No. 6 and titanium dioxide. The edible imprinting ink for all the capsules contains: shellac glaze, dehydrated alcohol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide. Meets USP Dissolution Test 6. Chemically, isotretinoin is 13- cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. The structural formula is:.</Description>
</NDC>
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<NDCCode>10122-326-10</NDCCode>
<PackageDescription>10 CARTON in 1 BOX (10122-326-10) > 1 BAG in 1 CARTON (10122-326-01) > 200 mL in 1 BAG</PackageDescription>
<NDC11Code>10122-0326-10</NDC11Code>
<ProductNDC>10122-326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cardene Iv</ProprietaryName>
<NonProprietaryName>Nicardipine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19920130</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019734</ApplicationNumber>
<LabelerName>Chiesi USA, Inc.</LabelerName>
<SubstanceName>NICARDIPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-30</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10695-326-80</NDCCode>
<PackageDescription>10 kg in 1 CONTAINER (10695-326-80) </PackageDescription>
<NDC11Code>10695-0326-80</NDC11Code>
<ProductNDC>10695-326</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Glycine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Willow Birch Pharma, LLC</LabelerName>
<SubstanceName>GLYCINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-17</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-DEC-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>15127-326-10</NDCCode>
<PackageDescription>296 mL in 1 BOTTLE, GLASS (15127-326-10) </PackageDescription>
<NDC11Code>15127-0326-10</NDC11Code>
<ProductNDC>15127-326</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Magnesium Citrate</ProprietaryName>
<ProprietaryNameSuffix>Cherry</ProprietaryNameSuffix>
<NonProprietaryName>Magnesium Citrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061003</StartMarketingDate>
<EndMarketingDate>20191231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Select Brand Dist.</LabelerName>
<SubstanceName>MAGNESIUM CITRATE</SubstanceName>
<StrengthNumber>1.745</StrengthNumber>
<StrengthUnit>g/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20061003</StartMarketingDatePackage>
<EndMarketingDatePackage>20191231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16590-326-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE, PLASTIC (16590-326-10)</PackageDescription>
<NDC11Code>16590-0326-10</NDC11Code>
<ProductNDC>16590-326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19740226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083677</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prednisone tablets are indicated in the following conditions: 1 Endocrine disordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer , 2 Rheumatic disordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis , 3 Collagen diseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis , 4 Dermatologic diseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis , 5 Allergic statesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisSerum sicknessBronchial asthmaContact dermatitisAtopic dermatitisDrug hypersensitivity reactions , 6 Ophthalmic diseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic conjunctivitisKeratitisAllergic corneal marginal ulcersHerpes zoster ophthalmicusIritis and iridocyclitisChorioretinitisAnterior segment inflammationDiffuse posterior uveitis and choroiditisOptic neuritisSympathetic ophthalmia , 7 Respiratory diseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis , 8 Hematologic disordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia , 9 Neoplastic diseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood , 10 Edematous statesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus , 11 Gastrointestinal diseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 Nervous SystemAcute exacerbations of multiple sclerosis , 13 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The molecular formula for prednisone is C21H26O5. Chemically, it is 17, 21-dihydroxypregna-1, 4-diene-3,11,20-trione and has the following structural formula. Prednisone is a white to practically white, odorless, crystalline powder and has a molecular weight of 358.44. It melts at about 230°C with some decomposition. Prednisone is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 1 mg, 2.5 mg, 5 mg, 10 mg, or 20 mg of prednisone. Inactive ingredients:1 mg: anhydrous lactose, corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.|2.5 mg: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc.5 mg: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc.10 mg: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc.20 mg: anhydrous lactose, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
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<NDCCode>19355-326-01</NDCCode>
<PackageDescription>10 mL in 1 BOTTLE, PLASTIC (19355-326-01) </PackageDescription>
<NDC11Code>19355-0326-01</NDC11Code>
<ProductNDC>19355-326</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Prismatic Protectant Spf50</ProprietaryName>
<NonProprietaryName>Zinc Oxide, Titanium Dioxide, Octinoxate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>PhytogenX, Inc.</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE</SubstanceName>
