{
"NDC": [
{
"NDCCode": "58980-522-80",
"PackageDescription": "1 BOTTLE in 1 BOX (58980-522-80) / 237 mL in 1 BOTTLE",
"NDC11Code": "58980-0522-80",
"ProductNDC": "58980-522",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pramoxine Hydrochloride Anorectal",
"NonProprietaryName": "Pramoxine Hydrochloride",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M015",
"LabelerName": "Stratus Pharmaceuticals",
"SubstanceName": "PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251101",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of itching and discomfort in the perianal area."
},
{
"NDCCode": "58980-522-40",
"PackageDescription": "1 BOTTLE in 1 BOX (58980-522-40) / 118 mL in 1 BOTTLE",
"NDC11Code": "58980-0522-40",
"ProductNDC": "58980-522",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pramoxine Hydrochloride Anorectal",
"NonProprietaryName": "Pramoxine Hydrochloride",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M015",
"LabelerName": "Stratus Pharmaceuticals",
"SubstanceName": "PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251101",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of itching and discomfort in the perianal area."
},
{
"NDCCode": "43419-522-38",
"PackageDescription": "1 BOTTLE in 1 CARTON (43419-522-38) > 80 mL in 1 BOTTLE",
"NDC11Code": "43419-0522-38",
"ProductNDC": "43419-522",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amorepacific Resort Collection Sun Protection Mist",
"NonProprietaryName": "Homosalate, Octocrylene, Octisalate, And Avobenzone",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150213",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "AMOREPACIFIC CORPORATION",
"SubstanceName": "HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE",
"StrengthNumber": "28000; 18000; 9000; 6000",
"StrengthUnit": "mg/200mL; mg/200mL; mg/200mL; mg/200mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180801",
"SamplePackage": "N"
},
{
"NDCCode": "50157-522-80",
"PackageDescription": "80 CLOTH in 1 PACKAGE (50157-522-80) ",
"NDC11Code": "50157-0522-80",
"ProductNDC": "50157-522",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Germs Be Gone Antiseptic Wipes",
"ProprietaryNameSuffix": "Scented",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210811",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Brands International corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "1/1001",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210812",
"SamplePackage": "N",
"IndicationAndUsage": "Kills (harmful) bacteria/germs."
},
{
"NDCCode": "70954-522-10",
"PackageDescription": "80 mL in 1 BOTTLE (70954-522-10) ",
"NDC11Code": "70954-0522-10",
"ProductNDC": "70954-522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inzirqo",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20250130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219141",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250130",
"SamplePackage": "N",
"IndicationAndUsage": "INZIRQO (hydrochlorothiazide) is a thiazide diuretic indicated for: 1 The treatment of hypertension in adult and pediatric patients alone or in combination with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction (1.1)., 2 The treatment of edema associated with congestive heart failure, hepatic cirrhosis and renal disease including the nephrotic syndrome in adult and pediatric patients. (1.2).",
"Description": "Hydrochlorothiazide, USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. The molecular formula is C7H8ClN3O4S2 and the molecular weight is 297.74. INZIRQO (hydrochlorothiazide) is supplied in one strength as an off-white to light-brown colored powder for oral suspension. When reconstituted with 66 mL of water, the total volume of the suspension is 80 mL containing 10 mg/mL of hydrochlorothiazide, USP. In addition, INZIRQO contains the following inactive ingredients: anhydrous citric acid, caramel flavor (artificial flavor, caramel, maltodextrin, molasses, propylene glycol, salt and sucrose), cellulose, peppermint flavor (acacia and natural flavor), potassium sorbate, sucrose, talc and xanthan gum."
},
{
"NDCCode": "58980-332-80",
"PackageDescription": "1 TUBE in 1 BOX (58980-332-80) / 226.8 g in 1 TUBE",
"NDC11Code": "58980-0332-80",
"ProductNDC": "58980-332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Benzoyl Peroxide Acne Wash 5%",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "SUSPENSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260921",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Stratus Pharmaceuticals",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/g",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "for the treatment of acne."
},
{
"NDCCode": "58980-608-80",
"PackageDescription": "1 BOTTLE in 1 BOX (58980-608-80) > 236.56 mL in 1 BOTTLE",
"NDC11Code": "58980-0608-80",
"ProductNDC": "58980-608",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Urea",
"NonProprietaryName": "Urea",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100520",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Stratus Pharmaceuticals, Inc",
"SubstanceName": "UREA",
"StrengthNumber": "1",
"StrengthUnit": "mL/10mL",
"Status": "Deprecated",
"LastUpdate": "2017-11-29"
},
{
"NDCCode": "58980-623-80",
"PackageDescription": "1 BOTTLE in 1 BOX (58980-623-80) > 237 mL in 1 BOTTLE",
"NDC11Code": "58980-0623-80",
"ProductNDC": "58980-623",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "X Viate",
"NonProprietaryName": "Urea",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED OTHER",
"LabelerName": "Stratus Pharamceuticals, Inc",
"SubstanceName": "UREA",
"StrengthNumber": "94.8",
"StrengthUnit": "mg/237mL",
"Status": "Deprecated",
"LastUpdate": "2017-09-07"
},
{
"NDCCode": "58980-913-80",
"PackageDescription": "1 BOTTLE in 1 BOX (58980-913-80) / 222 mL in 1 BOTTLE",
"NDC11Code": "58980-0913-80",
"ProductNDC": "58980-913",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Peviderm Pramoxine Hydrocholride 1%",
"NonProprietaryName": "Pramoxine Hydrochloride",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Stratus Pharmaceuticals Inc",
"SubstanceName": "PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2024-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac."
