{
"NDC": [
{
"NDCCode": "71930-022-43",
"PackageDescription": "1 BOTTLE in 1 CARTON (71930-022-43) / 473 mL in 1 BOTTLE",
"NDC11Code": "71930-0022-43",
"ProductNDC": "71930-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207511",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190301",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride oral solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including oxycodone hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone hydrochloride oral solution is an opioid agonist, available as solution in 5 mg/5mL (1 mg/mL) strength for oral administration. Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6one hydrochloride and has the following structural formula. C18H21NO4HCl MW 351.82. Oxycodone hydrochloride, USP is a white to off-white fine crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Oxycodone hydrochloride oral solution USP, 5 mg per 5 mL contains equivalent of 4.5 mg of oxycodone free base per 5 mL and contains the following inactive ingredients: sorbitol solution, saccharin sodium, anhydrous citric acid, sodium citrate dihydrate, sodium benzoate, FD&C red #40, mixed berry flavor, and purified water."
},
{
"NDCCode": "71930-026-43",
"PackageDescription": "473 mL in 1 BOTTLE (71930-026-43) ",
"NDC11Code": "71930-0026-43",
"ProductNDC": "71930-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride,",
"NonProprietaryName": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride,",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20200626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211170",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "2; 30; 10",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200626",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.",
"Description": "Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup, 2 mg/30 mg/10 mg per 5 mL is a clear, light pink syrup with a butterscotch flavour. Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate, USP 2 mg Pseudoephedrine Hydrochloride, USP 30 mg Dextromethorphan Hydrobromide, USP 10 mg Alcohol 0.95% v/v In a palatable, aromatic vehicle. Inactive Ingredients: artificial butterscotch flavor, citric acid anhydrous, alcohol, FD&C Red No. 40, glycerin, sucrose, methylparaben, propylene glycol, purified water and sodium benzoate. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 4.0 and 6.0. Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration."
},
{
"NDCCode": "71930-027-43",
"PackageDescription": "473 mL in 1 BOTTLE (71930-027-43) ",
"NDC11Code": "71930-0027-43",
"ProductNDC": "71930-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211023",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 325",
"StrengthUnit": "mg/15mL; mg/15mL",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190408",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including hydrocodone bitartrate and acetaminophen oral solution for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Hydrocodone bitartrate and acetaminophen are available in liquid form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:. C18H21NO3C4H6O62½H2O M. W. 494.490 Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non- opiate, non- salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2 M. W. 151.16. In addition, the liquid contains the following inactive ingredients: citric acid anhydrous, ethyl maltol, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Red #33 and FD&C Red #40 as coloring and natural and artificial flavoring."
},
{
"NDCCode": "71930-016-12",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71930-016-12) ",
"NDC11Code": "71930-0016-12",
"ProductNDC": "71930-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quinidine Gluconate",
"NonProprietaryName": "Quinidine Gluonate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212589",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "QUINIDINE GLUCONATE",
"StrengthNumber": "324",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-03-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220320",
"SamplePackage": "N",
"IndicationAndUsage": "Conversion of atrial fibrillation/flutter In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine gluconate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine gluconate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION), then quinidine gluconate should be discontinued. Reduction of frequency of relapse into atrial fibrillation/flutter Chronic therapy with quinidine gluconate is indicated for some patients at high risk of symptomatic atrial fibrillation/flutter, generally patients who have had previous episodes of atrial fibrillation/flutter that were so frequent and poorly tolerated as to outweigh, in the judgment of the physician and the patient, the risks of prophylactic therapy with quinidine gluconate. The increased risk of death should specifically be considered. Quinidine gluconate should be used only after alternative measures (e.g., use of other drugs to control the ventricular rate) have been found to be inadequate. In patients with histories of frequent symptomatic episodes of atrial fibrillation/flutter, the goal of therapy should be an increase in the average time between episodes. In most patients, the tachyarrhythmia will recur during therapy, and a single recurrence should not be interpreted as therapeutic failure. Suppression of ventricular arrhythmias Quinidine gluconate is also indicated for the suppression of recurrent documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. Because of the proarrhythmic effects of quinidine, its use with ventricular arrhythmias of lesser severity is generally not recommended, and treatment of patients with asymptomatic ventricular premature contractions should be avoided. Where possible, therapy should be guided by the results of programmed electrical stimulation and/or Holter monitoring with exercise. Antiarrhythmic drugs (including quinidine gluconate) have not been shown to enhance survival in patients with ventricular arrhythmias.",
"Description": "Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with Class Ia activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine gluconate is the gluconate salt of quinidine; its chemical name is cinchonan-9-ol, 6'-methoxy-, (9S)-, mono-D-gluconate; its structural formula is. Its empirical formula is C20H24N2O2 C6H12O7, and its molecular weight is 520.58, of which 62.3% is quinidine base. Each quinidine gluconate extended-release tablet contains 324 mg of quinidine gluconate (202 mg of quinidine base) in a matrix to provide extended-release; the inactive ingredients include corn starch, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, alcohol and sodium alginate. Meets USP Dissolution Test 6."
