{
"NDC": [
{
"NDCCode": "71288-175-05",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (71288-175-05) / 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "71288-0175-05",
"ProductNDC": "71288-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etoposide",
"NonProprietaryName": "Etoposide",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074529",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "ETOPOSIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250201",
"SamplePackage": "N",
"IndicationAndUsage": "Etoposide Injection is indicated in the management of the following neoplasms.",
"Description": "Etoposide Injection, USP (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. It is 4'-demethylepipodophyllotoxin 9-[4,6-0-(R)-ethylidene-β-D-glucopyranoside]. It is very soluble in methanol and chloroform, slightly soluble in ethanol, and sparingly soluble in water and ether. It is made more miscible with water by means of organic solvents. Etoposide Injection, USP is available for intravenous use as a sterile 20 mg per mL solution in 100 mg (5 mL), 500 mg (25 mL), or 1 g (50 mL) sterile, multiple dose vials. The pH of the clear, colorless to yellow solution is 3.0 to 4.0. Each mL contains: 20 mg etoposide, USP, 2 mg citric acid anhydrous, 80 mg polysorbate 80, 650 mg polyethylene glycol 300 (57.5% v/v and 65.0% w/v), and 262 mg dehydrated alcohol (33.2% v/v and 26.2% w/v). The structural formula is."
},
{
"NDCCode": "71288-100-05",
"PackageDescription": "1 VIAL in 1 CARTON (71288-100-05) > 5 mL in 1 VIAL",
"NDC11Code": "71288-0100-05",
"ProductNDC": "71288-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carboplatin",
"NonProprietaryName": "Carboplatin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170619",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077096",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "CARBOPLATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]",
"Status": "Deprecated",
"LastUpdate": "2022-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170619",
"SamplePackage": "N"
},
{
"NDCCode": "71288-108-06",
"PackageDescription": "5 VIAL, SINGLE-DOSE in 1 CARTON (71288-108-06) > 5 mL in 1 VIAL, SINGLE-DOSE (71288-108-05) ",
"NDC11Code": "71288-0108-06",
"ProductNDC": "71288-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cytarabine",
"NonProprietaryName": "Cytarabine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20200626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206189",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "CYTARABINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2022-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200626",
"SamplePackage": "N",
"IndicationAndUsage": "Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia.",
"Description": "Cytarabine Injection 100 mg per 5 mL (20 mg per mL), an antineoplastic, is a sterile solution of cytarabine for intravenous, intrathecal or subcutaneous administration. Each mL contains 20 mg Cytarabine, USP (20 mg per mL) in a single dose vial (100 mg per 5 mL). Cytarabine Injection 100 mg per 5 mL is a sterile solution for intravenous, intrathecal or subcutaneous administration. Each mL contains 20 mg Cytarabine, USP, and the following inactive ingredients: sodium chloride 6.8 mg and Water for Injection q.s. When necessary the pH is adjusted with hydrochloric acid and/or sodium hydroxide to a pH of 7.4. Each vial contains approximately 0.58 mEq sodium. Cytarabine is chemically 1-β-D-Arabinofuranosylcytosine. The structural formula is:. Cytarabine is an odorless, white to off-white crystalline powder which is freely soluble in water and slightly soluble in alcohol and in chloroform."
},
{
"NDCCode": "71288-156-05",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-156-05) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "71288-0156-05",
"ProductNDC": "71288-156",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thiotepa",
"NonProprietaryName": "Thiotepa",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRACAVITARY; INTRAVENOUS; INTRAVESICAL",
"StartMarketingDate": "20231226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216037",
"LabelerName": "Meitheal Pharmaceuticals Inc",
"SubstanceName": "THIOTEPA",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231226",
"SamplePackage": "N",
"IndicationAndUsage": "Thiotepa for Injection is an alkylating drug indicated: 1 For treatment of adenocarcinoma of the breast or ovary. (1.2), 2 For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. (1.3), 3 For treatment of superficial papillary carcinoma of the urinary bladder. (1.4).",
"Description": "Thiotepa for Injection, USP is an alkylating agent. Thiotepa for Injection, USP is supplied as a nonpyrogenic, sterile, white lyophilized powder or lyophilized cake for intravenous, intracavitary, or intravesical use after reconstitution and dilution. Thiotepa for Injection, USP is available in a single-dose vial containing: 1 15 mg thiotepa. After reconstitution with 1.5 mL of water for injection, each mL contains 10 mg thiotepa., 2 100 mg thiotepa. After reconstitution with 10 mL of water for injection, each mL contains 10 mg thiotepa."
},
{
"NDCCode": "71288-182-05",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (71288-182-05) / 4 mL in 1 VIAL, SINGLE-DOSE (71288-182-04) ",
"NDC11Code": "71288-0182-05",
"ProductNDC": "71288-182",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daunorubicin Hydrochloride",
"NonProprietaryName": "Daunorubicin Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065035",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "DAUNORUBICIN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250601",
"SamplePackage": "N",
"IndicationAndUsage": "Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.",
"Description": "Daunorubicin Hydrochloride Injection consists of the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of Streptomyces coeruleorubidus. It is provided as a deep red sterile liquid in vials for intravenous administration only. Each mL contains daunorubicin hydrochloride, USP equivalent to 5 mg of daunorubicin, 9 mg sodium chloride, hydrochloric acid (to adjust pH), and water for injection, q.s. It has the following structural formula which may be described with the chemical name of (1S,3S)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranoside hydrochloride. C27H29NO10HCl M.W. 563.99. It is a hygroscopic crystalline powder. The pH of a 5 mg/mL aqueous solution is 3 to 4."
},
{
"NDCCode": "71288-184-05",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-184-05) / 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "71288-0184-05",
"ProductNDC": "71288-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Idarubicin Hydrochloride",
"NonProprietaryName": "Idarubicin Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065036",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "IDARUBICIN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250601",
"SamplePackage": "N",
"IndicationAndUsage": "Idarubicin Hydrochloride Injection in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. This includes French-American-British (FAB) classifications M1 through M7.",
"Description": "Idarubicin Hydrochloride Injection, USP contains idarubicin hydrochloride, USP and is a sterile, semi-synthetic, preservative-free solution (PFS) antineoplastic anthracycline for intravenous use. Chemically, idarubicin hydrochloride, USP is 5, 12-Naphthacenedione, 9-acetyl-7-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,9,11-trihydroxyhydrochloride, (7S-cis). The structural formula is as follows. C26H27NO9HCl M.W. 533.95. Idarubicin Hydrochloride Injection, USP is a sterile, clear, orange-red, isotonic parenteral preservative-free solution, available in 5 mL (5 mg), 10 mL (10 mg) and 20 mL (20 mg) single-dose-only vials. Each mL contains idarubicin hydrochloride USP, 1 mg (equivalent to 0.93 mg idarubicin free base) and the following inactive ingredients: glycerin USP, 25 mg and q.s. water for injection, USP. Hydrochloric acid and/or sodium hydroxide is used to adjust pH to a target of 3.5."
