{
"NDC": [
{
"NDCCode": "54897-701-14",
"PackageDescription": "21 g in 1 TUBE (54897-701-14) ",
"NDC11Code": "54897-0701-14",
"ProductNDC": "54897-701",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Salivea",
"NonProprietaryName": "Fluoride Toothpaste",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Laclede, Inc.",
"SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
"StrengthNumber": "1.4",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "Y",
"IndicationAndUsage": "Aids in the prevention of dental cavities."
},
{
"NDCCode": "54897-701-13",
"PackageDescription": "121.9 g in 1 TUBE (54897-701-13) ",
"NDC11Code": "54897-0701-13",
"ProductNDC": "54897-701",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Salivea",
"NonProprietaryName": "Fluoride Toothpaste",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20180219",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Laclede, Inc.",
"SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
"StrengthNumber": "1.4",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180219",
"SamplePackage": "N",
"IndicationAndUsage": "Aids in the prevention of dental cavities."
},
{
"NDCCode": "35000-701-05",
"PackageDescription": "14.1 g in 1 CONTAINER (35000-701-05)",
"NDC11Code": "35000-0701-05",
"ProductNDC": "35000-701",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Speed Stick",
"ProprietaryNameSuffix": "Irish Spring Original Antiperspirant Deodorant",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110609",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "160",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "55289-701-14",
"PackageDescription": "14 TABLET in 1 BOTTLE, PLASTIC (55289-701-14) ",
"NDC11Code": "55289-0701-14",
"ProductNDC": "55289-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040876",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150929",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride, USP 37.5 mg is indicated as short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including Phentermine hydrochloride, [see CLINICAL PHARMACOLOGY ( 12.1, 12.2) ] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride is available as a capsule and tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride capsules, USP contain the inactive ingredients: corn starch, D&C Red #33, FD&C Blue #1, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide. Phentermine hydrochloride tablets, USP contain the inactive ingredients: corn starch, colloidal silicon dioxide, FD&C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, stearic acid, and sucrose."
},
{
"NDCCode": "58602-701-14",
"PackageDescription": "1 BOTTLE in 1 CARTON (58602-701-14) > 50 TABLET in 1 BOTTLE",
"NDC11Code": "58602-0701-14",
"ProductNDC": "58602-701",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loperamide Hydrochloride",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206548",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20151215",
"SamplePackage": "N"
},
{
"NDCCode": "70994-701-15",
"PackageDescription": "1 JAR in 1 BOX (70994-701-15) > 1.82 g in 1 JAR (70994-701-14) ",
"NDC11Code": "70994-0701-15",
"ProductNDC": "70994-701",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Care",
"NonProprietaryName": "Calendula Officials, Stellaria Media, St. Johns Wort, Rosemary Oil, Plantago Major, Commiphora Myrrha, Comfrey Leaf, Salvia Officinalis, Sunflower Oil",
"DosageFormName": "SALVE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190725",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sierra Sage Herbs LLC",
"SubstanceName": "ACHILLEA MILLEFOLIUM FLOWER; ST. JOHN'S WORT; STELLARIA MEDIA; CALENDULA OFFICINALIS FLOWER; PLANTAGO MAJOR; COMMIPHORA MYRRHA WHOLE; SALVIA OFFICINALIS WHOLE; COMFREY LEAF",
"StrengthNumber": "1; 1; 1; 1; 1; 1; 1; 1",
"StrengthUnit": "[hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g",
"Status": "Deprecated",
"LastUpdate": "2019-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190725",
"SamplePackage": "N"
},
{
"NDCCode": "75111-701-14",
"PackageDescription": "80 CLOTH in 1 CANISTER (75111-701-14) ",
"NDC11Code": "75111-0701-14",
"ProductNDC": "75111-701",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Sanitizing Wipes",
"NonProprietaryName": "Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Enping Jiaxin Daily Necessities Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "1/1001",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "ANTIBACTERIAL SANITIZING WIPES to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79539-701-14",
"PackageDescription": "120 CLOTH in 1 BAG (79539-701-14) ",
"NDC11Code": "79539-0701-14",
"ProductNDC": "79539-701",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Instant Hand Sanitizeing Wipe",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20201121",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Shandong Yayun Sanitary Products Co., Ltd.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "g/1001",
"Status": "Deprecated",
"LastUpdate": "2023-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20201121",
"SamplePackage": "N"
},
{
"NDCCode": "43068-701-02",
"PackageDescription": "60 TABLET in 1 BOTTLE (43068-701-02) ",
"NDC11Code": "43068-0701-02",
"ProductNDC": "43068-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bysanti",
"NonProprietaryName": "Milsaperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220358",
"LabelerName": "Vanda Pharmaceuticals Inc.",
"SubstanceName": "MILSAPERIDONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "BYSANTI is indicated for the: 1 Treatment of schizophrenia in adults [see Clinical Studies (14.1)]., 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults [see Clinical Studies (14.2)].",
"Description": "The active ingredient in BYSANTI is milsaperidone, an atypical antipsychotic that is in the piperidinyl-benzisoxazole derivative chemical class. Its chemical name is benzenemethanol, 4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy]-3-methoxy-α- methyl-, (αS)-. Its molecular formula is C24H29FN2O4 and its molecular weight is 428.50. Milsaperidone is a white to off-white finely crystalline powder. The structural formula of milsaperidone is. Milsaperidone is a white to off-white finely crystalline powder. BYSANTI (milsaperidone) tablets are for oral administration only. Coated tablets contain 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of milsaperidone. Inactive ingredients are the following: colloidal silicon dioxide, crospovidone, hydroxypropylmethylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and water (removed during processing)."
