{
"NDC": [
{
"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": "30698-202-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (30698-202-01) ",
"NDC11Code": "30698-0202-01",
"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": "30698-006-01",
"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": "30698-102-30",
"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": "30698-143-23",
"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": "30698-460-03",
"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": "11410-202-10",
"PackageDescription": "30 mL in 1 BOTTLE (11410-202-10)",
"NDC11Code": "11410-0202-10",
"ProductNDC": "11410-202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv",
"ProprietaryNameSuffix": "Gentle Formula Clarifying Day",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20031201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Guthy-Renker LLC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "2",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "13537-202-10",
"PackageDescription": "1 BOTTLE in 1 BOX (13537-202-10) > 30 mL in 1 BOTTLE (13537-202-09)",
"NDC11Code": "13537-0202-10",
"ProductNDC": "13537-202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Filling Effect Foundation Spf 10",
"ProprietaryNameSuffix": "(claire 3) - Beige",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131216",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".07",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "13668-202-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-30) ",
"NDC11Code": "13668-0202-30",
"ProductNDC": "13668-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Darifenacin",
"NonProprietaryName": "Darifenacin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20161118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205209",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "DARIFENACIN HYDROBROMIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161118",
"SamplePackage": "N",
"IndicationAndUsage": "Darifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.",
"Description": "Darifenacin extended-release tablet is an extended-release tablet for oral administration which contains 7.5 mg or 15 mg darifenacin as its hydrobromide salt. The active moiety, darifenacin, is a potent muscarinic receptor antagonist. Chemically, darifenacin hydrobromide is (S)-2-{1-[2-(2,3-dihydrobenzofuran-5-yl)ethyl]-3-pyrrolidinyl}-2,2-diphenylacetamide hydrobromide. The empirical formula of darifenacin hydrobromide is C 28H 30N 2O 2HBr. The structural formula is. Darifenacin hydrobromide is a white to almost white to off-white powder, with a molecular weight of 507.5. Darifenacin extended-release tablet is a once-a-day extended-release tablet and contains the following inactive ingredients: colloidal silicon dioxide, hypromellose (E15 LV), hypromellose (methocel K4M CR), magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, talc and titanium dioxide. The 15 mg tablet also contains ferric oxide red and ferric oxide yellow."
},
{
"NDCCode": "14783-202-10",
"PackageDescription": "1 BOTTLE in 1 BOX (14783-202-10) > 30 mL in 1 BOTTLE (14783-202-09)",
"NDC11Code": "14783-0202-10",
"ProductNDC": "14783-202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Filling Effect Foundation Spf 10",
"ProprietaryNameSuffix": "(claire 3) - Beige",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131216",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".07",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "25208-202-13",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (25208-202-13) ",
"NDC11Code": "25208-0202-13",
"ProductNDC": "25208-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zypitamag",
"NonProprietaryName": "Pitavastatin Magnesium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180309",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208379",
"LabelerName": "Medicure International Inc",
"SubstanceName": "PITAVASTATIN",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180309",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "ZYPITAMAG is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Pediatric use information is approved for Kowa Co Ltd LIVALO (pitavastatin) tablets. However, due to Kowa Co Ltd marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "ZYPITAMAG (pitavastatin) tablets for oral use is an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (3R,5S)-7-[2-Cyclopropyl-4-(4-fluorophenyl) quinoline-3-yl]3,5-dihydroxy-6(E)-heptanoic acid hemi magnesium. The structural formula is. The molecular formula for pitavastatin is C50H46MgF2N2O8 and the molecular weight is 865.21. Pitavastatin is a white to off-white powder. It is freely soluble in acetone, ethyl acetate; soluble in dimethylsulfoxide and insoluble in dichloromethane and isopropyl alcohol. Pitavastatin is hygroscopic and slightly unstable in light. Each film-coated tablet of ZYPITAMAG contains 2.053 mg or 4.106 mg of pitavastatin magnesium, which is equivalent to 2 mg or 4 mg, respectively of free base and the following inactive ingredients: calcium carbonate, crospovidone, hypromellose, lactose monohydrate, magnesium stearate and sodium carbonate anhydrous and film-coating containing the following inactive ingredients: hypromellose, polyethylene glycol, talc and titanium dioxide."
