{
"NDC": [
{
"NDCCode": "70095-080-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (70095-080-01) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "70095-0080-01",
"ProductNDC": "70095-080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eribulin Mesylate",
"NonProprietaryName": "Eribulin Mesylate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218743",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "ERIBULIN MESYLATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250515",
"SamplePackage": "N",
"IndicationAndUsage": "Eribulin mesylate injection is a microtubule inhibitor indicated for the treatment of patients with. · Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. (1.1). · Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. (1.2).",
"Description": "Eribulin mesylate injection contains eribulin mesylate, a microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai. The chemical name for eribulin mesylate is 11,15:18,21:24,28- Triepoxy-7,9-ethano-12,15-methano-9H,15H-furo[3,2-i]furo[2',3':5,6]pyrano[4,3-b][1,4]dioxacyclopentacosin-5(4H)-one, 2-[(2S)-3- amino-2-hydroxypropyl]hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)-, (2R,3R,3aS,7R,8aS,9S,10aR,11S,12R,13aR,13bS,15S,18S,21S,24S,26R,28R,29aS)-, methanesulfonate (salt). It has a molecular weight of 826.0 (729.9 for free base). The empirical formula is C40H59NO11CH4O3S. Eribulin mesylate has the following structural formula. Eribulin mesylate injection is a clear, colorless, sterile solution for intravenous administration. Each single-dose vial contains 1 mg of eribulin mesylate in 2 mL of solution. Each mL of solution contains 0.5 mg of eribulin mesylate (equivalent to 0.44 mg eribulin) in dehydrated alcohol (5% v/v) and water for injection (95% v/v). Sodium hydroxide or hydrochloric acid may be used for pH adjustment."
},
{
"NDCCode": "70095-017-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70095-017-01) ",
"NDC11Code": "70095-0017-01",
"ProductNDC": "70095-017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Theophylline",
"NonProprietaryName": "Theophylline",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214806",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "THEOPHYLLINE ANHYDROUS",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Methylxanthine [EPC], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240322",
"SamplePackage": "N",
"IndicationAndUsage": "Theophylline extended-release tablets are indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.",
"Description": "Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H- Purine. -2, 6-dione, 3,7-dihydro-1, 3-dimethyl-, and is represented by the following structural formula. C7H8N4O2 M.W. 180.17.This product allows a 12-hour dosing interval for a majority of patients and a 24-hour dosing interval for selected patients (see DOSAGE AND ADMINISTRATION section for description of appropriate patient populations). Each extended-release tablet for oral administration contains either 300 mg or 450 mg of anhydrous theophylline. Tablets also contain as inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, povidone and colloidal silicone dioxide."
},
{
"NDCCode": "70095-018-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70095-018-01) ",
"NDC11Code": "70095-0018-01",
"ProductNDC": "70095-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Theophylline",
"NonProprietaryName": "Theophylline",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214806",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "THEOPHYLLINE ANHYDROUS",
"StrengthNumber": "450",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Methylxanthine [EPC], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240322",
"SamplePackage": "N",
"IndicationAndUsage": "Theophylline extended-release tablets are indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.",
"Description": "Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H- Purine. -2, 6-dione, 3,7-dihydro-1, 3-dimethyl-, and is represented by the following structural formula. C7H8N4O2 M.W. 180.17.This product allows a 12-hour dosing interval for a majority of patients and a 24-hour dosing interval for selected patients (see DOSAGE AND ADMINISTRATION section for description of appropriate patient populations). Each extended-release tablet for oral administration contains either 300 mg or 450 mg of anhydrous theophylline. Tablets also contain as inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, povidone and colloidal silicone dioxide."
},
{
"NDCCode": "70095-019-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, UNIT-DOSE (70095-019-01) ",
"NDC11Code": "70095-0019-01",
"ProductNDC": "70095-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217617",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240310",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate is indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Bisoprolol fumarate, USP is a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol (E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C18H31NO4)2C4H4O4 and its structure is. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform. Bisoprolol fumarate tablets, USP are available as 5 and 10 mg tablets for oral administration. Inactive ingredients include microcrystalline cellulose, butylated hydroxy anisole, dibasic calcium phosphate anhydrous, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, hydroxypropyl cellulose and titanium dioxide. The 5 mg tablets also contain talc, FD&C red#40 and FD&C blue #2. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "70095-020-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, UNIT-DOSE (70095-020-01) ",
"NDC11Code": "70095-0020-01",
"ProductNDC": "70095-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217617",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240310",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate is indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Bisoprolol fumarate, USP is a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol (E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C18H31NO4)2C4H4O4 and its structure is. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform. Bisoprolol fumarate tablets, USP are available as 5 and 10 mg tablets for oral administration. Inactive ingredients include microcrystalline cellulose, butylated hydroxy anisole, dibasic calcium phosphate anhydrous, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, hydroxypropyl cellulose and titanium dioxide. The 5 mg tablets also contain talc, FD&C red#40 and FD&C blue #2. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "70095-024-02",
"PackageDescription": "10 CARTON in 1 PACKAGE (70095-024-02) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL (70095-024-01) ",
"NDC11Code": "70095-0024-02",
"ProductNDC": "70095-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204400",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230403",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium is a proton pump inhibitor (PPI) indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. (1) pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults. (1). Limitations of UseThe safety and effectiveness of pantoprazole sodium for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. (1).",
"Description": "The active ingredient in pantoprazole sodium for injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is. Pantoprazole sodium USP is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The reconstituted solution of pantoprazole sodium for injection is in the pH range of 9.0 to 10.5. Pantoprazole sodium for injection is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium, USP), edetate disodium (1 mg), and sodium hydroxide to adjust pH."
},
{
"NDCCode": "70095-024-03",
"PackageDescription": "25 CARTON in 1 PACKAGE (70095-024-03) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL (70095-024-01) ",
"NDC11Code": "70095-0024-03",
"ProductNDC": "70095-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204400",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230403",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium is a proton pump inhibitor (PPI) indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. (1) pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults. (1). Limitations of UseThe safety and effectiveness of pantoprazole sodium for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. (1).",
"Description": "The active ingredient in pantoprazole sodium for injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is. Pantoprazole sodium USP is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The reconstituted solution of pantoprazole sodium for injection is in the pH range of 9.0 to 10.5. Pantoprazole sodium for injection is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium, USP), edetate disodium (1 mg), and sodium hydroxide to adjust pH."
