{
"NDC": [
{
"NDCCode": "52584-410-31",
"PackageDescription": "1 AMPULE in 1 BAG (52584-410-31) > 2 mL in 1 AMPULE",
"NDC11Code": "52584-0410-31",
"ProductNDC": "52584-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20100701",
"EndMarketingDate": "20241130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083391",
"LabelerName": "General Injectables and Vaccines, Inc",
"SubstanceName": "DIGOXIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100701",
"EndMarketingDatePackage": "20241130",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Heart Failure in Adults. Digoxin is indicated for the treatment of mild to moderate heart failure in adults. Digoxin increases left ventricular ejection fraction and imporves heart failure symptoms, as evidenced by improves heart failure symptoms, as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. 1.2 Atrial Fibrillation in Adults. Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”). Digoxin has the chemical name: 3β-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide, and the following structural formula. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Injection is a sterile solution for slow intravenous or deep intramuscular injection. Each mL contains digoxin 250 mcg (0.25 mg), alcohol 0.1 mL, propylene glycol 0.4 mL, dibasic sodium phosphate, anhydrous 3 mg and citric acid, anhydrous 0.8 mg in Water for Injection. pH 6.7-7.3; citric acid and/or sodium phosphate added, if necessary, for pH adjustment. Dilution is not required."
},
{
"NDCCode": "52584-290-31",
"PackageDescription": "1 CARTRIDGE in 1 BAG (52584-290-31) > 1 mL in 1 CARTRIDGE",
"NDC11Code": "52584-0290-31",
"ProductNDC": "52584-290",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diphenhydramine Hydrochloride",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20100301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040140",
"LabelerName": "General Injectables and Vaccines",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-11-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160913",
"SamplePackage": "N"
},
{
"NDCCode": "52584-397-31",
"PackageDescription": "1 AMPULE in 1 BAG (52584-397-31) > 1 mL in 1 AMPULE",
"NDC11Code": "52584-0397-31",
"ProductNDC": "52584-397",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorpromazine Hydrochloride",
"NonProprietaryName": "Chlorpromazine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20180702",
"EndMarketingDate": "20240731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083329",
"LabelerName": "General Injectables and Vaccines, Inc.",
"SubstanceName": "CHLORPROMAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180702",
"EndMarketingDatePackage": "20240731",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of schizophrenia; to control nausea and vomiting; for relief of restlessness and apprehension before surgery; for acute intermittent porphyria; as an adjunct in the treatment of tetanus; to control the manifestations of the manic type of manic-depressive illness; for relief of intractable hiccups; for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance.",
"Description": "Chlorpromazine HCl is chemically designated as 2-Chloro-10-[3-(dimethylamino)propyl]-phenothiazine monohydrochloride and has the following structural formula. Chlorpromazine Hydrochloride Injection, USP is a sterile aqueous solution intended for deep intramuscular use. Each mL contains chlorpromazine hydrochloride 25 mg, ascorbic acid 2 mg, sodium metabisulfite 1 mg, sodium sulfite 1 mg and sodium chloride 6 mg in Water for Injection. pH is 3.4-5.4."
},
{
"NDCCode": "52584-495-31",
"PackageDescription": "1 AMPULE in 1 BAG (52584-495-31) > 1 mL in 1 AMPULE",
"NDC11Code": "52584-0495-31",
"ProductNDC": "52584-495",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20100801",
"EndMarketingDate": "20240630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083312",
"LabelerName": "General Injectables & Vaccines, Inc",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100801",
"EndMarketingDatePackage": "20240630",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride injection is indicated for the following conditions: 1 Amelioration of allergic reactions to blood or plasma., 2 In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled., 3 For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated., 4 For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused., 5 Active treatment of motion sickness., 6 Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery., 7 As an adjunct to analgesics for the control of postoperative pain., 8 Preoperative, postoperative, and obstetric (during labor) sedation., 9 Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.",
"Description": "Promethazine hydrochloride injection, USP is a sterile, pyrogen-free solution for deep intramuscular or intravenous administration. Promethazine hydrochloride (10H-Phenothiazine-10-ethanamine,N,N,a-trimethyl-, monohydrochloride, (±)-) is a racemic compound and has the following structural formula. Each mL contains promethazine hydrochloride, either 25 mg or 50 mg, edetate disodium 0.1 mg, calcium chloride 0.04 mg, sodium metabisulfite 0.25 mg and phenol 5 mg in Water for Injection. pH 4.0 to 5.5; buffered with acetic acid-sodium acetate. Promethazine hydrochloride injection is a clear, colorless solution. The product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed."