},
{
"NDCCode": "71288-203-05",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-05) / 4 mL in 1 VIAL, SINGLE-DOSE (71288-203-04) ",
"NDC11Code": "71288-0203-05",
"ProductNDC": "71288-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20220127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212803",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220127",
"SamplePackage": "N",
"IndicationAndUsage": "Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations.",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide Injection, USP 10 mg per mL is a sterile, nonpyrogenic solution in vials for intravenous and intramuscular injection. Furosemide is a white to slightly yellow odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each mL contains: Furosemide 10 mg, Water for Injection q.s., Sodium Chloride for isotonicity, Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3."
},
{
"NDCCode": "71288-404-05",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (71288-404-05) / 4 mL in 1 VIAL, MULTI-DOSE (71288-404-04) ",
"NDC11Code": "71288-0404-05",
"ProductNDC": "71288-404",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heparin Sodium",
"NonProprietaryName": "Heparin Sodium",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20190615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211007",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "HEPARIN SODIUM",
"StrengthNumber": "10000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190615",
"SamplePackage": "N",
"IndicationAndUsage": "Heparin Sodium Injection is indicated for: 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism;, 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease;, 3 Atrial fibrillation with embolization;, 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation);, 5 Prevention of clotting in arterial and cardiac surgery;, 6 Prophylaxis and treatment of peripheral arterial embolism., 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.",
"Description": "Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of heparin sodium (representative subunits). Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Heparin Sodium Injection, USP preserved with Benzyl Alcohol is available in the following concentrations per mL. pH 5.0-7.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment."
},
{
"NDCCode": "71288-408-06",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (71288-408-06) > 5 mL in 1 VIAL, MULTI-DOSE (71288-408-05) ",
"NDC11Code": "71288-0408-06",
"ProductNDC": "71288-408",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20190515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211705",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190515",
"EndMarketingDatePackage": "20231030",
"SamplePackage": "N",
"IndicationAndUsage": "Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.",
"Description": "Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains. Glycopyrrolate, USP 0.2 mg. Water for Injection, USP q.s. Benzyl Alcohol, NF 0.9% (preservative). pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. For Intramuscular (IM) or Intravenous (IV) administration. Glycopyrrolate is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33. Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection, USP is a clear, colorless, sterile liquid; pH 2.0 – 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P = -1.52) at ambient room temperature (24°C)."
},
{
"NDCCode": "71288-409-05",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-409-05) / 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "71288-0409-05",
"ProductNDC": "71288-409",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Palonosetron Hydrochloride",
"NonProprietaryName": "Palonosetron Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230814",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215861",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "PALONOSETRON HYDROCHLORIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230814",
"SamplePackage": "N",
"IndicationAndUsage": "Palonosetron Hydrochloride Injection is a serotonin-3 (5-HT3) receptor antagonist indicated in. Adults for prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). (1), 2 acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). (1), 3 postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated (1).",
"Description": "Palonosetron Hydrochloride Injection contains palonosetron as palonosetron hydrochloride, an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1Hbenz[de]isoquinoline hydrochloride. The empirical formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron Hydrochloride Injection is a sterile, clear, colorless, nonpyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron Hydrochloride Injection is available as a 5 mL single-dose vial. Each 5 mL vial contains: 0.25 mg palonosetron (equivalent to 0.28 mg palonosetron hydrochloride), 207.5 mg mannitol, USP, edetate disodium dihydrate, USP, and citrate and citric acid buffers in water for intravenous administration. Hydrochloric acid, NF or sodium hydroxide, NF may have been added to adjust the pH of the solution to 4.5 to 5.5."
},
{
"NDCCode": "71288-415-06",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (71288-415-06) / 5 mL in 1 VIAL, MULTI-DOSE (71288-415-05) ",
"NDC11Code": "71288-0415-06",
"ProductNDC": "71288-415",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20210706",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212802",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210706",
"SamplePackage": "N",
"IndicationAndUsage": "Glycopyrrolate Injection is an anticholinergic indicated. in anesthesia (adult and pediatric patients): 1 for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation., 2 intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias., 3 for protection against peripheral muscarinic effects of cholinergic agents. (1).",
"Description": "Glycopyrrolate is a synthetic anticholinergic agent. It is a quaternary ammonium salt with the following chemical name. 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.34. Its structural formula is as follows. C19H28BrNO3 398.34. Glycopyrrolate occurs as a white, odorless, crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. It is completely ionized at physiological pH values. Glycopyrrolate Injection, USP is a clear, colorless, sterile liquid with a pH of 2.0 to 3.0. The partition coefficient of glycopyrrolate in n-octanol/water system is 0.304 (log10 P = -1.52) at ambient room temperature (24°C). Glycopyrrolate Injection, USP is intended for intramuscular or intravenous administration. Each 1 mL contains 0.2 mg of glycopyrrolate, water for injection, and hydrochloric acid or sodium hydroxide as pH adjusters."
},
{
"NDCCode": "71288-439-05",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (71288-439-05) / 4 mL in 1 VIAL, SINGLE-USE (71288-439-04) ",
"NDC11Code": "71288-0439-05",
"ProductNDC": "71288-439",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norepinephrine Bitartrate",
"NonProprietaryName": "Norepinephrine Bitartrate",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20241201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040455",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "NOREPINEPHRINE BITARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
"Status": "Active",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241201",
"SamplePackage": "N",
"IndicationAndUsage": "Norepinephrine Bitartrate Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.",
"Description": "Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a sympathomimetic amine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. Norepinephrine bitartrate, USP is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.3 g/mol) and has the following structural formula. Norepinephrine Bitartrate Injection, USP is supplied in a sterile aqueous solution in the form of the bitartrate salt to be administered by intravenous infusion. Norepinephrine is sparingly soluble in water, very slightly soluble in alcohol and ether, and readily soluble in acids. Each mL contains 1 mg of norepinephrine base (equivalent to 1.89 mg of norepinephrine bitartrate, anhydrous basis), sodium chloride for isotonicity, not more than 2 mg of sodium metabisulfite as an antioxidant. It has a pH of 3.0 to 4.5. The air in the vials has been displaced by nitrogen gas."
