{
"NDC": [
{
"NDCCode": "70069-880-08",
"PackageDescription": "8 CARTON in 1 KIT (70069-880-08) / 1 VIAL in 1 CARTON (70069-880-01) / 1 mL in 1 VIAL",
"NDC11Code": "70069-0880-08",
"ProductNDC": "70069-880",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dihydroergotamine Mesylate",
"NonProprietaryName": "Dihydroergotamine Mesylate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20260324",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215228",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "DIHYDROERGOTAMINE MESYLATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Ergotamine Derivative [EPC], Ergotamines [CS]",
"Status": "Active",
"LastUpdate": "2026-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260324",
"SamplePackage": "N",
"IndicationAndUsage": "Dihydroergotamine mesylate nasal spray is indicated for the acute treatment of migraine headaches with or without aura. Dihydroergotamine mesylate nasal spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.",
"Description": "Dihydroergotamine mesylate is ergotamine hydrogenated in the 9,10 position as the mesylate salt. Dihydroergotamine mesylate is known chemically as ergotaman-3', 6', 18-trione, 9,10-dihydro-12'-hydroxy-2'-methyl-5'-(phenylmethyl)-, (5'α)-, monomethane-sulfonate. Its molecular weight is 679.78 and its empirical formula is C33H37N5O5CH4O3S. The chemical structure is. Dihydroergotamine mesylate nasal spray is provided for intranasal administration as a clear, colorless to light yellow aqueous solution in an amber glass vial containing. Dihydroergotamine mesylate ……………………………………… 4 mg. caffeine, anhydrous………………………………………………… 10 mg. dextrose, anhydrous ……………………………………………….. 50 mg. carbon dioxide …………………………………………………….. qs. purified water ……………………………………………………… qs 1 mL. Each milliliter contains. Dihydroergotamine mesylate ……………………………………… 4 mg. (equivalent to 3.43 mg dihydroergotamine)."
},
{
"NDCCode": "70069-824-08",
"PackageDescription": "8 TABLET in 1 BOTTLE (70069-824-08) ",
"NDC11Code": "70069-0824-08",
"ProductNDC": "70069-824",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cabergoline",
"NonProprietaryName": "Cabergoline",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218109",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "CABERGOLINE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergolines [CS], Ergot Derivative [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241018",
"SamplePackage": "N",
"IndicationAndUsage": "Cabergoline tablets are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas.",
"Description": "Cabergoline Tablets, USP contain cabergoline, USP a dopamine receptor agonist. The chemical name for cabergoline is 1-[(6-allylergolin-8β-yl)-carbonyl]-1-[3-(dimethylamino)propyl]-3-ethylurea. Its empirical formula is C26H37N5O2, and its molecular weight is 451.62. The structural formula is as follows. Cabergoline, USP is a white powder soluble in ethyl alcohol, chloroform, and N, N-dimethylformamide (DMF); slightly soluble in 0.1N hydrochloric acid; very slightly soluble in n-hexane; and insoluble in water. Cabergoline Tablets, USP for oral administration, contain 0.5 mg of cabergoline, USP. Inactive ingredients consist of citric acid anhydrous, croscarmellose sodium, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "14783-880-08",
"PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (14783-880-08) > 7 mL in 1 TUBE, WITH APPLICATOR (14783-880-07)",
"NDC11Code": "14783-0880-08",
"ProductNDC": "14783-880",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel",
"ProprietaryNameSuffix": "Couleur Luxe Supreme Laque",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101205",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International, Limited",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".07; .03",
"StrengthUnit": "mL/mL; mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "36800-880-08",
"PackageDescription": "2 BOTTLE, PLASTIC in 1 CARTON (36800-880-08) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC",
"NDC11Code": "36800-0880-08",
"ProductNDC": "36800-880",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin 81mg",
"ProprietaryNameSuffix": "Adult Low Dose",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20161003",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "TopCare",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161003",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for this product."
},
{
"NDCCode": "98132-880-08",
"PackageDescription": "72 JAR in 1 CASE (98132-880-08) > 8 g in 1 JAR",
"NDC11Code": "98132-0880-08",
"ProductNDC": "98132-880",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medium Foundation Spf 15",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120116",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bare Escentuals Beauty Inc.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "25",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "70069-072-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (70069-072-01) > 10 mL in 1 VIAL, GLASS",
"NDC11Code": "70069-0072-01",
"ProductNDC": "70069-072",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naloxone Hydrochloride",
"NonProprietaryName": "Naloxone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20170803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207634",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "NALOXONE HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Opioid Antagonist [EPC],Opioid Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-08-29"
},
{
"NDCCode": "70069-311-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (70069-311-01) / 10 mL in 1 BOTTLE",
"NDC11Code": "70069-0311-01",
"ProductNDC": "70069-311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Polymyxin B Sulfate And Trimethoprim Sulfate",
"NonProprietaryName": "Polymyxin B Sulfate And Trimethoprim Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20240806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211572",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "POLYMYXIN B SULFATE; TRIMETHOPRIM",
"StrengthNumber": "10000; 1",
"StrengthUnit": "[iU]/mL; mg/mL",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Active",
"LastUpdate": "2024-08-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240806",
"SamplePackage": "N",
"IndicationAndUsage": "Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa.*. *Efficacy for this organism in this organ system was studied in fewer than 10 infections.",
"Description": "Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP is a sterile antimicrobial solution for topical ophthalmic use. It has pH of 4.0 to 6.2 and osmolality of 270 to 310 mOsm/kg. Chemical Names. Trimethoprim, 5-(3,4,5-Trimethoxybenzyl)pyrimidine-2,4-,diamine, is a white, odorless, crystalline powder with a molecular weight of 290.3 and the following structural formula. Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are. Contains: Actives: polymyxin B sulfate 10,000 units/mL; trimethoprim sulfate equivalent to trimethoprim 1 mg/mL. Preservative: benzalkonium chloride 0.04 mg/mL. Inactives: water for injection; sodium chloride; and sulfuric acid. May also contain sodium hydroxide to adjust the pH."
},
{
"NDCCode": "70069-821-01",
"PackageDescription": "1 BOTTLE in 1 BOTTLE (70069-821-01) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "70069-0821-01",
"ProductNDC": "70069-821",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prucalopride Succinate",
"NonProprietaryName": "Prucalopride Succinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250624",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219078",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "PRUCALOPRIDE SUCCINATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250624",
"SamplePackage": "N",
"IndicationAndUsage": "Prucalopride tablet is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.",
"Description": "Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydrobenzofuran-7-carboxamide succinate. The molecular formula is C18H26ClN3O3.C4H6O4 and the molecular weight is 485.96. The structural formula is. Prucalopride succinate is a white to almost white powder. It is highly soluble in acidic aqueous media and alkaline aqueous media up to a pH of approximately 9. Each 1-mg film-coated tablet of prucalopride contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 1-mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol 4000, titanium dioxide, and triacetin. Each 2-mg film-coated tablet of prucalopride contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 2-mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol 4000, titanium dioxide, triacetin, red iron oxide, yellow iron oxide, and FD&C Blue #2 aluminum lake."
},
{
"NDCCode": "70069-822-01",
"PackageDescription": "1 BOTTLE in 1 BOTTLE (70069-822-01) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "70069-0822-01",
"ProductNDC": "70069-822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prucalopride Succinate",
"NonProprietaryName": "Prucalopride Succinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250624",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219078",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "PRUCALOPRIDE SUCCINATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250624",
"SamplePackage": "N",
"IndicationAndUsage": "Prucalopride tablet is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.",
"Description": "Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydrobenzofuran-7-carboxamide succinate. The molecular formula is C18H26ClN3O3.C4H6O4 and the molecular weight is 485.96. The structural formula is. Prucalopride succinate is a white to almost white powder. It is highly soluble in acidic aqueous media and alkaline aqueous media up to a pH of approximately 9. Each 1-mg film-coated tablet of prucalopride contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 1-mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol 4000, titanium dioxide, and triacetin. Each 2-mg film-coated tablet of prucalopride contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 2-mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol 4000, titanium dioxide, triacetin, red iron oxide, yellow iron oxide, and FD&C Blue #2 aluminum lake."