},
{
"NDCCode": "52584-496-31",
"PackageDescription": "1 AMPULE in 1 BAG (52584-496-31) > 1 mL in 1 AMPULE",
"NDC11Code": "52584-0496-31",
"ProductNDC": "52584-496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20100801",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083312",
"LabelerName": "General Injectables & Vaccines, Inc",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100801",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride injection is indicated for the following conditions: 1 Amelioration of allergic reactions to blood or plasma., 2 In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled., 3 For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated., 4 For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused., 5 Active treatment of motion sickness., 6 Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery., 7 As an adjunct to analgesics for the control of postoperative pain., 8 Preoperative, postoperative, and obstetric (during labor) sedation., 9 Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.",
"Description": "Promethazine hydrochloride injection, USP is a sterile, pyrogen-free solution for deep intramuscular or intravenous administration. Promethazine hydrochloride (10H-Phenothiazine-10-ethanamine,N,N,a-trimethyl-, monohydrochloride, (±)-) is a racemic compound and has the following structural formula. Each mL contains promethazine hydrochloride, either 25 mg or 50 mg, edetate disodium 0.1 mg, calcium chloride 0.04 mg, sodium metabisulfite 0.25 mg and phenol 5 mg in Water for Injection. pH 4.0 to 5.5; buffered with acetic acid-sodium acetate. Promethazine hydrochloride injection is a clear, colorless solution. The product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed."
},
{
"NDCCode": "10356-410-31",
"PackageDescription": "500 mL in 1 BOTTLE (10356-410-31)",
"NDC11Code": "10356-0410-31",
"ProductNDC": "10356-410",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nivea Body Natural Tone",
"NonProprietaryName": "Octinoxate, Avobenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080105",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Beiersdorf Inc",
"SubstanceName": "OCTINOXATE; AVOBENZONE",
"StrengthNumber": "1.8; .3",
"StrengthUnit": "mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2016-03-11"
},
{
"NDCCode": "66129-410-31",
"PackageDescription": "50 g in 1 TUBE (66129-410-31)",
"NDC11Code": "66129-0410-31",
"ProductNDC": "66129-410",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Idole Skin Lightening",
"NonProprietaryName": "Hydroquinone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part358A",
"LabelerName": "International Beauty Exchange",
"SubstanceName": "HYDROQUINONE; OCTINOXATE",
"StrengthNumber": "1; .25",
"StrengthUnit": "g/50g; g/50g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the gradual fading of dark areas in the skin such as freckles, age and liver spots."
},
{
"NDCCode": "73069-410-31",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BOX (73069-410-31) > 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0410-31",
"ProductNDC": "73069-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-pigmentation",
"NonProprietaryName": "Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN",
"StrengthNumber": "31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "79043-410-90",
"PackageDescription": "1 KIT in 1 CARTON (79043-410-90) * 236.6 mL in 1 BOTTLE * 29.6 mL in 1 BOTTLE (28595-225-31) ",
"NDC11Code": "79043-0410-90",
"ProductNDC": "79043-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocort",
"NonProprietaryName": "Hydrocortisone Lotion Kit",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230610",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Scite Pharma",
"Status": "Deprecated",
"LastUpdate": "2024-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230610",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocortisone Lotion is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Topical corticosteroids constitute a class of primarily synthetic steroids used a anti-inflammatory and antipruritic agents. Hydrocortisone is a member of this class. Chemically hydrocortisone is pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy, (11Β)-. Its structural formula is. Each mL of ALA-SCALP (Hydrocortisone Lotion USP), 2% contains 20 mg of hydrocortisone USP in a vehicle of isopropyl alcohol, polysorbate 20, purified water, propylene glycol, and benzalkonium chloride."
