{
"NDC": [
{
"NDCCode": "30698-102-30",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-102-30)",
"NDC11Code": "30698-0102-30",
"ProductNDC": "30698-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Parlodel",
"NonProprietaryName": "Bromocriptine Mesylate",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19780628",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017962",
"LabelerName": "Validus Pharmaceuticals LLC",
"SubstanceName": "BROMOCRIPTINE MESYLATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergolines [Chemical/Ingredient],Ergot Derivative [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-04-28"
},
{
"NDCCode": "30698-006-01",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (30698-006-01) ",
"NDC11Code": "30698-0006-01",
"ProductNDC": "30698-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trental",
"NonProprietaryName": "Pentoxifylline",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018631",
"LabelerName": "Validus Pharmaceuticals LLC",
"SubstanceName": "PENTOXIFYLLINE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Viscosity Reducer [EPC], Hematologic Activity Alteration [PE]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "TRENTAL is indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. TRENTAL can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.",
"Description": "TRENTAL ®(pentoxifylline) extended-release tablets for oral administration contain 400 mg of the active drug and the following inactive ingredients: FD&C Red No. 3, hydroxyethyl cellulose USP, hypromellose USP, magnesium stearate NF, polyethylene glycol NF, povidone USP, talc USP, titanium dioxide USP in an extended-release formulation. TRENTAL is a tri-substituted xanthine derivative designated chemically as 1-(5-oxohexyl)-3, 7 dimethylxanthine that, unlike theophylline, is a hemorrheologic agent, i.e. an agent that affects blood viscosity. Pentoxifylline is soluble in water and ethanol, and sparingly soluble in toluene. The CAS Registry Number is 6493-05-6. The chemical structure is."
},
{
"NDCCode": "30698-017-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (30698-017-30)",
"NDC11Code": "30698-0017-30",
"ProductNDC": "30698-017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Parlodel",
"NonProprietaryName": "Bromocriptine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19780628",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017962",
"LabelerName": "Validus Pharmaceuticals LLC",
"SubstanceName": "BROMOCRIPTINE MESYLATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergolines [Chemical/Ingredient],Ergot Derivative [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-04-28"
},
{
"NDCCode": "30698-143-23",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-143-23) ",
"NDC11Code": "30698-0143-23",
"ProductNDC": "30698-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rocaltrol",
"NonProprietaryName": "Calcitriol",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090820",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018044",
"LabelerName": "Validus Pharmaceuticals LLC",
"SubstanceName": "CALCITRIOL",
"StrengthNumber": ".25",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090820",
"SamplePackage": "N",
"IndicationAndUsage": "Predialysis Patients. Rocaltrol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients. Rocaltrol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, Rocaltrol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Hypoparathyroidism Patients. Rocaltrol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.",
"Description": "Rocaltrol (calcitriol) is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Rocaltrol is available as capsules containing 0.25 mcg or 0.5 mcg calcitriol and as an oral solution containing 1 mcg/mL of calcitriol. All dosage forms contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules contain a fractionated triglyceride of coconut oil, and the oral solution contains a fractionated triglyceride of palm seed oil. Gelatin capsule shells contain glycerin, and sorbitol, with the following dye systems: 0.25 mcg - FD&C Yellow No. 6 and titanium dioxide; 0.5 mcg - FD&C Red No. 3, FD&C Yellow No. 6 and titanium dioxide. The oral solution contains no additional adjuvants or coloring principles. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula. The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC. CLINICAL PHARMACOLOGY. Man's natural supply of vitamin D depends mainly on exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol in the skin to vitamin D3 (cholecalciferol). Vitamin D3 must be metabolically activated in the liver and the kidney before it is fully active as a regulator of calcium and phosphorus metabolism at target tissues. The initial transformation of vitamin D3 is catalyzed by a vitamin D3-25-hydroxylase enzyme (25-OHase) present in the liver, and the product of this reaction is 25-hydroxyvitamin D3 [25-(OH) D3]. Hydroxylation of 25-(OH) D3 occurs in the mitochondria of kidney tissue, activated by the renal 25-hydroxyvitamin D3-1 alpha-hydroxylase (alpha-OHase), to produce 1,25-(OH)2D3 (calcitriol), the active form of vitamin D3. Endogenous synthesis and catabolism of calcitriol, as well as physiological control mechanisms affecting these processes, play a critical role regulating the serum level of calcitriol. Physiological daily production is normally 0.5 to 1.0 mcg and is somewhat higher during periods of increased bone synthesis (e.g., growth or pregnancy)."
},
{
"NDCCode": "30698-201-30",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-201-30) ",
"NDC11Code": "30698-0201-30",
"ProductNDC": "30698-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Parlodel",
"NonProprietaryName": "Bromocriptine Mesylate",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140428",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017962",
"LabelerName": "Validus Pharmaceuticals LLC",
"SubstanceName": "BROMOCRIPTINE MESYLATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergolines [CS], Ergot Derivative [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140428",
"SamplePackage": "N",
"IndicationAndUsage": "Parlodel (bromocriptine mesylate) is indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Parlodel treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of Parlodel therapy may be used to reduce the tumor mass prior to surgery.",
"Description": "Parlodel® (bromocriptine mesylate) is an ergot derivative with potent dopamine receptor agonist activity. Each Parlodel® (bromocriptine mesylate) SnapTabs® tablet for oral administration contains 2½ mg and each capsule contains 5 mg bromocriptine (as the mesylate). Bromocriptine mesylate is chemically designated as Ergotaman-3′, 6′, 18-trione, 2-bromo-12′- hydroxy-2′- (1-methylethyl) -5′-(2-methylpropyl) -, (5′α) -monomethanesulfonate (salt). The structural formula is. 2½ mg SnapTabs®. Active Ingredient: bromocriptine mesylate, USP. Inactive Ingredients: colloidal silicon dioxide, lactose, magnesium stearate, maleic acid, povidone, starch, and another ingredient. 5 mg Capsules. Active Ingredient: bromocriptine mesylate, USP. Inactive Ingredients: colloidal silicon dioxide, gelatin, lactose, magnesium stearate, red iron oxide, silicon dioxide, sodium lauryl sulfate, starch, maleic acid, titanium dioxide, yellow iron oxide, and another ingredient."