},
{
"NDCCode": "71288-504-05",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (71288-504-05) / 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "71288-0504-05",
"ProductNDC": "71288-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol Decanoate",
"NonProprietaryName": "Haloperidol Decanoate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20210726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214507",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "HALOPERIDOL DECANOATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210726",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol Decanoate Injection is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product.",
"Description": "Haloperidol Decanoate Injection is the decanoate ester of haloperidol, for intramuscular use. Haloperidol is a typical antipsychotic. The structural formula of haloperidol decanoate is 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl] piperidin-4-yl decanoate. The molecular formula is C31H41CIFNO3 and has a molecular weight of 530.12. Haloperidol decanoate is almost insoluble in water (0.01 mg/mL) but is soluble in most organic solvents. Each mL of Haloperidol Decanoate Injection contains: 1 50 mg of haloperidol (present as 70.52 mg of haloperidol decanoate) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative., 2 100 mg of haloperidol (present as 141.04 mg of haloperidol decanoate) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative."
},
{
"NDCCode": "71288-700-06",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (71288-700-06) / 5 mL in 1 VIAL, MULTI-DOSE (71288-700-05) ",
"NDC11Code": "71288-0700-06",
"ProductNDC": "71288-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rocuronium Bromide",
"NonProprietaryName": "Rocuronium Bromide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213453",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "ROCURONIUM BROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230508",
"SamplePackage": "N",
"IndicationAndUsage": "Rocuronium Bromide Injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2-propenyl)pyrrolidinium bromide. The structural formula is. The chemical formula is C32H53BrN2O4 with a molecular weight of 609.70. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium Bromide Injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow, for intravenous injection only. Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate trihydrate. The aqueous solution is adjusted to isotonicity with sodium chloride (3.3 mg per mL) and to a pH of 4 with glacial acetic acid and/or sodium hydroxide."
},
{
"NDCCode": "71288-701-05",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (71288-701-05) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-701-06) ",
"NDC11Code": "71288-0701-05",
"ProductNDC": "71288-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atracurium Besylate",
"NonProprietaryName": "Atracurium Besylate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091488",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "ATRACURIUM BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180515",
"SamplePackage": "N",
"IndicationAndUsage": "Atracurium besylate injection is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Atracurium besylate is an intermediate-duration, nondepolarizing, skeletal muscle relaxant for intravenous administration. Atracurium besylate is designated as 2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester. It has a molecular weight of 1243.49, and its molecular formula is C65H82N2O18S2. The structural formula is. Atracurium besylate is a complex molecule containing four sites at which different stereochemical configurations can occur. The symmetry of the molecule, however, results in only ten, instead of sixteen, possible different isomers. The manufacture of atracurium besylate results in these isomers being produced in unequal amounts but with a consistent ratio. Those molecules in which the methyl group attached to the quaternary nitrogen projects on the opposite side to the adjacent substituted-benzyl moiety predominate by approximately 3:1. Atracurium Besylate Injection, USP is a sterile, non-pyrogenic aqueous solution. Each mL contains 10 mg atracurium besylate. The pH is adjusted to 3.25 to 3.65 with benzenesulfonic acid. The multiple dose vial contains 0.9% benzyl alcohol added as a preservative. Atracurium besylate injection slowly loses potency with time at the rate of approximately 6% per year under refrigeration (5°C). Atracurium besylate injection should be refrigerated at 2° to 8°C (36° to 46°F) to preserve potency. Rate of loss in potency increases to approximately 5% per month at 25°C (77°F). Upon removal from refrigeration to room temperature storage conditions (25°C / 77°F), use atracurium besylate injection within 14 days even if re-refrigerated."
},
{
"NDCCode": "71288-712-06",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (71288-712-06) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-712-05) ",
"NDC11Code": "71288-0712-06",
"ProductNDC": "71288-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cisatracurium Besylate",
"NonProprietaryName": "Cisatracurium Besylate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211668",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "CISATRACURIUM BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191031",
"SamplePackage": "N",
"IndicationAndUsage": "Cisatracurium Besylate Injection is indicated: : 1 as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age , 2 to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU , 3 to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older .",
"Description": "Cisatracurium besylate is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium Besylate Injection, USP contains cisatracurium besylate as the active pharmaceutical ingredient. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1R-[1α,2α(1'R*,2'R*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C53H72N2O12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C65H82N2O18S2 and the molecular weight is 1243.48. The structural formula of cisatracurium besylate is. The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25°C. Cisatracurium Besylate Injection, USP is a sterile, nonpyrogenic aqueous solution. Each mL in the single-dose vials contains either 2 mg or 10 mg of cisatracurium (equivalent to 2.68 mg and 13.38 mg of cisatracurium besylate; respectively), and benzenesulfonic acid as pH adjuster in water for injection. Each mL in the multi-dose vials contains 2 mg of cisatracurium (equivalent to 2.68 mg of cisatracurium besylate), benzenesulfonic acid as pH adjuster, and also contains 9 mg of benzyl alcohol as preservative, in water for injection. The pH of Cisatracurium Besylate Injection, USP is between 3.0 and 3.8."
},
{
"NDCCode": "71288-805-06",
"PackageDescription": "6 VIAL, SINGLE-DOSE in 1 CARTON (71288-805-06) > 5 mL in 1 VIAL, SINGLE-DOSE (71288-805-05) ",
"NDC11Code": "71288-0805-06",
"ProductNDC": "71288-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosulfan Blue",
"NonProprietaryName": "Isosulfan Blue",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20211103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213130",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "ISOSULFAN BLUE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2021-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211103",
"SamplePackage": "N",
"IndicationAndUsage": "Isosulfan Blue Injection 1% upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; lymph node response to therapeutic modalities (1.1).",
"Description": "The chemical name of Isosulfan Blue Injection 1% is N-[4-[[4-(diethylamino)phenyl] (2,5- disulfophenyl) methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide, inner salt, sodium salt. Its structural formula is. Isosulfan Blue Injection 1% is a sterile aqueous solution for subcutaneous administration. Phosphate buffer in sterile, nonpyrogenic water is added in sufficient quantity to yield a final pH of 6.8 to 7.4. Each mL of solution contains 10 mg isosulfan blue, 6.6 mg dibasic sodium phosphate, anhydrous and 2.7 mg monobasic potassium phosphate. The solution contains no preservative. Isosulfan Blue Injection 1% is a contrast agent for the delineation of lymphatic vessels."