},
{
"NDCCode": "52584-103-01",
"PackageDescription": "1 AMPULE in 1 BAG (52584-103-01) > 1 mL in 1 AMPULE",
"NDC11Code": "52584-0103-01",
"ProductNDC": "52584-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrine",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180702",
"EndMarketingDate": "20230731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205029",
"LabelerName": "General Injectables and Vaccines, Inc.",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180702",
"EndMarketingDatePackage": "20230731",
"SamplePackage": "N"
},
{
"NDCCode": "52584-353-05",
"PackageDescription": "1 VIAL in 1 BAG (52584-353-05) > 10 mL in 1 VIAL",
"NDC11Code": "52584-0353-05",
"ProductNDC": "52584-353",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lincomycin",
"NonProprietaryName": "Lincomycin Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL",
"StartMarketingDate": "20201106",
"EndMarketingDate": "20230731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201746",
"LabelerName": "General Injectables and Vaccines, INC.",
"SubstanceName": "LINCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201106",
"EndMarketingDatePackage": "20230731",
"SamplePackage": "N"
},
{
"NDCCode": "52584-415-10",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BAG (52584-415-10) > 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "52584-0415-10",
"ProductNDC": "52584-415",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neostigmine Methylsulfate",
"NonProprietaryName": "Neostigmine Methylsulfate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160811",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203629",
"LabelerName": "General Injectables and Vaccines, Inc",
"SubstanceName": "NEOSTIGMINE METHYLSULFATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-08-31",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "52584-482-57",
"PackageDescription": "1 VIAL in 1 BAG (52584-482-57) > 50 mL in 1 VIAL",
"NDC11Code": "52584-0482-57",
"ProductNDC": "52584-482",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xylocaine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION; PERINEURAL",
"StartMarketingDate": "20110912",
"EndMarketingDate": "20231231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA006488",
"LabelerName": "General Injectables & Vaccines, Inc",
"SubstanceName": "EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS",
"StrengthNumber": ".01; 10",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110912",
"EndMarketingDatePackage": "20230731",
"SamplePackage": "N"
},
{
"NDCCode": "52584-616-03",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (52584-616-03) > 3 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "52584-0616-03",
"ProductNDC": "52584-616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amiodarone Hydrochloride",
"NonProprietaryName": "Amiodarone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075761",
"LabelerName": "General Injectables and Vaccines, Inc.",
"SubstanceName": "AMIODARONE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-08-31",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "52584-795-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (52584-795-01) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "52584-0795-01",
"ProductNDC": "52584-795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20120410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074802",
"LabelerName": "General Injectables & Vaccines, Inc",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-08-31",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0573-0720-12",
"PackageDescription": "1 CYLINDER in 1 BLISTER PACK (0573-0720-12) / 4 g in 1 CYLINDER",
"NDC11Code": "00573-0720-12",
"ProductNDC": "0573-0720",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chapstick Medicated",
"NonProprietaryName": "Camphor, Menthol, Petrolatum, Phenol",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180610",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; PETROLATUM; PHENOL",
"StrengthNumber": "10; 6; 410; 5",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180610",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent and temporarily protects chafed, chapped or cracked lips. temporary relief of pain associated with fever blisters and cold sores. helps prevent and protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "0573-0720-51",
"PackageDescription": "4 g in 1 CYLINDER (0573-0720-51) ",
"NDC11Code": "00573-0720-51",
"ProductNDC": "0573-0720",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chapstick Medicated",
"NonProprietaryName": "Camphor, Menthol, Petrolatum, Phenol",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180610",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; PETROLATUM; PHENOL",
"StrengthNumber": "10; 6; 410; 5",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180610",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent and temporarily protects chafed, chapped or cracked lips. temporary relief of pain associated with fever blisters and cold sores. helps prevent and protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "0573-0720-70",
"PackageDescription": "2 CYLINDER in 1 BLISTER PACK (0573-0720-70) / 4 g in 1 CYLINDER",
"NDC11Code": "00573-0720-70",
"ProductNDC": "0573-0720",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chapstick Medicated",