},
{
"NDCCode": "58980-574-10",
"PackageDescription": "1 TUBE in 1 BOX (58980-574-10) > 28.4 g in 1 TUBE",
"NDC11Code": "58980-0574-10",
"ProductNDC": "58980-574",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nuquin Hp",
"NonProprietaryName": "Hydroquinone, Padimate O, Dioxybenzone, And Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20031209",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Stratus Pharmaceuticals",
"SubstanceName": "DIOXYBENZONE; HYDROQUINONE; OXYBENZONE; PADIMATE O",
"StrengthNumber": "30; 40; 20; 80",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Pharm_Classes": "Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-07-17"
},
{
"NDCCode": "58980-574-20",
"PackageDescription": "1 TUBE in 1 BOX (58980-574-20) > 56.7 g in 1 TUBE",
"NDC11Code": "58980-0574-20",
"ProductNDC": "58980-574",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nuquin Hp",
"NonProprietaryName": "Hydroquinone, Padimate O, Dioxybenzone, And Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20031209",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Stratus Pharmaceuticals",
"SubstanceName": "DIOXYBENZONE; HYDROQUINONE; OXYBENZONE; PADIMATE O",
"StrengthNumber": "30; 40; 20; 80",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Pharm_Classes": "Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-07-17"
},
{
"NDCCode": "42291-522-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-522-01) ",
"NDC11Code": "42291-0522-01",
"ProductNDC": "42291-522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078703",
"LabelerName": "AvKARE",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170516",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol Hydrochloride Extended-Release Capsules, USP, are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules, USP, are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It's molecular and structural formulae are. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP, are formulated to provide a sustained release of propranolol hydrochloride. Propranolol Hydrochloride Extended-Release Capsules, USP, are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. Each capsule for oral administration contains sugar spheres, ethylcellulose, hypromellose phthalate, povidone, diethyl phthalate, polyethylene glycol, titanium dioxide, ammonium hydroxide, potassium hydroxide, black iron oxide, and gelatin. The 80 mg, 120 mg, and 160 mg capsules contain red and yellow iron oxide. In addition, the 160 mg capsules contain FD&C Blue No. 2. These capsules comply with USP Dissolution Test 1."
},
{
"NDCCode": "42291-522-10",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-522-10) ",
"NDC11Code": "42291-0522-10",
"ProductNDC": "42291-522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078703",
"LabelerName": "AvKARE",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170731",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol Hydrochloride Extended-Release Capsules, USP, are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules, USP, are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It's molecular and structural formulae are. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP, are formulated to provide a sustained release of propranolol hydrochloride. Propranolol Hydrochloride Extended-Release Capsules, USP, are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. Each capsule for oral administration contains sugar spheres, ethylcellulose, hypromellose phthalate, povidone, diethyl phthalate, polyethylene glycol, titanium dioxide, ammonium hydroxide, potassium hydroxide, black iron oxide, and gelatin. The 80 mg, 120 mg, and 160 mg capsules contain red and yellow iron oxide. In addition, the 160 mg capsules contain FD&C Blue No. 2. These capsules comply with USP Dissolution Test 1."
},
{
"NDCCode": "50242-014-03",
"PackageDescription": "1 KIT in 1 CARTON (50242-014-03) * 1 VIAL, SINGLE-USE in 1 CARTON (50242-009-01) / 5 mL in 1 VIAL, SINGLE-USE * 1 VIAL, SINGLE-USE in 1 CARTON (50242-907-01) / 5.2 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0014-03",
"ProductNDC": "50242-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tnkase",
"NonProprietaryName": "Tenecteplase",
"DosageFormName": "KIT",
"StartMarketingDate": "20250228",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103909",
"LabelerName": "Genentech, Inc.",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "TNKase is a tissue plasminogen activator (tPA) indicated: 1 for the treatment of acute ischemic stroke (AIS) in adults. (1.1), 2 to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. (1.2).",
"Description": "Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each 25 mg single-dose vial of TNKase nominally contains 25 mg of tenecteplase, arginine (261 mg), phosphoric acid (approximately 80 mg), and polysorbate 20 (2.0 mg). Following reconstitution with the supplied 5.2 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3. Each 50 mg single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3."
},
{
"NDCCode": "50242-176-01",
"PackageDescription": "1 KIT in 1 CARTON (50242-176-01) * 1 VIAL, SINGLE-USE in 1 CARTON (50242-037-06) / 10 mL in 1 VIAL, SINGLE-USE * 1 VIAL, SINGLE-USE in 1 CARTON (50242-901-09) / 10 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0176-01",
"ProductNDC": "50242-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tnkase",
"NonProprietaryName": "Tenecteplase",
"DosageFormName": "KIT",
"StartMarketingDate": "20240105",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103909",
"LabelerName": "Genentech, Inc.",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240105",
"SamplePackage": "N",
"IndicationAndUsage": "TNKase is a tissue plasminogen activator (tPA) indicated: 1 for the treatment of acute ischemic stroke (AIS) in adults. (1.1), 2 to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. (1.2).",
"Description": "Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each 25 mg single-dose vial of TNKase nominally contains 25 mg of tenecteplase, arginine (261 mg), phosphoric acid (approximately 80 mg), and polysorbate 20 (2.0 mg). Following reconstitution with the supplied 5.2 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3. Each 50 mg single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3."