},
{
"NDCCode": "11084-175-05",
"PackageDescription": "3780 mL in 1 BOTTLE, PLASTIC (11084-175-05)",
"NDC11Code": "11084-0175-05",
"ProductNDC": "11084-175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sbs Ultragreen",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130725",
"EndMarketingDate": "20200801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Deb USA, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-08-04",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "16590-175-05",
"PackageDescription": "5 mL in 1 BOTTLE, DROPPER (16590-175-05)",
"NDC11Code": "16590-0175-05",
"ProductNDC": "16590-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20040514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076615",
"LabelerName": "STAT RX LLC USA",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:. *Efficacy for this organism was studied in fewer than 10 infections.",
"Description": "Ofloxacin ophthalmic solution 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use. (±)-9-Fluoro-2, 3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4 benzoxazine-6-carboxylic acid. Contains. Active: ofloxacin 0.3% (3 mg/mL). Preservative: benzalkonium chloride (0.005%). Inactives: sodium chloride and purified water. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. Ofloxacin ophthalmic solution is unbuffered and formulated with a pH of 6.4 (range - 6.0 to 6.8). It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure."
},
{
"NDCCode": "29300-175-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (29300-175-05) ",
"NDC11Code": "29300-0175-05",
"ProductNDC": "29300-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203025",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220221",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole tablets are indicated for the treatment of: : 1 Schizophrenia, 2 Irritability Associated with Autistic Disorder, 3 Treatment of Tourette's Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as aripiprazole tablets, Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1 piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include hydroxypropyl cellulose, lactose monohydrate, corn starch, magnesium stearate, and microcrystalline cellulose. Additionally, 10 mg, 15 mg, 20 mg, and 30 mg include colorant ferric oxide (red)."
},
{
"NDCCode": "31722-175-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (31722-175-05) ",
"NDC11Code": "31722-0175-05",
"ProductNDC": "31722-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207416",
"LabelerName": "Camber Pharmaceutical Inc",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-08-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151001",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults, 2 Narcolepsy.",
"Description": "Methylphenidate hydrochloride tablets, USP is a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white to off white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablets, USP contain the following inactive ingredients: compressible sugar, colloidal silicon dioxide, D&C yellow no. 10 (5 mg and 20 mg tablets), lactose monohydrate, magnesium stearate, and microcrystalline cellulose."
},
{
"NDCCode": "41415-175-05",
"PackageDescription": "50 TABLET in 1 BOTTLE (41415-175-05) ",
"NDC11Code": "41415-0175-05",
"ProductNDC": "41415-175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260715",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "PUBLIX SUPERMARKETS, INC",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260715",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ backache ■ minor pain of arthritis ■ the common cold ■ toothache ■ premenstrual and menstrual cramps. temporarily reduces fever."
},
{
"NDCCode": "46783-175-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (46783-175-05) > 15 mL in 1 BOTTLE",
"NDC11Code": "46783-0175-05",
"ProductNDC": "46783-175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Journee Riche Bio-restorative Day Balm Broad-spectrum Sunscreen Spf 30",
"NonProprietaryName": "Octinoxate And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150518",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Merz North America, Inc.",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "7.5; 7.3",
"StrengthUnit": "mg/100mL; mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150518",
"SamplePackage": "N"
},
{
"NDCCode": "47781-175-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (47781-175-05)",
"NDC11Code": "47781-0175-05",
"ProductNDC": "47781-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 7.5 Mg,cll",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207388",
"LabelerName": "Alvogen inc.",
"SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "1.875; 1.875; 1.875; 1.875",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-09-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "49643-175-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-175-05) ",
"NDC11Code": "49643-0175-05",
"ProductNDC": "49643-175",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Trichophyton Rubrum",
"NonProprietaryName": "Trichophyton Rubrum",
"DosageFormName": "LIQUID",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "TRICHOPHYTON RUBRUM",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease.(4,5,6). Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms.(7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency."
},
{
"NDCCode": "49884-175-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (49884-175-05) ",
"NDC11Code": "49884-0175-05",
"ProductNDC": "49884-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine, Valsartan, Hydrochlorothiazide",
"NonProprietaryName": "Amlodipine Besylate Valsartan Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201087",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
"StrengthNumber": "10; 25; 320",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-04-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20150601",
"SamplePackage": "N"
},
{
"NDCCode": "50228-175-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-175-05) ",
"NDC11Code": "50228-0175-05",
"ProductNDC": "50228-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Sr",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205794",
"LabelerName": "ScieGen Pharmaceuticals, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180420",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .",
"Description": "Bupropion hydrochloride extended-release tablets, USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, powder, soluble in 0.1N HCl, alcohol 96% and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (SR), are supplied for oral administration as 100 mg (blue), 150 mg (purple), and 200 mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: copovidone, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. In addition, the 100 mg tablet contains FD&C Blue No. 1 Brilliant Blue FCF Aluminium Lake, the 150 mg tablet contains FD&C Blue No. 2 Indigo Carmine Aluminium Lake and FD&C Red No. 40 Allura Red AC Aluminium Lake, and the 200 mg tablet contains FD&C Red No. 40 Allura Red AC Aluminium Lake. In addition, flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol, and silicon dioxide. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP Dissolution Test2."
},
{
"NDCCode": "50742-175-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-175-05) ",
"NDC11Code": "50742-0175-05",
"ProductNDC": "50742-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Mononitrate",
"NonProprietaryName": "Isosorbide Mononitrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210918",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "ISOSORBIDE MONONITRATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2023-11-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181113",
"SamplePackage": "N",
"IndicationAndUsage": "Isosorbide mononitrate extended-release tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Isosorbide mononitrate tablets contain either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose, colloidal silicon dioxide, lactose monohydrate and magnesium stearate. The molecular formula of ISMN is C6H9NO6 and the molecular weight is 191.14. The chemical name for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula. ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +140° to 146° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, acetic acid, alcohol, acetone and ethyl acetate; soluble in ether and chloroform, slightly soluble in toluene; practically insoluble in aliphatic hydrocarbons. Isosorbide mononitrate extended-release tablets, USP meets USP Dissolution Test 8."