},
{
"NDCCode": "70069-825-10",
"PackageDescription": "10 SYRINGE in 1 CARTON (70069-825-10) / 1 mL in 1 SYRINGE (70069-825-01) ",
"NDC11Code": "70069-0825-10",
"ProductNDC": "70069-825",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carboprost Tromethamine",
"NonProprietaryName": "Carboprost Tromethamine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20260605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219529",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "CARBOPROST TROMETHAMINE",
"StrengthNumber": "250",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Prostaglandin Analog [EPC], Prostaglandins [CS]",
"Status": "Active",
"LastUpdate": "2026-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260605",
"SamplePackage": "N",
"IndicationAndUsage": "Carboprost tromethamine injection sterile solution is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion. 1. Failure of expulsion of the fetus during the course of treatment by another method;. 2. Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity;. 3. Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus;. 4. Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion. Carboprost tromethamine injection is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. Prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage and, unless contraindicated, intramuscular ergot preparations. Studies have shown that in such cases, the use of carboprost tromethamine injection has resulted in satisfactory control of hemorrhage, although it is unclear whether or not ongoing or delayed effects of previously administered ecbolic agents have contributed to the outcome. In a high proportion of cases, carboprost tromethamine injection used in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention.",
"Description": "Carboprost tromethamine injection, USP sterile solution, an oxytocic, contains the tromethamine salt of the (15S)- 15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection. Carboprost tromethamine is the established name for the active ingredient in carboprost tromethamine injection, USP. Four other chemical names are. 1. (15S)-15-methyl prostaglandin F2α tromethamine salt. 2. 7-(3α,5α-dihydroxy-2ß-[(3S)-3-hydroxy-3-methyl-trans-1-octenyl]-1α-cyclopentyl]-cis-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol. 3. (15S)-9α,11α,15-trihydroxy-15-methylprosta-cis-5, trans-13-dienoic acid tromethamine salt. 4. (15S)-15-methyl PGF2α-THAM The structural formula is represented below. The molecular formula is C25H47O8N. The molecular weight of carboprost tromethamine, USP is 489.64. It is a white to slightly off-white crystalline powder. It generally melts between 95° and 105° C, depending on the rate of heating. Carboprost tromethamine, USP dissolves readily in water at room temperature at a concentration greater than 75 mg/mL. Each mL of carboprost tromethamine injection, USP sterile solution contains carboprost tromethamine, USP equivalent to 250 mcg of carboprost, and also contains tromethamine 83 mcg, sodium chloride 9 mg, and benzyl alcohol 9.45 mg added as preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. The solution is sterile."
},
{
"NDCCode": "70069-841-01",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (70069-841-01) ",
"NDC11Code": "70069-0841-01",
"ProductNDC": "70069-841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tofacitinib",
"NonProprietaryName": "Tofacitinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220137",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "TOFACITINIB CITRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260603",
"SamplePackage": "N",
"IndicationAndUsage": "Tofacitinib tablets are Janus kinase (JAK) inhibitors. Tofacitinib tablets are indicated for the treatment of adult patients with: 1 Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers., 2 Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers., 3 Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers., 4 Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers.",
"Description": "Tofacitinib tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1- piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The solubility of tofacitinib citrate in water is 2.9 mg/mL. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H8O7. The chemical structure of tofacitinib citrate is. Tofacitinib tablets are supplied for oral administration as a: 1 5 mg white round, biconvex, debossed with \"T5\" on one side and no debossing on the other side, immediate-release film-coated tablet. Each tofacitinib tablet contains 5 mg of tofacitinib (equivalent to 8.08 mg of tofacitinib citrate) and the following inactive ingredients: croscarmellose sodium, hypromellose 2910, lactose monohydrate, macrogol/PEG400, magnesium stearate, microcrystalline cellulose, and titanium dioxide., 2 10 mg blue round, biconvex, debossed with \"T10\" on one side and no debossing on the other side, immediate-release film-coated tablet. Each tofacitinib tablet contains 10 mg of tofacitinib (equivalent to 16.16 mg of tofacitinib citrate) and the following inactive ingredients: croscarmellose sodium, FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 2910, lactose monohydrate, macrogol/PEG4000, magnesium stearate, microcrystalline cellulose, and titanium dioxide."
},
{
"NDCCode": "70069-842-01",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (70069-842-01) ",
"NDC11Code": "70069-0842-01",
"ProductNDC": "70069-842",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tofacitinib",
"NonProprietaryName": "Tofacitinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220137",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "TOFACITINIB CITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260603",
"SamplePackage": "N",
"IndicationAndUsage": "Tofacitinib tablets are Janus kinase (JAK) inhibitors. Tofacitinib tablets are indicated for the treatment of adult patients with: 1 Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers., 2 Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers., 3 Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers., 4 Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers.",
"Description": "Tofacitinib tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1- piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The solubility of tofacitinib citrate in water is 2.9 mg/mL. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H8O7. The chemical structure of tofacitinib citrate is. Tofacitinib tablets are supplied for oral administration as a: 1 5 mg white round, biconvex, debossed with \"T5\" on one side and no debossing on the other side, immediate-release film-coated tablet. Each tofacitinib tablet contains 5 mg of tofacitinib (equivalent to 8.08 mg of tofacitinib citrate) and the following inactive ingredients: croscarmellose sodium, hypromellose 2910, lactose monohydrate, macrogol/PEG400, magnesium stearate, microcrystalline cellulose, and titanium dioxide., 2 10 mg blue round, biconvex, debossed with \"T10\" on one side and no debossing on the other side, immediate-release film-coated tablet. Each tofacitinib tablet contains 10 mg of tofacitinib (equivalent to 16.16 mg of tofacitinib citrate) and the following inactive ingredients: croscarmellose sodium, FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 2910, lactose monohydrate, macrogol/PEG4000, magnesium stearate, microcrystalline cellulose, and titanium dioxide."
},
{
"NDCCode": "70069-857-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (70069-857-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS",
"NDC11Code": "70069-0857-01",
"ProductNDC": "70069-857",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azacitidine",
"NonProprietaryName": "Azacitidine",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20250829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217453",
"LabelerName": "Somerset Therapeutics LLC",
"SubstanceName": "AZACITIDINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250829",
"SamplePackage": "N",
"IndicationAndUsage": "Azacitidine for injection (Azacitidine), is a nucleoside metabolic inhibitor indicated for the treatment of. Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). (1.1).",
"Description": "Azacitidine for injection contains azacitidine, which is a nucleoside metabolic inhibitor. Azacitidine is 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1H)-one. The structural formula is as follows. The empirical formula is C 8H 12N 4O 5. The molecular weight is 244. Azacitidine is a white to off white solid. Azacitidine was found to be insoluble in acetone, ethanol, and methyl ethyl ketone; slightly soluble in ethanol/water (50/50), propylene glycol, and polyethylene glycol; sparingly soluble in water, water saturated octanol, 5% dextrose in water, N-methyl-2-pyrrolidone, normal saline and 5% Tween 80 in water; and soluble in dimethylsulfoxide (DMSO). The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Vials of azacitidine for injection contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder."