},
{
"NDCCode": "51862-557-00",
"PackageDescription": "6 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-557-00) ",
"NDC11Code": "51862-0557-00",
"ProductNDC": "51862-557",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doryx",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150526",
"EndMarketingDate": "20240131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050795",
"LabelerName": "Mayne Pharma Commercial LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150526",
"EndMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "DORYX is 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": "DORYX (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 C 22H 24N 2O 8, HCl, ½ C 2H 6O, ½ H 2O 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, 80 mg or 200 mg (equivalent to doxycycline hyclate 57.7 mg, 92.3 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 DORYX 50 mg tablet contains 3 mg (0.131 mEq) of sodium, each DORYX 80 mg tablet contains 4.8 mg (0.209 mEq) of sodium, and each DORYX 200 mg tablet contains 12 mg (0.522 mEq) of sodium."
},
{
"NDCCode": "51862-557-12",
"PackageDescription": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-557-12) ",
"NDC11Code": "51862-0557-12",
"ProductNDC": "51862-557",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doryx",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150526",
"EndMarketingDate": "20240131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050795",
"LabelerName": "Mayne Pharma Commercial LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150526",
"EndMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "DORYX is 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": "DORYX (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 C 22H 24N 2O 8, HCl, ½ C 2H 6O, ½ H 2O 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, 80 mg or 200 mg (equivalent to doxycycline hyclate 57.7 mg, 92.3 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 DORYX 50 mg tablet contains 3 mg (0.131 mEq) of sodium, each DORYX 80 mg tablet contains 4.8 mg (0.209 mEq) of sodium, and each DORYX 200 mg tablet contains 12 mg (0.522 mEq) of sodium."
},
{
"NDCCode": "51862-558-00",
"PackageDescription": "3 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-558-00) ",
"NDC11Code": "51862-0558-00",
"ProductNDC": "51862-558",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doryx",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150413",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050795",
"LabelerName": "Mayne Pharma Commercial LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150413",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "DORYX is 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": "DORYX (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, 80 mg or 200 mg (equivalent to doxycycline hyclate 57.7 mg, 92.3 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 DORYX 50 mg tablet contains 3 mg (0.131 mEq) of sodium, each DORYX 80 mg tablet contains 4.8 mg (0.209 mEq) of sodium, and each DORYX 200 mg tablet contains 12 mg (0.522 mEq) of sodium."
},
{
"NDCCode": "51862-558-06",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-558-06) ",
"NDC11Code": "51862-0558-06",
"ProductNDC": "51862-558",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doryx",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150413",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050795",
"LabelerName": "Mayne Pharma Commercial LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150413",
"EndMarketingDatePackage": "20230831",
"SamplePackage": "N",
"IndicationAndUsage": "DORYX is 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": "DORYX (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 C 22H 24N 2O 8, HCl, ½ C 2H 6O, ½ H 2O 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, 80 mg or 200 mg (equivalent to doxycycline hyclate 57.7 mg, 92.3 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 DORYX 50 mg tablet contains 3 mg (0.131 mEq) of sodium, each DORYX 80 mg tablet contains 4.8 mg (0.209 mEq) of sodium, and each DORYX 200 mg tablet contains 12 mg (0.522 mEq) of sodium."
},
{
"NDCCode": "51862-571-30",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-571-30) ",
"NDC11Code": "51862-0571-30",
"ProductNDC": "51862-571",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201002",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050795",
"LabelerName": "Mayne Pharma Commercial LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201002",
"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": "51862-709-12",
"PackageDescription": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-709-12) ",
"NDC11Code": "51862-0709-12",
"ProductNDC": "51862-709",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160526",
"EndMarketingDate": "20240731",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050795",
"LabelerName": "Mayne Pharma Commercial LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160526",
"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": "55111-522-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (55111-522-05) ",
"NDC11Code": "55111-0522-05",
"ProductNDC": "55111-522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090609",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180223",
"SamplePackage": "N",
"Description": "Atomoxetine HCl is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCL, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which is sparingly soluble in water. Atomoxetine capsules, USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP, equivalent to 10, 18, 25, 40, 60, 80 or 100 mg of atomoxetine. The capsules also contain pregelatinized starch, dimethicone. The capsule shells contain one or more of the following: FD&C Blue No. 2, gelatin, iron oxide red, iron oxide yellow,sodium lauryl sulfate and titanium dioxide. The capsules are imprinted with edible black ink. The edible black ink contains black iron oxide E172, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "55111-522-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (55111-522-30) ",
"NDC11Code": "55111-0522-30",
"ProductNDC": "55111-522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090609",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180223",
"SamplePackage": "N",
"Description": "Atomoxetine HCl is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCL, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which is sparingly soluble in water. Atomoxetine capsules, USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP, equivalent to 10, 18, 25, 40, 60, 80 or 100 mg of atomoxetine. The capsules also contain pregelatinized starch, dimethicone. The capsule shells contain one or more of the following: FD&C Blue No. 2, gelatin, iron oxide red, iron oxide yellow,sodium lauryl sulfate and titanium dioxide. The capsules are imprinted with edible black ink. The edible black ink contains black iron oxide E172, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "55111-522-78",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (55111-522-78) > 10 CAPSULE in 1 BLISTER PACK (55111-522-79) ",
"NDC11Code": "55111-0522-78",
"ProductNDC": "55111-522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090609",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180223",
"SamplePackage": "N",
"Description": "Atomoxetine HCl is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCL, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which is sparingly soluble in water. Atomoxetine capsules, USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP, equivalent to 10, 18, 25, 40, 60, 80 or 100 mg of atomoxetine. The capsules also contain pregelatinized starch, dimethicone. The capsule shells contain one or more of the following: FD&C Blue No. 2, gelatin, iron oxide red, iron oxide yellow,sodium lauryl sulfate and titanium dioxide. The capsules are imprinted with edible black ink. The edible black ink contains black iron oxide E172, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "62559-522-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-522-01) ",
"NDC11Code": "62559-0522-01",
"ProductNDC": "62559-522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inderal",
"ProprietaryNameSuffix": "La",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170428",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018553",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170428",
"SamplePackage": "N",
"IndicationAndUsage": "Inderal LA is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Inderal LA is not indicated in the management of hypertensive emergencies.",
"Description": "Inderal® LA (propranolol hydrochloride) is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are. C16H21NO2 · HCl. Propranolol hydrochloride USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Inderal LA is formulated to provide a sustained release of propranolol hydrochloride USP. Inderal LA is available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each Inderal LA 60 mg capsule contains 60 mg propranolol hydrochloride USP (equivalent to 52.60 mg of propranolol)., 2 Each Inderal LA 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol)., 3 Each Inderal LA 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol)., 4 Each Inderal LA 160 mg capsule contains 160 mg propranolol hydrochloride USP (equivalent to 140.28 mg of propranolol)."