},
{
"NDCCode": "54162-175-05",
"PackageDescription": "113 g in 1 BOTTLE, WITH APPLICATOR (54162-175-05)",
"NDC11Code": "54162-0175-05",
"ProductNDC": "54162-175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mineral Oil",
"NonProprietaryName": "Mineral Oil",
"DosageFormName": "OIL",
"RouteName": "RECTAL",
"StartMarketingDate": "20150731",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "GERITREX LLC",
"SubstanceName": "MINERAL OIL",
"StrengthNumber": "100",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "61919-175-05",
"PackageDescription": "5 mL in 1 BOTTLE, DROPPER (61919-175-05)",
"NDC11Code": "61919-0175-05",
"ProductNDC": "61919-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076407",
"LabelerName": "DIRECT RX",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below.",
"Description": "Ofloxacin Ophthalmic Solution USP, 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use. Chemical Name: (±)-9-Fluoro-2, 3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4 benzoxazine-6-carboxylic acid. Contains: Active: ofloxacin 0.3% (3 mg/mL);. Preservative: benzalkonium chloride (0.005%);. Inactives: sodium chloride and water for injection. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. Ofloxacin Ophthalmic Solution USP, 0.3% is unbuffered and formulated with a pH of 6.4 (range - 6.0 to 6.8). It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>71288-175-05</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (71288-175-05) / 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>71288-0175-05</NDC11Code>
<ProductNDC>71288-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etoposide</ProprietaryName>
<NonProprietaryName>Etoposide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074529</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ETOPOSIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Etoposide Injection is indicated in the management of the following neoplasms.</IndicationAndUsage>
<Description>Etoposide Injection, USP (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. It is 4'-demethylepipodophyllotoxin 9-[4,6-0-(R)-ethylidene-β-D-glucopyranoside]. It is very soluble in methanol and chloroform, slightly soluble in ethanol, and sparingly soluble in water and ether. It is made more miscible with water by means of organic solvents. Etoposide Injection, USP is available for intravenous use as a sterile 20 mg per mL solution in 100 mg (5 mL), 500 mg (25 mL), or 1 g (50 mL) sterile, multiple dose vials. The pH of the clear, colorless to yellow solution is 3.0 to 4.0. Each mL contains: 20 mg etoposide, USP, 2 mg citric acid anhydrous, 80 mg polysorbate 80, 650 mg polyethylene glycol 300 (57.5% v/v and 65.0% w/v), and 262 mg dehydrated alcohol (33.2% v/v and 26.2% w/v). The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>71288-100-05</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (71288-100-05) > 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>71288-0100-05</NDC11Code>
<ProductNDC>71288-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carboplatin</ProprietaryName>
<NonProprietaryName>Carboplatin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077096</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CARBOPLATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71288-108-06</NDCCode>
<PackageDescription>5 VIAL, SINGLE-DOSE in 1 CARTON (71288-108-06) > 5 mL in 1 VIAL, SINGLE-DOSE (71288-108-05) </PackageDescription>
<NDC11Code>71288-0108-06</NDC11Code>
<ProductNDC>71288-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cytarabine</ProprietaryName>
<NonProprietaryName>Cytarabine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206189</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CYTARABINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia.</IndicationAndUsage>
<Description>Cytarabine Injection 100 mg per 5 mL (20 mg per mL), an antineoplastic, is a sterile solution of cytarabine for intravenous, intrathecal or subcutaneous administration. Each mL contains 20 mg Cytarabine, USP (20 mg per mL) in a single dose vial (100 mg per 5 mL). Cytarabine Injection 100 mg per 5 mL is a sterile solution for intravenous, intrathecal or subcutaneous administration. Each mL contains 20 mg Cytarabine, USP, and the following inactive ingredients: sodium chloride 6.8 mg and Water for Injection q.s. When necessary the pH is adjusted with hydrochloric acid and/or sodium hydroxide to a pH of 7.4. Each vial contains approximately 0.58 mEq sodium. Cytarabine is chemically 1-β-D-Arabinofuranosylcytosine. The structural formula is:. Cytarabine is an odorless, white to off-white crystalline powder which is freely soluble in water and slightly soluble in alcohol and in chloroform.</Description>
</NDC>
<NDC>
<NDCCode>71288-156-05</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (71288-156-05) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>71288-0156-05</NDC11Code>
<ProductNDC>71288-156</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thiotepa</ProprietaryName>
<NonProprietaryName>Thiotepa</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRACAVITARY; INTRAVENOUS; INTRAVESICAL</RouteName>
<StartMarketingDate>20231226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216037</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc</LabelerName>
<SubstanceName>THIOTEPA</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Thiotepa for Injection is an alkylating drug indicated: 1 For treatment of adenocarcinoma of the breast or ovary. (1.2), 2 For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. (1.3), 3 For treatment of superficial papillary carcinoma of the urinary bladder. (1.4).</IndicationAndUsage>
<Description>Thiotepa for Injection, USP is an alkylating agent. Thiotepa for Injection, USP is supplied as a nonpyrogenic, sterile, white lyophilized powder or lyophilized cake for intravenous, intracavitary, or intravesical use after reconstitution and dilution. Thiotepa for Injection, USP is available in a single-dose vial containing: 1 15 mg thiotepa. After reconstitution with 1.5 mL of water for injection, each mL contains 10 mg thiotepa., 2 100 mg thiotepa. After reconstitution with 10 mL of water for injection, each mL contains 10 mg thiotepa.</Description>
</NDC>
<NDC>
<NDCCode>71288-182-05</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (71288-182-05) / 4 mL in 1 VIAL, SINGLE-DOSE (71288-182-04) </PackageDescription>
<NDC11Code>71288-0182-05</NDC11Code>
<ProductNDC>71288-182</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Daunorubicin Hydrochloride</ProprietaryName>
<NonProprietaryName>Daunorubicin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065035</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DAUNORUBICIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.</IndicationAndUsage>
<Description>Daunorubicin Hydrochloride Injection consists of the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of Streptomyces coeruleorubidus. It is provided as a deep red sterile liquid in vials for intravenous administration only. Each mL contains daunorubicin hydrochloride, USP equivalent to 5 mg of daunorubicin, 9 mg sodium chloride, hydrochloric acid (to adjust pH), and water for injection, q.s. It has the following structural formula which may be described with the chemical name of (1S,3S)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranoside hydrochloride. C27H29NO10HCl M.W. 563.99. It is a hygroscopic crystalline powder. The pH of a 5 mg/mL aqueous solution is 3 to 4.</Description>
</NDC>
<NDC>
<NDCCode>71288-184-05</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (71288-184-05) / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>71288-0184-05</NDC11Code>
<ProductNDC>71288-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Idarubicin Hydrochloride</ProprietaryName>
<NonProprietaryName>Idarubicin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065036</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IDARUBICIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Idarubicin Hydrochloride Injection in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. This includes French-American-British (FAB) classifications M1 through M7.</IndicationAndUsage>
<Description>Idarubicin Hydrochloride Injection, USP contains idarubicin hydrochloride, USP and is a sterile, semi-synthetic, preservative-free solution (PFS) antineoplastic anthracycline for intravenous use. Chemically, idarubicin hydrochloride, USP is 5, 12-Naphthacenedione, 9-acetyl-7-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,9,11-trihydroxyhydrochloride, (7S-cis). The structural formula is as follows. C26H27NO9HCl M.W. 533.95. Idarubicin Hydrochloride Injection, USP is a sterile, clear, orange-red, isotonic parenteral preservative-free solution, available in 5 mL (5 mg), 10 mL (10 mg) and 20 mL (20 mg) single-dose-only vials. Each mL contains idarubicin hydrochloride USP, 1 mg (equivalent to 0.93 mg idarubicin free base) and the following inactive ingredients: glycerin USP, 25 mg and q.s. water for injection, USP. Hydrochloric acid and/or sodium hydroxide is used to adjust pH to a target of 3.5.</Description>