},
{
"NDCCode": "70095-025-02",
"PackageDescription": "10 VIAL in 1 CARTON (70095-025-02) / 10 mL in 1 VIAL (70095-025-01) ",
"NDC11Code": "70095-0025-02",
"ProductNDC": "70095-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin Monohydrate",
"NonProprietaryName": "Azithromycin Monohydrate",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065501",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230327",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin for injection is a macrolide antibacterial drug indicated for the treatment of the following infections caused by designated susceptible microorganisms: Community-acquired pneumonia in adults ( 1.1) Pelvic inflammatory disease in adults ( 1.2) To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.3).",
"Description": "Azithromycin for Injection, USP contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibacterial drug, for intravenous injection. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3- C-methyl-3- O-methyl-α- L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-hepta-methyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β- D- xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749. Azithromycin has the following structural formula:. Azithromycin, as the monohydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 12·H 2O and a molecular weight of 767. Azithromycin for Injection, USP consists of azithromycin monohydrate USP and the following inactive ingredients: citric acid and sodium hydroxide. Sodium hydroxide is added to adjust the pH. Azithromycin for Injection, USP is supplied as white to off-white lyophilized powder in a single-dose vial for intravenous administration. Each vial contains azithromycin monohydrate USP equivalent to 500 mg of azithromycin, 384.5 mg citric acid, and sodium hydroxide. Reconstitution, according to label directions, results in approximately 5 mL of azithromycin for intravenous injection with each mL containing azithromycin monohydrate USP equivalent to 100 mg of azithromycin, 76.9 mg citric acid, and sodium hydroxide."
},
{
"NDCCode": "70095-026-02",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (70095-026-02) / 1 mL in 1 VIAL, SINGLE-DOSE (70095-026-01) ",
"NDC11Code": "70095-0026-02",
"ProductNDC": "70095-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desmopressin Acetate",
"NonProprietaryName": "Desmopressin Acetate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20230403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216922",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "DESMOPRESSIN ACETATE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
"Status": "Active",
"LastUpdate": "2023-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230403",
"SamplePackage": "N",
"IndicationAndUsage": "Desmopressin acetate injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).",
"Description": "Desmopressin acetate injection, USP is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1183.34Molecular Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate injection, USP is a sterile solution in a 1 mL single-dose vial: Each mL contains 4 mcg of desmopressin acetate, USP which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride USP, hydrochloric acid, NF and water for injection, USP. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH."
},
{
"NDCCode": "70095-031-01",
"PackageDescription": "1 VIAL in 1 CARTON (70095-031-01) / 10 mL in 1 VIAL",
"NDC11Code": "70095-0031-01",
"ProductNDC": "70095-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desmopressin Acetate",
"NonProprietaryName": "Desmopressin Acetate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20230620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216904",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "DESMOPRESSIN ACETATE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
"Status": "Active",
"LastUpdate": "2023-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230620",
"SamplePackage": "N",
"IndicationAndUsage": "Desmopressin acetate injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).",
"Description": "Desmopressin acetate injection, USP is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1183.34Molecular Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate injection, USP is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate, USP which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride USP, chlorobutanol hemihydrate, USP (5 mg per mL), hydrochloric acid, NF and water for injection, USP. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH."
},
{
"NDCCode": "70095-040-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (70095-040-01) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "70095-0040-01",
"ProductNDC": "70095-040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deflazacort",
"NonProprietaryName": "Deflazacort",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217741",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DEFLAZACORT",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250319",
"SamplePackage": "N",
"IndicationAndUsage": "Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza TM(deflazacort) tablets. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "The active ingredient in deflazacort tablets is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for deflazacort is C 25H 31NO 6. The chemical name for deflazacort is 16α,17-isoxazole-11β,21-dihydroxypregna-1,4-diene-3,20-dione 21acetate, and the structure is:. Deflazacort is a white or almost white crystalline powder and has a molecular weight of 441.52. Deflazacort is soluble in dichloromethane and chloroform, slightly soluble in ethanol and ethyl acetate, almost insoluble in water. Deflazacort tablets for oral administration are available as an immediate-release tablet in strengths of 6, 18, 30 and 36 mg. Each tablet contains deflazacort and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch (maize)."
},
{
"NDCCode": "70095-050-03",
"PackageDescription": "25 VIAL in 1 CARTON (70095-050-03) / 50 mL in 1 VIAL (70095-050-01) ",
"NDC11Code": "70095-0050-03",
"ProductNDC": "70095-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Bicarbonate",
"NonProprietaryName": "Sodium Bicarbonate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217594",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "84",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Alkalinizing Activity [MoA]",
"Status": "Active",
"LastUpdate": "2024-03-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240315",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Bicarbonate Injection is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis - e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself.Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial - e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.",
"Description": "Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solutions are offered in concentration of 8.4%. See table in HOW SUPPLIED section for contents and characteristics. The solutions contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as a single-dose injection, the approximate pH of the solutions is 8. When smaller doses are required, the unused portion should be discarded. Sodium bicarbonate, 84 mg is equal to one milliequivalent each of Na+ and HCO3-. Sodium Bicarbonate, USP is chemically designated NaHCO3, a white crystalline powder soluble in water. Water for Injection is chemically designated H2O."
},
{
"NDCCode": "70095-057-01",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (70095-057-01) ",
"NDC11Code": "70095-0057-01",
"ProductNDC": "70095-057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pomalidomide",
"NonProprietaryName": "Pomalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210232",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "POMALIDOMIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260831",
"SamplePackage": "N",
"IndicationAndUsage": "Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).",
"Description": "Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C 13H 11N 3O 4and the gram molecular weight is 273.24. Pomalidomide is a yellow solid powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide capsules are available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: microcrystalline cellulose, maltodextrin, and sodium stearyl fumarate. The 1 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, red iron oxide, and white ink. The 2 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, red iron oxide, and white ink. The 3 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, red iron oxide, and white ink. The 4 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, red iron oxide, and white ink."
},
{
"NDCCode": "70095-058-01",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (70095-058-01) ",
"NDC11Code": "70095-0058-01",
"ProductNDC": "70095-058",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pomalidomide",
"NonProprietaryName": "Pomalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210232",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "POMALIDOMIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260831",
"SamplePackage": "N",
"IndicationAndUsage": "Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).",
"Description": "Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C 13H 11N 3O 4and the gram molecular weight is 273.24. Pomalidomide is a yellow solid powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide capsules are available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: microcrystalline cellulose, maltodextrin, and sodium stearyl fumarate. The 1 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, red iron oxide, and white ink. The 2 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, red iron oxide, and white ink. The 3 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, red iron oxide, and white ink. The 4 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, red iron oxide, and white ink."