},
{
"NDCCode": "49483-701-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (49483-701-01) ",
"NDC11Code": "49483-0701-01",
"ProductNDC": "49483-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075465",
"LabelerName": "TIME CAP LABORATORIES, INC.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220212",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2)]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3)]. Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine and the following inactive ingredients: pregelatinized starch. The capsule shells and imprinting ink contain FD&C Blue- 1 (brilliant blue FCF), gelatin, titanium dioxide, sodium lauryl sulfate, shellac, povidone, sodium hydroxide, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "49483-701-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (49483-701-10) ",
"NDC11Code": "49483-0701-10",
"ProductNDC": "49483-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075465",
"LabelerName": "TIME CAP LABORATORIES, INC.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220212",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2)]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3)]. Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine and the following inactive ingredients: pregelatinized starch. The capsule shells and imprinting ink contain FD&C Blue- 1 (brilliant blue FCF), gelatin, titanium dioxide, sodium lauryl sulfate, shellac, povidone, sodium hydroxide, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "50804-701-25",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (50804-701-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC",
"NDC11Code": "50804-0701-25",
"ProductNDC": "50804-701",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stool Softener Laxative",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20230203",
"EndMarketingDate": "20261130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Good Sense (Geiss, Destin & Dunn, Inc.)",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230203",
"EndMarketingDatePackage": "20261130",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional constipation and irregularity. this product generally produces bowel movement in 12 to 72 hours."
},
{
"NDCCode": "55111-701-60",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-701-60) ",
"NDC11Code": "55111-0701-60",
"ProductNDC": "55111-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen And Esomeprazole Magnesium",
"NonProprietaryName": "Naproxen And Esomeprazole Magnesium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204206",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "NAPROXEN; ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "500; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200218",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component of naproxen and esomeprazole magnesium delayed-release tablet is indicated for relief of signs and symptoms of:. osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults. juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component of naproxen and esomeprazole magnesium delayed-release tablet is indicated to decrease the risk of developing naproxen-associated gastric ulcers. Limitations of Use:. Do not substitute naproxen and esomeprazole magnesium delayed-release tablet with the single-ingredient products of naproxen and esomeprazole magnesium. Naproxen and esomeprazole magnesium delayed-release tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months [see Use in Specific Populations (8.4), Clinical Studies (14)].",
"Description": "The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as modified capsule shaped, off white to yellow colored 375 mg/20 mg and 500 mg/20 mg, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) or 500 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) for oral administration. The inactive ingredients are ammonium hydroxide, croscarmellose sodium, ferric oxide yellow, hypromellose, iron oxide black, lactose monohydrate, magnesium oxide, magnesium stearate, methacrylic acid copolymer, poloxamer, polyethylene glycol 400, povidone, propylene glycol, shellac glaze, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen USP is white to off-white practically odourless crystalline powder. It is soluble in chloroform, in dehydrated alcohol and in alcohol, sparingly soluble in ether and practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 6.48 is 1.5. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium amorphous. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C17H18N3O3S)2Mg with molecular weight of 713.1. The structural formula is. The esomepraozle magnesium USP is a white to pale cream colored powder. It is slightly soluble in methanol and soluble in N,N-Dimethyl formamide and practically insoluble in heptane and in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C."
},
{
"NDCCode": "60951-701-70",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (60951-701-70) ",
"NDC11Code": "60951-0701-70",
"ProductNDC": "60951-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Endocet",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030306",
"EndMarketingDate": "20280331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040330",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "2.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030306",
"EndMarketingDatePackage": "20280331",
"SamplePackage": "N",
"IndicationAndUsage": "ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 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, reserve opioid analgesics, including ENDOCET, 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 and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. All strengths of ENDOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula."
},
{
"NDCCode": "61919-701-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (61919-701-20) ",
"NDC11Code": "61919-0701-20",
"ProductNDC": "61919-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin Calcium",
"NonProprietaryName": "Rosuvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207616",
"LabelerName": "DIRECT RX",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190424",
"SamplePackage": "N",
"IndicationAndUsage": "Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.3 Hypertriglyceridemia. Rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 1.4 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia). Rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). 1.5 Adult Patients with Homozygous Familial Hypercholesterolemia. Rosuvastatin calcium tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia. 1.8 Limitations of Use. Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias.",
"Description": "Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. [strucural formula]. The empirical formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin calcium tablets for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: For 5 mg: Each film coated tablet contains: microcrystalline cellulose, lactose monohydrate, anhydrous lactose, crospovidone, magnesium oxide, magnesium stearate, hypromellose, triacetin, titanium dioxide, and ferric oxide yellow. For 10, 20 and 40 mg: Each film coated tablet contains: microcrystalline cellulose, lactose monohydrate, anhydrous lactose, crospovidone, magnesium oxide, magnesium stearate, hypromellose, triacetin, titanium dioxide, FD & C yellow No. 6, FD & C red No. 40, and FD & C blue No.1."
},
{
"NDCCode": "61919-701-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (61919-701-30) ",
"NDC11Code": "61919-0701-30",
"ProductNDC": "61919-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin Calcium",
"NonProprietaryName": "Rosuvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207616",
"LabelerName": "Direct_Rx",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190819",
"SamplePackage": "N",
"IndicationAndUsage": "Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.3 Hypertriglyceridemia. Rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 1.4 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia). Rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). 1.5 Adult Patients with Homozygous Familial Hypercholesterolemia. Rosuvastatin calcium tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia. 1.8 Limitations of Use. Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias.",
"Description": "Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl (methylsulfonyl) amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula. [structure]. The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to almost white powder that is sparingly soluble in methanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient of 1.14 by HPLC. Rosuvastatin calcium tablets for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake."
},
{
"NDCCode": "61919-701-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (61919-701-90) ",
"NDC11Code": "61919-0701-90",
"ProductNDC": "61919-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin Calcium",
"NonProprietaryName": "Rosuvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207616",
"LabelerName": "Direct_Rx",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190819",
"SamplePackage": "N",
"IndicationAndUsage": "Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.3 Hypertriglyceridemia. Rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 1.4 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia). Rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). 1.5 Adult Patients with Homozygous Familial Hypercholesterolemia. Rosuvastatin calcium tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia. 1.8 Limitations of Use. Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias.",
"Description": "Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl (methylsulfonyl) amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula. [structure]. The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to almost white powder that is sparingly soluble in methanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient of 1.14 by HPLC. Rosuvastatin calcium tablets for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake."