</NDC>
<NDC>
<NDCCode>71288-203-05</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-05) / 4 mL in 1 VIAL, SINGLE-DOSE (71288-203-04) </PackageDescription>
<NDC11Code>71288-0203-05</NDC11Code>
<ProductNDC>71288-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20220127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212803</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations.</IndicationAndUsage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide Injection, USP 10 mg per mL is a sterile, nonpyrogenic solution in vials for intravenous and intramuscular injection. Furosemide is a white to slightly yellow odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each mL contains: Furosemide 10 mg, Water for Injection q.s., Sodium Chloride for isotonicity, Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3.</Description>
</NDC>
<NDC>
<NDCCode>71288-404-05</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (71288-404-05) / 4 mL in 1 VIAL, MULTI-DOSE (71288-404-04) </PackageDescription>
<NDC11Code>71288-0404-05</NDC11Code>
<ProductNDC>71288-404</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heparin Sodium</ProprietaryName>
<NonProprietaryName>Heparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211007</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HEPARIN SODIUM</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Heparin Sodium Injection is indicated for: 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism;, 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease;, 3 Atrial fibrillation with embolization;, 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation);, 5 Prevention of clotting in arterial and cardiac surgery;, 6 Prophylaxis and treatment of peripheral arterial embolism., 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.</IndicationAndUsage>
<Description>Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of heparin sodium (representative subunits). Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Heparin Sodium Injection, USP preserved with Benzyl Alcohol is available in the following concentrations per mL. pH 5.0-7.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>71288-408-06</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (71288-408-06) > 5 mL in 1 VIAL, MULTI-DOSE (71288-408-05) </PackageDescription>
<NDC11Code>71288-0408-06</NDC11Code>
<ProductNDC>71288-408</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20190515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211705</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190515</StartMarketingDatePackage>
<EndMarketingDatePackage>20231030</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.</IndicationAndUsage>
<Description>Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains. Glycopyrrolate, USP 0.2 mg. Water for Injection, USP q.s. Benzyl Alcohol, NF 0.9% (preservative). pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. For Intramuscular (IM) or Intravenous (IV) administration. Glycopyrrolate is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33. Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection, USP is a clear, colorless, sterile liquid; pH 2.0 – 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P = -1.52) at ambient room temperature (24°C).</Description>
</NDC>
<NDC>
<NDCCode>71288-409-05</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (71288-409-05) / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>71288-0409-05</NDC11Code>
<ProductNDC>71288-409</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Palonosetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Palonosetron Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230814</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215861</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PALONOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Palonosetron Hydrochloride Injection is a serotonin-3 (5-HT3) receptor antagonist indicated in. Adults for prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). (1), 2 acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). (1), 3 postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated (1).</IndicationAndUsage>
<Description>Palonosetron Hydrochloride Injection contains palonosetron as palonosetron hydrochloride, an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1Hbenz[de]isoquinoline hydrochloride. The empirical formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron Hydrochloride Injection is a sterile, clear, colorless, nonpyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron Hydrochloride Injection is available as a 5 mL single-dose vial. Each 5 mL vial contains: 0.25 mg palonosetron (equivalent to 0.28 mg palonosetron hydrochloride), 207.5 mg mannitol, USP, edetate disodium dihydrate, USP, and citrate and citric acid buffers in water for intravenous administration. Hydrochloric acid, NF or sodium hydroxide, NF may have been added to adjust the pH of the solution to 4.5 to 5.5.</Description>
</NDC>
<NDC>
<NDCCode>71288-415-06</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (71288-415-06) / 5 mL in 1 VIAL, MULTI-DOSE (71288-415-05) </PackageDescription>
<NDC11Code>71288-0415-06</NDC11Code>
<ProductNDC>71288-415</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20210706</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212802</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glycopyrrolate Injection is an anticholinergic indicated. in anesthesia (adult and pediatric patients): 1 for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation., 2 intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias., 3 for protection against peripheral muscarinic effects of cholinergic agents. (1).</IndicationAndUsage>
<Description>Glycopyrrolate is a synthetic anticholinergic agent. It is a quaternary ammonium salt with the following chemical name. 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.34. Its structural formula is as follows. C19H28BrNO3 398.34. Glycopyrrolate occurs as a white, odorless, crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. It is completely ionized at physiological pH values. Glycopyrrolate Injection, USP is a clear, colorless, sterile liquid with a pH of 2.0 to 3.0. The partition coefficient of glycopyrrolate in n-octanol/water system is 0.304 (log10 P = -1.52) at ambient room temperature (24°C). Glycopyrrolate Injection, USP is intended for intramuscular or intravenous administration. Each 1 mL contains 0.2 mg of glycopyrrolate, water for injection, and hydrochloric acid or sodium hydroxide as pH adjusters.</Description>
</NDC>
<NDC>
<NDCCode>71288-439-05</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (71288-439-05) / 4 mL in 1 VIAL, SINGLE-USE (71288-439-04) </PackageDescription>
<NDC11Code>71288-0439-05</NDC11Code>
<ProductNDC>71288-439</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norepinephrine Bitartrate</ProprietaryName>
<NonProprietaryName>Norepinephrine Bitartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20241201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040455</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NOREPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC], Catecholamines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Norepinephrine Bitartrate Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.</IndicationAndUsage>
<Description>Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a sympathomimetic amine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. Norepinephrine bitartrate, USP is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.3 g/mol) and has the following structural formula. Norepinephrine Bitartrate Injection, USP is supplied in a sterile aqueous solution in the form of the bitartrate salt to be administered by intravenous infusion. Norepinephrine is sparingly soluble in water, very slightly soluble in alcohol and ether, and readily soluble in acids. Each mL contains 1 mg of norepinephrine base (equivalent to 1.89 mg of norepinephrine bitartrate, anhydrous basis), sodium chloride for isotonicity, not more than 2 mg of sodium metabisulfite as an antioxidant. It has a pH of 3.0 to 4.5. The air in the vials has been displaced by nitrogen gas.</Description>
</NDC>
<NDC>
<NDCCode>71288-504-05</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (71288-504-05) / 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>71288-0504-05</NDC11Code>
<ProductNDC>71288-504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol Decanoate</ProprietaryName>
<NonProprietaryName>Haloperidol Decanoate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20210726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214507</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HALOPERIDOL DECANOATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol Decanoate Injection is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product.</IndicationAndUsage>