},
{
"NDCCode": "70095-059-01",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (70095-059-01) ",
"NDC11Code": "70095-0059-01",
"ProductNDC": "70095-059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pomalidomide",
"NonProprietaryName": "Pomalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210232",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "POMALIDOMIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260831",
"SamplePackage": "N",
"IndicationAndUsage": "Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).",
"Description": "Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C 13H 11N 3O 4and the gram molecular weight is 273.24. Pomalidomide is a yellow solid powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide capsules are available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: microcrystalline cellulose, maltodextrin, and sodium stearyl fumarate. The 1 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, red iron oxide, and white ink. The 2 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, red iron oxide, and white ink. The 3 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, red iron oxide, and white ink. The 4 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, red iron oxide, and white ink."
},
{
"NDCCode": "70095-060-01",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (70095-060-01) ",
"NDC11Code": "70095-0060-01",
"ProductNDC": "70095-060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pomalidomide",
"NonProprietaryName": "Pomalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210232",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "POMALIDOMIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260831",
"SamplePackage": "N",
"IndicationAndUsage": "Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).",
"Description": "Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C 13H 11N 3O 4and the gram molecular weight is 273.24. Pomalidomide is a yellow solid powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide capsules are available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: microcrystalline cellulose, maltodextrin, and sodium stearyl fumarate. The 1 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, red iron oxide, and white ink. The 2 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, red iron oxide, and white ink. The 3 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, red iron oxide, and white ink. The 4 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, red iron oxide, and white ink."
},
{
"NDCCode": "70095-130-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (70095-130-01) / 5 mL in 1 VIAL, GLASS",
"NDC11Code": "70095-0130-01",
"ProductNDC": "70095-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Unloxcyt",
"NonProprietaryName": "Cosibelimab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251208",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761297",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "COSIBELIMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], Programmed Death Ligand-1 Antagonists [MoA], Programmed Death Ligand-1 Blocker [EPC], Programmed Death Ligand-1-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251208",
"SamplePackage": "N",
"IndicationAndUsage": "UNLOXCYT® is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.",
"Description": "Cosibelimab-ipdl is a human programmed death ligand-1 (PD-L1) blocking antibody. Cosibelimab-ipdl is a human IgG1 lambda monoclonal antibody. Cosibelimab-ipdl is produced in Chinese hamster ovary (CHO) cells and has a calculated molecular weight of approximately 147 kDa. UNLOXCYT (cosibelimab-ipdl) injection for intravenous use is a sterile, preservative-free, clear to opalescent, colorless to yellow or slightly brown solution. It is supplied in single-dose vials. Each vial contains 300 mg of UNLOXCYT in 5 mL of solution with a pH of 5.3. Each mL of solution contains 60 mg of cosibelimab-ipdl, acetic acid (0.24 mg), mannitol (37.35 mg), polysorbate 80 (1.1 mg), sodium acetate (1.31 mg), sodium chloride (4.09 mg), and Water for Injection, USP."
},
{
"NDCCode": "70095-136-03",
"PackageDescription": "1 CARTON in 1 CARTON (70095-136-03) / 21 BLISTER PACK in 1 CARTON (70095-136-02) / 1 INSERT in 1 BLISTER PACK (70095-136-01) ",
"NDC11Code": "70095-0136-03",
"ProductNDC": "70095-136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Progesterone",
"NonProprietaryName": "Progesterone",
"DosageFormName": "INSERT",
"RouteName": "VAGINAL",
"StartMarketingDate": "20260427",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022057",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "PROGESTERONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone [CS], Progesterone [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260427",
"SamplePackage": "N",
"IndicationAndUsage": "Progesterone vaginal insert is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.",
"Description": "Progesterone vaginal insert contains micronized progesterone, USP. Progesterone vaginal insert is supplied with polyethylene vaginal applicators. The active ingredient, progesterone, USP is present in 100 mg amount along with other excipients. The chemical name for progesterone is pregn-4-ene-3,20-dione. It has an molecular formula of C 21H 30O 2and a molecular weight of 314.5. Progesterone exists in two polymorphic forms. The form used in progesterone vaginal insert, the alpha-form, has a melting point of 127°C to 131°C. The structural formula is. Each progesterone vaginal insert delivers 100 mg of progesterone, USP in a base containing lactose monohydrate, polyvinylpyrrolidone, adipic acid, sodium bicarbonate, sodium lauryl sulfate, magnesium stearate, pregelatinized starch, and colloidal silicon dioxide."
},
{
"NDCCode": "70095-154-02",
"PackageDescription": "10 CARTON in 1 CARTON (70095-154-02) / 1 BLISTER PACK in 1 CARTON (70095-154-01) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE",
"NDC11Code": "70095-0154-02",
"ProductNDC": "70095-154",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phytonadione",
"NonProprietaryName": "Phytonadione",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20260610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216298",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "PHYTONADIONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260610",
"SamplePackage": "N",
"IndicationAndUsage": "Phytonadione injectable emulsion is a vitamin K replacement indicated for the treatment of the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. : 1 Anticoagulant-induced hypoprothrombinemia deficiency caused by coumarin or indanedione derivatives; ( 1.1) , 2 Hypoprothrombinemia due to antibacterial therapy; ( 1.1) , 3 Hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; ( 1.1) , 4 Other drug-induced hypoprothrombinemia where is it definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates. ( 1.1) .",
"Description": "Phytonadione, USP is a vitamin K replacement, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.70. Phytonadione, USP is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C 31H 46O 2 and its molecular structure is:. Phytonadione injectable emulsion, USP injection is a yellow, sterile, aqueous colloidal solution of vitamin K 1, with a pH of 3.5 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes. Phytonadione injectable emulsion, USP is available in 1 mg (1 mg/0.5 mL) single-dose prefilled syringes. Each 0.5 mL of phytonadione injectable emulsion, USP contains the following inactive ingredients: 10 mg polysorbate 80, 10.4 mg propylene glycol, 0.17 mg sodium acetate anhydrous, and 0.00002 mL glacial acetic acid. Additional glacial acetic acid or sodium acetate anhydrous may have been added to adjust pH to meet USP limits of 3.5 to 7.0."