},
{
"NDCCode": "37000-022-04",
"PackageDescription": "1 TUBE in 1 CARTON (37000-022-04) > 124 g in 1 TUBE",
"NDC11Code": "37000-0022-04",
"ProductNDC": "37000-022",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crest Complete Multi-benefit",
"ProprietaryNameSuffix": "Whitening Plus Scope",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Procter & Gamble Manufacturing Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "2.43",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "50881-022-08",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50881-022-08) ",
"NDC11Code": "50881-0022-08",
"ProductNDC": "50881-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jakafi Xr",
"NonProprietaryName": "Ruxolitinib",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217180",
"LabelerName": "Incyte Corporation",
"SubstanceName": "RUXOLITINIB",
"StrengthNumber": "22",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260501",
"SamplePackage": "N",
"IndicationAndUsage": "JAKAFI/JAKAFI XR is a kinase inhibitor indicated for treatment of: 1 intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults. (1.1), 2 polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. (1.2), 3 steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. (1.3), 4 chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. (1.4).",
"Description": "Ruxolitinib phosphate is a kinase inhibitor with the chemical name (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate and a molecular weight of 404.36. Ruxolitinib phosphate has the following structural formula. Ruxolitinib phosphate is a white to off-white to light pink powder and is soluble in aqueous buffers across a pH range of 1 to 8. JAKAFI (ruxolitinib) tablets are for oral administration. Each tablet contains 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg of ruxolitinib free base, equivalent to 6.6 mg, 13.2 mg, 19.8 mg, 26.4 mg, or 33 mg of ruxolitinib phosphate, respectively, and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. JAKAFI XR (ruxolitinib) extended-release tablets are for oral administration. Each tablet contains 11 mg, 22 mg, 33 mg, 44 mg, or 55 mg of ruxolitinib free base equivalent to 14.5 mg, 29 mg, 43.6 mg, 58.1 mg, or 72.6 mg of ruxolitinib phosphate, respectively, and the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: colorants (black iron oxide, red iron oxide, and yellow iron oxide), copovidone, hypromellose, polydextrose, polyethylene glycol, titanium dioxide, and triglycerides."
},
{
"NDCCode": "61957-0114-1",
"PackageDescription": "1 BOTTLE in 1 CARTON (61957-0114-1) > 30 mL in 1 BOTTLE",
"NDC11Code": "61957-0114-01",
"ProductNDC": "61957-0114",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cd Diorskin Nude Skin-glowing Makeup Sunscreen Broad Spectrum Spf 15 022 Cameo",
"NonProprietaryName": "Octinoxate, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120827",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Parfums Christian Dior",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "30; 43.5",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120827",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "64141-022-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (64141-022-01) > 30 mL in 1 BOTTLE",
"NDC11Code": "64141-0022-01",
"ProductNDC": "64141-022",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bobbi Brown Intensive Skin Serum Foundation Broad Spectrum Spf 35",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M020",
"LabelerName": "Bobbi Brown Professional Cosmetics Inc.",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "83.25; 23.31; 14.43",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160201",
"SamplePackage": "N"
},
{
"NDCCode": "75987-022-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (75987-022-01) / 30 TABLET, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "75987-0022-01",
"ProductNDC": "75987-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rayos",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120727",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202020",
"LabelerName": "Horizon Therapeutics USA, Inc.",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120727",
"SamplePackage": "N",
"IndicationAndUsage": "RAYOS is indicated in the treatment of the following diseases or conditions.",
"Description": "The active ingredient in RAYOS is prednisone (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for prednisone is C21H26O5. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-diene-3,11,20-trione, and the structural formula is. Prednisone is a white to practically white, odorless, crystalline powder and has a molecular weight of 358.43. Prednisone is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. RAYOS is a delayed-release prednisone tablet. It consists of a prednisone-containing core tablet in an inactive shell, which delays the onset of in vitro drug dissolution by approximately 4 hours. Each tablet contains 1 mg, 2 mg, or 5 mg of prednisone, with the following inactive ingredients: dibasic calcium phosphate dihydrate, colloidal silicon dioxide, croscarmellose sodium, glycerol dibehenate, lactose monohydrate, magnesium stearate, povidone, yellow ferric oxide, and red ferric oxide."
},
{
"NDCCode": "75987-022-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (75987-022-02) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "75987-0022-02",
"ProductNDC": "75987-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rayos",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120727",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202020",
"LabelerName": "Horizon Therapeutics USA, Inc.",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120727",
"SamplePackage": "N",
"IndicationAndUsage": "RAYOS is indicated in the treatment of the following diseases or conditions.",
"Description": "The active ingredient in RAYOS is prednisone (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for prednisone is C21H26O5. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-diene-3,11,20-trione, and the structural formula is. Prednisone is a white to practically white, odorless, crystalline powder and has a molecular weight of 358.43. Prednisone is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. RAYOS is a delayed-release prednisone tablet. It consists of a prednisone-containing core tablet in an inactive shell, which delays the onset of in vitro drug dissolution by approximately 4 hours. Each tablet contains 1 mg, 2 mg, or 5 mg of prednisone, with the following inactive ingredients: dibasic calcium phosphate dihydrate, colloidal silicon dioxide, croscarmellose sodium, glycerol dibehenate, lactose monohydrate, magnesium stearate, povidone, yellow ferric oxide, and red ferric oxide."
},
{
"NDCCode": "75987-022-70",
"PackageDescription": "1 BOTTLE in 1 CARTON (75987-022-70) / 7 TABLET, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "75987-0022-70",
"ProductNDC": "75987-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rayos",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120727",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202020",
"LabelerName": "Horizon Therapeutics USA, Inc.",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120727",
"SamplePackage": "N",
"IndicationAndUsage": "RAYOS is indicated in the treatment of the following diseases or conditions.",
"Description": "The active ingredient in RAYOS is prednisone (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for prednisone is C21H26O5. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-diene-3,11,20-trione, and the structural formula is. Prednisone is a white to practically white, odorless, crystalline powder and has a molecular weight of 358.43. Prednisone is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. RAYOS is a delayed-release prednisone tablet. It consists of a prednisone-containing core tablet in an inactive shell, which delays the onset of in vitro drug dissolution by approximately 4 hours. Each tablet contains 1 mg, 2 mg, or 5 mg of prednisone, with the following inactive ingredients: dibasic calcium phosphate dihydrate, colloidal silicon dioxide, croscarmellose sodium, glycerol dibehenate, lactose monohydrate, magnesium stearate, povidone, yellow ferric oxide, and red ferric oxide."
},
{
"NDCCode": "71930-006-12",
"PackageDescription": "100 TABLET in 1 BOTTLE (71930-006-12) ",
"NDC11Code": "71930-0006-12",
"ProductNDC": "71930-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211555",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210527",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen Tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen Tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen Tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen USP, is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Anhydrous Dibasic Calcium Phosphate, Microcrystalline Cellulose, Lactose Monohydrate, Sodium Starch Glycolate, Magnesium Stearate."