},
{
"NDCCode": "70069-860-18",
"PackageDescription": "180 TABLET, DELAYED RELEASE in 1 BOTTLE (70069-860-18) ",
"NDC11Code": "70069-0860-18",
"ProductNDC": "70069-860",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acamprosate Calcium",
"NonProprietaryName": "Acamprosate Calcium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218984",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "ACAMPROSATE CALCIUM",
"StrengthNumber": "333",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260810",
"SamplePackage": "N",
"IndicationAndUsage": "Acamprosate calcium is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with acamprosate calcium should be part of a comprehensive management program that includes psychosocial support. The efficacy of acamprosate calcium in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning acamprosate calcium treatment. The efficacy of acamprosate calcium in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.",
"Description": "Acamprosate calcium is supplied in an enteric-coated tablet for oral administration. Acamprosate calcium is a synthetic compound with a chemical structure similar to that of the endogenous amino acid homotaurine, which is a structural analogue of the amino acid neurotransmitter γ-aminobutyric acid and the amino acid neuromodulator taurine. Its chemical name calcium 3-( acetylamino) propane-1-sulfonate. Its chemical formula is C10H20N2O8S2Ca and molecular weight is 400.50. Its structural formula is. Acamprosate calcium is a white or almost white powder. It is freely soluble in water, practically insoluble in alcohol and Methylene Chloride. Each Acamprosate calcium delayed-release tablet contains acamprosate calcium 333 mg, equivalent to 300 mg of acamprosate. Inactive ingredients in Acamprosate calcium delayed-release tablet include: colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, povidone, sodium starch glycolate, talc and triethylcitrate. Sulfites were used in the synthesis of the drug substance and traces of residual sulfites may be present in the drug product."
},
{
"NDCCode": "70069-860-30",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (70069-860-30) ",
"NDC11Code": "70069-0860-30",
"ProductNDC": "70069-860",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acamprosate Calcium",
"NonProprietaryName": "Acamprosate Calcium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218984",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "ACAMPROSATE CALCIUM",
"StrengthNumber": "333",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260810",
"SamplePackage": "N",
"IndicationAndUsage": "Acamprosate calcium is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with acamprosate calcium should be part of a comprehensive management program that includes psychosocial support. The efficacy of acamprosate calcium in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning acamprosate calcium treatment. The efficacy of acamprosate calcium in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.",
"Description": "Acamprosate calcium is supplied in an enteric-coated tablet for oral administration. Acamprosate calcium is a synthetic compound with a chemical structure similar to that of the endogenous amino acid homotaurine, which is a structural analogue of the amino acid neurotransmitter γ-aminobutyric acid and the amino acid neuromodulator taurine. Its chemical name calcium 3-( acetylamino) propane-1-sulfonate. Its chemical formula is C10H20N2O8S2Ca and molecular weight is 400.50. Its structural formula is. Acamprosate calcium is a white or almost white powder. It is freely soluble in water, practically insoluble in alcohol and Methylene Chloride. Each Acamprosate calcium delayed-release tablet contains acamprosate calcium 333 mg, equivalent to 300 mg of acamprosate. Inactive ingredients in Acamprosate calcium delayed-release tablet include: colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, povidone, sodium starch glycolate, talc and triethylcitrate. Sulfites were used in the synthesis of the drug substance and traces of residual sulfites may be present in the drug product."
},
{
"NDCCode": "70069-892-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (70069-892-10) / 2 mL in 1 VIAL, SINGLE-DOSE (70069-892-01) ",
"NDC11Code": "70069-0892-10",
"ProductNDC": "70069-892",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sugammadex",
"NonProprietaryName": "Sugammadex",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215260",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "SUGAMMADEX SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "gamma-Cyclodextrins [CS]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260728",
"SamplePackage": "N",
"IndicationAndUsage": "Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Sugammadex Injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)- 6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is. Sugammadex Injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex Injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2- carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is."
},
{
"NDCCode": "70069-893-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (70069-893-10) / 5 mL in 1 VIAL, SINGLE-DOSE (70069-893-01) ",
"NDC11Code": "70069-0893-10",
"ProductNDC": "70069-893",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sugammadex",
"NonProprietaryName": "Sugammadex",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215260",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "SUGAMMADEX SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "gamma-Cyclodextrins [CS]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260728",
"SamplePackage": "N",
"IndicationAndUsage": "Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Sugammadex Injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)- 6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is. Sugammadex Injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex Injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2- carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is."
},
{
"NDCCode": "0378-5055-77",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5055-77) ",
"NDC11Code": "00378-5055-77",
"ProductNDC": "0378-5055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pitavastatin Calcium",
"NonProprietaryName": "Pitavastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206070",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PITAVASTATIN CALCIUM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231102",
"SamplePackage": "N",
"IndicationAndUsage": "Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: 1 Adults with primary hyperlipidemia., 2 Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). .",
"Description": "Pitavastatin tablets for oral use are an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (+)Monocalcium bis [(3R,5S,6E)-7-[2-cyclopropyl- 4-(4- fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate]. The structural formula is. The molecular formula for pitavastatin is (C25H23FNO4)2.Ca and the molecular weight is 880.98. Pitavastatin is odorless and occurs as off-white to pale yellow color powder. It is freely soluble in pyridine, chloroform, dilute hydrochloric acid, and tetrahydrofuran, soluble in ethylene glycol, sparingly soluble in octanol, slightly soluble in methanol, very slightly soluble in water or ethanol, and practically insoluble in acetonitrile or diethyl ether. Pitavastatin is hygroscopic and slightly unstable in light. Each film-coated tablet of pitavastatin contains 1 mg, 2 mg, or 4 mg of pitavastatin, which is equivalent to 1.045 mg, 2.090 mg, or 4.180 mg, respectively, of pitavastatin calcium and the following inactive ingredients: hypromellose, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium oxide, magnesium stearate, polyethylene glycol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "0378-5056-77",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5056-77) ",
"NDC11Code": "00378-5056-77",
"ProductNDC": "0378-5056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pitavastatin Calcium",
"NonProprietaryName": "Pitavastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206070",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PITAVASTATIN CALCIUM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231102",
"SamplePackage": "N",
"IndicationAndUsage": "Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: 1 Adults with primary hyperlipidemia., 2 Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). .",
"Description": "Pitavastatin tablets for oral use are an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (+)Monocalcium bis [(3R,5S,6E)-7-[2-cyclopropyl- 4-(4- fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate]. The structural formula is. The molecular formula for pitavastatin is (C25H23FNO4)2.Ca and the molecular weight is 880.98. Pitavastatin is odorless and occurs as off-white to pale yellow color powder. It is freely soluble in pyridine, chloroform, dilute hydrochloric acid, and tetrahydrofuran, soluble in ethylene glycol, sparingly soluble in octanol, slightly soluble in methanol, very slightly soluble in water or ethanol, and practically insoluble in acetonitrile or diethyl ether. Pitavastatin is hygroscopic and slightly unstable in light. Each film-coated tablet of pitavastatin contains 1 mg, 2 mg, or 4 mg of pitavastatin, which is equivalent to 1.045 mg, 2.090 mg, or 4.180 mg, respectively, of pitavastatin calcium and the following inactive ingredients: hypromellose, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium oxide, magnesium stearate, polyethylene glycol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "0378-5057-77",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5057-77) ",
"NDC11Code": "00378-5057-77",
"ProductNDC": "0378-5057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pitavastatin Calcium",
"NonProprietaryName": "Pitavastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206070",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PITAVASTATIN CALCIUM",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231102",
"SamplePackage": "N",
"IndicationAndUsage": "Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: 1 Adults with primary hyperlipidemia., 2 Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). .",
"Description": "Pitavastatin tablets for oral use are an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (+)Monocalcium bis [(3R,5S,6E)-7-[2-cyclopropyl- 4-(4- fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate]. The structural formula is. The molecular formula for pitavastatin is (C25H23FNO4)2.Ca and the molecular weight is 880.98. Pitavastatin is odorless and occurs as off-white to pale yellow color powder. It is freely soluble in pyridine, chloroform, dilute hydrochloric acid, and tetrahydrofuran, soluble in ethylene glycol, sparingly soluble in octanol, slightly soluble in methanol, very slightly soluble in water or ethanol, and practically insoluble in acetonitrile or diethyl ether. Pitavastatin is hygroscopic and slightly unstable in light. Each film-coated tablet of pitavastatin contains 1 mg, 2 mg, or 4 mg of pitavastatin, which is equivalent to 1.045 mg, 2.090 mg, or 4.180 mg, respectively, of pitavastatin calcium and the following inactive ingredients: hypromellose, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium oxide, magnesium stearate, polyethylene glycol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "49884-880-86",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (49884-880-86)",
"NDC11Code": "49884-0880-86",
"ProductNDC": "49884-880",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20130602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204158",
"LabelerName": "Par Pharmaceutical Companies, Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "25",
"StrengthUnit": "1/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-01-08"
},
{
"NDCCode": "51407-880-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (51407-880-01) ",
"NDC11Code": "51407-0880-01",
"ProductNDC": "51407-880",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methenamine Hippurate",
"NonProprietaryName": "Methenamine Hippurate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210068",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "METHENAMINE HIPPURATE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Status": "Active",
"LastUpdate": "2024-03-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240130",
"SamplePackage": "N",
"IndicationAndUsage": "Methenamine hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. This drug should only be used after eradication of the infection by other appropriate antimicrobial agents. To reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine hippurate and other antibacterial drugs, methenamine hippurate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Methenamine Hippurate Tablets, USP is a urinary tract antiseptic drug. Each peach color, capsule-shaped bi-convex tablet contains 1 g methenamine hippurate which is the hippuric acid salt of methenamine (hexamethylene tetramine). The tablet also contains inactive ingredients: FD&C Yellow No. 6, Magnesium Stearate, Colloidal Silicon Dioxide, Povidone, and Saccharin Sodium. Structural Formula."