},
{
"NDCCode": "30698-202-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (30698-202-30) ",
"NDC11Code": "30698-0202-30",
"ProductNDC": "30698-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Parlodel",
"NonProprietaryName": "Bromocriptine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140428",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017962",
"LabelerName": "Validus Pharmaceuticals LLC",
"SubstanceName": "BROMOCRIPTINE MESYLATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergolines [CS], Ergot Derivative [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140428",
"SamplePackage": "N",
"IndicationAndUsage": "Parlodel (bromocriptine mesylate) is indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Parlodel treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of Parlodel therapy may be used to reduce the tumor mass prior to surgery.",
"Description": "Parlodel® (bromocriptine mesylate) is an ergot derivative with potent dopamine receptor agonist activity. Each Parlodel® (bromocriptine mesylate) SnapTabs® tablet for oral administration contains 2½ mg and each capsule contains 5 mg bromocriptine (as the mesylate). Bromocriptine mesylate is chemically designated as Ergotaman-3′, 6′, 18-trione, 2-bromo-12′- hydroxy-2′- (1-methylethyl) -5′-(2-methylpropyl) -, (5′α) -monomethanesulfonate (salt). The structural formula is. 2½ mg SnapTabs®. Active Ingredient: bromocriptine mesylate, USP. Inactive Ingredients: colloidal silicon dioxide, lactose, magnesium stearate, maleic acid, povidone, starch, and another ingredient. 5 mg Capsules. Active Ingredient: bromocriptine mesylate, USP. Inactive Ingredients: colloidal silicon dioxide, gelatin, lactose, magnesium stearate, red iron oxide, silicon dioxide, sodium lauryl sulfate, starch, maleic acid, titanium dioxide, yellow iron oxide, and another ingredient."
},
{
"NDCCode": "30698-460-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (30698-460-03) ",
"NDC11Code": "30698-0460-03",
"ProductNDC": "30698-460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lopressor",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250811",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218698",
"LabelerName": "VALIDUS PHARMACEUTICALS LLC",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250811",
"SamplePackage": "N",
"Description": "LOPRESSOR tablets contain metoprolol tartrate, a beta-adrenergic blocker. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82 g/mol. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. LOPRESSOR is available as 12.5 mg tablets for oral administration containing 12.5 mg metoprolol tartrate (equivalent to 9.76 mg of metoprolol). Inactive Ingredients: Tablets contain colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. Film coating contains D&C Red 30, hypromellose, polyethylene glycol, talc, and titanium dioxide."
},
{
"NDCCode": "30698-464-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (30698-464-30) / 300 mL in 1 BOTTLE",
"NDC11Code": "30698-0464-30",
"ProductNDC": "30698-464",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lopressor",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250411",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219373",
"LabelerName": "VALIDUS PHARMACEUTICALS LLC",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250411",
"SamplePackage": "N",
"Description": "LOPRESSOR Oral Solution contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)- tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82 g/mol. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. LOPRESSOR: Each mL contains 10 mg metoprolol tartrate (equivalent to 3.9 mg metoprolol) and the following inactive ingredients: citric acid monohydrate, disodium edetate, glycerin, purified water, sodium benzoate, sucralose, and xanthan gum."
},
{
"NDCCode": "30698-007-01",
"PackageDescription": "100 TABLET, SUGAR COATED in 1 BOTTLE (30698-007-01) ",
"NDC11Code": "30698-0007-01",
"ProductNDC": "30698-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norpramin",
"NonProprietaryName": "Desipramine Hydrochloride",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19641120",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA014399",
"LabelerName": "Validus Pharmaceuticals LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19641120",
"SamplePackage": "N",
"IndicationAndUsage": "NORPRAMIN is indicated for the treatment of depression.",
"Description": "NORPRAMIN ®(desipramine hydrochloride USP) is an antidepressant drug of the tricyclic type, and is chemically: 5 H-Dibenz[ bƒ]azepine-5-propanamine,10,11-dihydro- N-methyl-, monohydrochloride. Each NORPRAMIN tablet contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride for oral administration. Inactive Ingredients. The following inactive ingredients are contained in all dosage strengths: acacia, calcium carbonate, corn starch, D&C Red No. 30 and D&C Yellow No. 10 (except 10 mg and 150 mg), FD&C Blue No. 1 (except 25 mg, 75 mg, and 100 mg), hydrogenated soy oil, iron oxide, light mineral oil, magnesium stearate, mannitol, polyethylene glycol 8000, pregelatinized corn starch, sodium benzoate (except 150 mg), sucrose, talc, titanium dioxide, and other ingredients."
},
{
"NDCCode": "30698-011-01",
"PackageDescription": "100 TABLET, SUGAR COATED in 1 BOTTLE (30698-011-01) ",
"NDC11Code": "30698-0011-01",
"ProductNDC": "30698-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norpramin",
"NonProprietaryName": "Desipramine Hydrochloride",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19641120",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA014399",
"LabelerName": "Validus Pharmaceuticals LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19641120",
"SamplePackage": "N",
"IndicationAndUsage": "NORPRAMIN is indicated for the treatment of depression.",
"Description": "NORPRAMIN ®(desipramine hydrochloride USP) is an antidepressant drug of the tricyclic type, and is chemically: 5 H-Dibenz[ bƒ]azepine-5-propanamine,10,11-dihydro- N-methyl-, monohydrochloride. Each NORPRAMIN tablet contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride for oral administration. Inactive Ingredients. The following inactive ingredients are contained in all dosage strengths: acacia, calcium carbonate, corn starch, D&C Red No. 30 and D&C Yellow No. 10 (except 10 mg and 150 mg), FD&C Blue No. 1 (except 25 mg, 75 mg, and 100 mg), hydrogenated soy oil, iron oxide, light mineral oil, magnesium stearate, mannitol, polyethylene glycol 8000, pregelatinized corn starch, sodium benzoate (except 150 mg), sucrose, talc, titanium dioxide, and other ingredients."
},
{
"NDCCode": "30698-015-01",
"PackageDescription": "100 TABLET, SUGAR COATED in 1 BOTTLE (30698-015-01) ",
"NDC11Code": "30698-0015-01",
"ProductNDC": "30698-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norpramin",
"NonProprietaryName": "Desipramine Hydrochloride",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19641120",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA014399",
"LabelerName": "Validus Pharmaceuticals LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19641120",
"SamplePackage": "N",
"IndicationAndUsage": "NORPRAMIN is indicated for the treatment of depression.",
"Description": "NORPRAMIN ®(desipramine hydrochloride USP) is an antidepressant drug of the tricyclic type, and is chemically: 5 H-Dibenz[ bƒ]azepine-5-propanamine,10,11-dihydro- N-methyl-, monohydrochloride. Each NORPRAMIN tablet contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride for oral administration. Inactive Ingredients. The following inactive ingredients are contained in all dosage strengths: acacia, calcium carbonate, corn starch, D&C Red No. 30 and D&C Yellow No. 10 (except 10 mg and 150 mg), FD&C Blue No. 1 (except 25 mg, 75 mg, and 100 mg), hydrogenated soy oil, iron oxide, light mineral oil, magnesium stearate, mannitol, polyethylene glycol 8000, pregelatinized corn starch, sodium benzoate (except 150 mg), sucrose, talc, titanium dioxide, and other ingredients."