},
{
"NDCCode": "30142-202-30",
"PackageDescription": "3 BOTTLE in 1 CARTON (30142-202-30) > 60 mL in 1 BOTTLE",
"NDC11Code": "30142-0202-30",
"ProductNDC": "30142-202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hair Regrowth Treatment",
"ProprietaryNameSuffix": "For Women",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110205",
"EndMarketingDate": "20191201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075357",
"LabelerName": "Kroger Company",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140710",
"EndMarketingDatePackage": "20191201",
"SamplePackage": "N"
},
{
"NDCCode": "33261-202-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (33261-202-30)",
"NDC11Code": "33261-0202-30",
"ProductNDC": "33261-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranitidine",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077824",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Ranitidine Tablets, USP is indicated in: 1 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.",
"Description": "The active ingredient in Ranitidine Tablets, USP 150 mg and Ranitidine Tablets, USP 300 mg is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure. The empirical formula is C13H22N4O3S·HCl, representing a molecular weight of 350.87. Ranitidine HCl is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfurlike odor. Each Ranitidine Tablets, USP 150 mg for oral administration contains 167.4 mg of ranitidine HCl equivalent to 150 mg of ranitidine. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide, triethyl citrate and FD&C Yellow #6. Each Ranitidine Tablets, USP 300 mg for oral administration contains 334.8 mg of ranitidine HCl equivalent to 300 mg of ranitidine. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide, triethyl citrate and D&C Yellow #10."
},
{
"NDCCode": "37808-202-30",
"PackageDescription": "3 BOTTLE in 1 CARTON (37808-202-30) > 60 mL in 1 BOTTLE",
"NDC11Code": "37808-0202-30",
"ProductNDC": "37808-202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Minoxidil",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075357",
"LabelerName": "H E B",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20110404",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the scalp."
},
{
"NDCCode": "41250-202-30",
"PackageDescription": "3 BOTTLE in 1 CARTON (41250-202-30) > 60 mL in 1 BOTTLE",
"NDC11Code": "41250-0202-30",
"ProductNDC": "41250-202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hair Regrowth Treatment",
"ProprietaryNameSuffix": "For Women",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075357",
"LabelerName": "Meijer Distribution Inc",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20110407",
"SamplePackage": "N"
},
{
"NDCCode": "42002-202-01",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (42002-202-01) > 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "42002-0202-01",
"ProductNDC": "42002-202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Visine Advanced Relief",
"NonProprietaryName": "Dextran 70, Polyethylene Glycol 400, Povidone, And Tetrahydrozoline Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20110515",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONES; TETRAHYDROZOLINE HYDROCHLORIDE",
"StrengthNumber": "1; 10; 10; .5",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "42002-202-02",
"PackageDescription": "2 CARTON in 1 PACKAGE, COMBINATION (42002-202-02) > 1 BOTTLE, DROPPER in 1 CARTON > 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "42002-0202-02",
"ProductNDC": "42002-202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Visine Advanced Relief",
"NonProprietaryName": "Dextran 70, Polyethylene Glycol 400, Povidone, And Tetrahydrozoline Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20110515",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONES; TETRAHYDROZOLINE HYDROCHLORIDE",
"StrengthNumber": "1; 10; 10; .5",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "42002-202-03",
"PackageDescription": "1 BOTTLE, DROPPER in 1 PACKAGE (42002-202-03) > 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "42002-0202-03",
"ProductNDC": "42002-202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Visine Advanced Relief",
"NonProprietaryName": "Dextran 70, Polyethylene Glycol 400, Povidone, And Tetrahydrozoline Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20110515",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONES; TETRAHYDROZOLINE HYDROCHLORIDE",
"StrengthNumber": "1; 10; 10; .5",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "42211-202-23",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (42211-202-23) ",
"NDC11Code": "42211-0202-23",
"ProductNDC": "42211-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tivorbex",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150706",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204768",
"LabelerName": "Iroko Pharmaceuticals, LLC",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150706",
"SamplePackage": "N",
"IndicationAndUsage": "TIVORBEX is indicated for treatment of mild to moderate acute pain in adults.",
"Description": "TIVORBEX (indomethacin) capsule is a nonsteroidal anti-inflammatory drug, available as hard gelatin capsules of 20 mg and 40 mg for oral administration. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure. Indomethacin is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. Indomethacin has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in TIVORBEX include: lactose monohydrate, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium and sodium stearyl fumarate. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #1, FD&C blue #2 and FD&C red #40. The imprinting on the gelatin capsules is white edible ink. The 20 mg capsules have a dark blue body imprinted with IP-201 and light blue cap imprinted with 20 mg in white ink. The 40 mg capsules have a dark blue body imprinted with IP-202 and blue cap imprinted with 40 mg in white ink."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<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>30698-202-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (30698-202-01) </PackageDescription>