},
{
"NDCCode": "55513-880-02",
"PackageDescription": "2 SYRINGE in 1 CARTON (55513-880-02) / 1.17 mL in 1 SYRINGE (55513-880-01) ",
"NDC11Code": "55513-0880-02",
"ProductNDC": "55513-880",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Evenity",
"NonProprietaryName": "Romosozumab-aqqg",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20190409",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761062",
"LabelerName": "Amgen, Inc",
"SubstanceName": "ROMOSOZUMAB",
"StrengthNumber": "105",
"StrengthUnit": "mg/1.17mL",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190409",
"SamplePackage": "N",
"IndicationAndUsage": "EVENITY is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. (1). Limitations of Use: Limit duration of use to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered. (1.2).",
"Description": "Romosozumab-aqqg is a humanized monoclonal antibody (IgG2) produced in a mammalian cell line (Chinese Hamster Ovary) by recombinant DNA technology that binds to and inhibits sclerostin. Romosozumab-aqqg has an approximate molecular weight of 149 kDa. EVENITY (romosozumab-aqqg) injection is supplied as a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection in a single-use prefilled syringe. Two 105 mg/1.17 mL single-use prefilled syringes are required to administer the recommended 210 mg dose of EVENITY [see Dosage and Administration (2.1)]. Each single-use prefilled syringe delivers 1.17 mL of solution containing 105 mg of romosozumab-aqqg, acetate (3.8 mg), calcium (0.61 mg), polysorbate 20 (0.07 mg) and sucrose (70 mg) in Water for Injection, USP, and sodium hydroxide to a pH of 5.2."
},
{
"NDCCode": "55910-880-05",
"PackageDescription": "1 TUBE in 1 CARTON (55910-880-05) / 15 g in 1 TUBE",
"NDC11Code": "55910-0880-05",
"ProductNDC": "55910-880",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Adapalene",
"NonProprietaryName": "Adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191129",
"EndMarketingDate": "20261129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091314",
"LabelerName": "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)",
"SubstanceName": "ADAPALENE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191129",
"EndMarketingDatePackage": "20261129",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of acne."
},
{
"NDCCode": "59651-880-37",
"PackageDescription": "50 kg in 1 DRUM (59651-880-37) ",
"NDC11Code": "59651-0880-37",
"ProductNDC": "59651-880",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bempedoic Acid",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240108",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "BEMPEDOIC ACID",
"StrengthNumber": "50",
"StrengthUnit": "kg/50kg",
"Status": "Unfinished",
"LastUpdate": "2024-01-08",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "08-JAN-24"
},
{
"NDCCode": "59779-880-78",
"PackageDescription": "100 TABLET, CHEWABLE in 1 BOTTLE (59779-880-78) ",
"NDC11Code": "59779-0880-78",
"ProductNDC": "59779-880",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Health Extra Strength Heartburn Relief Antacid",
"ProprietaryNameSuffix": "Original Flavor",
"NonProprietaryName": "Aluminum Hydroxide And Magnesium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20150827",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "CVS Pharmacy,Inc.",
"SubstanceName": "ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE",
"StrengthNumber": "160; 105",
"StrengthUnit": "mg/1; mg/1",
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150827",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 acid indigestion, 2 heartburn, 3 sour stomach, 4 upset stomach associated with these symptoms."
},
{
"NDCCode": "60758-880-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (60758-880-05) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "60758-0880-05",
"ProductNDC": "60758-880",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluorometholone",
"NonProprietaryName": "Fluorometholone",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19971031",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA016851",
"LabelerName": "Pacific Pharma, Inc.",
"SubstanceName": "FLUOROMETHOLONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19971031",
"SamplePackage": "N",
"IndicationAndUsage": "Fluorometholone ophthalmic suspension 0.1% is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.",
"Description": "Fluorometholone ophthalmic suspension, USP 0.1% is a sterile topical anti-inflammatory agent for ophthalmic use. Chemical Name. Fluorometholone: 9-Fluoro-11β,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione. Contains. Active: fluorometholone 0.1%. Preservative: benzalkonium chloride 0.004%. Inactives: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; sodium phosphate, monobasic; and sodium hydroxide to adjust pH. Fluorometholone suspension is formulated with a pH from 6.2 to 7.5. It has an osmolality range of 290-350 mOsm/kg. Structural Formula. fluorometholone."
},
{
"NDCCode": "60758-880-10",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (60758-880-10) / 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "60758-0880-10",
"ProductNDC": "60758-880",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluorometholone",
"NonProprietaryName": "Fluorometholone",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19971031",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA016851",
"LabelerName": "Pacific Pharma, Inc.",
"SubstanceName": "FLUOROMETHOLONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19971031",
"SamplePackage": "N",
"IndicationAndUsage": "Fluorometholone ophthalmic suspension 0.1% is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.",
"Description": "Fluorometholone ophthalmic suspension, USP 0.1% is a sterile topical anti-inflammatory agent for ophthalmic use. Chemical Name. Fluorometholone: 9-Fluoro-11β,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione. Contains. Active: fluorometholone 0.1%. Preservative: benzalkonium chloride 0.004%. Inactives: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; sodium phosphate, monobasic; and sodium hydroxide to adjust pH. Fluorometholone suspension is formulated with a pH from 6.2 to 7.5. It has an osmolality range of 290-350 mOsm/kg. Structural Formula. fluorometholone."
},
{
"NDCCode": "60760-880-05",
"PackageDescription": "5 POUCH in 1 BAG (60760-880-05) / 1 g in 1 POUCH",
"NDC11Code": "60760-0880-05",
"ProductNDC": "60760-880",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "PATCH",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20200204",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020612",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200204",
"SamplePackage": "N",
"IndicationAndUsage": "LIDOCAINE PATCH 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "LIDOCAINE PATCH 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a non‑woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2‑(diethylamino)‑N‑(2,6‑ dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, D-sorbitol, tartaric acid, and urea."