},
{
"NDCCode": "30698-019-01",
"PackageDescription": "100 TABLET, SUGAR COATED in 1 BOTTLE (30698-019-01) ",
"NDC11Code": "30698-0019-01",
"ProductNDC": "30698-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norpramin",
"NonProprietaryName": "Desipramine Hydrochloride",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19641120",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA014399",
"LabelerName": "Validus Pharmaceuticals LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19641120",
"SamplePackage": "N",
"IndicationAndUsage": "NORPRAMIN is indicated for the treatment of depression.",
"Description": "NORPRAMIN ®(desipramine hydrochloride USP) is an antidepressant drug of the tricyclic type, and is chemically: 5 H-Dibenz[ bƒ]azepine-5-propanamine,10,11-dihydro- N-methyl-, monohydrochloride. Each NORPRAMIN tablet contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride for oral administration. Inactive Ingredients. The following inactive ingredients are contained in all dosage strengths: acacia, calcium carbonate, corn starch, D&C Red No. 30 and D&C Yellow No. 10 (except 10 mg and 150 mg), FD&C Blue No. 1 (except 25 mg, 75 mg, and 100 mg), hydrogenated soy oil, iron oxide, light mineral oil, magnesium stearate, mannitol, polyethylene glycol 8000, pregelatinized corn starch, sodium benzoate (except 150 mg), sucrose, talc, titanium dioxide, and other ingredients."
},
{
"NDCCode": "30698-020-01",
"PackageDescription": "100 TABLET, SUGAR COATED in 1 BOTTLE (30698-020-01) ",
"NDC11Code": "30698-0020-01",
"ProductNDC": "30698-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norpramin",
"NonProprietaryName": "Desipramine Hydrochloride",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19641120",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA014399",
"LabelerName": "Validus Pharmaceuticals LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19641120",
"SamplePackage": "N",
"IndicationAndUsage": "NORPRAMIN is indicated for the treatment of depression.",
"Description": "NORPRAMIN ®(desipramine hydrochloride USP) is an antidepressant drug of the tricyclic type, and is chemically: 5 H-Dibenz[ bƒ]azepine-5-propanamine,10,11-dihydro- N-methyl-, monohydrochloride. Each NORPRAMIN tablet contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride for oral administration. Inactive Ingredients. The following inactive ingredients are contained in all dosage strengths: acacia, calcium carbonate, corn starch, D&C Red No. 30 and D&C Yellow No. 10 (except 10 mg and 150 mg), FD&C Blue No. 1 (except 25 mg, 75 mg, and 100 mg), hydrogenated soy oil, iron oxide, light mineral oil, magnesium stearate, mannitol, polyethylene glycol 8000, pregelatinized corn starch, sodium benzoate (except 150 mg), sucrose, talc, titanium dioxide, and other ingredients."
},
{
"NDCCode": "30698-021-50",
"PackageDescription": "50 TABLET, SUGAR COATED in 1 BOTTLE (30698-021-50) ",
"NDC11Code": "30698-0021-50",
"ProductNDC": "30698-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norpramin",
"NonProprietaryName": "Desipramine Hydrochloride",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19641120",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA014399",
"LabelerName": "Validus Pharmaceuticals LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19641120",
"SamplePackage": "N",
"IndicationAndUsage": "NORPRAMIN is indicated for the treatment of depression.",
"Description": "NORPRAMIN ®(desipramine hydrochloride USP) is an antidepressant drug of the tricyclic type, and is chemically: 5 H-Dibenz[ bƒ]azepine-5-propanamine,10,11-dihydro- N-methyl-, monohydrochloride. Each NORPRAMIN tablet contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride for oral administration. Inactive Ingredients. The following inactive ingredients are contained in all dosage strengths: acacia, calcium carbonate, corn starch, D&C Red No. 30 and D&C Yellow No. 10 (except 10 mg and 150 mg), FD&C Blue No. 1 (except 25 mg, 75 mg, and 100 mg), hydrogenated soy oil, iron oxide, light mineral oil, magnesium stearate, mannitol, polyethylene glycol 8000, pregelatinized corn starch, sodium benzoate (except 150 mg), sucrose, talc, titanium dioxide, and other ingredients."
},
{
"NDCCode": "30698-460-01",
"PackageDescription": "60 TABLET in 1 BOTTLE (30698-460-01) ",
"NDC11Code": "30698-0460-01",
"ProductNDC": "30698-460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lopressor",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250811",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218698",
"LabelerName": "VALIDUS PHARMACEUTICALS LLC",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260125",
"SamplePackage": "N",
"Description": "LOPRESSOR tablets contain metoprolol tartrate, a beta-adrenergic blocker. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82 g/mol. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. LOPRESSOR is available as 12.5 mg tablets for oral administration containing 12.5 mg metoprolol tartrate (equivalent to 9.76 mg of metoprolol). Inactive Ingredients: Tablets contain colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. Film coating contains D&C Red 30, hypromellose, polyethylene glycol, talc, and titanium dioxide."
},
{
"NDCCode": "30698-460-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (30698-460-10) ",
"NDC11Code": "30698-0460-10",
"ProductNDC": "30698-460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lopressor",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250811",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218698",
"LabelerName": "VALIDUS PHARMACEUTICALS LLC",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250811",
"SamplePackage": "N",
"Description": "LOPRESSOR tablets contain metoprolol tartrate, a beta-adrenergic blocker. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82 g/mol. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. LOPRESSOR is available as 12.5 mg tablets for oral administration containing 12.5 mg metoprolol tartrate (equivalent to 9.76 mg of metoprolol). Inactive Ingredients: Tablets contain colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. Film coating contains D&C Red 30, hypromellose, polyethylene glycol, talc, and titanium dioxide."
},
{
"NDCCode": "10237-102-01",
"PackageDescription": "1 BOTTLE, SPRAY in 1 POUCH (10237-102-01) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "10237-0102-01",
"ProductNDC": "10237-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Touchland Power Mist Hand Sanitizer Berry Bliss",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": "hand sanitizer to decrease bacteria on the skin recommended for repeated use."