<StrengthNumber>190; 33; 75</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>23155-326-31</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (23155-326-31) / 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>23155-0326-31</NDC11Code>
<ProductNDC>23155-326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibutilide Fumarate</ProprietaryName>
<NonProprietaryName>Ibutilide Fumarate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204146</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IBUTILIDE FUMARATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ibutilide fumarate injection is indicated for the rapid conversion of atrial fibrillation or atrial flutter of recent onset to sinus rhythm. Patients with atrial arrhythmias of longer duration are less likely to respond to ibutilide fumarate. The effectiveness of ibutilide has not been determined in patients with arrhythmias of more than 90 days in duration.LIFE-THREATENING ARRHYTHMIAS—APPROPRIATE TREATMENT ENVIRONMENT Ibutilide fumarate can cause potentially fatal arrhythmias, particularly sustained polymorphic ventricular tachycardia, usually in association with QT prolongation (torsades de pointes), but sometimes without documented QT prolongation. In registration studies, these arrhythmias, which require cardioversion, occurred in 1.7% of treated patients during, or within a number of hours of, use of Ibutilide fumarate. These arrhythmias can be reversed if treated promptly (see WARNINGS, Proarrhythmia). It is essential that Ibutilide fumarate be administered in a setting of continuous ECG monitoring and by personnel trained in identification and treatment of acute ventricular arrhythmias, particularly polymorphic ventricular tachycardia. Patients with atrial fibrillation of more than 2 to 3 days’ duration must be adequately anticoagulated, generally for at least 2 weeks. CHOICE OF PATIENTS Patients with chronic atrial fibrillation have a strong tendency to revert after conversion to sinus rhythm (see CLINICAL STUDIES) and treatments to maintain sinus rhythm carry risks. Patients to be treated with Ibutilide fumarate , therefore, should be carefully selected such that the expected benefits of maintaining sinus rhythm outweigh the immediate risks of Ibutilide fumarate , and the risks of maintenance therapy, and are likely to offer an advantage compared with alternative management.</IndicationAndUsage>
<Description>Ibutilide Fumarate Injection is an antiarrhythmic drug with predominantly class III (cardiac action potential prolongation) properties according to the Vaughan Williams Classification. Each milliliter of Ibutilide Fumarate Injection contains 0.1 mg of ibutilide fumarate, USP (equivalent to 0.087 mg ibutilide free base), 0.189 mg sodium acetate trihydrate, USP, 8.90 mg sodium chloride, USP, hydrochloric acid NF and/or sodium hydroxide NF to adjust pH to approximately 4.6, and Water for Injection, USP. Ibutilide Fumarate Injection is an isotonic, clear, colorless, sterile aqueous solution. Ibutilide fumarate has one chiral center, and exists as a racemate of the (+) and (−) enantiomers. The chemical name for ibutilide fumarate is Methanesulfonamide, N-{4-{4-(ethylheptylamino)-1-hydroxybutyl} phenyl}, (+) (−), (E)-2-butenedioate (1:0.5) (hemifumarate salt) Its molecular formula is C22H38N2O5S, and its molecular weight is 442.62. Ibutilide fumarate is a white to off-white powder with an aqueous solubility of over 100 mg/mL at pH 7 or lower.The structural formula is represented below.</Description>
</NDC>
<NDC>
<NDCCode>41520-326-10</NDCCode>
<PackageDescription>296 mL in 1 BOTTLE, GLASS (41520-326-10) </PackageDescription>
<NDC11Code>41520-0326-10</NDC11Code>
<ProductNDC>41520-326</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Magnesium Citrate</ProprietaryName>
<NonProprietaryName>Magnesium Citrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150531</StartMarketingDate>
<EndMarketingDate>20231229</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Care One (American Sales Company)</LabelerName>
<SubstanceName>MAGNESIUM CITRATE</SubstanceName>
<StrengthNumber>1.745</StrengthNumber>
<StrengthUnit>g/29.6mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150531</StartMarketingDatePackage>
<EndMarketingDatePackage>20231229</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43063-326-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE, PLASTIC (43063-326-10) </PackageDescription>
<NDC11Code>43063-0326-10</NDC11Code>
<ProductNDC>43063-326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077253</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48433-326-10</NDCCode>
<PackageDescription>100 POUCH in 1 BOX, UNIT-DOSE (48433-326-10) > 1 TABLET, FILM COATED in 1 POUCH (48433-326-01)</PackageDescription>
<NDC11Code>48433-0326-10</NDC11Code>
<ProductNDC>48433-326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075978</ApplicationNumber>
<LabelerName>Safecor Health, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC],Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. C4H11N5HCl M.W. 165.63. Metformin hydrochloride is a white to off-white crystalline compound. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, polyethylene glycol, povidone and titanium dioxide.</Description>
</NDC>
</NDCList>