},
{
"NDCCode": "65084-880-01",
"PackageDescription": "25 BLISTER PACK in 1 BOX (65084-880-01) > 30 TABLET in 1 BLISTER PACK",
"NDC11Code": "65084-0880-01",
"ProductNDC": "65084-880",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen 325mg",
"ProprietaryNameSuffix": "Rs",
"NonProprietaryName": "Acetaminophen 325mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160415",
"EndMarketingDate": "20210731",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "McKesson Corporation dba RX Pak",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190917",
"EndMarketingDatePackage": "20210731",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>70069-880-08</NDCCode>
<PackageDescription>8 CARTON in 1 KIT (70069-880-08) / 1 VIAL in 1 CARTON (70069-880-01) / 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>70069-0880-08</NDC11Code>
<ProductNDC>70069-880</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dihydroergotamine Mesylate</ProprietaryName>
<NonProprietaryName>Dihydroergotamine Mesylate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20260324</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215228</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>DIHYDROERGOTAMINE MESYLATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Ergotamine Derivative [EPC], Ergotamines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dihydroergotamine mesylate nasal spray is indicated for the acute treatment of migraine headaches with or without aura. Dihydroergotamine mesylate nasal spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.</IndicationAndUsage>
<Description>Dihydroergotamine mesylate is ergotamine hydrogenated in the 9,10 position as the mesylate salt. Dihydroergotamine mesylate is known chemically as ergotaman-3', 6', 18-trione, 9,10-dihydro-12'-hydroxy-2'-methyl-5'-(phenylmethyl)-, (5'α)-, monomethane-sulfonate. Its molecular weight is 679.78 and its empirical formula is C33H37N5O5CH4O3S. The chemical structure is. Dihydroergotamine mesylate nasal spray is provided for intranasal administration as a clear, colorless to light yellow aqueous solution in an amber glass vial containing. Dihydroergotamine mesylate ……………………………………… 4 mg. caffeine, anhydrous………………………………………………… 10 mg. dextrose, anhydrous ……………………………………………….. 50 mg. carbon dioxide …………………………………………………….. qs. purified water ……………………………………………………… qs 1 mL. Each milliliter contains. Dihydroergotamine mesylate ……………………………………… 4 mg. (equivalent to 3.43 mg dihydroergotamine).</Description>
</NDC>
<NDC>
<NDCCode>70069-824-08</NDCCode>
<PackageDescription>8 TABLET in 1 BOTTLE (70069-824-08) </PackageDescription>
<NDC11Code>70069-0824-08</NDC11Code>
<ProductNDC>70069-824</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cabergoline</ProprietaryName>
<NonProprietaryName>Cabergoline</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218109</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>CABERGOLINE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergolines [CS], Ergot Derivative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cabergoline tablets are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas.</IndicationAndUsage>
<Description>Cabergoline Tablets, USP contain cabergoline, USP a dopamine receptor agonist. The chemical name for cabergoline is 1-[(6-allylergolin-8β-yl)-carbonyl]-1-[3-(dimethylamino)propyl]-3-ethylurea. Its empirical formula is C26H37N5O2, and its molecular weight is 451.62. The structural formula is as follows. Cabergoline, USP is a white powder soluble in ethyl alcohol, chloroform, and N, N-dimethylformamide (DMF); slightly soluble in 0.1N hydrochloric acid; very slightly soluble in n-hexane; and insoluble in water. Cabergoline Tablets, USP for oral administration, contain 0.5 mg of cabergoline, USP. Inactive ingredients consist of citric acid anhydrous, croscarmellose sodium, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>14783-880-08</NDCCode>
<PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (14783-880-08) > 7 mL in 1 TUBE, WITH APPLICATOR (14783-880-07)</PackageDescription>
<NDC11Code>14783-0880-08</NDC11Code>
<ProductNDC>14783-880</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel</ProprietaryName>
<ProprietaryNameSuffix>Couleur Luxe Supreme Laque</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20101205</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International, Limited</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.07; .03</StrengthNumber>
<StrengthUnit>mL/mL; mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-880-08</NDCCode>
<PackageDescription>2 BOTTLE, PLASTIC in 1 CARTON (36800-880-08) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>36800-0880-08</NDC11Code>
<ProductNDC>36800-880</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin 81mg</ProprietaryName>
<ProprietaryNameSuffix>Adult Low Dose</ProprietaryNameSuffix>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161003</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>TopCare</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for this product.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>98132-880-08</NDCCode>
<PackageDescription>72 JAR in 1 CASE (98132-880-08) > 8 g in 1 JAR</PackageDescription>
<NDC11Code>98132-0880-08</NDC11Code>
<ProductNDC>98132-880</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medium Foundation Spf 15</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120116</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bare Escentuals Beauty Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70069-072-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (70069-072-01) > 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>70069-0072-01</NDC11Code>
<ProductNDC>70069-072</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naloxone Hydrochloride</ProprietaryName>
<NonProprietaryName>Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20170803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207634</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC],Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>70069-311-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70069-311-01) / 10 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>70069-0311-01</NDC11Code>
<ProductNDC>70069-311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Polymyxin B Sulfate And Trimethoprim Sulfate</ProprietaryName>
<NonProprietaryName>Polymyxin B Sulfate And Trimethoprim Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20240806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211572</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>POLYMYXIN B SULFATE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>10000; 1</StrengthNumber>
<StrengthUnit>[iU]/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa.*. *Efficacy for this organism in this organ system was studied in fewer than 10 infections.</IndicationAndUsage>
<Description>Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP is a sterile antimicrobial solution for topical ophthalmic use. It has pH of 4.0 to 6.2 and osmolality of 270 to 310 mOsm/kg. Chemical Names. Trimethoprim, 5-(3,4,5-Trimethoxybenzyl)pyrimidine-2,4-,diamine, is a white, odorless, crystalline powder with a molecular weight of 290.3 and the following structural formula. Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are. Contains: Actives: polymyxin B sulfate 10,000 units/mL; trimethoprim sulfate equivalent to trimethoprim 1 mg/mL. Preservative: benzalkonium chloride 0.04 mg/mL. Inactives: water for injection; sodium chloride; and sulfuric acid. May also contain sodium hydroxide to adjust the pH.</Description>
</NDC>
<NDC>
<NDCCode>70069-821-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOTTLE (70069-821-01) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>70069-0821-01</NDC11Code>
<ProductNDC>70069-821</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prucalopride Succinate</ProprietaryName>
<NonProprietaryName>Prucalopride Succinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250624</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219078</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>PRUCALOPRIDE SUCCINATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prucalopride tablet is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.</IndicationAndUsage>
<Description>Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydrobenzofuran-7-carboxamide succinate. The molecular formula is C18H26ClN3O3.C4H6O4 and the molecular weight is 485.96. The structural formula is. Prucalopride succinate is a white to almost white powder. It is highly soluble in acidic aqueous media and alkaline aqueous media up to a pH of approximately 9. Each 1-mg film-coated tablet of prucalopride contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 1-mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol 4000, titanium dioxide, and triacetin. Each 2-mg film-coated tablet of prucalopride contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 2-mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol 4000, titanium dioxide, triacetin, red iron oxide, yellow iron oxide, and FD&C Blue #2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>70069-822-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOTTLE (70069-822-01) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>70069-0822-01</NDC11Code>
<ProductNDC>70069-822</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prucalopride Succinate</ProprietaryName>
<NonProprietaryName>Prucalopride Succinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250624</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219078</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>PRUCALOPRIDE SUCCINATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prucalopride tablet is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.</IndicationAndUsage>