},
{
"NDCCode": "10237-133-00",
"PackageDescription": "1 KIT in 1 CARTON (10237-133-00) * 30 mL in 1 BOTTLE, SPRAY (10237-114-00) * 30 mL in 1 BOTTLE, SPRAY (10237-102-00) * 30 mL in 1 BOTTLE, SPRAY (10237-100-00) * 30 mL in 1 BOTTLE, SPRAY (10237-103-00) * 30 mL in 1 BOTTLE, SPRAY (10237-110-00) ",
"NDC11Code": "10237-0133-00",
"ProductNDC": "10237-133",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Touchland The All-star Set Power Mist Hydrating Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20260801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Church & Dwight Co., Inc.",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260801",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "10237-136-00",
"PackageDescription": "1 KIT in 1 CARTON (10237-136-00) * 30 mL in 1 BOTTLE, SPRAY (10237-107-00) * 30 mL in 1 BOTTLE, SPRAY (10237-102-00) * 30 mL in 1 BOTTLE, SPRAY (10237-100-00) * 30 mL in 1 BOTTLE, SPRAY (10237-111-00) ",
"NDC11Code": "10237-0136-00",
"ProductNDC": "10237-136",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Touchland The Daydream Set Power Mist Power Mist Hydrating Hand Sanitizer Mist",
"NonProprietaryName": "Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20260801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Church & Dwight Co., Inc.",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260801",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "10237-138-00",
"PackageDescription": "1 KIT in 1 CARTON (10237-138-00) * 30 mL in 1 BOTTLE, SPRAY (10237-102-00) * 30 mL in 1 BOTTLE, SPRAY (72033-100-01) * 30 mL in 1 BOTTLE, SPRAY (10237-124-00) * 30 mL in 1 BOTTLE, SPRAY (10237-130-00) * 30 mL in 1 BOTTLE, SPRAY (10237-112-00) ",
"NDC11Code": "10237-0138-00",
"ProductNDC": "10237-138",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Touchland The Endless Summer Set",
"NonProprietaryName": "Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20260801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Church & Dwight Co., Inc.",
"Status": "Active",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260801",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "10370-102-03",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-102-03) ",
"NDC11Code": "10370-0102-03",
"ProductNDC": "10370-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070612",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077284",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20070612",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) is an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).",
"Description": "Bupropion Hydrochloride Extended-Release Tablets USP (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (XL) are supplied for oral administration as 150 mg and 300 mg white to off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: dehydrated alcohol, ethylcellulose, hydrochloric acid, hydroxypropylcellulose, methacrylic acid copolymer, povidone, silicon dioxide, hydrogenated vegetable oil and ethyl alcohol. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. Meets USP Dissolution Test 8."
},
{
"NDCCode": "11090-102-01",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (11090-102-01) ",
"NDC11Code": "11090-0102-01",
"ProductNDC": "11090-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Beauty Manufacturing Solutions Corp.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N"
},
{
"NDCCode": "11090-102-04",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (11090-102-04) ",
"NDC11Code": "11090-0102-04",
"ProductNDC": "11090-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Beauty Manufacturing Solutions Corp.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N"
},
{
"NDCCode": "11788-102-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (11788-102-30) ",
"NDC11Code": "11788-0102-30",
"ProductNDC": "11788-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090544",
"LabelerName": "AiPing Pharmaceutical, Inc.",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan Potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).",
"Description": "Losartan potassium is an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 1H-Imidazole-5-methanol,2-butyl-4-chloro-1-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-, monopotassium salt. Its empirical formula is C22H22CIKN6O, and its structural formula is. Losartan potassium, USP is a white to almost white crystalline powder with a molecular weight of 461.00. It is freely soluble in water and in methanol, slightly soluble in acetonitrile. Losartan Potassium Tablets, USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. The tablets are coated with Opadry Green which contains D&C Yellow #10 Aluminum Lake, FD&C Blue #2, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "13310-102-07",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (13310-102-07)",
"NDC11Code": "13310-0102-07",
"ProductNDC": "13310-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fibricor",
"NonProprietaryName": "Fenofibric Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090814",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022418",
"LabelerName": "AR Scientific, Inc.",
"SubstanceName": "FENOFIBRIC ACID",
"StrengthNumber": "105",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "FIBRICOR is a peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet: 1 to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (≥ 500 mg/dL) (1.1)., 2 to reduce elevated total cholesterol (TC), low-density-lipoprotein cholesterol (LDL-C), TG and apolipoprotein (Apo) B and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.2).",
"Description": "FIBRICOR is a lipid regulating agent available as tablets for oral administration. Each tablet contains 35 mg or 105 mg of fenofibric acid. The chemical name for fenofibric acid is 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid with the following structural formula. Fenofibric acid is a white to almost white crystalline powder that is stable under ordinary conditions, and has a melting point of 179 – 183°C. Its empirical formula is C17H15ClO4 and molecular weight 318.75. Fenofibric acid is insoluble in water; its solubility increases with pH in buffered media. Inactive Ingredients: Each tablet contains copovidone, crospovidone, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "13668-102-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (13668-102-30) ",
"NDC11Code": "13668-0102-30",
"ProductNDC": "13668-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090686",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110531",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride tablets are an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease.",
"Description": "Donepezil hydrochloride USP is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride, USP is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 5 or 10 mg of donepezil hydrochloride, USP. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, magnesium stearate, maize starch ( Zea mays) and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Additionally, the 10 mg tablet contains ferric oxide red and ferric oxide yellow as coloring agents."
},
{
"NDCCode": "15572-102-00",
"PackageDescription": "1 TUBE in 1 CARTON (15572-102-00) > 30 mL in 1 TUBE",
"NDC11Code": "15572-0102-00",
"ProductNDC": "15572-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Burberry Fresh Glow B.b. Luminous Skin Perfecting Beauty Balm Sunscreen Broad Spectrum Spf 20 Medium 02",
"NonProprietaryName": "Octinoxate, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141113",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Intercos Europe S.p.A.",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "60; 20",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2018-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20141113",
"SamplePackage": "N"
},
{
"NDCCode": "16590-102-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (16590-102-30)",
"NDC11Code": "16590-0102-30",
"ProductNDC": "16590-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20041004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075350",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Postherpetic Neuralgia. Gabapentin is indicated for the management of postherpetic neuralgia in adults. Epilepsy. Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years.",
"Description": "Gabapentin capsules, USP are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin. The inactive ingredients are: black iron oxide, corn starch, D&C Yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, gelatin, mannitol, pharmaceutical glaze, propylene glycol, red iron oxide T3469, silicon dioxide, sodium lauryl sulfate, synthetic black iron oxide, talc, titanium dioxide, and yellow iron oxide T3506. Gabapentin, USP is described as 1-(aminomethyl)cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25."