},
{
"NDCCode": "64406-701-01",
"PackageDescription": "1 POWDER, FOR SUSPENSION in 1 VIAL, SINGLE-USE (64406-701-01) ",
"NDC11Code": "64406-0701-01",
"ProductNDC": "64406-701",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Eftrenonacog Alfa",
"DosageFormName": "POWDER, FOR SUSPENSION",
"StartMarketingDate": "20140505",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Biogen Inc.",
"SubstanceName": "EFTRENONACOG ALFA",
"StrengthNumber": "500",
"StrengthUnit": "[iU]/1",
"Status": "Unfinished",
"LastUpdate": "2026-02-25",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "05-MAY-14"
},
{
"NDCCode": "64896-701-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-701-01) ",
"NDC11Code": "64896-0701-01",
"ProductNDC": "64896-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxymorphone Hydrochloride",
"NonProprietaryName": "Oxymorphone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079087",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "OXYMORPHONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130102",
"SamplePackage": "N",
"IndicationAndUsage": "Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Usage: 1 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 (5.1)], reserve opioid analgesics, including Oxymorphone Hydrochloride Extended-Release Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Oxymorphone Hydrochloride Extended-Release Tablets are not indicated as an as-needed (prn) analgesic.",
"Description": "Oxymorphone Hydrochloride Extended-Release Tablets, USP are for oral use and contain oxymorphone, an opioid agonist. Oxymorphone Hydrochloride Extended-Release Tablets, USP are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride per tablet. The tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, hypromellose, xanthan gum, magnesium stearate, polyvinyl alcohol - partially hydrolyzed, polyethylene glycol, talc, and titanium dioxide. The 5 mg, 7.5 mg, 10 mg, 20 mg and 40 mg tablets contain FD&C Yellow No. 6 Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue No. 2 and D&C Red No. 27. The 7.5 mg tablets contain FD&C Blue No. 2 and FD&C Red No. 40. The 10 mg tablets contain FD&C Red No. 40. The 20 mg tablets contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1, and FD&C Blue No. 2. The 30 mg tablets contain Iron Oxide Yellow and Iron Oxide Black. The 40 mg tablets contain D&C Yellow No. 10 Aluminum Lake. The chemical name of oxymorphone hydrochloride is 4,5α-epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride. Oxymorphone hydrochloride, USP is a white or slightly off-white, odorless powder, which is sparingly soluble in alcohol and ether, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The pKa1 and pKa2 of oxymorphone at 37°C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37°C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "64896-701-03",
"PackageDescription": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-701-03) ",
"NDC11Code": "64896-0701-03",
"ProductNDC": "64896-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxymorphone Hydrochloride",
"NonProprietaryName": "Oxymorphone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079087",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "OXYMORPHONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130102",
"SamplePackage": "N",
"IndicationAndUsage": "Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Usage: 1 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 (5.1)], reserve opioid analgesics, including Oxymorphone Hydrochloride Extended-Release Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Oxymorphone Hydrochloride Extended-Release Tablets are not indicated as an as-needed (prn) analgesic.",
"Description": "Oxymorphone Hydrochloride Extended-Release Tablets, USP are for oral use and contain oxymorphone, an opioid agonist. Oxymorphone Hydrochloride Extended-Release Tablets, USP are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride per tablet. The tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, hypromellose, xanthan gum, magnesium stearate, polyvinyl alcohol - partially hydrolyzed, polyethylene glycol, talc, and titanium dioxide. The 5 mg, 7.5 mg, 10 mg, 20 mg and 40 mg tablets contain FD&C Yellow No. 6 Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue No. 2 and D&C Red No. 27. The 7.5 mg tablets contain FD&C Blue No. 2 and FD&C Red No. 40. The 10 mg tablets contain FD&C Red No. 40. The 20 mg tablets contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1, and FD&C Blue No. 2. The 30 mg tablets contain Iron Oxide Yellow and Iron Oxide Black. The 40 mg tablets contain D&C Yellow No. 10 Aluminum Lake. The chemical name of oxymorphone hydrochloride is 4,5α-epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride. Oxymorphone hydrochloride, USP is a white or slightly off-white, odorless powder, which is sparingly soluble in alcohol and ether, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The pKa1 and pKa2 of oxymorphone at 37°C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37°C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "64896-701-08",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-701-08) ",
"NDC11Code": "64896-0701-08",
"ProductNDC": "64896-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxymorphone Hydrochloride",
"NonProprietaryName": "Oxymorphone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079087",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "OXYMORPHONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130102",
"SamplePackage": "N",
"IndicationAndUsage": "Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Usage: 1 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 (5.1)], reserve opioid analgesics, including Oxymorphone Hydrochloride Extended-Release Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Oxymorphone Hydrochloride Extended-Release Tablets are not indicated as an as-needed (prn) analgesic.",
"Description": "Oxymorphone Hydrochloride Extended-Release Tablets, USP are for oral use and contain oxymorphone, an opioid agonist. Oxymorphone Hydrochloride Extended-Release Tablets, USP are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride per tablet. The tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, hypromellose, xanthan gum, magnesium stearate, polyvinyl alcohol - partially hydrolyzed, polyethylene glycol, talc, and titanium dioxide. The 5 mg, 7.5 mg, 10 mg, 20 mg and 40 mg tablets contain FD&C Yellow No. 6 Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue No. 2 and D&C Red No. 27. The 7.5 mg tablets contain FD&C Blue No. 2 and FD&C Red No. 40. The 10 mg tablets contain FD&C Red No. 40. The 20 mg tablets contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1, and FD&C Blue No. 2. The 30 mg tablets contain Iron Oxide Yellow and Iron Oxide Black. The 40 mg tablets contain D&C Yellow No. 10 Aluminum Lake. The chemical name of oxymorphone hydrochloride is 4,5α-epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride. Oxymorphone hydrochloride, USP is a white or slightly off-white, odorless powder, which is sparingly soluble in alcohol and ether, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The pKa1 and pKa2 of oxymorphone at 37°C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37°C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "64896-701-13",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-701-13) ",
"NDC11Code": "64896-0701-13",
"ProductNDC": "64896-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxymorphone Hydrochloride",
"NonProprietaryName": "Oxymorphone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079087",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "OXYMORPHONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130102",
"SamplePackage": "N",
"IndicationAndUsage": "Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Usage: 1 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 (5.1)], reserve opioid analgesics, including Oxymorphone Hydrochloride Extended-Release Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Oxymorphone Hydrochloride Extended-Release Tablets are not indicated as an as-needed (prn) analgesic.",