<Description>Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydrobenzofuran-7-carboxamide succinate. The molecular formula is C18H26ClN3O3.C4H6O4 and the molecular weight is 485.96. The structural formula is. Prucalopride succinate is a white to almost white powder. It is highly soluble in acidic aqueous media and alkaline aqueous media up to a pH of approximately 9. Each 1-mg film-coated tablet of prucalopride contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 1-mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol 4000, titanium dioxide, and triacetin. Each 2-mg film-coated tablet of prucalopride contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 2-mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol 4000, titanium dioxide, triacetin, red iron oxide, yellow iron oxide, and FD&C Blue #2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>70069-825-10</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (70069-825-10) / 1 mL in 1 SYRINGE (70069-825-01) </PackageDescription>
<NDC11Code>70069-0825-10</NDC11Code>
<ProductNDC>70069-825</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carboprost Tromethamine</ProprietaryName>
<NonProprietaryName>Carboprost Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20260605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219529</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>CARBOPROST TROMETHAMINE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carboprost tromethamine injection sterile solution is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion. 1. Failure of expulsion of the fetus during the course of treatment by another method;. 2. Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity;. 3. Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus;. 4. Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion. Carboprost tromethamine injection is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. Prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage and, unless contraindicated, intramuscular ergot preparations. Studies have shown that in such cases, the use of carboprost tromethamine injection has resulted in satisfactory control of hemorrhage, although it is unclear whether or not ongoing or delayed effects of previously administered ecbolic agents have contributed to the outcome. In a high proportion of cases, carboprost tromethamine injection used in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention.</IndicationAndUsage>
<Description>Carboprost tromethamine injection, USP sterile solution, an oxytocic, contains the tromethamine salt of the (15S)- 15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection. Carboprost tromethamine is the established name for the active ingredient in carboprost tromethamine injection, USP. Four other chemical names are. 1. (15S)-15-methyl prostaglandin F2α tromethamine salt. 2. 7-(3α,5α-dihydroxy-2ß-[(3S)-3-hydroxy-3-methyl-trans-1-octenyl]-1α-cyclopentyl]-cis-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol. 3. (15S)-9α,11α,15-trihydroxy-15-methylprosta-cis-5, trans-13-dienoic acid tromethamine salt. 4. (15S)-15-methyl PGF2α-THAM The structural formula is represented below. The molecular formula is C25H47O8N. The molecular weight of carboprost tromethamine, USP is 489.64. It is a white to slightly off-white crystalline powder. It generally melts between 95° and 105° C, depending on the rate of heating. Carboprost tromethamine, USP dissolves readily in water at room temperature at a concentration greater than 75 mg/mL. Each mL of carboprost tromethamine injection, USP sterile solution contains carboprost tromethamine, USP equivalent to 250 mcg of carboprost, and also contains tromethamine 83 mcg, sodium chloride 9 mg, and benzyl alcohol 9.45 mg added as preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. The solution is sterile.</Description>
</NDC>
<NDC>
<NDCCode>70069-841-01</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (70069-841-01) </PackageDescription>
<NDC11Code>70069-0841-01</NDC11Code>
<ProductNDC>70069-841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tofacitinib</ProprietaryName>
<NonProprietaryName>Tofacitinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220137</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>TOFACITINIB CITRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tofacitinib tablets are Janus kinase (JAK) inhibitors. Tofacitinib tablets are indicated for the treatment of adult patients with: 1 Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers., 2 Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers., 3 Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers., 4 Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers.</IndicationAndUsage>
<Description>Tofacitinib tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1- piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The solubility of tofacitinib citrate in water is 2.9 mg/mL. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H8O7. The chemical structure of tofacitinib citrate is. Tofacitinib tablets are supplied for oral administration as a: 1 5 mg white round, biconvex, debossed with "T5" on one side and no debossing on the other side, immediate-release film-coated tablet. Each tofacitinib tablet contains 5 mg of tofacitinib (equivalent to 8.08 mg of tofacitinib citrate) and the following inactive ingredients: croscarmellose sodium, hypromellose 2910, lactose monohydrate, macrogol/PEG400, magnesium stearate, microcrystalline cellulose, and titanium dioxide., 2 10 mg blue round, biconvex, debossed with "T10" on one side and no debossing on the other side, immediate-release film-coated tablet. Each tofacitinib tablet contains 10 mg of tofacitinib (equivalent to 16.16 mg of tofacitinib citrate) and the following inactive ingredients: croscarmellose sodium, FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 2910, lactose monohydrate, macrogol/PEG4000, magnesium stearate, microcrystalline cellulose, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70069-842-01</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (70069-842-01) </PackageDescription>
<NDC11Code>70069-0842-01</NDC11Code>
<ProductNDC>70069-842</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tofacitinib</ProprietaryName>
<NonProprietaryName>Tofacitinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220137</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>TOFACITINIB CITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tofacitinib tablets are Janus kinase (JAK) inhibitors. Tofacitinib tablets are indicated for the treatment of adult patients with: 1 Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers., 2 Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers., 3 Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers., 4 Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers.</IndicationAndUsage>
<Description>Tofacitinib tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1- piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The solubility of tofacitinib citrate in water is 2.9 mg/mL. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H8O7. The chemical structure of tofacitinib citrate is. Tofacitinib tablets are supplied for oral administration as a: 1 5 mg white round, biconvex, debossed with "T5" on one side and no debossing on the other side, immediate-release film-coated tablet. Each tofacitinib tablet contains 5 mg of tofacitinib (equivalent to 8.08 mg of tofacitinib citrate) and the following inactive ingredients: croscarmellose sodium, hypromellose 2910, lactose monohydrate, macrogol/PEG400, magnesium stearate, microcrystalline cellulose, and titanium dioxide., 2 10 mg blue round, biconvex, debossed with "T10" on one side and no debossing on the other side, immediate-release film-coated tablet. Each tofacitinib tablet contains 10 mg of tofacitinib (equivalent to 16.16 mg of tofacitinib citrate) and the following inactive ingredients: croscarmellose sodium, FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 2910, lactose monohydrate, macrogol/PEG4000, magnesium stearate, microcrystalline cellulose, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70069-857-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (70069-857-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>70069-0857-01</NDC11Code>
<ProductNDC>70069-857</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azacitidine</ProprietaryName>
<NonProprietaryName>Azacitidine</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250829</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217453</ApplicationNumber>
<LabelerName>Somerset Therapeutics LLC</LabelerName>
<SubstanceName>AZACITIDINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azacitidine for injection (Azacitidine), is a nucleoside metabolic inhibitor indicated for the treatment of. Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). (1.1).</IndicationAndUsage>
<Description>Azacitidine for injection contains azacitidine, which is a nucleoside metabolic inhibitor. Azacitidine is 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1H)-one. The structural formula is as follows. The empirical formula is C 8H 12N 4O 5. The molecular weight is 244. Azacitidine is a white to off white solid. Azacitidine was found to be insoluble in acetone, ethanol, and methyl ethyl ketone; slightly soluble in ethanol/water (50/50), propylene glycol, and polyethylene glycol; sparingly soluble in water, water saturated octanol, 5% dextrose in water, N-methyl-2-pyrrolidone, normal saline and 5% Tween 80 in water; and soluble in dimethylsulfoxide (DMSO). The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Vials of azacitidine for injection contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder.</Description>
</NDC>
<NDC>
<NDCCode>70069-860-18</NDCCode>
<PackageDescription>180 TABLET, DELAYED RELEASE in 1 BOTTLE (70069-860-18) </PackageDescription>
<NDC11Code>70069-0860-18</NDC11Code>
<ProductNDC>70069-860</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acamprosate Calcium</ProprietaryName>
<NonProprietaryName>Acamprosate Calcium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218984</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>ACAMPROSATE CALCIUM</SubstanceName>