},
{
"NDCCode": "16714-102-01",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16714-102-01) ",
"NDC11Code": "16714-0102-01",
"ProductNDC": "16714-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202261",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-04-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20121119",
"SamplePackage": "N"
},
{
"NDCCode": "17772-102-03",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-102-03) ",
"NDC11Code": "17772-0102-03",
"ProductNDC": "17772-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trokendi Xr",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201635",
"LabelerName": "Supernus Pharmaceuticals",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-03-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130816",
"SamplePackage": "Y"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>30698-102-30</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-102-30)</PackageDescription>
<NDC11Code>30698-0102-30</NDC11Code>
<ProductNDC>30698-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Parlodel</ProprietaryName>
<NonProprietaryName>Bromocriptine Mesylate</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19780628</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017962</ApplicationNumber>
<LabelerName>Validus Pharmaceuticals LLC</LabelerName>
<SubstanceName>BROMOCRIPTINE MESYLATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergolines [Chemical/Ingredient],Ergot Derivative [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-28</LastUpdate>
</NDC>
<NDC>
<NDCCode>30698-006-01</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (30698-006-01) </PackageDescription>
<NDC11Code>30698-0006-01</NDC11Code>
<ProductNDC>30698-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trental</ProprietaryName>
<NonProprietaryName>Pentoxifylline</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018631</ApplicationNumber>
<LabelerName>Validus Pharmaceuticals LLC</LabelerName>
<SubstanceName>PENTOXIFYLLINE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Viscosity Reducer [EPC], Hematologic Activity Alteration [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRENTAL is indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. TRENTAL can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.</IndicationAndUsage>
<Description>TRENTAL ®(pentoxifylline) extended-release tablets for oral administration contain 400 mg of the active drug and the following inactive ingredients: FD&C Red No. 3, hydroxyethyl cellulose USP, hypromellose USP, magnesium stearate NF, polyethylene glycol NF, povidone USP, talc USP, titanium dioxide USP in an extended-release formulation. TRENTAL is a tri-substituted xanthine derivative designated chemically as 1-(5-oxohexyl)-3, 7 dimethylxanthine that, unlike theophylline, is a hemorrheologic agent, i.e. an agent that affects blood viscosity. Pentoxifylline is soluble in water and ethanol, and sparingly soluble in toluene. The CAS Registry Number is 6493-05-6. The chemical structure is.</Description>
</NDC>
<NDC>
<NDCCode>30698-017-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (30698-017-30)</PackageDescription>
<NDC11Code>30698-0017-30</NDC11Code>
<ProductNDC>30698-017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Parlodel</ProprietaryName>
<NonProprietaryName>Bromocriptine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19780628</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017962</ApplicationNumber>
<LabelerName>Validus Pharmaceuticals LLC</LabelerName>
<SubstanceName>BROMOCRIPTINE MESYLATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergolines [Chemical/Ingredient],Ergot Derivative [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-28</LastUpdate>
</NDC>
<NDC>
<NDCCode>30698-143-23</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-143-23) </PackageDescription>
<NDC11Code>30698-0143-23</NDC11Code>
<ProductNDC>30698-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rocaltrol</ProprietaryName>
<NonProprietaryName>Calcitriol</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090820</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018044</ApplicationNumber>
<LabelerName>Validus Pharmaceuticals LLC</LabelerName>
<SubstanceName>CALCITRIOL</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Predialysis Patients. Rocaltrol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients. Rocaltrol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, Rocaltrol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Hypoparathyroidism Patients. Rocaltrol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.</IndicationAndUsage>
<Description>Rocaltrol (calcitriol) is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Rocaltrol is available as capsules containing 0.25 mcg or 0.5 mcg calcitriol and as an oral solution containing 1 mcg/mL of calcitriol. All dosage forms contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules contain a fractionated triglyceride of coconut oil, and the oral solution contains a fractionated triglyceride of palm seed oil. Gelatin capsule shells contain glycerin, and sorbitol, with the following dye systems: 0.25 mcg - FD&C Yellow No. 6 and titanium dioxide; 0.5 mcg - FD&C Red No. 3, FD&C Yellow No. 6 and titanium dioxide. The oral solution contains no additional adjuvants or coloring principles. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula. The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC. CLINICAL PHARMACOLOGY. Man's natural supply of vitamin D depends mainly on exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol in the skin to vitamin D3 (cholecalciferol). Vitamin D3 must be metabolically activated in the liver and the kidney before it is fully active as a regulator of calcium and phosphorus metabolism at target tissues. The initial transformation of vitamin D3 is catalyzed by a vitamin D3-25-hydroxylase enzyme (25-OHase) present in the liver, and the product of this reaction is 25-hydroxyvitamin D3 [25-(OH) D3]. Hydroxylation of 25-(OH) D3 occurs in the mitochondria of kidney tissue, activated by the renal 25-hydroxyvitamin D3-1 alpha-hydroxylase (alpha-OHase), to produce 1,25-(OH)2D3 (calcitriol), the active form of vitamin D3. Endogenous synthesis and catabolism of calcitriol, as well as physiological control mechanisms affecting these processes, play a critical role regulating the serum level of calcitriol. Physiological daily production is normally 0.5 to 1.0 mcg and is somewhat higher during periods of increased bone synthesis (e.g., growth or pregnancy).</Description>
</NDC>
<NDC>
<NDCCode>30698-201-30</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-201-30) </PackageDescription>
<NDC11Code>30698-0201-30</NDC11Code>
<ProductNDC>30698-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Parlodel</ProprietaryName>
<NonProprietaryName>Bromocriptine Mesylate</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140428</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017962</ApplicationNumber>
<LabelerName>Validus Pharmaceuticals LLC</LabelerName>
<SubstanceName>BROMOCRIPTINE MESYLATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergolines [CS], Ergot Derivative [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Parlodel (bromocriptine mesylate) is indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Parlodel treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of Parlodel therapy may be used to reduce the tumor mass prior to surgery.</IndicationAndUsage>
<Description>Parlodel® (bromocriptine mesylate) is an ergot derivative with potent dopamine receptor agonist activity. Each Parlodel® (bromocriptine mesylate) SnapTabs® tablet for oral administration contains 2½ mg and each capsule contains 5 mg bromocriptine (as the mesylate). Bromocriptine mesylate is chemically designated as Ergotaman-3′, 6′, 18-trione, 2-bromo-12′- hydroxy-2′- (1-methylethyl) -5′-(2-methylpropyl) -, (5′α) -monomethanesulfonate (salt). The structural formula is. 2½ mg SnapTabs®. Active Ingredient: bromocriptine mesylate, USP. Inactive Ingredients: colloidal silicon dioxide, lactose, magnesium stearate, maleic acid, povidone, starch, and another ingredient. 5 mg Capsules. Active Ingredient: bromocriptine mesylate, USP. Inactive Ingredients: colloidal silicon dioxide, gelatin, lactose, magnesium stearate, red iron oxide, silicon dioxide, sodium lauryl sulfate, starch, maleic acid, titanium dioxide, yellow iron oxide, and another ingredient.</Description>