},
{
"NDCCode": "71930-006-13",
"PackageDescription": "1000 TABLET in 1 BOTTLE (71930-006-13) ",
"NDC11Code": "71930-0006-13",
"ProductNDC": "71930-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211555",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210527",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen Tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen Tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen Tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen USP, is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Anhydrous Dibasic Calcium Phosphate, Microcrystalline Cellulose, Lactose Monohydrate, Sodium Starch Glycolate, Magnesium Stearate."
},
{
"NDCCode": "71930-006-52",
"PackageDescription": "500 TABLET in 1 BOTTLE (71930-006-52) ",
"NDC11Code": "71930-0006-52",
"ProductNDC": "71930-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211555",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210527",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen Tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen Tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen Tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen USP, is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Anhydrous Dibasic Calcium Phosphate, Microcrystalline Cellulose, Lactose Monohydrate, Sodium Starch Glycolate, Magnesium Stearate."
},
{
"NDCCode": "71930-007-12",
"PackageDescription": "100 TABLET in 1 BOTTLE (71930-007-12) ",
"NDC11Code": "71930-0007-12",
"ProductNDC": "71930-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211555",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210527",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen Tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen Tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen Tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen USP, is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Anhydrous Dibasic Calcium Phosphate, Microcrystalline Cellulose, Lactose Monohydrate, Sodium Starch Glycolate, Magnesium Stearate."
},
{
"NDCCode": "71930-007-13",
"PackageDescription": "1000 TABLET in 1 BOTTLE (71930-007-13) ",
"NDC11Code": "71930-0007-13",
"ProductNDC": "71930-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211555",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210527",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen Tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen Tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen Tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen USP, is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Anhydrous Dibasic Calcium Phosphate, Microcrystalline Cellulose, Lactose Monohydrate, Sodium Starch Glycolate, Magnesium Stearate."
},
{
"NDCCode": "71930-007-52",
"PackageDescription": "500 TABLET in 1 BOTTLE (71930-007-52) ",
"NDC11Code": "71930-0007-52",
"ProductNDC": "71930-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211555",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210527",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen Tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen Tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen Tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen USP, is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Anhydrous Dibasic Calcium Phosphate, Microcrystalline Cellulose, Lactose Monohydrate, Sodium Starch Glycolate, Magnesium Stearate."
},
{
"NDCCode": "71930-008-12",
"PackageDescription": "100 TABLET in 1 BOTTLE (71930-008-12) ",
"NDC11Code": "71930-0008-12",
"ProductNDC": "71930-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetazolamide",
"NonProprietaryName": "Acetazolamide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211556",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "ACETAZOLAMIDE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200130",
"SamplePackage": "N",
"IndicationAndUsage": "For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide Tablets are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent.",
"Description": "Acetazolamide, an inhibitor of the enzyme carbonic anhydrase is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2-yl) acetamide and has the following chemical structure. Acetazolamide is available as oral tablets containing 125 mg and 250 mg of acetazolamide respectively and the following inactive ingredients: dibasic calcium phosphate dihydrate, corn starch, crospovidone, povidone, purified water and magnesium stearate."
},
{
"NDCCode": "71930-009-12",
"PackageDescription": "100 TABLET in 1 BOTTLE (71930-009-12) ",
"NDC11Code": "71930-0009-12",
"ProductNDC": "71930-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetazolamide",
"NonProprietaryName": "Acetazolamide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211556",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "ACETAZOLAMIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200130",
"SamplePackage": "N",
"IndicationAndUsage": "For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide Tablets are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent.",
"Description": "Acetazolamide, an inhibitor of the enzyme carbonic anhydrase is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2-yl) acetamide and has the following chemical structure. Acetazolamide is available as oral tablets containing 125 mg and 250 mg of acetazolamide respectively and the following inactive ingredients: dibasic calcium phosphate dihydrate, corn starch, crospovidone, povidone, purified water and magnesium stearate."
},
{
"NDCCode": "71930-010-10",
"PackageDescription": "30 TABLET in 1 BOTTLE (71930-010-10) ",
"NDC11Code": "71930-0010-10",
"ProductNDC": "71930-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alosetron Hydrochloride",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211621",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250801",
"SamplePackage": "N",
"IndicationAndUsage": "Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .",
"Description": "The active ingredient in alosetron tablets, USP is alosetron hydrochloride (HCl), USP a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4 yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to pale brown colored powder that has a solubility of 66.82 mg/mL in water, 83.34 mg/mL in 0.1N hydrochloric acid, 74.65 mg/mL in pH 6.8 phosphate buffer, and 60.79 mg/mL in pH 8.0 phosphate buffer. The chemical structure of alosetron is. Alosetron Tablets USP are supplied for oral administration as 0.5 mg (white) and 1 mg (white) tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride, USP equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron hydrochloride, USP equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, macrogol and triacetin. The white film coat for the 1 mg tablet contains hypromellose, titanium dioxide, macrogol and triacetin."
},
{
"NDCCode": "71930-010-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (71930-010-30) ",
"NDC11Code": "71930-0010-30",
"ProductNDC": "71930-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alosetron Hydrochloride",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211621",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190201",
"SamplePackage": "N",
"IndicationAndUsage": "Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .",
"Description": "The active ingredient in alosetron tablets, USP is alosetron hydrochloride (HCl), USP a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4 yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to pale brown colored powder that has a solubility of 66.82 mg/mL in water, 83.34 mg/mL in 0.1N hydrochloric acid, 74.65 mg/mL in pH 6.8 phosphate buffer, and 60.79 mg/mL in pH 8.0 phosphate buffer. The chemical structure of alosetron is. Alosetron Tablets USP are supplied for oral administration as 0.5 mg (white) and 1 mg (white) tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride, USP equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron hydrochloride, USP equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, macrogol and triacetin. The white film coat for the 1 mg tablet contains hypromellose, titanium dioxide, macrogol and triacetin."