<Description>Haloperidol Decanoate Injection is the decanoate ester of haloperidol, for intramuscular use. Haloperidol is a typical antipsychotic. The structural formula of haloperidol decanoate is 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl] piperidin-4-yl decanoate. The molecular formula is C31H41CIFNO3 and has a molecular weight of 530.12. Haloperidol decanoate is almost insoluble in water (0.01 mg/mL) but is soluble in most organic solvents. Each mL of Haloperidol Decanoate Injection contains: 1 50 mg of haloperidol (present as 70.52 mg of haloperidol decanoate) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative., 2 100 mg of haloperidol (present as 141.04 mg of haloperidol decanoate) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>71288-700-06</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (71288-700-06) / 5 mL in 1 VIAL, MULTI-DOSE (71288-700-05) </PackageDescription>
<NDC11Code>71288-0700-06</NDC11Code>
<ProductNDC>71288-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rocuronium Bromide</ProprietaryName>
<NonProprietaryName>Rocuronium Bromide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213453</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ROCURONIUM BROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rocuronium Bromide Injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2-propenyl)pyrrolidinium bromide. The structural formula is. The chemical formula is C32H53BrN2O4 with a molecular weight of 609.70. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium Bromide Injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow, for intravenous injection only. Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate trihydrate. The aqueous solution is adjusted to isotonicity with sodium chloride (3.3 mg per mL) and to a pH of 4 with glacial acetic acid and/or sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>71288-701-05</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (71288-701-05) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-701-06) </PackageDescription>
<NDC11Code>71288-0701-05</NDC11Code>
<ProductNDC>71288-701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atracurium Besylate</ProprietaryName>
<NonProprietaryName>Atracurium Besylate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091488</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ATRACURIUM BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atracurium besylate injection is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Atracurium besylate is an intermediate-duration, nondepolarizing, skeletal muscle relaxant for intravenous administration. Atracurium besylate is designated as 2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester. It has a molecular weight of 1243.49, and its molecular formula is C65H82N2O18S2. The structural formula is. Atracurium besylate is a complex molecule containing four sites at which different stereochemical configurations can occur. The symmetry of the molecule, however, results in only ten, instead of sixteen, possible different isomers. The manufacture of atracurium besylate results in these isomers being produced in unequal amounts but with a consistent ratio. Those molecules in which the methyl group attached to the quaternary nitrogen projects on the opposite side to the adjacent substituted-benzyl moiety predominate by approximately 3:1. Atracurium Besylate Injection, USP is a sterile, non-pyrogenic aqueous solution. Each mL contains 10 mg atracurium besylate. The pH is adjusted to 3.25 to 3.65 with benzenesulfonic acid. The multiple dose vial contains 0.9% benzyl alcohol added as a preservative. Atracurium besylate injection slowly loses potency with time at the rate of approximately 6% per year under refrigeration (5°C). Atracurium besylate injection should be refrigerated at 2° to 8°C (36° to 46°F) to preserve potency. Rate of loss in potency increases to approximately 5% per month at 25°C (77°F). Upon removal from refrigeration to room temperature storage conditions (25°C / 77°F), use atracurium besylate injection within 14 days even if re-refrigerated.</Description>
</NDC>
<NDC>
<NDCCode>71288-712-06</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (71288-712-06) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-712-05) </PackageDescription>
<NDC11Code>71288-0712-06</NDC11Code>
<ProductNDC>71288-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cisatracurium Besylate</ProprietaryName>
<NonProprietaryName>Cisatracurium Besylate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20191031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211668</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CISATRACURIUM BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cisatracurium Besylate Injection is indicated: : 1 as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age , 2 to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU , 3 to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older .</IndicationAndUsage>
<Description>Cisatracurium besylate is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium Besylate Injection, USP contains cisatracurium besylate as the active pharmaceutical ingredient. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1R-[1α,2α(1'R*,2'R*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C53H72N2O12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C65H82N2O18S2 and the molecular weight is 1243.48. The structural formula of cisatracurium besylate is. The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25°C. Cisatracurium Besylate Injection, USP is a sterile, nonpyrogenic aqueous solution. Each mL in the single-dose vials contains either 2 mg or 10 mg of cisatracurium (equivalent to 2.68 mg and 13.38 mg of cisatracurium besylate; respectively), and benzenesulfonic acid as pH adjuster in water for injection. Each mL in the multi-dose vials contains 2 mg of cisatracurium (equivalent to 2.68 mg of cisatracurium besylate), benzenesulfonic acid as pH adjuster, and also contains 9 mg of benzyl alcohol as preservative, in water for injection. The pH of Cisatracurium Besylate Injection, USP is between 3.0 and 3.8.</Description>
</NDC>
<NDC>
<NDCCode>71288-805-06</NDCCode>
<PackageDescription>6 VIAL, SINGLE-DOSE in 1 CARTON (71288-805-06) > 5 mL in 1 VIAL, SINGLE-DOSE (71288-805-05) </PackageDescription>
<NDC11Code>71288-0805-06</NDC11Code>
<ProductNDC>71288-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosulfan Blue</ProprietaryName>
<NonProprietaryName>Isosulfan Blue</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20211103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213130</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ISOSULFAN BLUE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isosulfan Blue Injection 1% upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; lymph node response to therapeutic modalities (1.1).</IndicationAndUsage>
<Description>The chemical name of Isosulfan Blue Injection 1% is N-[4-[[4-(diethylamino)phenyl] (2,5- disulfophenyl) methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide, inner salt, sodium salt. Its structural formula is. Isosulfan Blue Injection 1% is a sterile aqueous solution for subcutaneous administration. Phosphate buffer in sterile, nonpyrogenic water is added in sufficient quantity to yield a final pH of 6.8 to 7.4. Each mL of solution contains 10 mg isosulfan blue, 6.6 mg dibasic sodium phosphate, anhydrous and 2.7 mg monobasic potassium phosphate. The solution contains no preservative. Isosulfan Blue Injection 1% is a contrast agent for the delineation of lymphatic vessels.</Description>
</NDC>
<NDC>
<NDCCode>11084-175-05</NDCCode>
<PackageDescription>3780 mL in 1 BOTTLE, PLASTIC (11084-175-05)</PackageDescription>
<NDC11Code>11084-0175-05</NDC11Code>
<ProductNDC>11084-175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sbs Ultragreen</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130725</StartMarketingDate>
<EndMarketingDate>20200801</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Deb USA, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>16590-175-05</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, DROPPER (16590-175-05)</PackageDescription>
<NDC11Code>16590-0175-05</NDC11Code>
<ProductNDC>16590-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ofloxacin</ProprietaryName>
<NonProprietaryName>Ofloxacin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20040514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076615</ApplicationNumber>
<LabelerName>STAT RX LLC USA</LabelerName>
<SubstanceName>OFLOXACIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:. *Efficacy for this organism was studied in fewer than 10 infections.</IndicationAndUsage>