<StrengthNumber>333</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acamprosate calcium is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with acamprosate calcium should be part of a comprehensive management program that includes psychosocial support. The efficacy of acamprosate calcium in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning acamprosate calcium treatment. The efficacy of acamprosate calcium in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.</IndicationAndUsage>
<Description>Acamprosate calcium is supplied in an enteric-coated tablet for oral administration. Acamprosate calcium is a synthetic compound with a chemical structure similar to that of the endogenous amino acid homotaurine, which is a structural analogue of the amino acid neurotransmitter γ-aminobutyric acid and the amino acid neuromodulator taurine. Its chemical name calcium 3-( acetylamino) propane-1-sulfonate. Its chemical formula is C10H20N2O8S2Ca and molecular weight is 400.50. Its structural formula is. Acamprosate calcium is a white or almost white powder. It is freely soluble in water, practically insoluble in alcohol and Methylene Chloride. Each Acamprosate calcium delayed-release tablet contains acamprosate calcium 333 mg, equivalent to 300 mg of acamprosate. Inactive ingredients in Acamprosate calcium delayed-release tablet include: colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, povidone, sodium starch glycolate, talc and triethylcitrate. Sulfites were used in the synthesis of the drug substance and traces of residual sulfites may be present in the drug product.</Description>
</NDC>
<NDC>
<NDCCode>70069-860-30</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (70069-860-30) </PackageDescription>
<NDC11Code>70069-0860-30</NDC11Code>
<ProductNDC>70069-860</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acamprosate Calcium</ProprietaryName>
<NonProprietaryName>Acamprosate Calcium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218984</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>ACAMPROSATE CALCIUM</SubstanceName>
<StrengthNumber>333</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acamprosate calcium is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with acamprosate calcium should be part of a comprehensive management program that includes psychosocial support. The efficacy of acamprosate calcium in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning acamprosate calcium treatment. The efficacy of acamprosate calcium in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.</IndicationAndUsage>
<Description>Acamprosate calcium is supplied in an enteric-coated tablet for oral administration. Acamprosate calcium is a synthetic compound with a chemical structure similar to that of the endogenous amino acid homotaurine, which is a structural analogue of the amino acid neurotransmitter γ-aminobutyric acid and the amino acid neuromodulator taurine. Its chemical name calcium 3-( acetylamino) propane-1-sulfonate. Its chemical formula is C10H20N2O8S2Ca and molecular weight is 400.50. Its structural formula is. Acamprosate calcium is a white or almost white powder. It is freely soluble in water, practically insoluble in alcohol and Methylene Chloride. Each Acamprosate calcium delayed-release tablet contains acamprosate calcium 333 mg, equivalent to 300 mg of acamprosate. Inactive ingredients in Acamprosate calcium delayed-release tablet include: colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, povidone, sodium starch glycolate, talc and triethylcitrate. Sulfites were used in the synthesis of the drug substance and traces of residual sulfites may be present in the drug product.</Description>
</NDC>
<NDC>
<NDCCode>70069-892-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (70069-892-10) / 2 mL in 1 VIAL, SINGLE-DOSE (70069-892-01) </PackageDescription>
<NDC11Code>70069-0892-10</NDC11Code>
<ProductNDC>70069-892</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sugammadex</ProprietaryName>
<NonProprietaryName>Sugammadex</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215260</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>SUGAMMADEX SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>gamma-Cyclodextrins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Sugammadex Injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)- 6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is. Sugammadex Injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex Injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2- carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>70069-893-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (70069-893-10) / 5 mL in 1 VIAL, SINGLE-DOSE (70069-893-01) </PackageDescription>
<NDC11Code>70069-0893-10</NDC11Code>
<ProductNDC>70069-893</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sugammadex</ProprietaryName>
<NonProprietaryName>Sugammadex</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215260</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>SUGAMMADEX SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>gamma-Cyclodextrins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Sugammadex Injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)- 6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is. Sugammadex Injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex Injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2- carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>0378-5055-77</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5055-77) </PackageDescription>
<NDC11Code>00378-5055-77</NDC11Code>
<ProductNDC>0378-5055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pitavastatin Calcium</ProprietaryName>
<NonProprietaryName>Pitavastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206070</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PITAVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: 1 Adults with primary hyperlipidemia., 2 Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). .</IndicationAndUsage>
<Description>Pitavastatin tablets for oral use are an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (+)Monocalcium bis [(3R,5S,6E)-7-[2-cyclopropyl- 4-(4- fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate]. The structural formula is. The molecular formula for pitavastatin is (C25H23FNO4)2.Ca and the molecular weight is 880.98. Pitavastatin is odorless and occurs as off-white to pale yellow color powder. It is freely soluble in pyridine, chloroform, dilute hydrochloric acid, and tetrahydrofuran, soluble in ethylene glycol, sparingly soluble in octanol, slightly soluble in methanol, very slightly soluble in water or ethanol, and practically insoluble in acetonitrile or diethyl ether. Pitavastatin is hygroscopic and slightly unstable in light. Each film-coated tablet of pitavastatin contains 1 mg, 2 mg, or 4 mg of pitavastatin, which is equivalent to 1.045 mg, 2.090 mg, or 4.180 mg, respectively, of pitavastatin calcium and the following inactive ingredients: hypromellose, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium oxide, magnesium stearate, polyethylene glycol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0378-5056-77</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5056-77) </PackageDescription>
<NDC11Code>00378-5056-77</NDC11Code>
<ProductNDC>0378-5056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pitavastatin Calcium</ProprietaryName>
<NonProprietaryName>Pitavastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206070</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PITAVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: 1 Adults with primary hyperlipidemia., 2 Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). .</IndicationAndUsage>
<Description>Pitavastatin tablets for oral use are an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (+)Monocalcium bis [(3R,5S,6E)-7-[2-cyclopropyl- 4-(4- fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate]. The structural formula is. The molecular formula for pitavastatin is (C25H23FNO4)2.Ca and the molecular weight is 880.98. Pitavastatin is odorless and occurs as off-white to pale yellow color powder. It is freely soluble in pyridine, chloroform, dilute hydrochloric acid, and tetrahydrofuran, soluble in ethylene glycol, sparingly soluble in octanol, slightly soluble in methanol, very slightly soluble in water or ethanol, and practically insoluble in acetonitrile or diethyl ether. Pitavastatin is hygroscopic and slightly unstable in light. Each film-coated tablet of pitavastatin contains 1 mg, 2 mg, or 4 mg of pitavastatin, which is equivalent to 1.045 mg, 2.090 mg, or 4.180 mg, respectively, of pitavastatin calcium and the following inactive ingredients: hypromellose, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium oxide, magnesium stearate, polyethylene glycol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0378-5057-77</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5057-77) </PackageDescription>
<NDC11Code>00378-5057-77</NDC11Code>
<ProductNDC>0378-5057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pitavastatin Calcium</ProprietaryName>
<NonProprietaryName>Pitavastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206070</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PITAVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: 1 Adults with primary hyperlipidemia., 2 Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). .</IndicationAndUsage>
<Description>Pitavastatin tablets for oral use are an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (+)Monocalcium bis [(3R,5S,6E)-7-[2-cyclopropyl- 4-(4- fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate]. The structural formula is. The molecular formula for pitavastatin is (C25H23FNO4)2.Ca and the molecular weight is 880.98. Pitavastatin is odorless and occurs as off-white to pale yellow color powder. It is freely soluble in pyridine, chloroform, dilute hydrochloric acid, and tetrahydrofuran, soluble in ethylene glycol, sparingly soluble in octanol, slightly soluble in methanol, very slightly soluble in water or ethanol, and practically insoluble in acetonitrile or diethyl ether. Pitavastatin is hygroscopic and slightly unstable in light. Each film-coated tablet of pitavastatin contains 1 mg, 2 mg, or 4 mg of pitavastatin, which is equivalent to 1.045 mg, 2.090 mg, or 4.180 mg, respectively, of pitavastatin calcium and the following inactive ingredients: hypromellose, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium oxide, magnesium stearate, polyethylene glycol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>49884-880-86</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (49884-880-86)</PackageDescription>