},
{
"NDCCode": "10019-080-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (10019-080-01) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "10019-0080-01",
"ProductNDC": "10019-080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eribulin Mesylate",
"NonProprietaryName": "Eribulin Mesylate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20241001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217250",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "ERIBULIN MESYLATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241201",
"SamplePackage": "N",
"IndicationAndUsage": "Eribulin Mesylate Injection is a microtubule inhibitor indicated for the treatment of patients with: 1 Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. (1.1), 2 Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. (1.2).",
"Description": "Eribulin Mesylate Injection contains eribulin mesylate, a microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai. The chemical name for eribulin mesylate is 11,15:18,21:24,28-Triepoxy-7,9-ethano-12,15-methano-9H,15H-furo[3,2-i]furo[2',3':5,6]pyrano[4,3-b][1,4]dioxacyclopentacosin-5(4H)-one, 2-[(2S)-3- amino-2-hydroxypropyl]hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)-, (2R,3R,3aS,7R,8aS,9S,10aR,11S,12R,13aR,13bS,15S,18S,21S,24S,26R,28R,29aS)-, methanesulfonate (salt). It has a molecular weight of 826.0 (729.9 for free base). The empirical formula is C40H59NO11CH4O3S. Eribulin mesylate has the following structural formula. Eribulin Mesylate Injection is a clear, colorless, sterile solution for intravenous administration. Each single-dose vial contains 1 mg of eribulin mesylate in 2 mL of solution. Each mL of solution contains 0.5 mg of eribulin mesylate (equivalent to 0.44 mg eribulin) in dehydrated alcohol (5% v/v) and water for injection (95% v/v). Sodium hydroxide or hydrochloric acid may be used for pH adjustment."
},
{
"NDCCode": "10129-080-01",
"PackageDescription": "59 mL in 1 BOTTLE, DISPENSING (10129-080-01) ",
"NDC11Code": "10129-0080-01",
"ProductNDC": "10129-080",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibrite Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200410",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Gingi-Pak",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200410",
"SamplePackage": "N",
"IndicationAndUsage": "Reduce bacteria that potentially can cause disease. Recommened for repeated use."
},
{
"NDCCode": "10297-080-01",
"PackageDescription": "637.13 L in 1 CYLINDER (10297-080-01) ",
"NDC11Code": "10297-0080-01",
"ProductNDC": "10297-080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heliox",
"NonProprietaryName": "Heliox",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20180601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205767",
"LabelerName": "A-OX Welding Supply, LLC",
"SubstanceName": "OXYGEN",
"StrengthNumber": "200",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180601",
"SamplePackage": "N"
},
{
"NDCCode": "10695-080-01",
"PackageDescription": "1 g in 1 BOTTLE (10695-080-01)",
"NDC11Code": "10695-0080-01",
"ProductNDC": "10695-080",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Semorelin Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20150301",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Willow Birch Pharma",
"SubstanceName": "SERMORELIN",
"StrengthNumber": "5",
"StrengthUnit": "g/5g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "11489-080-01",
"PackageDescription": "1 JAR in 1 CARTON (11489-080-01) > 50 g in 1 JAR",
"NDC11Code": "11489-0080-01",
"ProductNDC": "11489-080",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Botanics Hydrating Day All Bright Sunscreen Broad Spectrum Spf 15",
"NonProprietaryName": "Avobenzone, Octisalate, Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130114",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "BCM Ltd",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "1.5; 1.5; 2.5",
"StrengthUnit": "g/50g; g/50g; g/50g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Directions for sunscreen use. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses."
},
{
"NDCCode": "11788-080-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (11788-080-01) ",
"NDC11Code": "11788-0080-01",
"ProductNDC": "11788-080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212654",
"LabelerName": "AiPing Pharmaceutical, Inc.",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251101",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
"Description": "Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless practically odorless, crystalline powder or small crystals and freely soluble in water, alcohol, chloroform and methanol and insoluble in ether. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a,d] cycloheptene- Δ5, γ-propylamine hydrochloride. It has the following structural formula. Amitriptyline hydrochloride, USP is supplied as 10, 25, 50, 75, 100 and 150 mg tablets. The inactive ingredients are croscarmellose sodium, magnesium stearate and silicified microcrystalline cellulose. The tablet coating ingredients are polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide. In addition, the tablet coating also contains. 10 mg – D&C Red No. 27 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. 25 mg – FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 5 (tartrazine) Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. 50 mg – FD&C Blue No.1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. 75 mg – D&C Red No. 7 Calcium Lake and FD&C Blue No. 1 Aluminum Lake. 100 mg – FD&C Red No. 40 Aluminum Lake, FD&C YellowNo. 6 Aluminum Lake, red iron oxide and yellow iron oxide. 150 mg – FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 5 (tartrazine) Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake."
},
{
"NDCCode": "12714-080-01",
"PackageDescription": ".1 mg in 1 VIAL, SINGLE-DOSE (12714-080-01) ",
"NDC11Code": "12714-0080-01",
"ProductNDC": "12714-080",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Interferon-gamma1b",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20010917",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Boehringer Ingelheim Pharma GmbH and Co. KG",
"SubstanceName": "INTERFERON GAMMA-1B",
"StrengthNumber": ".1",
"StrengthUnit": "mg/.1mg",
"Status": "Unfinished",
"LastUpdate": "2024-07-27",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "17-SEP-01"
},
{
"NDCCode": "13107-080-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (13107-080-01) ",
"NDC11Code": "13107-0080-01",
"ProductNDC": "13107-080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trazodone Hydrochloride",
"NonProprietaryName": "Trazodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204852",
"LabelerName": "Aurolife Pharma LLC",
"SubstanceName": "TRAZODONE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150915",
"SamplePackage": "N",
"IndicationAndUsage": "Trazodone Hydrochloride Tablets are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Trazodone hydrochloride tablets for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows. Molecular Formula: C19H22CIN5O HCl. Molecular Weight: 408.33. Each tablet, for oral administration, contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (physically modified corn (maize) starch), sodium lauryl sulfate, and sodium starch glycolate."