},
{
"NDCCode": "62559-522-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-522-30) ",
"NDC11Code": "62559-0522-30",
"ProductNDC": "62559-522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inderal",
"ProprietaryNameSuffix": "La",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170428",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018553",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240805",
"SamplePackage": "N",
"IndicationAndUsage": "Inderal LA is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Inderal LA is not indicated in the management of hypertensive emergencies.",
"Description": "Inderal® LA (propranolol hydrochloride) is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are. C16H21NO2 · HCl. Propranolol hydrochloride USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Inderal LA is formulated to provide a sustained release of propranolol hydrochloride USP. Inderal LA is available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each Inderal LA 60 mg capsule contains 60 mg propranolol hydrochloride USP (equivalent to 52.60 mg of propranolol)., 2 Each Inderal LA 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol)., 3 Each Inderal LA 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol)., 4 Each Inderal LA 160 mg capsule contains 160 mg propranolol hydrochloride USP (equivalent to 140.28 mg of propranolol)."
},
{
"NDCCode": "62756-522-69",
"PackageDescription": "9 BLISTER PACK in 1 CARTON (62756-522-69) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "62756-0522-69",
"ProductNDC": "62756-522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan Succinate",
"NonProprietaryName": "Sumatriptan Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078295",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090810",
"SamplePackage": "N",
"IndicationAndUsage": "Sumatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: : 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan succinate tablets, reconsider the diagnosis of migraine before sumatriptan succinate tablets are administered to treat any subsequent attacks. , 2 Sumatriptan succinate tablets are not indicated for the prevention of migraine attacks. , 3 Safety and effectiveness of sumatriptan succinate tablets have not been established for cluster headache.",
"Description": "Sumatriptan succinate tablets contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The molecular formula is C14H21N3O2S·C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan succinate tablet for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate, USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C Red # 27 aluminum lake (100 mg only), dibasic calcium phosphate, hypromellose, iron oxide red (100 mg only), magnesium stearate, microcrystalline cellulose, polyethylene glycol (25 mg & 50 mg only), polysorbate 80 (25 mg & 50 mg only) propylene glycol (100 mg only), talc and titanium dioxide."
},
{
"NDCCode": "62756-522-88",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (62756-522-88) ",
"NDC11Code": "62756-0522-88",
"ProductNDC": "62756-522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan Succinate",
"NonProprietaryName": "Sumatriptan Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078295",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090810",
"SamplePackage": "N",
"IndicationAndUsage": "Sumatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: : 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan succinate tablets, reconsider the diagnosis of migraine before sumatriptan succinate tablets are administered to treat any subsequent attacks. , 2 Sumatriptan succinate tablets are not indicated for the prevention of migraine attacks. , 3 Safety and effectiveness of sumatriptan succinate tablets have not been established for cluster headache.",
"Description": "Sumatriptan succinate tablets contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The molecular formula is C14H21N3O2S·C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan succinate tablet for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate, USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C Red # 27 aluminum lake (100 mg only), dibasic calcium phosphate, hypromellose, iron oxide red (100 mg only), magnesium stearate, microcrystalline cellulose, polyethylene glycol (25 mg & 50 mg only), polysorbate 80 (25 mg & 50 mg only) propylene glycol (100 mg only), talc and titanium dioxide."
},
{
"NDCCode": "63187-522-30",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-522-30) ",
"NDC11Code": "63187-0522-30",
"ProductNDC": "63187-522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19960326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074514",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150201",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets, USP and other treatment options before deciding to use diclofenac sodium delayed-release tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.",
"Description": "Diclofenac sodium delayed-release tablets, USP are a benzeneacetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.13. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. Each enteric-coated tablet for oral administration contains 50 mg or 75 mg of diclofenac sodium, USP. In addition, each tablet contains the following inactive ingredients: aluminum hydrate, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium starch glycolate (Type A), stearic acid, synthetic black iron oxide, talc, and titanium dioxide."