"Description": "Oxymorphone Hydrochloride Extended-Release Tablets, USP are for oral use and contain oxymorphone, an opioid agonist. Oxymorphone Hydrochloride Extended-Release Tablets, USP are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride per tablet. The tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, hypromellose, xanthan gum, magnesium stearate, polyvinyl alcohol - partially hydrolyzed, polyethylene glycol, talc, and titanium dioxide. The 5 mg, 7.5 mg, 10 mg, 20 mg and 40 mg tablets contain FD&C Yellow No. 6 Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue No. 2 and D&C Red No. 27. The 7.5 mg tablets contain FD&C Blue No. 2 and FD&C Red No. 40. The 10 mg tablets contain FD&C Red No. 40. The 20 mg tablets contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1, and FD&C Blue No. 2. The 30 mg tablets contain Iron Oxide Yellow and Iron Oxide Black. The 40 mg tablets contain D&C Yellow No. 10 Aluminum Lake. The chemical name of oxymorphone hydrochloride is 4,5α-epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride. Oxymorphone hydrochloride, USP is a white or slightly off-white, odorless powder, which is sparingly soluble in alcohol and ether, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The pKa1 and pKa2 of oxymorphone at 37°C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37°C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "69315-701-50",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (69315-701-50) / 50 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "69315-0701-50",
"ProductNDC": "69315-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ethacrynate Sodium",
"NonProprietaryName": "Ethacrynate Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208663",
"LabelerName": "Leading Pharma, LLC",
"SubstanceName": "ETHACRYNATE SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/50mL",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260109",
"SamplePackage": "N",
"IndicationAndUsage": "Ethacrynate sodium is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. : 1 Treatment of the edema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome., 2 Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema., 3 Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome., 4 Intravenous ethacrynate sodium is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable.",
"Description": "Ethacrynic acid is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2-methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of 303.14. Ethacrynic acid is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene. Its empirical formula is C13H12Cl2O4 and its structural formula is. Ethacrynate sodium, the sodium salt of ethacrynic acid, is soluble in water at 25°C to the extent of about 7 percent. Solutions of the sodium salt are relatively stable at about pH 7 at room temperature for short periods, but as the pH or temperature increases the solutions are less stable. The molecular weight of ethacrynate sodium is 325.12. Its empirical formula is C13H11Cl2NaO4 and its structural formula is. Intravenous Ethacrynate Sodium is a sterile freeze-dried powder and is supplied in a vial containing. Ethacrynate sodium equivalent to ethacrynic acid - 50 mg. Inactive ingredient. Mannitol - 62.5 mg."
},
{
"NDCCode": "71288-701-05",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (71288-701-05) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-701-06) ",
"NDC11Code": "71288-0701-05",
"ProductNDC": "71288-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atracurium Besylate",
"NonProprietaryName": "Atracurium Besylate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091488",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "ATRACURIUM BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180515",
"SamplePackage": "N",
"IndicationAndUsage": "Atracurium besylate injection is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Atracurium besylate is an intermediate-duration, nondepolarizing, skeletal muscle relaxant for intravenous administration. Atracurium besylate is designated as 2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester. It has a molecular weight of 1243.49, and its molecular formula is C65H82N2O18S2. The structural formula is. Atracurium besylate is a complex molecule containing four sites at which different stereochemical configurations can occur. The symmetry of the molecule, however, results in only ten, instead of sixteen, possible different isomers. The manufacture of atracurium besylate results in these isomers being produced in unequal amounts but with a consistent ratio. Those molecules in which the methyl group attached to the quaternary nitrogen projects on the opposite side to the adjacent substituted-benzyl moiety predominate by approximately 3:1. Atracurium Besylate Injection, USP is a sterile, non-pyrogenic aqueous solution. Each mL contains 10 mg atracurium besylate. The pH is adjusted to 3.25 to 3.65 with benzenesulfonic acid. The multiple dose vial contains 0.9% benzyl alcohol added as a preservative. Atracurium besylate injection slowly loses potency with time at the rate of approximately 6% per year under refrigeration (5°C). Atracurium besylate injection should be refrigerated at 2° to 8°C (36° to 46°F) to preserve potency. Rate of loss in potency increases to approximately 5% per month at 25°C (77°F). Upon removal from refrigeration to room temperature storage conditions (25°C / 77°F), use atracurium besylate injection within 14 days even if re-refrigerated."
},
{
"NDCCode": "71896-701-37",
"PackageDescription": "1200 mL in 1 BOTTLE, DISPENSING (71896-701-37) ",
"NDC11Code": "71896-0701-37",
"ProductNDC": "71896-701",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pacific Blue Ultra Foaming",
"ProprietaryNameSuffix": "Fragrance Free",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160602",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Interline Brands, Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201006",
"SamplePackage": "N"
},
{
"NDCCode": "54897-507-17",
"PackageDescription": "165 g in 1 BOTTLE (54897-507-17)",
"NDC11Code": "54897-0507-17",
"ProductNDC": "54897-507",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topical Fluoride Foam Bumble Bee Bubble Gum",
"NonProprietaryName": "Acidulated Phosphate Fluoride",
"DosageFormName": "AEROSOL",
"RouteName": "DENTAL",
"StartMarketingDate": "20000504",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Laclede, Inc.",
"SubstanceName": "SODIUM FLUORIDE; HYDROFLUORIC ACID",
"StrengthNumber": "10; 2.3",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "54897-601-11",
"PackageDescription": "1500 mg in 1 POUCH (54897-601-11)",
"NDC11Code": "54897-0601-11",
"ProductNDC": "54897-601",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Luvena Feminine Wipes",
"NonProprietaryName": "Pramoxine Hydrochloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120404",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "LACLEDE, INC.",
"SubstanceName": "PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1000mg",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0869-0816-35",
"PackageDescription": "701 mL in 1 BOTTLE, PLASTIC (0869-0816-35) ",
"NDC11Code": "00869-0816-35",
"ProductNDC": "0869-0816",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dandruff",
"NonProprietaryName": "Selenium Sulfide",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160925",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "Vi-Jon, LLC",
"SubstanceName": "SELENIUM SULFIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-02-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160925",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent recurrence of itching, irritation, redness, flaking and scaling associated with dandruff and seborrheic dermatitis."