</NDC>
<NDC>
<NDCCode>30698-202-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (30698-202-30) </PackageDescription>
<NDC11Code>30698-0202-30</NDC11Code>
<ProductNDC>30698-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Parlodel</ProprietaryName>
<NonProprietaryName>Bromocriptine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140428</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017962</ApplicationNumber>
<LabelerName>Validus Pharmaceuticals LLC</LabelerName>
<SubstanceName>BROMOCRIPTINE MESYLATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergolines [CS], Ergot Derivative [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Parlodel (bromocriptine mesylate) is indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Parlodel treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of Parlodel therapy may be used to reduce the tumor mass prior to surgery.</IndicationAndUsage>
<Description>Parlodel® (bromocriptine mesylate) is an ergot derivative with potent dopamine receptor agonist activity. Each Parlodel® (bromocriptine mesylate) SnapTabs® tablet for oral administration contains 2½ mg and each capsule contains 5 mg bromocriptine (as the mesylate). Bromocriptine mesylate is chemically designated as Ergotaman-3′, 6′, 18-trione, 2-bromo-12′- hydroxy-2′- (1-methylethyl) -5′-(2-methylpropyl) -, (5′α) -monomethanesulfonate (salt). The structural formula is. 2½ mg SnapTabs®. Active Ingredient: bromocriptine mesylate, USP. Inactive Ingredients: colloidal silicon dioxide, lactose, magnesium stearate, maleic acid, povidone, starch, and another ingredient. 5 mg Capsules. Active Ingredient: bromocriptine mesylate, USP. Inactive Ingredients: colloidal silicon dioxide, gelatin, lactose, magnesium stearate, red iron oxide, silicon dioxide, sodium lauryl sulfate, starch, maleic acid, titanium dioxide, yellow iron oxide, and another ingredient.</Description>
</NDC>
<NDC>
<NDCCode>30698-460-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (30698-460-03) </PackageDescription>
<NDC11Code>30698-0460-03</NDC11Code>
<ProductNDC>30698-460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lopressor</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250811</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218698</ApplicationNumber>
<LabelerName>VALIDUS PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>LOPRESSOR tablets contain metoprolol tartrate, a beta-adrenergic blocker. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82 g/mol. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. LOPRESSOR is available as 12.5 mg tablets for oral administration containing 12.5 mg metoprolol tartrate (equivalent to 9.76 mg of metoprolol). Inactive Ingredients: Tablets contain colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. Film coating contains D&C Red 30, hypromellose, polyethylene glycol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>30698-464-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (30698-464-30) / 300 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>30698-0464-30</NDC11Code>
<ProductNDC>30698-464</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lopressor</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250411</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219373</ApplicationNumber>
<LabelerName>VALIDUS PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>LOPRESSOR Oral Solution contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)- tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82 g/mol. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. LOPRESSOR: Each mL contains 10 mg metoprolol tartrate (equivalent to 3.9 mg metoprolol) and the following inactive ingredients: citric acid monohydrate, disodium edetate, glycerin, purified water, sodium benzoate, sucralose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>30698-007-01</NDCCode>
<PackageDescription>100 TABLET, SUGAR COATED in 1 BOTTLE (30698-007-01) </PackageDescription>
<NDC11Code>30698-0007-01</NDC11Code>
<ProductNDC>30698-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norpramin</ProprietaryName>
<NonProprietaryName>Desipramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19641120</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA014399</ApplicationNumber>
<LabelerName>Validus Pharmaceuticals LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19641120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NORPRAMIN is indicated for the treatment of depression.</IndicationAndUsage>
<Description>NORPRAMIN ®(desipramine hydrochloride USP) is an antidepressant drug of the tricyclic type, and is chemically: 5 H-Dibenz[ bƒ]azepine-5-propanamine,10,11-dihydro- N-methyl-, monohydrochloride. Each NORPRAMIN tablet contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride for oral administration. Inactive Ingredients. The following inactive ingredients are contained in all dosage strengths: acacia, calcium carbonate, corn starch, D&C Red No. 30 and D&C Yellow No. 10 (except 10 mg and 150 mg), FD&C Blue No. 1 (except 25 mg, 75 mg, and 100 mg), hydrogenated soy oil, iron oxide, light mineral oil, magnesium stearate, mannitol, polyethylene glycol 8000, pregelatinized corn starch, sodium benzoate (except 150 mg), sucrose, talc, titanium dioxide, and other ingredients.</Description>
</NDC>
<NDC>
<NDCCode>30698-011-01</NDCCode>
<PackageDescription>100 TABLET, SUGAR COATED in 1 BOTTLE (30698-011-01) </PackageDescription>
<NDC11Code>30698-0011-01</NDC11Code>
<ProductNDC>30698-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norpramin</ProprietaryName>
<NonProprietaryName>Desipramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19641120</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA014399</ApplicationNumber>
<LabelerName>Validus Pharmaceuticals LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19641120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NORPRAMIN is indicated for the treatment of depression.</IndicationAndUsage>
<Description>NORPRAMIN ®(desipramine hydrochloride USP) is an antidepressant drug of the tricyclic type, and is chemically: 5 H-Dibenz[ bƒ]azepine-5-propanamine,10,11-dihydro- N-methyl-, monohydrochloride. Each NORPRAMIN tablet contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride for oral administration. Inactive Ingredients. The following inactive ingredients are contained in all dosage strengths: acacia, calcium carbonate, corn starch, D&C Red No. 30 and D&C Yellow No. 10 (except 10 mg and 150 mg), FD&C Blue No. 1 (except 25 mg, 75 mg, and 100 mg), hydrogenated soy oil, iron oxide, light mineral oil, magnesium stearate, mannitol, polyethylene glycol 8000, pregelatinized corn starch, sodium benzoate (except 150 mg), sucrose, talc, titanium dioxide, and other ingredients.</Description>
</NDC>
<NDC>
<NDCCode>30698-015-01</NDCCode>
<PackageDescription>100 TABLET, SUGAR COATED in 1 BOTTLE (30698-015-01) </PackageDescription>
<NDC11Code>30698-0015-01</NDC11Code>
<ProductNDC>30698-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norpramin</ProprietaryName>
<NonProprietaryName>Desipramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19641120</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA014399</ApplicationNumber>
<LabelerName>Validus Pharmaceuticals LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19641120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NORPRAMIN is indicated for the treatment of depression.</IndicationAndUsage>
<Description>NORPRAMIN ®(desipramine hydrochloride USP) is an antidepressant drug of the tricyclic type, and is chemically: 5 H-Dibenz[ bƒ]azepine-5-propanamine,10,11-dihydro- N-methyl-, monohydrochloride. Each NORPRAMIN tablet contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride for oral administration. Inactive Ingredients. The following inactive ingredients are contained in all dosage strengths: acacia, calcium carbonate, corn starch, D&C Red No. 30 and D&C Yellow No. 10 (except 10 mg and 150 mg), FD&C Blue No. 1 (except 25 mg, 75 mg, and 100 mg), hydrogenated soy oil, iron oxide, light mineral oil, magnesium stearate, mannitol, polyethylene glycol 8000, pregelatinized corn starch, sodium benzoate (except 150 mg), sucrose, talc, titanium dioxide, and other ingredients.</Description>