},
{
"NDCCode": "71930-011-11",
"PackageDescription": "30 TABLET in 1 BOTTLE (71930-011-11) ",
"NDC11Code": "71930-0011-11",
"ProductNDC": "71930-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alosetron Hydrochloride",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211621",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250801",
"SamplePackage": "N",
"IndicationAndUsage": "Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .",
"Description": "The active ingredient in alosetron tablets, USP is alosetron hydrochloride (HCl), USP a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4 yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to pale brown colored powder that has a solubility of 66.82 mg/mL in water, 83.34 mg/mL in 0.1N hydrochloric acid, 74.65 mg/mL in pH 6.8 phosphate buffer, and 60.79 mg/mL in pH 8.0 phosphate buffer. The chemical structure of alosetron is. Alosetron Tablets USP are supplied for oral administration as 0.5 mg (white) and 1 mg (white) tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride, USP equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron hydrochloride, USP equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, macrogol and triacetin. The white film coat for the 1 mg tablet contains hypromellose, titanium dioxide, macrogol and triacetin."
},
{
"NDCCode": "71930-011-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (71930-011-30) ",
"NDC11Code": "71930-0011-30",
"ProductNDC": "71930-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alosetron Hydrochloride",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211621",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190201",
"SamplePackage": "N",
"IndicationAndUsage": "Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .",
"Description": "The active ingredient in alosetron tablets, USP is alosetron hydrochloride (HCl), USP a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4 yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to pale brown colored powder that has a solubility of 66.82 mg/mL in water, 83.34 mg/mL in 0.1N hydrochloric acid, 74.65 mg/mL in pH 6.8 phosphate buffer, and 60.79 mg/mL in pH 8.0 phosphate buffer. The chemical structure of alosetron is. Alosetron Tablets USP are supplied for oral administration as 0.5 mg (white) and 1 mg (white) tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride, USP equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron hydrochloride, USP equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, macrogol and triacetin. The white film coat for the 1 mg tablet contains hypromellose, titanium dioxide, macrogol and triacetin."
},
{
"NDCCode": "71930-015-12",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (71930-015-12) ",
"NDC11Code": "71930-0015-12",
"ProductNDC": "71930-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ursodiol",
"NonProprietaryName": "Ursodiol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212452",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "URSODIOL",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bile Acid [EPC], Bile Acids and Salts [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200205",
"SamplePackage": "N",
"IndicationAndUsage": "1. Ursodiol capsules, USP are indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol capsules beyond 24 months is not established. 2. Ursodiol capsules are indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.",
"Description": "Ursodiol Capsules, USP are a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol (ursodeoxycholic acid) is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a white or almost white crystalline powder freely soluble in alcohol and in glacial acetic acid, sparingly soluble in chloroform, slightly soluble in ether; practically insoluble in water. The chemical name for ursodiol is 3α,7β-Dihydroxy-5β-cholan-24-oic acid (C24H40O4). Ursodiol has a molecular weight of 392.57. Its structure is shown below:. Each capsule contains 300 mg of ursodiol with the following inactive ingredients: Pregelatinized starch, Silicon Dioxide, Magnesium Stearate and Hard Gelatin capsule shell. Capsule shell contains iron oxide red, iron oxide yellow, titanium dioxide and gelatin. The imprinting ink contains the following: Shellac, Dehydrated Alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Strong Ammonia Solution, Black Iron Oxide and Potassium Hydroxide."
},
{
"NDCCode": "71930-017-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (71930-017-30) ",
"NDC11Code": "71930-0017-30",
"ProductNDC": "71930-017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077851",
"LabelerName": "Eywa Pharma Inc.",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180711",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2. , 2 initial and repeat courses of moderately emetogenic cancer chemotherapy. , 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. .",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.5. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin, and iron oxide yellow (8 mg tablet only). This product meets USP Dissolution Test 3."
},
{
"NDCCode": "71930-017-52",
"PackageDescription": "500 TABLET in 1 BOTTLE (71930-017-52) ",
"NDC11Code": "71930-0017-52",
"ProductNDC": "71930-017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077851",
"LabelerName": "Eywa Pharma Inc.",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200206",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2. , 2 initial and repeat courses of moderately emetogenic cancer chemotherapy. , 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. .",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.5. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin, and iron oxide yellow (8 mg tablet only). This product meets USP Dissolution Test 3."
},
{
"NDCCode": "71930-018-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (71930-018-30) ",
"NDC11Code": "71930-0018-30",
"ProductNDC": "71930-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077851",
"LabelerName": "Eywa Pharma Inc.",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180711",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2. , 2 initial and repeat courses of moderately emetogenic cancer chemotherapy. , 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. .",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.5. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin, and iron oxide yellow (8 mg tablet only). This product meets USP Dissolution Test 3."
},
{
"NDCCode": "71930-018-52",
"PackageDescription": "500 TABLET in 1 BOTTLE (71930-018-52) ",
"NDC11Code": "71930-0018-52",
"ProductNDC": "71930-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077851",
"LabelerName": "Eywa Pharma Inc.",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200206",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2. , 2 initial and repeat courses of moderately emetogenic cancer chemotherapy. , 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. .",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.5. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin, and iron oxide yellow (8 mg tablet only). This product meets USP Dissolution Test 3."
},
{
"NDCCode": "71930-019-12",
"PackageDescription": "100 TABLET in 1 BOTTLE (71930-019-12) ",
"NDC11Code": "71930-0019-12",
"ProductNDC": "71930-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210211",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180713",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone Bitartrate and Acetaminophen Tablet is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at dosage or duration [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydrocodone Bitartrate and Acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non- salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet USP, 5 mg/325 mg contains: Hydrocodone Bitartrate………………………..5 mg Acetaminophen……………………………….325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet USP, 7.5 mg/325 mg contains: Hydrocodone Bitartrate………………………..7.5 mg Acetaminophen……………………………….325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet USP, 10 mg/325 mg contains: Hydrocodone Bitartrate………………………..10 mg Acetaminophen……………………………….325 mg In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, FD&C yellow#6 aluminum lake (5 mg/325 mg only), and FD&C blue#1 aluminum lake (10 mg/325 mg only). Meets USP Dissolution Test 2."