},
{
"NDCCode": "10056-701-34",
"PackageDescription": "170 g in 1 BOTTLE, PLASTIC (10056-701-34)",
"NDC11Code": "10056-0701-34",
"ProductNDC": "10056-701",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Peter Island Continuous Sport Sunscreen",
"ProprietaryNameSuffix": "Spf 50",
"NonProprietaryName": "Homosalate, Oxybenzone, Octisalate, Avobenzone, Octocrylene",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130627",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Access Business Group LLC",
"SubstanceName": "HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "15; 6; 3; 5; 2",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "10135-701-04",
"PackageDescription": "113 g in 1 TUBE (10135-701-04) ",
"NDC11Code": "10135-0701-04",
"ProductNDC": "10135-701",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Menthol And Zinc Oxide",
"NonProprietaryName": "Menthol And Zinc Oxide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M015",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "MENTHOL; ZINC OXIDE",
"StrengthNumber": ".44; 20.625",
"StrengthUnit": "g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210501",
"SamplePackage": "N",
"IndicationAndUsage": "A moisture barrier that prevents & helps heal skin irritations from. : 1 Urine, 2 Diarrhea, 3 Perspiration, 4 Fistula drainage, 5 Feeding tube site leakage, 6 Wound drainage (peri-wound skin), 7 Minor burns, 8 Cuts, 9 Scrapes, 10 Itching."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>54897-701-14</NDCCode>
<PackageDescription>21 g in 1 TUBE (54897-701-14) </PackageDescription>
<NDC11Code>54897-0701-14</NDC11Code>
<ProductNDC>54897-701</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Salivea</ProprietaryName>
<NonProprietaryName>Fluoride Toothpaste</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Laclede, Inc.</LabelerName>
<SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
<StrengthNumber>1.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54897-701-13</NDCCode>
<PackageDescription>121.9 g in 1 TUBE (54897-701-13) </PackageDescription>
<NDC11Code>54897-0701-13</NDC11Code>
<ProductNDC>54897-701</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Salivea</ProprietaryName>
<NonProprietaryName>Fluoride Toothpaste</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20180219</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Laclede, Inc.</LabelerName>
<SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
<StrengthNumber>1.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35000-701-05</NDCCode>
<PackageDescription>14.1 g in 1 CONTAINER (35000-701-05)</PackageDescription>
<NDC11Code>35000-0701-05</NDC11Code>
<ProductNDC>35000-701</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Speed Stick</ProprietaryName>
<ProprietaryNameSuffix>Irish Spring Original Antiperspirant Deodorant</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110609</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55289-701-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE, PLASTIC (55289-701-14) </PackageDescription>
<NDC11Code>55289-0701-14</NDC11Code>
<ProductNDC>55289-701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040876</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride, USP 37.5 mg is indicated as short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including Phentermine hydrochloride, [see CLINICAL PHARMACOLOGY ( 12.1, 12.2) ] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride is available as a capsule and tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride capsules, USP contain the inactive ingredients: corn starch, D&C Red #33, FD&C Blue #1, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide. Phentermine hydrochloride tablets, USP contain the inactive ingredients: corn starch, colloidal silicon dioxide, FD&C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, stearic acid, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>58602-701-14</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (58602-701-14) > 50 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>58602-0701-14</NDC11Code>
<ProductNDC>58602-701</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loperamide Hydrochloride</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206548</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70994-701-15</NDCCode>
<PackageDescription>1 JAR in 1 BOX (70994-701-15) > 1.82 g in 1 JAR (70994-701-14) </PackageDescription>
<NDC11Code>70994-0701-15</NDC11Code>
<ProductNDC>70994-701</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Care</ProprietaryName>
<NonProprietaryName>Calendula Officials, Stellaria Media, St. Johns Wort, Rosemary Oil, Plantago Major, Commiphora Myrrha, Comfrey Leaf, Salvia Officinalis, Sunflower Oil</NonProprietaryName>
<DosageFormName>SALVE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190725</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sierra Sage Herbs LLC</LabelerName>
<SubstanceName>ACHILLEA MILLEFOLIUM FLOWER; ST. JOHN'S WORT; STELLARIA MEDIA; CALENDULA OFFICINALIS FLOWER; PLANTAGO MAJOR; COMMIPHORA MYRRHA WHOLE; SALVIA OFFICINALIS WHOLE; COMFREY LEAF</SubstanceName>
<StrengthNumber>1; 1; 1; 1; 1; 1; 1; 1</StrengthNumber>
<StrengthUnit>[hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75111-701-14</NDCCode>
<PackageDescription>80 CLOTH in 1 CANISTER (75111-701-14) </PackageDescription>
<NDC11Code>75111-0701-14</NDC11Code>
<ProductNDC>75111-701</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Sanitizing Wipes</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Enping Jiaxin Daily Necessities Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>1/1001</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ANTIBACTERIAL SANITIZING WIPES to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79539-701-14</NDCCode>
<PackageDescription>120 CLOTH in 1 BAG (79539-701-14) </PackageDescription>
<NDC11Code>79539-0701-14</NDC11Code>
<ProductNDC>79539-701</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Instant Hand Sanitizeing Wipe</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>20201121</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Shandong Yayun Sanitary Products Co., Ltd.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/1001</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43068-701-02</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (43068-701-02) </PackageDescription>
<NDC11Code>43068-0701-02</NDC11Code>
<ProductNDC>43068-701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bysanti</ProprietaryName>
<NonProprietaryName>Milsaperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220358</ApplicationNumber>
<LabelerName>Vanda Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MILSAPERIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BYSANTI is indicated for the: 1 Treatment of schizophrenia in adults [see Clinical Studies (14.1)]., 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>The active ingredient in BYSANTI is milsaperidone, an atypical antipsychotic that is in the piperidinyl-benzisoxazole derivative chemical class. Its chemical name is benzenemethanol, 4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy]-3-methoxy-α- methyl-, (αS)-. Its molecular formula is C24H29FN2O4 and its molecular weight is 428.50. Milsaperidone is a white to off-white finely crystalline powder. The structural formula of milsaperidone is. Milsaperidone is a white to off-white finely crystalline powder. BYSANTI (milsaperidone) tablets are for oral administration only. Coated tablets contain 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of milsaperidone. Inactive ingredients are the following: colloidal silicon dioxide, crospovidone, hydroxypropylmethylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and water (removed during processing).</Description>
</NDC>
<NDC>
<NDCCode>49483-701-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (49483-701-01) </PackageDescription>
<NDC11Code>49483-0701-01</NDC11Code>
<ProductNDC>49483-701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075465</ApplicationNumber>
<LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2)]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3)]. Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine and the following inactive ingredients: pregelatinized starch. The capsule shells and imprinting ink contain FD&C Blue- 1 (brilliant blue FCF), gelatin, titanium dioxide, sodium lauryl sulfate, shellac, povidone, sodium hydroxide, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>49483-701-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (49483-701-10) </PackageDescription>