},
{
"NDCCode": "63187-522-60",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-522-60) ",
"NDC11Code": "63187-0522-60",
"ProductNDC": "63187-522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19960326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074514",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150201",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets, USP and other treatment options before deciding to use diclofenac sodium delayed-release tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.",
"Description": "Diclofenac sodium delayed-release tablets, USP are a benzeneacetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.13. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. Each enteric-coated tablet for oral administration contains 50 mg or 75 mg of diclofenac sodium, USP. In addition, each tablet contains the following inactive ingredients: aluminum hydrate, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium starch glycolate (Type A), stearic acid, synthetic black iron oxide, talc, and titanium dioxide."
}
]
}
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<PackageDescription>1 BOTTLE in 1 BOX (58980-522-80) / 237 mL in 1 BOTTLE</PackageDescription>
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<ProductNDC>58980-522</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pramoxine Hydrochloride Anorectal</ProprietaryName>
<NonProprietaryName>Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<LabelerName>Stratus Pharmaceuticals</LabelerName>
<SubstanceName>PRAMOXINE HYDROCHLORIDE</SubstanceName>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of itching and discomfort in the perianal area.</IndicationAndUsage>
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<PackageDescription>1 BOTTLE in 1 BOX (58980-522-40) / 118 mL in 1 BOTTLE</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pramoxine Hydrochloride Anorectal</ProprietaryName>
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<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<SubstanceName>PRAMOXINE HYDROCHLORIDE</SubstanceName>
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<Status>Active</Status>
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<IndicationAndUsage>for the temporary relief of itching and discomfort in the perianal area.</IndicationAndUsage>
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<NDCCode>43419-522-38</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (43419-522-38) > 80 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>43419-0522-38</NDC11Code>
<ProductNDC>43419-522</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Amorepacific Resort Collection Sun Protection Mist</ProprietaryName>
<NonProprietaryName>Homosalate, Octocrylene, Octisalate, And Avobenzone</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>AMOREPACIFIC CORPORATION</LabelerName>
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<StrengthUnit>mg/200mL; mg/200mL; mg/200mL; mg/200mL</StrengthUnit>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDC11Code>50157-0522-80</NDC11Code>
<ProductNDC>50157-522</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Germs Be Gone Antiseptic Wipes</ProprietaryName>
<ProprietaryNameSuffix>Scented</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210811</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Brands International corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>1/1001</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Kills (harmful) bacteria/germs.</IndicationAndUsage>
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<NDC>
<NDCCode>70954-522-10</NDCCode>
<PackageDescription>80 mL in 1 BOTTLE (70954-522-10) </PackageDescription>
<NDC11Code>70954-0522-10</NDC11Code>
<ProductNDC>70954-522</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inzirqo</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250130</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219141</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INZIRQO (hydrochlorothiazide) is a thiazide diuretic indicated for: 1 The treatment of hypertension in adult and pediatric patients alone or in combination with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction (1.1)., 2 The treatment of edema associated with congestive heart failure, hepatic cirrhosis and renal disease including the nephrotic syndrome in adult and pediatric patients. (1.2).</IndicationAndUsage>
<Description>Hydrochlorothiazide, USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. The molecular formula is C7H8ClN3O4S2 and the molecular weight is 297.74. INZIRQO (hydrochlorothiazide) is supplied in one strength as an off-white to light-brown colored powder for oral suspension. When reconstituted with 66 mL of water, the total volume of the suspension is 80 mL containing 10 mg/mL of hydrochlorothiazide, USP. In addition, INZIRQO contains the following inactive ingredients: anhydrous citric acid, caramel flavor (artificial flavor, caramel, maltodextrin, molasses, propylene glycol, salt and sucrose), cellulose, peppermint flavor (acacia and natural flavor), potassium sorbate, sucrose, talc and xanthan gum.</Description>
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<PackageDescription>1 TUBE in 1 BOX (58980-332-80) / 226.8 g in 1 TUBE</PackageDescription>
<NDC11Code>58980-0332-80</NDC11Code>
<ProductNDC>58980-332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Benzoyl Peroxide Acne Wash 5%</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260921</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>Stratus Pharmaceuticals</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the treatment of acne.</IndicationAndUsage>
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<NDCCode>58980-608-80</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (58980-608-80) > 236.56 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>58980-0608-80</NDC11Code>
<ProductNDC>58980-608</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Urea</ProprietaryName>
<NonProprietaryName>Urea</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100520</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Stratus Pharmaceuticals, Inc</LabelerName>
<SubstanceName>UREA</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mL/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>58980-623-80</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (58980-623-80) > 237 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>58980-0623-80</NDC11Code>
<ProductNDC>58980-623</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>X Viate</ProprietaryName>
<NonProprietaryName>Urea</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED OTHER</MarketingCategoryName>
<LabelerName>Stratus Pharamceuticals, Inc</LabelerName>
<SubstanceName>UREA</SubstanceName>
<StrengthNumber>94.8</StrengthNumber>
<StrengthUnit>mg/237mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-09-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>58980-913-80</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (58980-913-80) / 222 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>58980-0913-80</NDC11Code>
<ProductNDC>58980-913</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Peviderm Pramoxine Hydrocholride 1%</ProprietaryName>
<NonProprietaryName>Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Stratus Pharmaceuticals Inc</LabelerName>
<SubstanceName>PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58980-574-10</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (58980-574-10) > 28.4 g in 1 TUBE</PackageDescription>