<NDC11Code>30698-0202-01</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>30698-006-01</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>30698-102-30</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>30698-143-23</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>30698-460-03</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>11410-202-10</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (11410-202-10)</PackageDescription>
<NDC11Code>11410-0202-10</NDC11Code>
<ProductNDC>11410-202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Proactiv</ProprietaryName>
<ProprietaryNameSuffix>Gentle Formula Clarifying Day</ProprietaryNameSuffix>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20031201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Guthy-Renker LLC</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13537-202-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (13537-202-10) > 30 mL in 1 BOTTLE (13537-202-09)</PackageDescription>
<NDC11Code>13537-0202-10</NDC11Code>
<ProductNDC>13537-202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Filling Effect Foundation Spf 10</ProprietaryName>
<ProprietaryNameSuffix>(claire 3) - Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131216</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>.07</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13668-202-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-30) </PackageDescription>
<NDC11Code>13668-0202-30</NDC11Code>
<ProductNDC>13668-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Darifenacin</ProprietaryName>
<NonProprietaryName>Darifenacin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205209</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>DARIFENACIN HYDROBROMIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Darifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.</IndicationAndUsage>
<Description>Darifenacin extended-release tablet is an extended-release tablet for oral administration which contains 7.5 mg or 15 mg darifenacin as its hydrobromide salt. The active moiety, darifenacin, is a potent muscarinic receptor antagonist. Chemically, darifenacin hydrobromide is (S)-2-{1-[2-(2,3-dihydrobenzofuran-5-yl)ethyl]-3-pyrrolidinyl}-2,2-diphenylacetamide hydrobromide. The empirical formula of darifenacin hydrobromide is C 28H 30N 2O 2HBr. The structural formula is. Darifenacin hydrobromide is a white to almost white to off-white powder, with a molecular weight of 507.5. Darifenacin extended-release tablet is a once-a-day extended-release tablet and contains the following inactive ingredients: colloidal silicon dioxide, hypromellose (E15 LV), hypromellose (methocel K4M CR), magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, talc and titanium dioxide. The 15 mg tablet also contains ferric oxide red and ferric oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>14783-202-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (14783-202-10) > 30 mL in 1 BOTTLE (14783-202-09)</PackageDescription>
<NDC11Code>14783-0202-10</NDC11Code>
<ProductNDC>14783-202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Filling Effect Foundation Spf 10</ProprietaryName>
<ProprietaryNameSuffix>(claire 3) - Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131216</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>.07</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>25208-202-13</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (25208-202-13) </PackageDescription>
<NDC11Code>25208-0202-13</NDC11Code>
<ProductNDC>25208-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zypitamag</ProprietaryName>
<NonProprietaryName>Pitavastatin Magnesium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180309</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208379</ApplicationNumber>
<LabelerName>Medicure International Inc</LabelerName>
<SubstanceName>PITAVASTATIN</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180309</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZYPITAMAG is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Pediatric use information is approved for Kowa Co Ltd LIVALO (pitavastatin) tablets. However, due to Kowa Co Ltd marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>ZYPITAMAG (pitavastatin) tablets for oral use is an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (3R,5S)-7-[2-Cyclopropyl-4-(4-fluorophenyl) quinoline-3-yl]3,5-dihydroxy-6(E)-heptanoic acid hemi magnesium. The structural formula is. The molecular formula for pitavastatin is C50H46MgF2N2O8 and the molecular weight is 865.21. Pitavastatin is a white to off-white powder. It is freely soluble in acetone, ethyl acetate; soluble in dimethylsulfoxide and insoluble in dichloromethane and isopropyl alcohol. Pitavastatin is hygroscopic and slightly unstable in light. Each film-coated tablet of ZYPITAMAG contains 2.053 mg or 4.106 mg of pitavastatin magnesium, which is equivalent to 2 mg or 4 mg, respectively of free base and the following inactive ingredients: calcium carbonate, crospovidone, hypromellose, lactose monohydrate, magnesium stearate and sodium carbonate anhydrous and film-coating containing the following inactive ingredients: hypromellose, polyethylene glycol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>30142-202-30</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (30142-202-30) > 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>30142-0202-30</NDC11Code>
<ProductNDC>30142-202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hair Regrowth Treatment</ProprietaryName>
<ProprietaryNameSuffix>For Women</ProprietaryNameSuffix>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110205</StartMarketingDate>