<NDC11Code>49483-0701-10</NDC11Code>
<ProductNDC>49483-701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075465</ApplicationNumber>
<LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2)]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3)]. Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine and the following inactive ingredients: pregelatinized starch. The capsule shells and imprinting ink contain FD&C Blue- 1 (brilliant blue FCF), gelatin, titanium dioxide, sodium lauryl sulfate, shellac, povidone, sodium hydroxide, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>50804-701-25</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (50804-701-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50804-0701-25</NDC11Code>
<ProductNDC>50804-701</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stool Softener Laxative</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230203</StartMarketingDate>
<EndMarketingDate>20261130</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>Good Sense (Geiss, Destin & Dunn, Inc.)</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230203</StartMarketingDatePackage>
<EndMarketingDatePackage>20261130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of occasional constipation and irregularity. this product generally produces bowel movement in 12 to 72 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55111-701-60</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-701-60) </PackageDescription>
<NDC11Code>55111-0701-60</NDC11Code>
<ProductNDC>55111-701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen And Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Naproxen And Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204206</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>NAPROXEN; ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>500; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component of naproxen and esomeprazole magnesium delayed-release tablet is indicated for relief of signs and symptoms of:. osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults. juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component of naproxen and esomeprazole magnesium delayed-release tablet is indicated to decrease the risk of developing naproxen-associated gastric ulcers. Limitations of Use:. Do not substitute naproxen and esomeprazole magnesium delayed-release tablet with the single-ingredient products of naproxen and esomeprazole magnesium. Naproxen and esomeprazole magnesium delayed-release tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months [see Use in Specific Populations (8.4), Clinical Studies (14)].</IndicationAndUsage>
<Description>The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as modified capsule shaped, off white to yellow colored 375 mg/20 mg and 500 mg/20 mg, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) or 500 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) for oral administration. The inactive ingredients are ammonium hydroxide, croscarmellose sodium, ferric oxide yellow, hypromellose, iron oxide black, lactose monohydrate, magnesium oxide, magnesium stearate, methacrylic acid copolymer, poloxamer, polyethylene glycol 400, povidone, propylene glycol, shellac glaze, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen USP is white to off-white practically odourless crystalline powder. It is soluble in chloroform, in dehydrated alcohol and in alcohol, sparingly soluble in ether and practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 6.48 is 1.5. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium amorphous. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C17H18N3O3S)2Mg with molecular weight of 713.1. The structural formula is. The esomepraozle magnesium USP is a white to pale cream colored powder. It is slightly soluble in methanol and soluble in N,N-Dimethyl formamide and practically insoluble in heptane and in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C.</Description>
</NDC>
<NDC>
<NDCCode>60951-701-70</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (60951-701-70) </PackageDescription>
<NDC11Code>60951-0701-70</NDC11Code>
<ProductNDC>60951-701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Endocet</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030306</StartMarketingDate>
<EndMarketingDate>20280331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040330</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>2.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20030306</StartMarketingDatePackage>
<EndMarketingDatePackage>20280331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 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, reserve opioid analgesics, including ENDOCET, 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 and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. All strengths of ENDOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>61919-701-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (61919-701-20) </PackageDescription>
<NDC11Code>61919-0701-20</NDC11Code>
<ProductNDC>61919-701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
<NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207616</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.3 Hypertriglyceridemia. Rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 1.4 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia). Rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). 1.5 Adult Patients with Homozygous Familial Hypercholesterolemia. Rosuvastatin calcium tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia. 1.8 Limitations of Use. Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. [strucural formula]. The empirical formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin calcium tablets for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: For 5 mg: Each film coated tablet contains: microcrystalline cellulose, lactose monohydrate, anhydrous lactose, crospovidone, magnesium oxide, magnesium stearate, hypromellose, triacetin, titanium dioxide, and ferric oxide yellow. For 10, 20 and 40 mg: Each film coated tablet contains: microcrystalline cellulose, lactose monohydrate, anhydrous lactose, crospovidone, magnesium oxide, magnesium stearate, hypromellose, triacetin, titanium dioxide, FD & C yellow No. 6, FD & C red No. 40, and FD & C blue No.1.</Description>
</NDC>
<NDC>
<NDCCode>61919-701-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (61919-701-30) </PackageDescription>
<NDC11Code>61919-0701-30</NDC11Code>
<ProductNDC>61919-701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
<NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207616</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.3 Hypertriglyceridemia. Rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 1.4 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia). Rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). 1.5 Adult Patients with Homozygous Familial Hypercholesterolemia. Rosuvastatin calcium tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia. 1.8 Limitations of Use. Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl (methylsulfonyl) amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula. [structure]. The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to almost white powder that is sparingly soluble in methanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient of 1.14 by HPLC. Rosuvastatin calcium tablets for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>61919-701-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (61919-701-90) </PackageDescription>
<NDC11Code>61919-0701-90</NDC11Code>
<ProductNDC>61919-701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
<NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207616</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.3 Hypertriglyceridemia. Rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 1.4 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia). Rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). 1.5 Adult Patients with Homozygous Familial Hypercholesterolemia. Rosuvastatin calcium tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia. 1.8 Limitations of Use. Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl (methylsulfonyl) amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula. [structure]. The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to almost white powder that is sparingly soluble in methanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient of 1.14 by HPLC. Rosuvastatin calcium tablets for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>64406-701-01</NDCCode>