},
{
"NDCCode": "13537-080-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-080-02) > 30 g in 1 TUBE (13537-080-01)",
"NDC11Code": "13537-0080-02",
"ProductNDC": "13537-080",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16",
"ProprietaryNameSuffix": "Claire 4- Beige",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161102",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".065; .024; .015",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "13733-080-01",
"PackageDescription": "45 g in 1 CARTON (13733-080-01)",
"NDC11Code": "13733-0080-01",
"ProductNDC": "13733-080",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Missha M Signature Real Complete Bb",
"ProprietaryNameSuffix": "Honey Beige",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ABLE C&C Co., Ltd.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "3.47; 1.73",
"StrengthUnit": "g/45g; g/45g",
"Status": "Deprecated",
"LastUpdate": "2019-01-08",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "14141-080-02",
"PackageDescription": "1 TUBE in 1 BOX (14141-080-02) > 30 g in 1 TUBE (14141-080-01) ",
"NDC11Code": "14141-0080-02",
"ProductNDC": "14141-080",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Mousse Matiffiant Matte Finish Mousse Foundation Spf 15",
"ProprietaryNameSuffix": "Claire 2/ Beige",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180808",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bel Star S.A. (Colombia)",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".065; .0244; .0157",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20180808",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
}
]
}
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<NDCList>
<NDC>
<NDCCode>70095-080-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (70095-080-01) / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>70095-0080-01</NDC11Code>
<ProductNDC>70095-080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eribulin Mesylate</ProprietaryName>
<NonProprietaryName>Eribulin Mesylate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218743</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>ERIBULIN MESYLATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eribulin mesylate injection is a microtubule inhibitor indicated for the treatment of patients with. · Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. (1.1). · Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. (1.2).</IndicationAndUsage>
<Description>Eribulin mesylate injection contains eribulin mesylate, a microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai. The chemical name for eribulin mesylate is 11,15:18,21:24,28- Triepoxy-7,9-ethano-12,15-methano-9H,15H-furo[3,2-i]furo[2',3':5,6]pyrano[4,3-b][1,4]dioxacyclopentacosin-5(4H)-one, 2-[(2S)-3- amino-2-hydroxypropyl]hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)-, (2R,3R,3aS,7R,8aS,9S,10aR,11S,12R,13aR,13bS,15S,18S,21S,24S,26R,28R,29aS)-, methanesulfonate (salt). It has a molecular weight of 826.0 (729.9 for free base). The empirical formula is C40H59NO11CH4O3S. Eribulin mesylate has the following structural formula. Eribulin mesylate injection is a clear, colorless, sterile solution for intravenous administration. Each single-dose vial contains 1 mg of eribulin mesylate in 2 mL of solution. Each mL of solution contains 0.5 mg of eribulin mesylate (equivalent to 0.44 mg eribulin) in dehydrated alcohol (5% v/v) and water for injection (95% v/v). Sodium hydroxide or hydrochloric acid may be used for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>70095-017-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70095-017-01) </PackageDescription>
<NDC11Code>70095-0017-01</NDC11Code>
<ProductNDC>70095-017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Theophylline</ProprietaryName>
<NonProprietaryName>Theophylline</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214806</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>THEOPHYLLINE ANHYDROUS</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Theophylline extended-release tablets are indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.</IndicationAndUsage>
<Description>Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H- Purine. -2, 6-dione, 3,7-dihydro-1, 3-dimethyl-, and is represented by the following structural formula. C7H8N4O2 M.W. 180.17.This product allows a 12-hour dosing interval for a majority of patients and a 24-hour dosing interval for selected patients (see DOSAGE AND ADMINISTRATION section for description of appropriate patient populations). Each extended-release tablet for oral administration contains either 300 mg or 450 mg of anhydrous theophylline. Tablets also contain as inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, povidone and colloidal silicone dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70095-018-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70095-018-01) </PackageDescription>
<NDC11Code>70095-0018-01</NDC11Code>
<ProductNDC>70095-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Theophylline</ProprietaryName>
<NonProprietaryName>Theophylline</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214806</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>THEOPHYLLINE ANHYDROUS</SubstanceName>
<StrengthNumber>450</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Theophylline extended-release tablets are indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.</IndicationAndUsage>
<Description>Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H- Purine. -2, 6-dione, 3,7-dihydro-1, 3-dimethyl-, and is represented by the following structural formula. C7H8N4O2 M.W. 180.17.This product allows a 12-hour dosing interval for a majority of patients and a 24-hour dosing interval for selected patients (see DOSAGE AND ADMINISTRATION section for description of appropriate patient populations). Each extended-release tablet for oral administration contains either 300 mg or 450 mg of anhydrous theophylline. Tablets also contain as inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, povidone and colloidal silicone dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70095-019-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, UNIT-DOSE (70095-019-01) </PackageDescription>
<NDC11Code>70095-0019-01</NDC11Code>
<ProductNDC>70095-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217617</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate is indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Bisoprolol fumarate, USP is a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol (E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C18H31NO4)2C4H4O4 and its structure is. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform. Bisoprolol fumarate tablets, USP are available as 5 and 10 mg tablets for oral administration. Inactive ingredients include microcrystalline cellulose, butylated hydroxy anisole, dibasic calcium phosphate anhydrous, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, hydroxypropyl cellulose and titanium dioxide. The 5 mg tablets also contain talc, FD&C red#40 and FD&C blue #2. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>70095-020-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, UNIT-DOSE (70095-020-01) </PackageDescription>
<NDC11Code>70095-0020-01</NDC11Code>
<ProductNDC>70095-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217617</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate is indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Bisoprolol fumarate, USP is a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol (E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C18H31NO4)2C4H4O4 and its structure is. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform. Bisoprolol fumarate tablets, USP are available as 5 and 10 mg tablets for oral administration. Inactive ingredients include microcrystalline cellulose, butylated hydroxy anisole, dibasic calcium phosphate anhydrous, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, hydroxypropyl cellulose and titanium dioxide. The 5 mg tablets also contain talc, FD&C red#40 and FD&C blue #2. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>70095-024-02</NDCCode>
<PackageDescription>10 CARTON in 1 PACKAGE (70095-024-02) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL (70095-024-01) </PackageDescription>
<NDC11Code>70095-0024-02</NDC11Code>
<ProductNDC>70095-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204400</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium is a proton pump inhibitor (PPI) indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. (1) pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults. (1). Limitations of UseThe safety and effectiveness of pantoprazole sodium for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. (1).</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium for injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is. Pantoprazole sodium USP is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The reconstituted solution of pantoprazole sodium for injection is in the pH range of 9.0 to 10.5. Pantoprazole sodium for injection is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium, USP), edetate disodium (1 mg), and sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>70095-024-03</NDCCode>