<NDC11Code>58980-0574-10</NDC11Code>
<ProductNDC>58980-574</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nuquin Hp</ProprietaryName>
<NonProprietaryName>Hydroquinone, Padimate O, Dioxybenzone, And Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20031209</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Stratus Pharmaceuticals</LabelerName>
<SubstanceName>DIOXYBENZONE; HYDROQUINONE; OXYBENZONE; PADIMATE O</SubstanceName>
<StrengthNumber>30; 40; 20; 80</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-07-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>58980-574-20</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (58980-574-20) > 56.7 g in 1 TUBE</PackageDescription>
<NDC11Code>58980-0574-20</NDC11Code>
<ProductNDC>58980-574</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nuquin Hp</ProprietaryName>
<NonProprietaryName>Hydroquinone, Padimate O, Dioxybenzone, And Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20031209</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Stratus Pharmaceuticals</LabelerName>
<SubstanceName>DIOXYBENZONE; HYDROQUINONE; OXYBENZONE; PADIMATE O</SubstanceName>
<StrengthNumber>30; 40; 20; 80</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-07-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>42291-522-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-522-01) </PackageDescription>
<NDC11Code>42291-0522-01</NDC11Code>
<ProductNDC>42291-522</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078703</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol Hydrochloride Extended-Release Capsules, USP, are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules, USP, are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It's molecular and structural formulae are. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP, are formulated to provide a sustained release of propranolol hydrochloride. Propranolol Hydrochloride Extended-Release Capsules, USP, are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. Each capsule for oral administration contains sugar spheres, ethylcellulose, hypromellose phthalate, povidone, diethyl phthalate, polyethylene glycol, titanium dioxide, ammonium hydroxide, potassium hydroxide, black iron oxide, and gelatin. The 80 mg, 120 mg, and 160 mg capsules contain red and yellow iron oxide. In addition, the 160 mg capsules contain FD&C Blue No. 2. These capsules comply with USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>42291-522-10</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-522-10) </PackageDescription>
<NDC11Code>42291-0522-10</NDC11Code>
<ProductNDC>42291-522</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078703</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol Hydrochloride Extended-Release Capsules, USP, are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules, USP, are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It's molecular and structural formulae are. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP, are formulated to provide a sustained release of propranolol hydrochloride. Propranolol Hydrochloride Extended-Release Capsules, USP, are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. Each capsule for oral administration contains sugar spheres, ethylcellulose, hypromellose phthalate, povidone, diethyl phthalate, polyethylene glycol, titanium dioxide, ammonium hydroxide, potassium hydroxide, black iron oxide, and gelatin. The 80 mg, 120 mg, and 160 mg capsules contain red and yellow iron oxide. In addition, the 160 mg capsules contain FD&C Blue No. 2. These capsules comply with USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>50242-014-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (50242-014-03) * 1 VIAL, SINGLE-USE in 1 CARTON (50242-009-01) / 5 mL in 1 VIAL, SINGLE-USE * 1 VIAL, SINGLE-USE in 1 CARTON (50242-907-01) / 5.2 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50242-0014-03</NDC11Code>
<ProductNDC>50242-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tnkase</ProprietaryName>
<NonProprietaryName>Tenecteplase</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250228</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103909</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TNKase is a tissue plasminogen activator (tPA) indicated: 1 for the treatment of acute ischemic stroke (AIS) in adults. (1.1), 2 to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. (1.2).</IndicationAndUsage>
<Description>Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each 25 mg single-dose vial of TNKase nominally contains 25 mg of tenecteplase, arginine (261 mg), phosphoric acid (approximately 80 mg), and polysorbate 20 (2.0 mg). Following reconstitution with the supplied 5.2 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3. Each 50 mg single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3.</Description>
</NDC>
<NDC>
<NDCCode>50242-176-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (50242-176-01) * 1 VIAL, SINGLE-USE in 1 CARTON (50242-037-06) / 10 mL in 1 VIAL, SINGLE-USE * 1 VIAL, SINGLE-USE in 1 CARTON (50242-901-09) / 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50242-0176-01</NDC11Code>
<ProductNDC>50242-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tnkase</ProprietaryName>
<NonProprietaryName>Tenecteplase</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240105</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103909</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TNKase is a tissue plasminogen activator (tPA) indicated: 1 for the treatment of acute ischemic stroke (AIS) in adults. (1.1), 2 to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. (1.2).</IndicationAndUsage>
<Description>Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each 25 mg single-dose vial of TNKase nominally contains 25 mg of tenecteplase, arginine (261 mg), phosphoric acid (approximately 80 mg), and polysorbate 20 (2.0 mg). Following reconstitution with the supplied 5.2 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3. Each 50 mg single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3.</Description>
</NDC>
<NDC>
<NDCCode>51862-557-00</NDCCode>
<PackageDescription>6 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-557-00) </PackageDescription>
<NDC11Code>51862-0557-00</NDC11Code>
<ProductNDC>51862-557</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doryx</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150526</StartMarketingDate>
<EndMarketingDate>20240131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050795</ApplicationNumber>
<LabelerName>Mayne Pharma Commercial LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150526</StartMarketingDatePackage>
<EndMarketingDatePackage>20240131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DORYX is 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>DORYX (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 C 22H 24N 2O 8, HCl, ½ C 2H 6O, ½ H 2O 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, 80 mg or 200 mg (equivalent to doxycycline hyclate 57.7 mg, 92.3 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 DORYX 50 mg tablet contains 3 mg (0.131 mEq) of sodium, each DORYX 80 mg tablet contains 4.8 mg (0.209 mEq) of sodium, and each DORYX 200 mg tablet contains 12 mg (0.522 mEq) of sodium.</Description>
</NDC>
<NDC>
<NDCCode>51862-557-12</NDCCode>