</NDC>
<NDC>
<NDCCode>30698-019-01</NDCCode>
<PackageDescription>100 TABLET, SUGAR COATED in 1 BOTTLE (30698-019-01) </PackageDescription>
<NDC11Code>30698-0019-01</NDC11Code>
<ProductNDC>30698-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norpramin</ProprietaryName>
<NonProprietaryName>Desipramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19641120</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA014399</ApplicationNumber>
<LabelerName>Validus Pharmaceuticals LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19641120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NORPRAMIN is indicated for the treatment of depression.</IndicationAndUsage>
<Description>NORPRAMIN ®(desipramine hydrochloride USP) is an antidepressant drug of the tricyclic type, and is chemically: 5 H-Dibenz[ bƒ]azepine-5-propanamine,10,11-dihydro- N-methyl-, monohydrochloride. Each NORPRAMIN tablet contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride for oral administration. Inactive Ingredients. The following inactive ingredients are contained in all dosage strengths: acacia, calcium carbonate, corn starch, D&C Red No. 30 and D&C Yellow No. 10 (except 10 mg and 150 mg), FD&C Blue No. 1 (except 25 mg, 75 mg, and 100 mg), hydrogenated soy oil, iron oxide, light mineral oil, magnesium stearate, mannitol, polyethylene glycol 8000, pregelatinized corn starch, sodium benzoate (except 150 mg), sucrose, talc, titanium dioxide, and other ingredients.</Description>
</NDC>
<NDC>
<NDCCode>30698-020-01</NDCCode>
<PackageDescription>100 TABLET, SUGAR COATED in 1 BOTTLE (30698-020-01) </PackageDescription>
<NDC11Code>30698-0020-01</NDC11Code>
<ProductNDC>30698-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norpramin</ProprietaryName>
<NonProprietaryName>Desipramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19641120</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA014399</ApplicationNumber>
<LabelerName>Validus Pharmaceuticals LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19641120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NORPRAMIN is indicated for the treatment of depression.</IndicationAndUsage>
<Description>NORPRAMIN ®(desipramine hydrochloride USP) is an antidepressant drug of the tricyclic type, and is chemically: 5 H-Dibenz[ bƒ]azepine-5-propanamine,10,11-dihydro- N-methyl-, monohydrochloride. Each NORPRAMIN tablet contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride for oral administration. Inactive Ingredients. The following inactive ingredients are contained in all dosage strengths: acacia, calcium carbonate, corn starch, D&C Red No. 30 and D&C Yellow No. 10 (except 10 mg and 150 mg), FD&C Blue No. 1 (except 25 mg, 75 mg, and 100 mg), hydrogenated soy oil, iron oxide, light mineral oil, magnesium stearate, mannitol, polyethylene glycol 8000, pregelatinized corn starch, sodium benzoate (except 150 mg), sucrose, talc, titanium dioxide, and other ingredients.</Description>
</NDC>
<NDC>
<NDCCode>30698-021-50</NDCCode>
<PackageDescription>50 TABLET, SUGAR COATED in 1 BOTTLE (30698-021-50) </PackageDescription>
<NDC11Code>30698-0021-50</NDC11Code>
<ProductNDC>30698-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norpramin</ProprietaryName>
<NonProprietaryName>Desipramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19641120</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA014399</ApplicationNumber>
<LabelerName>Validus Pharmaceuticals LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19641120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NORPRAMIN is indicated for the treatment of depression.</IndicationAndUsage>
<Description>NORPRAMIN ®(desipramine hydrochloride USP) is an antidepressant drug of the tricyclic type, and is chemically: 5 H-Dibenz[ bƒ]azepine-5-propanamine,10,11-dihydro- N-methyl-, monohydrochloride. Each NORPRAMIN tablet contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride for oral administration. Inactive Ingredients. The following inactive ingredients are contained in all dosage strengths: acacia, calcium carbonate, corn starch, D&C Red No. 30 and D&C Yellow No. 10 (except 10 mg and 150 mg), FD&C Blue No. 1 (except 25 mg, 75 mg, and 100 mg), hydrogenated soy oil, iron oxide, light mineral oil, magnesium stearate, mannitol, polyethylene glycol 8000, pregelatinized corn starch, sodium benzoate (except 150 mg), sucrose, talc, titanium dioxide, and other ingredients.</Description>
</NDC>
<NDC>
<NDCCode>30698-460-01</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (30698-460-01) </PackageDescription>
<NDC11Code>30698-0460-01</NDC11Code>
<ProductNDC>30698-460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lopressor</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250811</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218698</ApplicationNumber>
<LabelerName>VALIDUS PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>LOPRESSOR tablets contain metoprolol tartrate, a beta-adrenergic blocker. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82 g/mol. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. LOPRESSOR is available as 12.5 mg tablets for oral administration containing 12.5 mg metoprolol tartrate (equivalent to 9.76 mg of metoprolol). Inactive Ingredients: Tablets contain colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. Film coating contains D&C Red 30, hypromellose, polyethylene glycol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>30698-460-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (30698-460-10) </PackageDescription>
<NDC11Code>30698-0460-10</NDC11Code>
<ProductNDC>30698-460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lopressor</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250811</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218698</ApplicationNumber>
<LabelerName>VALIDUS PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>LOPRESSOR tablets contain metoprolol tartrate, a beta-adrenergic blocker. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82 g/mol. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. LOPRESSOR is available as 12.5 mg tablets for oral administration containing 12.5 mg metoprolol tartrate (equivalent to 9.76 mg of metoprolol). Inactive Ingredients: Tablets contain colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. Film coating contains D&C Red 30, hypromellose, polyethylene glycol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>10237-102-01</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 POUCH (10237-102-01) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>10237-0102-01</NDC11Code>
<ProductNDC>10237-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Touchland Power Mist Hand Sanitizer Berry Bliss</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>hand sanitizer to decrease bacteria on the skin recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10237-133-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (10237-133-00) * 30 mL in 1 BOTTLE, SPRAY (10237-114-00) * 30 mL in 1 BOTTLE, SPRAY (10237-102-00) * 30 mL in 1 BOTTLE, SPRAY (10237-100-00) * 30 mL in 1 BOTTLE, SPRAY (10237-103-00) * 30 mL in 1 BOTTLE, SPRAY (10237-110-00) </PackageDescription>
<NDC11Code>10237-0133-00</NDC11Code>
<ProductNDC>10237-133</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Touchland The All-star Set Power Mist Hydrating Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10237-136-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (10237-136-00) * 30 mL in 1 BOTTLE, SPRAY (10237-107-00) * 30 mL in 1 BOTTLE, SPRAY (10237-102-00) * 30 mL in 1 BOTTLE, SPRAY (10237-100-00) * 30 mL in 1 BOTTLE, SPRAY (10237-111-00) </PackageDescription>
<NDC11Code>10237-0136-00</NDC11Code>