<PackageDescription>25 CARTON in 1 PACKAGE (70095-024-03) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL (70095-024-01) </PackageDescription>
<NDC11Code>70095-0024-03</NDC11Code>
<ProductNDC>70095-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204400</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium is a proton pump inhibitor (PPI) indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. (1) pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults. (1). Limitations of UseThe safety and effectiveness of pantoprazole sodium for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. (1).</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium for injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is. Pantoprazole sodium USP is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The reconstituted solution of pantoprazole sodium for injection is in the pH range of 9.0 to 10.5. Pantoprazole sodium for injection is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium, USP), edetate disodium (1 mg), and sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>70095-025-02</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70095-025-02) / 10 mL in 1 VIAL (70095-025-01) </PackageDescription>
<NDC11Code>70095-0025-02</NDC11Code>
<ProductNDC>70095-025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin Monohydrate</ProprietaryName>
<NonProprietaryName>Azithromycin Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065501</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin for injection is a macrolide antibacterial drug indicated for the treatment of the following infections caused by designated susceptible microorganisms: Community-acquired pneumonia in adults ( 1.1) Pelvic inflammatory disease in adults ( 1.2) To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.3).</IndicationAndUsage>
<Description>Azithromycin for Injection, USP contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibacterial drug, for intravenous injection. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3- C-methyl-3- O-methyl-α- L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-hepta-methyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β- D- xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749. Azithromycin has the following structural formula:. Azithromycin, as the monohydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 12·H 2O and a molecular weight of 767. Azithromycin for Injection, USP consists of azithromycin monohydrate USP and the following inactive ingredients: citric acid and sodium hydroxide. Sodium hydroxide is added to adjust the pH. Azithromycin for Injection, USP is supplied as white to off-white lyophilized powder in a single-dose vial for intravenous administration. Each vial contains azithromycin monohydrate USP equivalent to 500 mg of azithromycin, 384.5 mg citric acid, and sodium hydroxide. Reconstitution, according to label directions, results in approximately 5 mL of azithromycin for intravenous injection with each mL containing azithromycin monohydrate USP equivalent to 100 mg of azithromycin, 76.9 mg citric acid, and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>70095-026-02</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (70095-026-02) / 1 mL in 1 VIAL, SINGLE-DOSE (70095-026-01) </PackageDescription>
<NDC11Code>70095-0026-02</NDC11Code>
<ProductNDC>70095-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desmopressin Acetate</ProprietaryName>
<NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216922</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desmopressin acetate injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).</IndicationAndUsage>
<Description>Desmopressin acetate injection, USP is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1183.34Molecular Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate injection, USP is a sterile solution in a 1 mL single-dose vial: Each mL contains 4 mcg of desmopressin acetate, USP which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride USP, hydrochloric acid, NF and water for injection, USP. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>70095-031-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (70095-031-01) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>70095-0031-01</NDC11Code>
<ProductNDC>70095-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desmopressin Acetate</ProprietaryName>
<NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216904</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desmopressin acetate injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).</IndicationAndUsage>
<Description>Desmopressin acetate injection, USP is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1183.34Molecular Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate injection, USP is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate, USP which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride USP, chlorobutanol hemihydrate, USP (5 mg per mL), hydrochloric acid, NF and water for injection, USP. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>70095-040-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70095-040-01) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>70095-0040-01</NDC11Code>
<ProductNDC>70095-040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deflazacort</ProprietaryName>
<NonProprietaryName>Deflazacort</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250319</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217741</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DEFLAZACORT</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza TM(deflazacort) tablets. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>The active ingredient in deflazacort tablets is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for deflazacort is C 25H 31NO 6. The chemical name for deflazacort is 16α,17-isoxazole-11β,21-dihydroxypregna-1,4-diene-3,20-dione 21acetate, and the structure is:. Deflazacort is a white or almost white crystalline powder and has a molecular weight of 441.52. Deflazacort is soluble in dichloromethane and chloroform, slightly soluble in ethanol and ethyl acetate, almost insoluble in water. Deflazacort tablets for oral administration are available as an immediate-release tablet in strengths of 6, 18, 30 and 36 mg. Each tablet contains deflazacort and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch (maize).</Description>
</NDC>
<NDC>
<NDCCode>70095-050-03</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (70095-050-03) / 50 mL in 1 VIAL (70095-050-01) </PackageDescription>
<NDC11Code>70095-0050-03</NDC11Code>
<ProductNDC>70095-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Bicarbonate</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217594</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>84</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Alkalinizing Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Bicarbonate Injection is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis - e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself.Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial - e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.</IndicationAndUsage>
<Description>Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solutions are offered in concentration of 8.4%. See table in HOW SUPPLIED section for contents and characteristics. The solutions contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as a single-dose injection, the approximate pH of the solutions is 8. When smaller doses are required, the unused portion should be discarded. Sodium bicarbonate, 84 mg is equal to one milliequivalent each of Na+ and HCO3-. Sodium Bicarbonate, USP is chemically designated NaHCO3, a white crystalline powder soluble in water. Water for Injection is chemically designated H2O.</Description>
</NDC>
<NDC>
<NDCCode>70095-057-01</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (70095-057-01) </PackageDescription>
<NDC11Code>70095-0057-01</NDC11Code>
<ProductNDC>70095-057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pomalidomide</ProprietaryName>
<NonProprietaryName>Pomalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210232</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>POMALIDOMIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).</IndicationAndUsage>
<Description>Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C 13H 11N 3O 4and the gram molecular weight is 273.24. Pomalidomide is a yellow solid powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide capsules are available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: microcrystalline cellulose, maltodextrin, and sodium stearyl fumarate. The 1 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, red iron oxide, and white ink. The 2 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, red iron oxide, and white ink. The 3 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, red iron oxide, and white ink. The 4 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, red iron oxide, and white ink.</Description>