<PackageDescription>120 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-557-12) </PackageDescription>
<NDC11Code>51862-0557-12</NDC11Code>
<ProductNDC>51862-557</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doryx</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150526</StartMarketingDate>
<EndMarketingDate>20240131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050795</ApplicationNumber>
<LabelerName>Mayne Pharma Commercial LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150526</StartMarketingDatePackage>
<EndMarketingDatePackage>20240131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DORYX is 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>DORYX (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 C 22H 24N 2O 8, HCl, ½ C 2H 6O, ½ H 2O 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, 80 mg or 200 mg (equivalent to doxycycline hyclate 57.7 mg, 92.3 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 DORYX 50 mg tablet contains 3 mg (0.131 mEq) of sodium, each DORYX 80 mg tablet contains 4.8 mg (0.209 mEq) of sodium, and each DORYX 200 mg tablet contains 12 mg (0.522 mEq) of sodium.</Description>
</NDC>
<NDC>
<NDCCode>51862-558-00</NDCCode>
<PackageDescription>3 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-558-00) </PackageDescription>
<NDC11Code>51862-0558-00</NDC11Code>
<ProductNDC>51862-558</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doryx</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150413</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050795</ApplicationNumber>
<LabelerName>Mayne Pharma Commercial LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150413</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DORYX is 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>DORYX (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, 80 mg or 200 mg (equivalent to doxycycline hyclate 57.7 mg, 92.3 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 DORYX 50 mg tablet contains 3 mg (0.131 mEq) of sodium, each DORYX 80 mg tablet contains 4.8 mg (0.209 mEq) of sodium, and each DORYX 200 mg tablet contains 12 mg (0.522 mEq) of sodium.</Description>
</NDC>
<NDC>
<NDCCode>51862-558-06</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-558-06) </PackageDescription>
<NDC11Code>51862-0558-06</NDC11Code>
<ProductNDC>51862-558</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doryx</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150413</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050795</ApplicationNumber>
<LabelerName>Mayne Pharma Commercial LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150413</StartMarketingDatePackage>
<EndMarketingDatePackage>20230831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DORYX is 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>DORYX (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 C 22H 24N 2O 8, HCl, ½ C 2H 6O, ½ H 2O 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, 80 mg or 200 mg (equivalent to doxycycline hyclate 57.7 mg, 92.3 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 DORYX 50 mg tablet contains 3 mg (0.131 mEq) of sodium, each DORYX 80 mg tablet contains 4.8 mg (0.209 mEq) of sodium, and each DORYX 200 mg tablet contains 12 mg (0.522 mEq) of sodium.</Description>
</NDC>
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<NDCCode>51862-571-30</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-571-30) </PackageDescription>
<NDC11Code>51862-0571-30</NDC11Code>
<ProductNDC>51862-571</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201002</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050795</ApplicationNumber>
<LabelerName>Mayne Pharma Commercial LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201002</StartMarketingDatePackage>
<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>51862-709-12</NDCCode>
<PackageDescription>120 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-709-12) </PackageDescription>
<NDC11Code>51862-0709-12</NDC11Code>
<ProductNDC>51862-709</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160526</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050795</ApplicationNumber>
<LabelerName>Mayne Pharma Commercial LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>50</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>20160526</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>55111-522-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (55111-522-05) </PackageDescription>
<NDC11Code>55111-0522-05</NDC11Code>
<ProductNDC>55111-522</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090609</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Atomoxetine HCl is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCL, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which is sparingly soluble in water. Atomoxetine capsules, USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP, equivalent to 10, 18, 25, 40, 60, 80 or 100 mg of atomoxetine. The capsules also contain pregelatinized starch, dimethicone. The capsule shells contain one or more of the following: FD&C Blue No. 2, gelatin, iron oxide red, iron oxide yellow,sodium lauryl sulfate and titanium dioxide. The capsules are imprinted with edible black ink. The edible black ink contains black iron oxide E172, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>55111-522-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (55111-522-30) </PackageDescription>
<NDC11Code>55111-0522-30</NDC11Code>
<ProductNDC>55111-522</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090609</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Atomoxetine HCl is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCL, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which is sparingly soluble in water. Atomoxetine capsules, USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP, equivalent to 10, 18, 25, 40, 60, 80 or 100 mg of atomoxetine. The capsules also contain pregelatinized starch, dimethicone. The capsule shells contain one or more of the following: FD&C Blue No. 2, gelatin, iron oxide red, iron oxide yellow,sodium lauryl sulfate and titanium dioxide. The capsules are imprinted with edible black ink. The edible black ink contains black iron oxide E172, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>55111-522-78</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (55111-522-78) > 10 CAPSULE in 1 BLISTER PACK (55111-522-79) </PackageDescription>
<NDC11Code>55111-0522-78</NDC11Code>
<ProductNDC>55111-522</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090609</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Atomoxetine HCl is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCL, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which is sparingly soluble in water. Atomoxetine capsules, USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP, equivalent to 10, 18, 25, 40, 60, 80 or 100 mg of atomoxetine. The capsules also contain pregelatinized starch, dimethicone. The capsule shells contain one or more of the following: FD&C Blue No. 2, gelatin, iron oxide red, iron oxide yellow,sodium lauryl sulfate and titanium dioxide. The capsules are imprinted with edible black ink. The edible black ink contains black iron oxide E172, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>62559-522-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-522-01) </PackageDescription>
<NDC11Code>62559-0522-01</NDC11Code>
<ProductNDC>62559-522</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inderal</ProprietaryName>