},
{
"NDCCode": "71930-019-13",
"PackageDescription": "1000 TABLET in 1 BOTTLE (71930-019-13) ",
"NDC11Code": "71930-0019-13",
"ProductNDC": "71930-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210211",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221006",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone Bitartrate and Acetaminophen Tablet is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at dosage or duration [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydrocodone Bitartrate and Acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non- salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet USP, 5 mg/325 mg contains: Hydrocodone Bitartrate………………………..5 mg Acetaminophen……………………………….325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet USP, 7.5 mg/325 mg contains: Hydrocodone Bitartrate………………………..7.5 mg Acetaminophen……………………………….325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet USP, 10 mg/325 mg contains: Hydrocodone Bitartrate………………………..10 mg Acetaminophen……………………………….325 mg In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, FD&C yellow#6 aluminum lake (5 mg/325 mg only), and FD&C blue#1 aluminum lake (10 mg/325 mg only). Meets USP Dissolution Test 2."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>71930-022-43</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71930-022-43) / 473 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>71930-0022-43</NDC11Code>
<ProductNDC>71930-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207511</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride oral solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including oxycodone hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone hydrochloride oral solution is an opioid agonist, available as solution in 5 mg/5mL (1 mg/mL) strength for oral administration. Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6one hydrochloride and has the following structural formula. C18H21NO4HCl MW 351.82. Oxycodone hydrochloride, USP is a white to off-white fine crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Oxycodone hydrochloride oral solution USP, 5 mg per 5 mL contains equivalent of 4.5 mg of oxycodone free base per 5 mL and contains the following inactive ingredients: sorbitol solution, saccharin sodium, anhydrous citric acid, sodium citrate dihydrate, sodium benzoate, FD&C red #40, mixed berry flavor, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>71930-026-43</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (71930-026-43) </PackageDescription>
<NDC11Code>71930-0026-43</NDC11Code>
<ProductNDC>71930-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brompheniramine Maleate, Pseudoephedrine Hydrochloride,</ProprietaryName>
<NonProprietaryName>Brompheniramine Maleate, Pseudoephedrine Hydrochloride,</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211170</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>2; 30; 10</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.</IndicationAndUsage>
<Description>Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup, 2 mg/30 mg/10 mg per 5 mL is a clear, light pink syrup with a butterscotch flavour. Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate, USP 2 mg Pseudoephedrine Hydrochloride, USP 30 mg Dextromethorphan Hydrobromide, USP 10 mg Alcohol 0.95% v/v In a palatable, aromatic vehicle. Inactive Ingredients: artificial butterscotch flavor, citric acid anhydrous, alcohol, FD&C Red No. 40, glycerin, sucrose, methylparaben, propylene glycol, purified water and sodium benzoate. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 4.0 and 6.0. Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>71930-027-43</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (71930-027-43) </PackageDescription>
<NDC11Code>71930-0027-43</NDC11Code>
<ProductNDC>71930-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211023</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 325</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including hydrocodone bitartrate and acetaminophen oral solution for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Hydrocodone bitartrate and acetaminophen are available in liquid form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:. C18H21NO3C4H6O62½H2O M. W. 494.490 Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non- opiate, non- salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2 M. W. 151.16. In addition, the liquid contains the following inactive ingredients: citric acid anhydrous, ethyl maltol, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Red #33 and FD&C Red #40 as coloring and natural and artificial flavoring.</Description>
</NDC>
<NDC>
<NDCCode>71930-016-12</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71930-016-12) </PackageDescription>
<NDC11Code>71930-0016-12</NDC11Code>
<ProductNDC>71930-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quinidine Gluconate</ProprietaryName>
<NonProprietaryName>Quinidine Gluonate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212589</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>QUINIDINE GLUCONATE</SubstanceName>
<StrengthNumber>324</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-03-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Conversion of atrial fibrillation/flutter In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine gluconate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine gluconate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION), then quinidine gluconate should be discontinued. Reduction of frequency of relapse into atrial fibrillation/flutter Chronic therapy with quinidine gluconate is indicated for some patients at high risk of symptomatic atrial fibrillation/flutter, generally patients who have had previous episodes of atrial fibrillation/flutter that were so frequent and poorly tolerated as to outweigh, in the judgment of the physician and the patient, the risks of prophylactic therapy with quinidine gluconate. The increased risk of death should specifically be considered. Quinidine gluconate should be used only after alternative measures (e.g., use of other drugs to control the ventricular rate) have been found to be inadequate. In patients with histories of frequent symptomatic episodes of atrial fibrillation/flutter, the goal of therapy should be an increase in the average time between episodes. In most patients, the tachyarrhythmia will recur during therapy, and a single recurrence should not be interpreted as therapeutic failure. Suppression of ventricular arrhythmias Quinidine gluconate is also indicated for the suppression of recurrent documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. Because of the proarrhythmic effects of quinidine, its use with ventricular arrhythmias of lesser severity is generally not recommended, and treatment of patients with asymptomatic ventricular premature contractions should be avoided. Where possible, therapy should be guided by the results of programmed electrical stimulation and/or Holter monitoring with exercise. Antiarrhythmic drugs (including quinidine gluconate) have not been shown to enhance survival in patients with ventricular arrhythmias.</IndicationAndUsage>
<Description>Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with Class Ia activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine gluconate is the gluconate salt of quinidine; its chemical name is cinchonan-9-ol, 6'-methoxy-, (9S)-, mono-D-gluconate; its structural formula is. Its empirical formula is C20H24N2O2 C6H12O7, and its molecular weight is 520.58, of which 62.3% is quinidine base. Each quinidine gluconate extended-release tablet contains 324 mg of quinidine gluconate (202 mg of quinidine base) in a matrix to provide extended-release; the inactive ingredients include corn starch, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, alcohol and sodium alginate. Meets USP Dissolution Test 6.</Description>
</NDC>
<NDC>
<NDCCode>37000-022-04</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (37000-022-04) > 124 g in 1 TUBE</PackageDescription>
<NDC11Code>37000-0022-04</NDC11Code>
<ProductNDC>37000-022</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Crest Complete Multi-benefit</ProprietaryName>
<ProprietaryNameSuffix>Whitening Plus Scope</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2.43</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>50881-022-08</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50881-022-08) </PackageDescription>
<NDC11Code>50881-0022-08</NDC11Code>
<ProductNDC>50881-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jakafi Xr</ProprietaryName>