</NDC>
<NDC>
<NDCCode>70095-058-01</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (70095-058-01) </PackageDescription>
<NDC11Code>70095-0058-01</NDC11Code>
<ProductNDC>70095-058</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pomalidomide</ProprietaryName>
<NonProprietaryName>Pomalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210232</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>POMALIDOMIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).</IndicationAndUsage>
<Description>Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C 13H 11N 3O 4and the gram molecular weight is 273.24. Pomalidomide is a yellow solid powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide capsules are available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: microcrystalline cellulose, maltodextrin, and sodium stearyl fumarate. The 1 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, red iron oxide, and white ink. The 2 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, red iron oxide, and white ink. The 3 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, red iron oxide, and white ink. The 4 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, red iron oxide, and white ink.</Description>
</NDC>
<NDC>
<NDCCode>70095-059-01</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (70095-059-01) </PackageDescription>
<NDC11Code>70095-0059-01</NDC11Code>
<ProductNDC>70095-059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pomalidomide</ProprietaryName>
<NonProprietaryName>Pomalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210232</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>POMALIDOMIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).</IndicationAndUsage>
<Description>Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C 13H 11N 3O 4and the gram molecular weight is 273.24. Pomalidomide is a yellow solid powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide capsules are available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: microcrystalline cellulose, maltodextrin, and sodium stearyl fumarate. The 1 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, red iron oxide, and white ink. The 2 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, red iron oxide, and white ink. The 3 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, red iron oxide, and white ink. The 4 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, red iron oxide, and white ink.</Description>
</NDC>
<NDC>
<NDCCode>70095-060-01</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (70095-060-01) </PackageDescription>
<NDC11Code>70095-0060-01</NDC11Code>
<ProductNDC>70095-060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pomalidomide</ProprietaryName>
<NonProprietaryName>Pomalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210232</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>POMALIDOMIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).</IndicationAndUsage>
<Description>Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C 13H 11N 3O 4and the gram molecular weight is 273.24. Pomalidomide is a yellow solid powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide capsules are available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: microcrystalline cellulose, maltodextrin, and sodium stearyl fumarate. The 1 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, red iron oxide, and white ink. The 2 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, red iron oxide, and white ink. The 3 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, red iron oxide, and white ink. The 4 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, red iron oxide, and white ink.</Description>
</NDC>
<NDC>
<NDCCode>70095-130-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (70095-130-01) / 5 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>70095-0130-01</NDC11Code>
<ProductNDC>70095-130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Unloxcyt</ProprietaryName>
<NonProprietaryName>Cosibelimab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251208</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761297</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>COSIBELIMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], Programmed Death Ligand-1 Antagonists [MoA], Programmed Death Ligand-1 Blocker [EPC], Programmed Death Ligand-1-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UNLOXCYT® is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.</IndicationAndUsage>
<Description>Cosibelimab-ipdl is a human programmed death ligand-1 (PD-L1) blocking antibody. Cosibelimab-ipdl is a human IgG1 lambda monoclonal antibody. Cosibelimab-ipdl is produced in Chinese hamster ovary (CHO) cells and has a calculated molecular weight of approximately 147 kDa. UNLOXCYT (cosibelimab-ipdl) injection for intravenous use is a sterile, preservative-free, clear to opalescent, colorless to yellow or slightly brown solution. It is supplied in single-dose vials. Each vial contains 300 mg of UNLOXCYT in 5 mL of solution with a pH of 5.3. Each mL of solution contains 60 mg of cosibelimab-ipdl, acetic acid (0.24 mg), mannitol (37.35 mg), polysorbate 80 (1.1 mg), sodium acetate (1.31 mg), sodium chloride (4.09 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>70095-136-03</NDCCode>
<PackageDescription>1 CARTON in 1 CARTON (70095-136-03) / 21 BLISTER PACK in 1 CARTON (70095-136-02) / 1 INSERT in 1 BLISTER PACK (70095-136-01) </PackageDescription>
<NDC11Code>70095-0136-03</NDC11Code>
<ProductNDC>70095-136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Progesterone</ProprietaryName>
<NonProprietaryName>Progesterone</NonProprietaryName>
<DosageFormName>INSERT</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20260427</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022057</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>PROGESTERONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Progesterone vaginal insert is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.</IndicationAndUsage>
<Description>Progesterone vaginal insert contains micronized progesterone, USP. Progesterone vaginal insert is supplied with polyethylene vaginal applicators. The active ingredient, progesterone, USP is present in 100 mg amount along with other excipients. The chemical name for progesterone is pregn-4-ene-3,20-dione. It has an molecular formula of C 21H 30O 2and a molecular weight of 314.5. Progesterone exists in two polymorphic forms. The form used in progesterone vaginal insert, the alpha-form, has a melting point of 127°C to 131°C. The structural formula is. Each progesterone vaginal insert delivers 100 mg of progesterone, USP in a base containing lactose monohydrate, polyvinylpyrrolidone, adipic acid, sodium bicarbonate, sodium lauryl sulfate, magnesium stearate, pregelatinized starch, and colloidal silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70095-154-02</NDCCode>
<PackageDescription>10 CARTON in 1 CARTON (70095-154-02) / 1 BLISTER PACK in 1 CARTON (70095-154-01) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>70095-0154-02</NDC11Code>
<ProductNDC>70095-154</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phytonadione</ProprietaryName>
<NonProprietaryName>Phytonadione</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20260610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216298</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>PHYTONADIONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phytonadione injectable emulsion is a vitamin K replacement indicated for the treatment of the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. : 1 Anticoagulant-induced hypoprothrombinemia deficiency caused by coumarin or indanedione derivatives; ( 1.1) , 2 Hypoprothrombinemia due to antibacterial therapy; ( 1.1) , 3 Hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; ( 1.1) , 4 Other drug-induced hypoprothrombinemia where is it definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates. ( 1.1) .</IndicationAndUsage>
<Description>Phytonadione, USP is a vitamin K replacement, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.70. Phytonadione, USP is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C 31H 46O 2 and its molecular structure is:. Phytonadione injectable emulsion, USP injection is a yellow, sterile, aqueous colloidal solution of vitamin K 1, with a pH of 3.5 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes. Phytonadione injectable emulsion, USP is available in 1 mg (1 mg/0.5 mL) single-dose prefilled syringes. Each 0.5 mL of phytonadione injectable emulsion, USP contains the following inactive ingredients: 10 mg polysorbate 80, 10.4 mg propylene glycol, 0.17 mg sodium acetate anhydrous, and 0.00002 mL glacial acetic acid. Additional glacial acetic acid or sodium acetate anhydrous may have been added to adjust pH to meet USP limits of 3.5 to 7.0.</Description>