<NDC11Code>49884-0880-86</NDC11Code>
<ProductNDC>49884-880</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204158</ApplicationNumber>
<LabelerName>Par Pharmaceutical Companies, Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>1/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>51407-880-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (51407-880-01) </PackageDescription>
<NDC11Code>51407-0880-01</NDC11Code>
<ProductNDC>51407-880</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methenamine Hippurate</ProprietaryName>
<NonProprietaryName>Methenamine Hippurate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210068</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>METHENAMINE HIPPURATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-03-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methenamine hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. This drug should only be used after eradication of the infection by other appropriate antimicrobial agents. To reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine hippurate and other antibacterial drugs, methenamine hippurate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Methenamine Hippurate Tablets, USP is a urinary tract antiseptic drug. Each peach color, capsule-shaped bi-convex tablet contains 1 g methenamine hippurate which is the hippuric acid salt of methenamine (hexamethylene tetramine). The tablet also contains inactive ingredients: FD&C Yellow No. 6, Magnesium Stearate, Colloidal Silicon Dioxide, Povidone, and Saccharin Sodium. Structural Formula.</Description>
</NDC>
<NDC>
<NDCCode>55513-880-02</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (55513-880-02) / 1.17 mL in 1 SYRINGE (55513-880-01) </PackageDescription>
<NDC11Code>55513-0880-02</NDC11Code>
<ProductNDC>55513-880</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Evenity</ProprietaryName>
<NonProprietaryName>Romosozumab-aqqg</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190409</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761062</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>ROMOSOZUMAB</SubstanceName>
<StrengthNumber>105</StrengthNumber>
<StrengthUnit>mg/1.17mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EVENITY is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. (1). Limitations of Use: Limit duration of use to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered. (1.2).</IndicationAndUsage>
<Description>Romosozumab-aqqg is a humanized monoclonal antibody (IgG2) produced in a mammalian cell line (Chinese Hamster Ovary) by recombinant DNA technology that binds to and inhibits sclerostin. Romosozumab-aqqg has an approximate molecular weight of 149 kDa. EVENITY (romosozumab-aqqg) injection is supplied as a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection in a single-use prefilled syringe. Two 105 mg/1.17 mL single-use prefilled syringes are required to administer the recommended 210 mg dose of EVENITY [see Dosage and Administration (2.1)]. Each single-use prefilled syringe delivers 1.17 mL of solution containing 105 mg of romosozumab-aqqg, acetate (3.8 mg), calcium (0.61 mg), polysorbate 20 (0.07 mg) and sucrose (70 mg) in Water for Injection, USP, and sodium hydroxide to a pH of 5.2.</Description>
</NDC>
<NDC>
<NDCCode>55910-880-05</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (55910-880-05) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>55910-0880-05</NDC11Code>
<ProductNDC>55910-880</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Adapalene</ProprietaryName>
<NonProprietaryName>Adapalene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191129</StartMarketingDate>
<EndMarketingDate>20261129</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091314</ApplicationNumber>
<LabelerName>Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)</LabelerName>
<SubstanceName>ADAPALENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191129</StartMarketingDatePackage>
<EndMarketingDatePackage>20261129</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59651-880-37</NDCCode>
<PackageDescription>50 kg in 1 DRUM (59651-880-37) </PackageDescription>
<NDC11Code>59651-0880-37</NDC11Code>
<ProductNDC>59651-880</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bempedoic Acid</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240108</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>BEMPEDOIC ACID</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>kg/50kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-01-08</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>08-JAN-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59779-880-78</NDCCode>
<PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE (59779-880-78) </PackageDescription>
<NDC11Code>59779-0880-78</NDC11Code>
<ProductNDC>59779-880</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Health Extra Strength Heartburn Relief Antacid</ProprietaryName>
<ProprietaryNameSuffix>Original Flavor</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Hydroxide And Magnesium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150827</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>CVS Pharmacy,Inc.</LabelerName>
<SubstanceName>ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE</SubstanceName>
<StrengthNumber>160; 105</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 acid indigestion, 2 heartburn, 3 sour stomach, 4 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60758-880-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (60758-880-05) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>60758-0880-05</NDC11Code>
<ProductNDC>60758-880</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluorometholone</ProprietaryName>
<NonProprietaryName>Fluorometholone</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19971031</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA016851</ApplicationNumber>
<LabelerName>Pacific Pharma, Inc.</LabelerName>
<SubstanceName>FLUOROMETHOLONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluorometholone ophthalmic suspension 0.1% is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.</IndicationAndUsage>
<Description>Fluorometholone ophthalmic suspension, USP 0.1% is a sterile topical anti-inflammatory agent for ophthalmic use. Chemical Name. Fluorometholone: 9-Fluoro-11β,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione. Contains. Active: fluorometholone 0.1%. Preservative: benzalkonium chloride 0.004%. Inactives: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; sodium phosphate, monobasic; and sodium hydroxide to adjust pH. Fluorometholone suspension is formulated with a pH from 6.2 to 7.5. It has an osmolality range of 290-350 mOsm/kg. Structural Formula. fluorometholone.</Description>
</NDC>
<NDC>
<NDCCode>60758-880-10</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (60758-880-10) / 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>60758-0880-10</NDC11Code>
<ProductNDC>60758-880</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluorometholone</ProprietaryName>
<NonProprietaryName>Fluorometholone</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19971031</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA016851</ApplicationNumber>
<LabelerName>Pacific Pharma, Inc.</LabelerName>
<SubstanceName>FLUOROMETHOLONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluorometholone ophthalmic suspension 0.1% is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.</IndicationAndUsage>
<Description>Fluorometholone ophthalmic suspension, USP 0.1% is a sterile topical anti-inflammatory agent for ophthalmic use. Chemical Name. Fluorometholone: 9-Fluoro-11β,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione. Contains. Active: fluorometholone 0.1%. Preservative: benzalkonium chloride 0.004%. Inactives: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; sodium phosphate, monobasic; and sodium hydroxide to adjust pH. Fluorometholone suspension is formulated with a pH from 6.2 to 7.5. It has an osmolality range of 290-350 mOsm/kg. Structural Formula. fluorometholone.</Description>
</NDC>
<NDC>
<NDCCode>60760-880-05</NDCCode>
<PackageDescription>5 POUCH in 1 BAG (60760-880-05) / 1 g in 1 POUCH</PackageDescription>
<NDC11Code>60760-0880-05</NDC11Code>
<ProductNDC>60760-880</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>20200204</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020612</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LIDOCAINE PATCH 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>LIDOCAINE PATCH 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a non‑woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2‑(diethylamino)‑N‑(2,6‑ dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, D-sorbitol, tartaric acid, and urea.</Description>
</NDC>
<NDC>
<NDCCode>65084-880-01</NDCCode>
<PackageDescription>25 BLISTER PACK in 1 BOX (65084-880-01) > 30 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65084-0880-01</NDC11Code>
<ProductNDC>65084-880</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen 325mg</ProprietaryName>
<ProprietaryNameSuffix>Rs</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen 325mg</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160415</StartMarketingDate>
<EndMarketingDate>20210731</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>McKesson Corporation dba RX Pak</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190917</StartMarketingDatePackage>
<EndMarketingDatePackage>20210731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>