<NonProprietaryName>Ruxolitinib</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217180</ApplicationNumber>
<LabelerName>Incyte Corporation</LabelerName>
<SubstanceName>RUXOLITINIB</SubstanceName>
<StrengthNumber>22</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JAKAFI/JAKAFI XR is a kinase inhibitor indicated for treatment of: 1 intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults. (1.1), 2 polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. (1.2), 3 steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. (1.3), 4 chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. (1.4).</IndicationAndUsage>
<Description>Ruxolitinib phosphate is a kinase inhibitor with the chemical name (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate and a molecular weight of 404.36. Ruxolitinib phosphate has the following structural formula. Ruxolitinib phosphate is a white to off-white to light pink powder and is soluble in aqueous buffers across a pH range of 1 to 8. JAKAFI (ruxolitinib) tablets are for oral administration. Each tablet contains 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg of ruxolitinib free base, equivalent to 6.6 mg, 13.2 mg, 19.8 mg, 26.4 mg, or 33 mg of ruxolitinib phosphate, respectively, and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. JAKAFI XR (ruxolitinib) extended-release tablets are for oral administration. Each tablet contains 11 mg, 22 mg, 33 mg, 44 mg, or 55 mg of ruxolitinib free base equivalent to 14.5 mg, 29 mg, 43.6 mg, 58.1 mg, or 72.6 mg of ruxolitinib phosphate, respectively, and the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: colorants (black iron oxide, red iron oxide, and yellow iron oxide), copovidone, hypromellose, polydextrose, polyethylene glycol, titanium dioxide, and triglycerides.</Description>
</NDC>
<NDC>
<NDCCode>61957-0114-1</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (61957-0114-1) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>61957-0114-01</NDC11Code>
<ProductNDC>61957-0114</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cd Diorskin Nude Skin-glowing Makeup Sunscreen Broad Spectrum Spf 15 022 Cameo</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120827</StartMarketingDate>
<EndMarketingDate>20201231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Parfums Christian Dior</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>30; 43.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120827</StartMarketingDatePackage>
<EndMarketingDatePackage>20201231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64141-022-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64141-022-01) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>64141-0022-01</NDC11Code>
<ProductNDC>64141-022</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bobbi Brown Intensive Skin Serum Foundation Broad Spectrum Spf 35</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Bobbi Brown Professional Cosmetics Inc.</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>83.25; 23.31; 14.43</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75987-022-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (75987-022-01) / 30 TABLET, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>75987-0022-01</NDC11Code>
<ProductNDC>75987-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rayos</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120727</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202020</ApplicationNumber>
<LabelerName>Horizon Therapeutics USA, Inc.</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RAYOS is indicated in the treatment of the following diseases or conditions.</IndicationAndUsage>
<Description>The active ingredient in RAYOS is prednisone (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for prednisone is C21H26O5. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-diene-3,11,20-trione, and the structural formula is. Prednisone is a white to practically white, odorless, crystalline powder and has a molecular weight of 358.43. Prednisone is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. RAYOS is a delayed-release prednisone tablet. It consists of a prednisone-containing core tablet in an inactive shell, which delays the onset of in vitro drug dissolution by approximately 4 hours. Each tablet contains 1 mg, 2 mg, or 5 mg of prednisone, with the following inactive ingredients: dibasic calcium phosphate dihydrate, colloidal silicon dioxide, croscarmellose sodium, glycerol dibehenate, lactose monohydrate, magnesium stearate, povidone, yellow ferric oxide, and red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>75987-022-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (75987-022-02) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>75987-0022-02</NDC11Code>
<ProductNDC>75987-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rayos</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120727</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202020</ApplicationNumber>
<LabelerName>Horizon Therapeutics USA, Inc.</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RAYOS is indicated in the treatment of the following diseases or conditions.</IndicationAndUsage>
<Description>The active ingredient in RAYOS is prednisone (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for prednisone is C21H26O5. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-diene-3,11,20-trione, and the structural formula is. Prednisone is a white to practically white, odorless, crystalline powder and has a molecular weight of 358.43. Prednisone is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. RAYOS is a delayed-release prednisone tablet. It consists of a prednisone-containing core tablet in an inactive shell, which delays the onset of in vitro drug dissolution by approximately 4 hours. Each tablet contains 1 mg, 2 mg, or 5 mg of prednisone, with the following inactive ingredients: dibasic calcium phosphate dihydrate, colloidal silicon dioxide, croscarmellose sodium, glycerol dibehenate, lactose monohydrate, magnesium stearate, povidone, yellow ferric oxide, and red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>75987-022-70</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (75987-022-70) / 7 TABLET, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>75987-0022-70</NDC11Code>
<ProductNDC>75987-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rayos</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120727</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202020</ApplicationNumber>
<LabelerName>Horizon Therapeutics USA, Inc.</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RAYOS is indicated in the treatment of the following diseases or conditions.</IndicationAndUsage>
<Description>The active ingredient in RAYOS is prednisone (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for prednisone is C21H26O5. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-diene-3,11,20-trione, and the structural formula is. Prednisone is a white to practically white, odorless, crystalline powder and has a molecular weight of 358.43. Prednisone is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. RAYOS is a delayed-release prednisone tablet. It consists of a prednisone-containing core tablet in an inactive shell, which delays the onset of in vitro drug dissolution by approximately 4 hours. Each tablet contains 1 mg, 2 mg, or 5 mg of prednisone, with the following inactive ingredients: dibasic calcium phosphate dihydrate, colloidal silicon dioxide, croscarmellose sodium, glycerol dibehenate, lactose monohydrate, magnesium stearate, povidone, yellow ferric oxide, and red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>71930-006-12</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (71930-006-12) </PackageDescription>
<NDC11Code>71930-0006-12</NDC11Code>
<ProductNDC>71930-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211555</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen Tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen Tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen Tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen USP, is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Anhydrous Dibasic Calcium Phosphate, Microcrystalline Cellulose, Lactose Monohydrate, Sodium Starch Glycolate, Magnesium Stearate.</Description>
</NDC>
<NDC>
<NDCCode>71930-006-13</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (71930-006-13) </PackageDescription>
<NDC11Code>71930-0006-13</NDC11Code>