<ProprietaryNameSuffix>La</ProprietaryNameSuffix>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170428</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018553</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Inderal LA is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Inderal LA is not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Inderal® LA (propranolol hydrochloride) is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are. C16H21NO2 · HCl. Propranolol hydrochloride USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Inderal LA is formulated to provide a sustained release of propranolol hydrochloride USP. Inderal LA is available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each Inderal LA 60 mg capsule contains 60 mg propranolol hydrochloride USP (equivalent to 52.60 mg of propranolol)., 2 Each Inderal LA 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol)., 3 Each Inderal LA 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol)., 4 Each Inderal LA 160 mg capsule contains 160 mg propranolol hydrochloride USP (equivalent to 140.28 mg of propranolol).</Description>
</NDC>
<NDC>
<NDCCode>62559-522-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-522-30) </PackageDescription>
<NDC11Code>62559-0522-30</NDC11Code>
<ProductNDC>62559-522</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inderal</ProprietaryName>
<ProprietaryNameSuffix>La</ProprietaryNameSuffix>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170428</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018553</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Inderal LA is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Inderal LA is not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Inderal® LA (propranolol hydrochloride) is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are. C16H21NO2 · HCl. Propranolol hydrochloride USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Inderal LA is formulated to provide a sustained release of propranolol hydrochloride USP. Inderal LA is available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each Inderal LA 60 mg capsule contains 60 mg propranolol hydrochloride USP (equivalent to 52.60 mg of propranolol)., 2 Each Inderal LA 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol)., 3 Each Inderal LA 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol)., 4 Each Inderal LA 160 mg capsule contains 160 mg propranolol hydrochloride USP (equivalent to 140.28 mg of propranolol).</Description>
</NDC>
<NDC>
<NDCCode>62756-522-69</NDCCode>
<PackageDescription>9 BLISTER PACK in 1 CARTON (62756-522-69) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>62756-0522-69</NDC11Code>
<ProductNDC>62756-522</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan Succinate</ProprietaryName>
<NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078295</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sumatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: : 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan succinate tablets, reconsider the diagnosis of migraine before sumatriptan succinate tablets are administered to treat any subsequent attacks. , 2 Sumatriptan succinate tablets are not indicated for the prevention of migraine attacks. , 3 Safety and effectiveness of sumatriptan succinate tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Sumatriptan succinate tablets contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The molecular formula is C14H21N3O2S·C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan succinate tablet for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate, USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C Red # 27 aluminum lake (100 mg only), dibasic calcium phosphate, hypromellose, iron oxide red (100 mg only), magnesium stearate, microcrystalline cellulose, polyethylene glycol (25 mg & 50 mg only), polysorbate 80 (25 mg & 50 mg only) propylene glycol (100 mg only), talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>62756-522-88</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (62756-522-88) </PackageDescription>
<NDC11Code>62756-0522-88</NDC11Code>
<ProductNDC>62756-522</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan Succinate</ProprietaryName>
<NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078295</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sumatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: : 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan succinate tablets, reconsider the diagnosis of migraine before sumatriptan succinate tablets are administered to treat any subsequent attacks. , 2 Sumatriptan succinate tablets are not indicated for the prevention of migraine attacks. , 3 Safety and effectiveness of sumatriptan succinate tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Sumatriptan succinate tablets contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The molecular formula is C14H21N3O2S·C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan succinate tablet for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate, USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C Red # 27 aluminum lake (100 mg only), dibasic calcium phosphate, hypromellose, iron oxide red (100 mg only), magnesium stearate, microcrystalline cellulose, polyethylene glycol (25 mg & 50 mg only), polysorbate 80 (25 mg & 50 mg only) propylene glycol (100 mg only), talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63187-522-30</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-522-30) </PackageDescription>
<NDC11Code>63187-0522-30</NDC11Code>
<ProductNDC>63187-522</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074514</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets, USP and other treatment options before deciding to use diclofenac sodium delayed-release tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.</IndicationAndUsage>
<Description>Diclofenac sodium delayed-release tablets, USP are a benzeneacetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.13. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. Each enteric-coated tablet for oral administration contains 50 mg or 75 mg of diclofenac sodium, USP. In addition, each tablet contains the following inactive ingredients: aluminum hydrate, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium starch glycolate (Type A), stearic acid, synthetic black iron oxide, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63187-522-60</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-522-60) </PackageDescription>
<NDC11Code>63187-0522-60</NDC11Code>
<ProductNDC>63187-522</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074514</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets, USP and other treatment options before deciding to use diclofenac sodium delayed-release tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.</IndicationAndUsage>
<Description>Diclofenac sodium delayed-release tablets, USP are a benzeneacetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.13. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. Each enteric-coated tablet for oral administration contains 50 mg or 75 mg of diclofenac sodium, USP. In addition, each tablet contains the following inactive ingredients: aluminum hydrate, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium starch glycolate (Type A), stearic acid, synthetic black iron oxide, talc, and titanium dioxide.</Description>
</NDC>
</NDCList>