<PackageDescription>1 POWDER, FOR SUSPENSION in 1 VIAL, SINGLE-USE (64406-701-01) </PackageDescription>
<NDC11Code>64406-0701-01</NDC11Code>
<ProductNDC>64406-701</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Eftrenonacog Alfa</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<StartMarketingDate>20140505</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Biogen Inc.</LabelerName>
<SubstanceName>EFTRENONACOG ALFA</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[iU]/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-02-25</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>05-MAY-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64896-701-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-701-01) </PackageDescription>
<NDC11Code>64896-0701-01</NDC11Code>
<ProductNDC>64896-701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079087</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</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>20130102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Usage: 1 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 (5.1)], reserve opioid analgesics, including Oxymorphone Hydrochloride Extended-Release Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Oxymorphone Hydrochloride Extended-Release Tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Oxymorphone Hydrochloride Extended-Release Tablets, USP are for oral use and contain oxymorphone, an opioid agonist. Oxymorphone Hydrochloride Extended-Release Tablets, USP are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride per tablet. The tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, hypromellose, xanthan gum, magnesium stearate, polyvinyl alcohol - partially hydrolyzed, polyethylene glycol, talc, and titanium dioxide. The 5 mg, 7.5 mg, 10 mg, 20 mg and 40 mg tablets contain FD&C Yellow No. 6 Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue No. 2 and D&C Red No. 27. The 7.5 mg tablets contain FD&C Blue No. 2 and FD&C Red No. 40. The 10 mg tablets contain FD&C Red No. 40. The 20 mg tablets contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1, and FD&C Blue No. 2. The 30 mg tablets contain Iron Oxide Yellow and Iron Oxide Black. The 40 mg tablets contain D&C Yellow No. 10 Aluminum Lake. The chemical name of oxymorphone hydrochloride is 4,5α-epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride. Oxymorphone hydrochloride, USP is a white or slightly off-white, odorless powder, which is sparingly soluble in alcohol and ether, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The pKa1 and pKa2 of oxymorphone at 37°C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37°C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>64896-701-03</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-701-03) </PackageDescription>
<NDC11Code>64896-0701-03</NDC11Code>
<ProductNDC>64896-701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079087</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</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>20130102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Usage: 1 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 (5.1)], reserve opioid analgesics, including Oxymorphone Hydrochloride Extended-Release Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Oxymorphone Hydrochloride Extended-Release Tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Oxymorphone Hydrochloride Extended-Release Tablets, USP are for oral use and contain oxymorphone, an opioid agonist. Oxymorphone Hydrochloride Extended-Release Tablets, USP are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride per tablet. The tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, hypromellose, xanthan gum, magnesium stearate, polyvinyl alcohol - partially hydrolyzed, polyethylene glycol, talc, and titanium dioxide. The 5 mg, 7.5 mg, 10 mg, 20 mg and 40 mg tablets contain FD&C Yellow No. 6 Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue No. 2 and D&C Red No. 27. The 7.5 mg tablets contain FD&C Blue No. 2 and FD&C Red No. 40. The 10 mg tablets contain FD&C Red No. 40. The 20 mg tablets contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1, and FD&C Blue No. 2. The 30 mg tablets contain Iron Oxide Yellow and Iron Oxide Black. The 40 mg tablets contain D&C Yellow No. 10 Aluminum Lake. The chemical name of oxymorphone hydrochloride is 4,5α-epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride. Oxymorphone hydrochloride, USP is a white or slightly off-white, odorless powder, which is sparingly soluble in alcohol and ether, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The pKa1 and pKa2 of oxymorphone at 37°C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37°C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>64896-701-08</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-701-08) </PackageDescription>
<NDC11Code>64896-0701-08</NDC11Code>
<ProductNDC>64896-701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079087</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</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>20130102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Usage: 1 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 (5.1)], reserve opioid analgesics, including Oxymorphone Hydrochloride Extended-Release Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Oxymorphone Hydrochloride Extended-Release Tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Oxymorphone Hydrochloride Extended-Release Tablets, USP are for oral use and contain oxymorphone, an opioid agonist. Oxymorphone Hydrochloride Extended-Release Tablets, USP are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride per tablet. The tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, hypromellose, xanthan gum, magnesium stearate, polyvinyl alcohol - partially hydrolyzed, polyethylene glycol, talc, and titanium dioxide. The 5 mg, 7.5 mg, 10 mg, 20 mg and 40 mg tablets contain FD&C Yellow No. 6 Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue No. 2 and D&C Red No. 27. The 7.5 mg tablets contain FD&C Blue No. 2 and FD&C Red No. 40. The 10 mg tablets contain FD&C Red No. 40. The 20 mg tablets contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1, and FD&C Blue No. 2. The 30 mg tablets contain Iron Oxide Yellow and Iron Oxide Black. The 40 mg tablets contain D&C Yellow No. 10 Aluminum Lake. The chemical name of oxymorphone hydrochloride is 4,5α-epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride. Oxymorphone hydrochloride, USP is a white or slightly off-white, odorless powder, which is sparingly soluble in alcohol and ether, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The pKa1 and pKa2 of oxymorphone at 37°C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37°C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>64896-701-13</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-701-13) </PackageDescription>
<NDC11Code>64896-0701-13</NDC11Code>
<ProductNDC>64896-701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079087</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</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>20130102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Usage: 1 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 (5.1)], reserve opioid analgesics, including Oxymorphone Hydrochloride Extended-Release Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Oxymorphone Hydrochloride Extended-Release Tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Oxymorphone Hydrochloride Extended-Release Tablets, USP are for oral use and contain oxymorphone, an opioid agonist. Oxymorphone Hydrochloride Extended-Release Tablets, USP are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride per tablet. The tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, hypromellose, xanthan gum, magnesium stearate, polyvinyl alcohol - partially hydrolyzed, polyethylene glycol, talc, and titanium dioxide. The 5 mg, 7.5 mg, 10 mg, 20 mg and 40 mg tablets contain FD&C Yellow No. 6 Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue No. 2 and D&C Red No. 27. The 7.5 mg tablets contain FD&C Blue No. 2 and FD&C Red No. 40. The 10 mg tablets contain FD&C Red No. 40. The 20 mg tablets contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1, and FD&C Blue No. 2. The 30 mg tablets contain Iron Oxide Yellow and Iron Oxide Black. The 40 mg tablets contain D&C Yellow No. 10 Aluminum Lake. The chemical name of oxymorphone hydrochloride is 4,5α-epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride. Oxymorphone hydrochloride, USP is a white or slightly off-white, odorless powder, which is sparingly soluble in alcohol and ether, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The pKa1 and pKa2 of oxymorphone at 37°C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37°C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>69315-701-50</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (69315-701-50) / 50 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>69315-0701-50</NDC11Code>