<ProductNDC>71930-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211555</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen Tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen Tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen Tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen USP, is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Anhydrous Dibasic Calcium Phosphate, Microcrystalline Cellulose, Lactose Monohydrate, Sodium Starch Glycolate, Magnesium Stearate.</Description>
</NDC>
<NDC>
<NDCCode>71930-006-52</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (71930-006-52) </PackageDescription>
<NDC11Code>71930-0006-52</NDC11Code>
<ProductNDC>71930-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211555</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen Tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen Tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen Tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen USP, is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Anhydrous Dibasic Calcium Phosphate, Microcrystalline Cellulose, Lactose Monohydrate, Sodium Starch Glycolate, Magnesium Stearate.</Description>
</NDC>
<NDC>
<NDCCode>71930-007-12</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (71930-007-12) </PackageDescription>
<NDC11Code>71930-0007-12</NDC11Code>
<ProductNDC>71930-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211555</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen Tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen Tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen Tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen USP, is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Anhydrous Dibasic Calcium Phosphate, Microcrystalline Cellulose, Lactose Monohydrate, Sodium Starch Glycolate, Magnesium Stearate.</Description>
</NDC>
<NDC>
<NDCCode>71930-007-13</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (71930-007-13) </PackageDescription>
<NDC11Code>71930-0007-13</NDC11Code>
<ProductNDC>71930-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211555</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen Tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen Tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen Tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen USP, is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Anhydrous Dibasic Calcium Phosphate, Microcrystalline Cellulose, Lactose Monohydrate, Sodium Starch Glycolate, Magnesium Stearate.</Description>
</NDC>
<NDC>
<NDCCode>71930-007-52</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (71930-007-52) </PackageDescription>
<NDC11Code>71930-0007-52</NDC11Code>
<ProductNDC>71930-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211555</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen Tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen Tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen Tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen USP, is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Anhydrous Dibasic Calcium Phosphate, Microcrystalline Cellulose, Lactose Monohydrate, Sodium Starch Glycolate, Magnesium Stearate.</Description>
</NDC>
<NDC>
<NDCCode>71930-008-12</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (71930-008-12) </PackageDescription>
<NDC11Code>71930-0008-12</NDC11Code>
<ProductNDC>71930-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetazolamide</ProprietaryName>
<NonProprietaryName>Acetazolamide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211556</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>ACETAZOLAMIDE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide Tablets are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent.</IndicationAndUsage>
<Description>Acetazolamide, an inhibitor of the enzyme carbonic anhydrase is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2-yl) acetamide and has the following chemical structure. Acetazolamide is available as oral tablets containing 125 mg and 250 mg of acetazolamide respectively and the following inactive ingredients: dibasic calcium phosphate dihydrate, corn starch, crospovidone, povidone, purified water and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>71930-009-12</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (71930-009-12) </PackageDescription>
<NDC11Code>71930-0009-12</NDC11Code>
<ProductNDC>71930-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetazolamide</ProprietaryName>
<NonProprietaryName>Acetazolamide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211556</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>ACETAZOLAMIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide Tablets are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent.</IndicationAndUsage>
<Description>Acetazolamide, an inhibitor of the enzyme carbonic anhydrase is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2-yl) acetamide and has the following chemical structure. Acetazolamide is available as oral tablets containing 125 mg and 250 mg of acetazolamide respectively and the following inactive ingredients: dibasic calcium phosphate dihydrate, corn starch, crospovidone, povidone, purified water and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>71930-010-10</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71930-010-10) </PackageDescription>
<NDC11Code>71930-0010-10</NDC11Code>
<ProductNDC>71930-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alosetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211621</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .</IndicationAndUsage>
<Description>The active ingredient in alosetron tablets, USP is alosetron hydrochloride (HCl), USP a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4 yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to pale brown colored powder that has a solubility of 66.82 mg/mL in water, 83.34 mg/mL in 0.1N hydrochloric acid, 74.65 mg/mL in pH 6.8 phosphate buffer, and 60.79 mg/mL in pH 8.0 phosphate buffer. The chemical structure of alosetron is. Alosetron Tablets USP are supplied for oral administration as 0.5 mg (white) and 1 mg (white) tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride, USP equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron hydrochloride, USP equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, macrogol and triacetin. The white film coat for the 1 mg tablet contains hypromellose, titanium dioxide, macrogol and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>71930-010-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71930-010-30) </PackageDescription>
<NDC11Code>71930-0010-30</NDC11Code>
<ProductNDC>71930-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alosetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211621</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .</IndicationAndUsage>
<Description>The active ingredient in alosetron tablets, USP is alosetron hydrochloride (HCl), USP a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4 yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to pale brown colored powder that has a solubility of 66.82 mg/mL in water, 83.34 mg/mL in 0.1N hydrochloric acid, 74.65 mg/mL in pH 6.8 phosphate buffer, and 60.79 mg/mL in pH 8.0 phosphate buffer. The chemical structure of alosetron is. Alosetron Tablets USP are supplied for oral administration as 0.5 mg (white) and 1 mg (white) tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride, USP equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron hydrochloride, USP equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, macrogol and triacetin. The white film coat for the 1 mg tablet contains hypromellose, titanium dioxide, macrogol and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>71930-011-11</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71930-011-11) </PackageDescription>
<NDC11Code>71930-0011-11</NDC11Code>
<ProductNDC>71930-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alosetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211621</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .</IndicationAndUsage>
<Description>The active ingredient in alosetron tablets, USP is alosetron hydrochloride (HCl), USP a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4 yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to pale brown colored powder that has a solubility of 66.82 mg/mL in water, 83.34 mg/mL in 0.1N hydrochloric acid, 74.65 mg/mL in pH 6.8 phosphate buffer, and 60.79 mg/mL in pH 8.0 phosphate buffer. The chemical structure of alosetron is. Alosetron Tablets USP are supplied for oral administration as 0.5 mg (white) and 1 mg (white) tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride, USP equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron hydrochloride, USP equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, macrogol and triacetin. The white film coat for the 1 mg tablet contains hypromellose, titanium dioxide, macrogol and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>71930-011-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71930-011-30) </PackageDescription>