<ProductNDC>10237-136</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Touchland The Daydream Set Power Mist Power Mist Hydrating Hand Sanitizer Mist</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10237-138-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (10237-138-00) * 30 mL in 1 BOTTLE, SPRAY (10237-102-00) * 30 mL in 1 BOTTLE, SPRAY (72033-100-01) * 30 mL in 1 BOTTLE, SPRAY (10237-124-00) * 30 mL in 1 BOTTLE, SPRAY (10237-130-00) * 30 mL in 1 BOTTLE, SPRAY (10237-112-00) </PackageDescription>
<NDC11Code>10237-0138-00</NDC11Code>
<ProductNDC>10237-138</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Touchland The Endless Summer Set</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10370-102-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-102-03) </PackageDescription>
<NDC11Code>10370-0102-03</NDC11Code>
<ProductNDC>10370-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070612</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077284</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20070612</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) is an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Bupropion Hydrochloride Extended-Release Tablets USP (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (XL) are supplied for oral administration as 150 mg and 300 mg white to off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: dehydrated alcohol, ethylcellulose, hydrochloric acid, hydroxypropylcellulose, methacrylic acid copolymer, povidone, silicon dioxide, hydrogenated vegetable oil and ethyl alcohol. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. Meets USP Dissolution Test 8.</Description>
</NDC>
<NDC>
<NDCCode>11090-102-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (11090-102-01) </PackageDescription>
<NDC11Code>11090-0102-01</NDC11Code>
<ProductNDC>11090-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Beauty Manufacturing Solutions Corp.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11090-102-04</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (11090-102-04) </PackageDescription>
<NDC11Code>11090-0102-04</NDC11Code>
<ProductNDC>11090-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Beauty Manufacturing Solutions Corp.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11788-102-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (11788-102-30) </PackageDescription>
<NDC11Code>11788-0102-30</NDC11Code>
<ProductNDC>11788-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090544</ApplicationNumber>
<LabelerName>AiPing Pharmaceutical, Inc.</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan Potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 1H-Imidazole-5-methanol,2-butyl-4-chloro-1-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-, monopotassium salt. Its empirical formula is C22H22CIKN6O, and its structural formula is. Losartan potassium, USP is a white to almost white crystalline powder with a molecular weight of 461.00. It is freely soluble in water and in methanol, slightly soluble in acetonitrile. Losartan Potassium Tablets, USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. The tablets are coated with Opadry Green which contains D&C Yellow #10 Aluminum Lake, FD&C Blue #2, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>13310-102-07</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (13310-102-07)</PackageDescription>
<NDC11Code>13310-0102-07</NDC11Code>
<ProductNDC>13310-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fibricor</ProprietaryName>
<NonProprietaryName>Fenofibric Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090814</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022418</ApplicationNumber>
<LabelerName>AR Scientific, Inc.</LabelerName>
<SubstanceName>FENOFIBRIC ACID</SubstanceName>
<StrengthNumber>105</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FIBRICOR is a peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet: 1 to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (≥ 500 mg/dL) (1.1)., 2 to reduce elevated total cholesterol (TC), low-density-lipoprotein cholesterol (LDL-C), TG and apolipoprotein (Apo) B and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.2).</IndicationAndUsage>
<Description>FIBRICOR is a lipid regulating agent available as tablets for oral administration. Each tablet contains 35 mg or 105 mg of fenofibric acid. The chemical name for fenofibric acid is 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid with the following structural formula. Fenofibric acid is a white to almost white crystalline powder that is stable under ordinary conditions, and has a melting point of 179 – 183°C. Its empirical formula is C17H15ClO4 and molecular weight 318.75. Fenofibric acid is insoluble in water; its solubility increases with pH in buffered media. Inactive Ingredients: Each tablet contains copovidone, crospovidone, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>13668-102-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (13668-102-30) </PackageDescription>
<NDC11Code>13668-0102-30</NDC11Code>
<ProductNDC>13668-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090686</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Donepezil hydrochloride tablets are an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease.</IndicationAndUsage>
<Description>Donepezil hydrochloride USP is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride, USP is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 5 or 10 mg of donepezil hydrochloride, USP. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, magnesium stearate, maize starch ( Zea mays) and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Additionally, the 10 mg tablet contains ferric oxide red and ferric oxide yellow as coloring agents.</Description>
</NDC>
<NDC>
<NDCCode>15572-102-00</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (15572-102-00) > 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>15572-0102-00</NDC11Code>
<ProductNDC>15572-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Burberry Fresh Glow B.b. Luminous Skin Perfecting Beauty Balm Sunscreen Broad Spectrum Spf 20 Medium 02</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141113</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Intercos Europe S.p.A.</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>60; 20</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16590-102-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (16590-102-30)</PackageDescription>
<NDC11Code>16590-0102-30</NDC11Code>
<ProductNDC>16590-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075350</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Postherpetic Neuralgia. Gabapentin is indicated for the management of postherpetic neuralgia in adults. Epilepsy. Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years.</IndicationAndUsage>
<Description>Gabapentin capsules, USP are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin. The inactive ingredients are: black iron oxide, corn starch, D&C Yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, gelatin, mannitol, pharmaceutical glaze, propylene glycol, red iron oxide T3469, silicon dioxide, sodium lauryl sulfate, synthetic black iron oxide, talc, titanium dioxide, and yellow iron oxide T3506. Gabapentin, USP is described as 1-(aminomethyl)cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25.</Description>
</NDC>
<NDC>
<NDCCode>16714-102-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16714-102-01) </PackageDescription>
<NDC11Code>16714-0102-01</NDC11Code>
<ProductNDC>16714-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202261</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-04-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>17772-102-03</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-102-03) </PackageDescription>
<NDC11Code>17772-0102-03</NDC11Code>
<ProductNDC>17772-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trokendi Xr</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130816</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201635</ApplicationNumber>
<LabelerName>Supernus Pharmaceuticals</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-03-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130816</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
</NDCList>