</NDC>
<NDC>
<NDCCode>10019-080-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (10019-080-01) / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>10019-0080-01</NDC11Code>
<ProductNDC>10019-080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eribulin Mesylate</ProprietaryName>
<NonProprietaryName>Eribulin Mesylate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20241001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217250</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>ERIBULIN MESYLATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eribulin Mesylate Injection is a microtubule inhibitor indicated for the treatment of patients with: 1 Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. (1.1), 2 Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. (1.2).</IndicationAndUsage>
<Description>Eribulin Mesylate Injection contains eribulin mesylate, a microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai. The chemical name for eribulin mesylate is 11,15:18,21:24,28-Triepoxy-7,9-ethano-12,15-methano-9H,15H-furo[3,2-i]furo[2',3':5,6]pyrano[4,3-b][1,4]dioxacyclopentacosin-5(4H)-one, 2-[(2S)-3- amino-2-hydroxypropyl]hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)-, (2R,3R,3aS,7R,8aS,9S,10aR,11S,12R,13aR,13bS,15S,18S,21S,24S,26R,28R,29aS)-, methanesulfonate (salt). It has a molecular weight of 826.0 (729.9 for free base). The empirical formula is C40H59NO11CH4O3S. Eribulin mesylate has the following structural formula. Eribulin Mesylate Injection is a clear, colorless, sterile solution for intravenous administration. Each single-dose vial contains 1 mg of eribulin mesylate in 2 mL of solution. Each mL of solution contains 0.5 mg of eribulin mesylate (equivalent to 0.44 mg eribulin) in dehydrated alcohol (5% v/v) and water for injection (95% v/v). Sodium hydroxide or hydrochloric acid may be used for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>10129-080-01</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DISPENSING (10129-080-01) </PackageDescription>
<NDC11Code>10129-0080-01</NDC11Code>
<ProductNDC>10129-080</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibrite Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200410</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Gingi-Pak</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Reduce bacteria that potentially can cause disease. Recommened for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10297-080-01</NDCCode>
<PackageDescription>637.13 L in 1 CYLINDER (10297-080-01) </PackageDescription>
<NDC11Code>10297-0080-01</NDC11Code>
<ProductNDC>10297-080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heliox</ProprietaryName>
<NonProprietaryName>Heliox</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20180601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205767</ApplicationNumber>
<LabelerName>A-OX Welding Supply, LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10695-080-01</NDCCode>
<PackageDescription>1 g in 1 BOTTLE (10695-080-01)</PackageDescription>
<NDC11Code>10695-0080-01</NDC11Code>
<ProductNDC>10695-080</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Semorelin Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20150301</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Willow Birch Pharma</LabelerName>
<SubstanceName>SERMORELIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/5g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11489-080-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (11489-080-01) > 50 g in 1 JAR</PackageDescription>
<NDC11Code>11489-0080-01</NDC11Code>
<ProductNDC>11489-080</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Botanics Hydrating Day All Bright Sunscreen Broad Spectrum Spf 15</ProprietaryName>
<NonProprietaryName>Avobenzone, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130114</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>BCM Ltd</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>1.5; 1.5; 2.5</StrengthNumber>
<StrengthUnit>g/50g; g/50g; g/50g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions for sunscreen use. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11788-080-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (11788-080-01) </PackageDescription>
<NDC11Code>11788-0080-01</NDC11Code>
<ProductNDC>11788-080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212654</ApplicationNumber>
<LabelerName>AiPing Pharmaceutical, Inc.</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless practically odorless, crystalline powder or small crystals and freely soluble in water, alcohol, chloroform and methanol and insoluble in ether. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a,d] cycloheptene- Δ5, γ-propylamine hydrochloride. It has the following structural formula. Amitriptyline hydrochloride, USP is supplied as 10, 25, 50, 75, 100 and 150 mg tablets. The inactive ingredients are croscarmellose sodium, magnesium stearate and silicified microcrystalline cellulose. The tablet coating ingredients are polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide. In addition, the tablet coating also contains. 10 mg – D&C Red No. 27 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. 25 mg – FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 5 (tartrazine) Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. 50 mg – FD&C Blue No.1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. 75 mg – D&C Red No. 7 Calcium Lake and FD&C Blue No. 1 Aluminum Lake. 100 mg – FD&C Red No. 40 Aluminum Lake, FD&C YellowNo. 6 Aluminum Lake, red iron oxide and yellow iron oxide. 150 mg – FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 5 (tartrazine) Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>12714-080-01</NDCCode>
<PackageDescription>.1 mg in 1 VIAL, SINGLE-DOSE (12714-080-01) </PackageDescription>
<NDC11Code>12714-0080-01</NDC11Code>
<ProductNDC>12714-080</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Interferon-gamma1b</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20010917</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Boehringer Ingelheim Pharma GmbH and Co. KG</LabelerName>
<SubstanceName>INTERFERON GAMMA-1B</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/.1mg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-07-27</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>17-SEP-01</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>13107-080-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (13107-080-01) </PackageDescription>
<NDC11Code>13107-0080-01</NDC11Code>
<ProductNDC>13107-080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204852</ApplicationNumber>
<LabelerName>Aurolife Pharma LLC</LabelerName>
<SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trazodone Hydrochloride Tablets are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Trazodone hydrochloride tablets for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows. Molecular Formula: C19H22CIN5O HCl. Molecular Weight: 408.33. Each tablet, for oral administration, contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (physically modified corn (maize) starch), sodium lauryl sulfate, and sodium starch glycolate.</Description>
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<PackageDescription>1 TUBE in 1 BOX (13537-080-02) > 30 g in 1 TUBE (13537-080-01)</PackageDescription>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.065; .024; .015</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
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<PackageDescription>45 g in 1 CARTON (13733-080-01)</PackageDescription>
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<ProductNDC>13733-080</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Missha M Signature Real Complete Bb</ProprietaryName>
<ProprietaryNameSuffix>Honey Beige</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>ABLE C&C Co., Ltd.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>3.47; 1.73</StrengthNumber>
<StrengthUnit>g/45g; g/45g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-01-08</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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<PackageDescription>1 TUBE in 1 BOX (14141-080-02) > 30 g in 1 TUBE (14141-080-01) </PackageDescription>
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<ProductNDC>14141-080</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Mousse Matiffiant Matte Finish Mousse Foundation Spf 15</ProprietaryName>
<ProprietaryNameSuffix>Claire 2/ Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180808</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bel Star S.A. (Colombia)</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.065; .0244; .0157</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
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