<NDC11Code>71930-0011-30</NDC11Code>
<ProductNDC>71930-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alosetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211621</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .</IndicationAndUsage>
<Description>The active ingredient in alosetron tablets, USP is alosetron hydrochloride (HCl), USP a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4 yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4OHCl, representing a molecular weight of 330.8. Alosetron is a white to pale brown colored powder that has a solubility of 66.82 mg/mL in water, 83.34 mg/mL in 0.1N hydrochloric acid, 74.65 mg/mL in pH 6.8 phosphate buffer, and 60.79 mg/mL in pH 8.0 phosphate buffer. The chemical structure of alosetron is. Alosetron Tablets USP are supplied for oral administration as 0.5 mg (white) and 1 mg (white) tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride, USP equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron hydrochloride, USP equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, macrogol and triacetin. The white film coat for the 1 mg tablet contains hypromellose, titanium dioxide, macrogol and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>71930-015-12</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (71930-015-12) </PackageDescription>
<NDC11Code>71930-0015-12</NDC11Code>
<ProductNDC>71930-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ursodiol</ProprietaryName>
<NonProprietaryName>Ursodiol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212452</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>URSODIOL</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bile Acid [EPC], Bile Acids and Salts [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1. Ursodiol capsules, USP are indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol capsules beyond 24 months is not established. 2. Ursodiol capsules are indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.</IndicationAndUsage>
<Description>Ursodiol Capsules, USP are a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol (ursodeoxycholic acid) is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a white or almost white crystalline powder freely soluble in alcohol and in glacial acetic acid, sparingly soluble in chloroform, slightly soluble in ether; practically insoluble in water. The chemical name for ursodiol is 3α,7β-Dihydroxy-5β-cholan-24-oic acid (C24H40O4). Ursodiol has a molecular weight of 392.57. Its structure is shown below:. Each capsule contains 300 mg of ursodiol with the following inactive ingredients: Pregelatinized starch, Silicon Dioxide, Magnesium Stearate and Hard Gelatin capsule shell. Capsule shell contains iron oxide red, iron oxide yellow, titanium dioxide and gelatin. The imprinting ink contains the following: Shellac, Dehydrated Alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Strong Ammonia Solution, Black Iron Oxide and Potassium Hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>71930-017-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71930-017-30) </PackageDescription>
<NDC11Code>71930-0017-30</NDC11Code>
<ProductNDC>71930-017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077851</ApplicationNumber>
<LabelerName>Eywa Pharma Inc.</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2. , 2 initial and repeat courses of moderately emetogenic cancer chemotherapy. , 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. .</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.5. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin, and iron oxide yellow (8 mg tablet only). This product meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>71930-017-52</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (71930-017-52) </PackageDescription>
<NDC11Code>71930-0017-52</NDC11Code>
<ProductNDC>71930-017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077851</ApplicationNumber>
<LabelerName>Eywa Pharma Inc.</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2. , 2 initial and repeat courses of moderately emetogenic cancer chemotherapy. , 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. .</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.5. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin, and iron oxide yellow (8 mg tablet only). This product meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>71930-018-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71930-018-30) </PackageDescription>
<NDC11Code>71930-0018-30</NDC11Code>
<ProductNDC>71930-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077851</ApplicationNumber>
<LabelerName>Eywa Pharma Inc.</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2. , 2 initial and repeat courses of moderately emetogenic cancer chemotherapy. , 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. .</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.5. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin, and iron oxide yellow (8 mg tablet only). This product meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>71930-018-52</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (71930-018-52) </PackageDescription>
<NDC11Code>71930-0018-52</NDC11Code>
<ProductNDC>71930-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077851</ApplicationNumber>
<LabelerName>Eywa Pharma Inc.</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2. , 2 initial and repeat courses of moderately emetogenic cancer chemotherapy. , 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. .</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.5. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin, and iron oxide yellow (8 mg tablet only). This product meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>71930-019-12</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (71930-019-12) </PackageDescription>
<NDC11Code>71930-0019-12</NDC11Code>
<ProductNDC>71930-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180713</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210211</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone Bitartrate and Acetaminophen Tablet is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at dosage or duration [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non- salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet USP, 5 mg/325 mg contains: Hydrocodone Bitartrate………………………..5 mg Acetaminophen……………………………….325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet USP, 7.5 mg/325 mg contains: Hydrocodone Bitartrate………………………..7.5 mg Acetaminophen……………………………….325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet USP, 10 mg/325 mg contains: Hydrocodone Bitartrate………………………..10 mg Acetaminophen……………………………….325 mg In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, FD&C yellow#6 aluminum lake (5 mg/325 mg only), and FD&C blue#1 aluminum lake (10 mg/325 mg only). Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>71930-019-13</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (71930-019-13) </PackageDescription>
<NDC11Code>71930-0019-13</NDC11Code>
<ProductNDC>71930-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180713</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210211</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone Bitartrate and Acetaminophen Tablet is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at dosage or duration [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non- salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet USP, 5 mg/325 mg contains: Hydrocodone Bitartrate………………………..5 mg Acetaminophen……………………………….325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet USP, 7.5 mg/325 mg contains: Hydrocodone Bitartrate………………………..7.5 mg Acetaminophen……………………………….325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet USP, 10 mg/325 mg contains: Hydrocodone Bitartrate………………………..10 mg Acetaminophen……………………………….325 mg In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, FD&C yellow#6 aluminum lake (5 mg/325 mg only), and FD&C blue#1 aluminum lake (10 mg/325 mg only). Meets USP Dissolution Test 2.</Description>
</NDC>
</NDCList>