<Description>Ofloxacin ophthalmic solution 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use. (±)-9-Fluoro-2, 3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4 benzoxazine-6-carboxylic acid. Contains. Active: ofloxacin 0.3% (3 mg/mL). Preservative: benzalkonium chloride (0.005%). Inactives: sodium chloride and purified water. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. Ofloxacin ophthalmic solution is unbuffered and formulated with a pH of 6.4 (range - 6.0 to 6.8). It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure.</Description>
</NDC>
<NDC>
<NDCCode>29300-175-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (29300-175-05) </PackageDescription>
<NDC11Code>29300-0175-05</NDC11Code>
<ProductNDC>29300-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203025</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole tablets are indicated for the treatment of: : 1 Schizophrenia, 2 Irritability Associated with Autistic Disorder, 3 Treatment of Tourette's Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as aripiprazole tablets, Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1 piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include hydroxypropyl cellulose, lactose monohydrate, corn starch, magnesium stearate, and microcrystalline cellulose. Additionally, 10 mg, 15 mg, 20 mg, and 30 mg include colorant ferric oxide (red).</Description>
</NDC>
<NDC>
<NDCCode>31722-175-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (31722-175-05) </PackageDescription>
<NDC11Code>31722-0175-05</NDC11Code>
<ProductNDC>31722-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207416</ApplicationNumber>
<LabelerName>Camber Pharmaceutical Inc</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-08-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults, 2 Narcolepsy.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride tablets, USP is a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white to off white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablets, USP contain the following inactive ingredients: compressible sugar, colloidal silicon dioxide, D&C yellow no. 10 (5 mg and 20 mg tablets), lactose monohydrate, magnesium stearate, and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>41415-175-05</NDCCode>
<PackageDescription>50 TABLET in 1 BOTTLE (41415-175-05) </PackageDescription>
<NDC11Code>41415-0175-05</NDC11Code>
<ProductNDC>41415-175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260715</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>PUBLIX SUPERMARKETS, INC</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ backache ■ minor pain of arthritis ■ the common cold ■ toothache ■ premenstrual and menstrual cramps. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>46783-175-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (46783-175-05) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>46783-0175-05</NDC11Code>
<ProductNDC>46783-175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Journee Riche Bio-restorative Day Balm Broad-spectrum Sunscreen Spf 30</ProprietaryName>
<NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150518</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Merz North America, Inc.</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>7.5; 7.3</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>47781-175-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (47781-175-05)</PackageDescription>
<NDC11Code>47781-0175-05</NDC11Code>
<ProductNDC>47781-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 7.5 Mg,cll</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207388</ApplicationNumber>
<LabelerName>Alvogen inc.</LabelerName>
<SubstanceName>AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>1.875; 1.875; 1.875; 1.875</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-09-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49643-175-05</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49643-175-05) </PackageDescription>
<NDC11Code>49643-0175-05</NDC11Code>
<ProductNDC>49643-175</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Trichophyton Rubrum</ProprietaryName>
<NonProprietaryName>Trichophyton Rubrum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>TRICHOPHYTON RUBRUM</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease.(4,5,6). Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms.(7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency.</Description>
</NDC>
<NDC>
<NDCCode>49884-175-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (49884-175-05) </PackageDescription>
<NDC11Code>49884-0175-05</NDC11Code>
<ProductNDC>49884-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine, Valsartan, Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate Valsartan Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201087</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN</SubstanceName>
<StrengthNumber>10; 25; 320</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-04-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50228-175-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-175-05) </PackageDescription>
<NDC11Code>50228-0175-05</NDC11Code>
<ProductNDC>50228-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Sr</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205794</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets, USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, powder, soluble in 0.1N HCl, alcohol 96% and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (SR), are supplied for oral administration as 100 mg (blue), 150 mg (purple), and 200 mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: copovidone, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. In addition, the 100 mg tablet contains FD&C Blue No. 1 Brilliant Blue FCF Aluminium Lake, the 150 mg tablet contains FD&C Blue No. 2 Indigo Carmine Aluminium Lake and FD&C Red No. 40 Allura Red AC Aluminium Lake, and the 200 mg tablet contains FD&C Red No. 40 Allura Red AC Aluminium Lake. In addition, flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol, and silicon dioxide. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP Dissolution Test2.</Description>
</NDC>
<NDC>
<NDCCode>50742-175-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-175-05) </PackageDescription>
<NDC11Code>50742-0175-05</NDC11Code>
<ProductNDC>50742-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210918</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isosorbide mononitrate extended-release tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Isosorbide mononitrate tablets contain either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose, colloidal silicon dioxide, lactose monohydrate and magnesium stearate. The molecular formula of ISMN is C6H9NO6 and the molecular weight is 191.14. The chemical name for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula. ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +140° to 146° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, acetic acid, alcohol, acetone and ethyl acetate; soluble in ether and chloroform, slightly soluble in toluene; practically insoluble in aliphatic hydrocarbons. Isosorbide mononitrate extended-release tablets, USP meets USP Dissolution Test 8.</Description>
</NDC>
<NDC>
<NDCCode>54162-175-05</NDCCode>
<PackageDescription>113 g in 1 BOTTLE, WITH APPLICATOR (54162-175-05)</PackageDescription>
<NDC11Code>54162-0175-05</NDC11Code>
<ProductNDC>54162-175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mineral Oil</ProprietaryName>
<NonProprietaryName>Mineral Oil</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20150731</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>GERITREX LLC</LabelerName>
<SubstanceName>MINERAL OIL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>61919-175-05</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, DROPPER (61919-175-05)</PackageDescription>
<NDC11Code>61919-0175-05</NDC11Code>
<ProductNDC>61919-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ofloxacin</ProprietaryName>
<NonProprietaryName>Ofloxacin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076407</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>OFLOXACIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below.</IndicationAndUsage>
<Description>Ofloxacin Ophthalmic Solution USP, 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use. Chemical Name: (±)-9-Fluoro-2, 3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4 benzoxazine-6-carboxylic acid. Contains: Active: ofloxacin 0.3% (3 mg/mL);. Preservative: benzalkonium chloride (0.005%);. Inactives: sodium chloride and water for injection. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. Ofloxacin Ophthalmic Solution USP, 0.3% is unbuffered and formulated with a pH of 6.4 (range - 6.0 to 6.8). It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure.</Description>
</NDC>
</NDCList>