<EndMarketingDate>20191201</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075357</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140710</StartMarketingDatePackage>
<EndMarketingDatePackage>20191201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>33261-202-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (33261-202-30)</PackageDescription>
<NDC11Code>33261-0202-30</NDC11Code>
<ProductNDC>33261-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranitidine</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077824</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ranitidine Tablets, USP is indicated in: 1 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.</IndicationAndUsage>
<Description>The active ingredient in Ranitidine Tablets, USP 150 mg and Ranitidine Tablets, USP 300 mg is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure. The empirical formula is C13H22N4O3S·HCl, representing a molecular weight of 350.87. Ranitidine HCl is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfurlike odor. Each Ranitidine Tablets, USP 150 mg for oral administration contains 167.4 mg of ranitidine HCl equivalent to 150 mg of ranitidine. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide, triethyl citrate and FD&C Yellow #6. Each Ranitidine Tablets, USP 300 mg for oral administration contains 334.8 mg of ranitidine HCl equivalent to 300 mg of ranitidine. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide, triethyl citrate and D&C Yellow #10.</Description>
</NDC>
<NDC>
<NDCCode>37808-202-30</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (37808-202-30) > 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>37808-0202-30</NDC11Code>
<ProductNDC>37808-202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Minoxidil</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110404</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075357</ApplicationNumber>
<LabelerName>H E B</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the scalp.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41250-202-30</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (41250-202-30) > 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>41250-0202-30</NDC11Code>
<ProductNDC>41250-202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hair Regrowth Treatment</ProprietaryName>
<ProprietaryNameSuffix>For Women</ProprietaryNameSuffix>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075357</ApplicationNumber>
<LabelerName>Meijer Distribution Inc</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42002-202-01</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (42002-202-01) > 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>42002-0202-01</NDC11Code>
<ProductNDC>42002-202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Visine Advanced Relief</ProprietaryName>
<NonProprietaryName>Dextran 70, Polyethylene Glycol 400, Povidone, And Tetrahydrozoline Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20110515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONES; TETRAHYDROZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1; 10; 10; .5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42002-202-02</NDCCode>
<PackageDescription>2 CARTON in 1 PACKAGE, COMBINATION (42002-202-02) > 1 BOTTLE, DROPPER in 1 CARTON > 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>42002-0202-02</NDC11Code>
<ProductNDC>42002-202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Visine Advanced Relief</ProprietaryName>
<NonProprietaryName>Dextran 70, Polyethylene Glycol 400, Povidone, And Tetrahydrozoline Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20110515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONES; TETRAHYDROZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1; 10; 10; .5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42002-202-03</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 PACKAGE (42002-202-03) > 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>42002-0202-03</NDC11Code>
<ProductNDC>42002-202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Visine Advanced Relief</ProprietaryName>
<NonProprietaryName>Dextran 70, Polyethylene Glycol 400, Povidone, And Tetrahydrozoline Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20110515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONES; TETRAHYDROZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1; 10; 10; .5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42211-202-23</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (42211-202-23) </PackageDescription>
<NDC11Code>42211-0202-23</NDC11Code>
<ProductNDC>42211-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tivorbex</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150706</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204768</ApplicationNumber>
<LabelerName>Iroko Pharmaceuticals, LLC</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TIVORBEX is indicated for treatment of mild to moderate acute pain in adults.</IndicationAndUsage>
<Description>TIVORBEX (indomethacin) capsule is a nonsteroidal anti-inflammatory drug, available as hard gelatin capsules of 20 mg and 40 mg for oral administration. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure. Indomethacin is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. Indomethacin has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in TIVORBEX include: lactose monohydrate, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium and sodium stearyl fumarate. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #1, FD&C blue #2 and FD&C red #40. The imprinting on the gelatin capsules is white edible ink. The 20 mg capsules have a dark blue body imprinted with IP-201 and light blue cap imprinted with 20 mg in white ink. The 40 mg capsules have a dark blue body imprinted with IP-202 and blue cap imprinted with 40 mg in white ink.</Description>
</NDC>
</NDCList>