<ProductNDC>69315-701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ethacrynate Sodium</ProprietaryName>
<NonProprietaryName>Ethacrynate Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208663</ApplicationNumber>
<LabelerName>Leading Pharma, LLC</LabelerName>
<SubstanceName>ETHACRYNATE SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ethacrynate sodium is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. : 1 Treatment of the edema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome., 2 Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema., 3 Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome., 4 Intravenous ethacrynate sodium is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable.</IndicationAndUsage>
<Description>Ethacrynic acid is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2-methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of 303.14. Ethacrynic acid is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene. Its empirical formula is C13H12Cl2O4 and its structural formula is. Ethacrynate sodium, the sodium salt of ethacrynic acid, is soluble in water at 25°C to the extent of about 7 percent. Solutions of the sodium salt are relatively stable at about pH 7 at room temperature for short periods, but as the pH or temperature increases the solutions are less stable. The molecular weight of ethacrynate sodium is 325.12. Its empirical formula is C13H11Cl2NaO4 and its structural formula is. Intravenous Ethacrynate Sodium is a sterile freeze-dried powder and is supplied in a vial containing. Ethacrynate sodium equivalent to ethacrynic acid - 50 mg. Inactive ingredient. Mannitol - 62.5 mg.</Description>
</NDC>
<NDC>
<NDCCode>71288-701-05</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (71288-701-05) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-701-06) </PackageDescription>
<NDC11Code>71288-0701-05</NDC11Code>
<ProductNDC>71288-701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atracurium Besylate</ProprietaryName>
<NonProprietaryName>Atracurium Besylate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091488</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ATRACURIUM BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atracurium besylate injection is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Atracurium besylate is an intermediate-duration, nondepolarizing, skeletal muscle relaxant for intravenous administration. Atracurium besylate is designated as 2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester. It has a molecular weight of 1243.49, and its molecular formula is C65H82N2O18S2. The structural formula is. Atracurium besylate is a complex molecule containing four sites at which different stereochemical configurations can occur. The symmetry of the molecule, however, results in only ten, instead of sixteen, possible different isomers. The manufacture of atracurium besylate results in these isomers being produced in unequal amounts but with a consistent ratio. Those molecules in which the methyl group attached to the quaternary nitrogen projects on the opposite side to the adjacent substituted-benzyl moiety predominate by approximately 3:1. Atracurium Besylate Injection, USP is a sterile, non-pyrogenic aqueous solution. Each mL contains 10 mg atracurium besylate. The pH is adjusted to 3.25 to 3.65 with benzenesulfonic acid. The multiple dose vial contains 0.9% benzyl alcohol added as a preservative. Atracurium besylate injection slowly loses potency with time at the rate of approximately 6% per year under refrigeration (5°C). Atracurium besylate injection should be refrigerated at 2° to 8°C (36° to 46°F) to preserve potency. Rate of loss in potency increases to approximately 5% per month at 25°C (77°F). Upon removal from refrigeration to room temperature storage conditions (25°C / 77°F), use atracurium besylate injection within 14 days even if re-refrigerated.</Description>
</NDC>
<NDC>
<NDCCode>71896-701-37</NDCCode>
<PackageDescription>1200 mL in 1 BOTTLE, DISPENSING (71896-701-37) </PackageDescription>
<NDC11Code>71896-0701-37</NDC11Code>
<ProductNDC>71896-701</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pacific Blue Ultra Foaming</ProprietaryName>
<ProprietaryNameSuffix>Fragrance Free</ProprietaryNameSuffix>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160602</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Interline Brands, Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54897-507-17</NDCCode>
<PackageDescription>165 g in 1 BOTTLE (54897-507-17)</PackageDescription>
<NDC11Code>54897-0507-17</NDC11Code>
<ProductNDC>54897-507</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topical Fluoride Foam Bumble Bee Bubble Gum</ProprietaryName>
<NonProprietaryName>Acidulated Phosphate Fluoride</NonProprietaryName>
<DosageFormName>AEROSOL</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20000504</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Laclede, Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE; HYDROFLUORIC ACID</SubstanceName>
<StrengthNumber>10; 2.3</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54897-601-11</NDCCode>
<PackageDescription>1500 mg in 1 POUCH (54897-601-11)</PackageDescription>
<NDC11Code>54897-0601-11</NDC11Code>
<ProductNDC>54897-601</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Luvena Feminine Wipes</ProprietaryName>
<NonProprietaryName>Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120404</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part346</ApplicationNumber>
<LabelerName>LACLEDE, INC.</LabelerName>
<SubstanceName>PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1000mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0869-0816-35</NDCCode>
<PackageDescription>701 mL in 1 BOTTLE, PLASTIC (0869-0816-35) </PackageDescription>
<NDC11Code>00869-0816-35</NDC11Code>
<ProductNDC>0869-0816</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dandruff</ProprietaryName>
<NonProprietaryName>Selenium Sulfide</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160925</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358H</ApplicationNumber>
<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>SELENIUM SULFIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent recurrence of itching, irritation, redness, flaking and scaling associated with dandruff and seborrheic dermatitis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10056-701-34</NDCCode>
<PackageDescription>170 g in 1 BOTTLE, PLASTIC (10056-701-34)</PackageDescription>
<NDC11Code>10056-0701-34</NDC11Code>
<ProductNDC>10056-701</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Peter Island Continuous Sport Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Spf 50</ProprietaryNameSuffix>
<NonProprietaryName>Homosalate, Oxybenzone, Octisalate, Avobenzone, Octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130627</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Access Business Group LLC</LabelerName>
<SubstanceName>HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>15; 6; 3; 5; 2</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10135-701-04</NDCCode>
<PackageDescription>113 g in 1 TUBE (10135-701-04) </PackageDescription>
<NDC11Code>10135-0701-04</NDC11Code>
<ProductNDC>10135-701</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Menthol And Zinc Oxide</ProprietaryName>
<NonProprietaryName>Menthol And Zinc Oxide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M015</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MENTHOL; ZINC OXIDE</SubstanceName>
<StrengthNumber>.44; 20.625</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>A moisture barrier that prevents & helps heal skin irritations from. : 1 Urine, 2 Diarrhea, 3 Perspiration, 4 Fistula drainage, 5 Feeding tube site leakage, 6 Wound drainage (peri-wound skin), 7 Minor burns, 8 Cuts, 9 Scrapes, 10 Itching.</IndicationAndUsage>
</NDC>
</NDCList>