"NonProprietaryName": "Camphor, Menthol, Petrolatum, Phenol",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180610",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; PETROLATUM; PHENOL",
"StrengthNumber": "10; 6; 410; 5",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180610",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent and temporarily protects chafed, chapped or cracked lips. temporary relief of pain associated with fever blisters and cold sores. helps prevent and protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "0615-8197-30",
"PackageDescription": "6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8197-30) / 5 TABLET in 1 BLISTER PACK",
"NDC11Code": "00615-8197-30",
"ProductNDC": "0615-8197",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077493",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180301",
"EndMarketingDatePackage": "20230731",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3) .",
"Description": "Risperidone is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone Tablets, USP, are for oral administration and are available in 0.25 mg (dark yellow), 0.5 mg (brownish red), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (white) strengths. Risperidone tablets contain the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and tartaric acid. The 0.25 mg tablets also contain Opadry II yellow 85F12383, for purposes of coating, which contains the following: iron oxide yellow, polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide. The 0.5 mg tablets also contain Opadry II red 85F15362, for purposes of coating, which contains the following: iron oxide red, polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide. The 1 mg and 4 mg tablets also contain Opadry II white 85F18422, for purposes of coating, which contains the following: polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide. The 2 mg tablets also contain Opadry II red 85F15404, for purposes of coating, which contains the following: calcium carbonate, calcium sulfate, iron oxide red, polyethylene glycol 3350, polyvinyl alcohol, and talc. The 3 mg tablets also contain Opadry II yellow 03B12447, for purposes of coating, which contains the following: hypromellose 2910 6cP, iron oxide red, iron oxide yellow, polyethylene glycol 400, and titanium dioxide."
},
{
"NDCCode": "31722-630-31",
"PackageDescription": "10 CAPSULE in 1 CARTON (31722-630-31) ",
"NDC11Code": "31722-0630-31",
"ProductNDC": "31722-630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseltamivir Phosphate",
"NonProprietaryName": "Oseltamivir Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209438",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "OSELTAMIVIR PHOSPHATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2018-03-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180223",
"SamplePackage": "N",
"IndicationAndUsage": "Oseltamivir phosphate is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2)Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.(1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).",
"Description": "Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as: Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide and black iron oxide. The 75 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide. Each capsule is printed with blue ink, which includes shellac, propylene glycol, strong ammonia solution and FD&C Blue No. 2 as the colorant. The botanical source for pregelatinized starch is maize starch. Oseltamivir phosphate USP is a white to off-white powder with the chemical name [3R-(3α,4β,5α)]-Ethyl 4-(acetyl amino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The molecular formula is C16H28N2O4.H3PO4. The relative molecular mass is 410.40 for oseltamivir phosphate salt. The structural formula is as follows:."
},
{
"NDCCode": "31722-631-31",
"PackageDescription": "10 CAPSULE in 1 CARTON (31722-631-31) ",
"NDC11Code": "31722-0631-31",
"ProductNDC": "31722-631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseltamivir Phosphate",
"NonProprietaryName": "Oseltamivir Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209438",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "OSELTAMIVIR PHOSPHATE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2018-03-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180223",
"SamplePackage": "N",
"IndicationAndUsage": "Oseltamivir phosphate is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2)Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.(1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).",
"Description": "Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as: Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide and black iron oxide. The 75 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide. Each capsule is printed with blue ink, which includes shellac, propylene glycol, strong ammonia solution and FD&C Blue No. 2 as the colorant. The botanical source for pregelatinized starch is maize starch. Oseltamivir phosphate USP is a white to off-white powder with the chemical name [3R-(3α,4β,5α)]-Ethyl 4-(acetyl amino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The molecular formula is C16H28N2O4.H3PO4. The relative molecular mass is 410.40 for oseltamivir phosphate salt. The structural formula is as follows:."
},
{
"NDCCode": "31722-632-31",
"PackageDescription": "10 CAPSULE in 1 CARTON (31722-632-31) ",
"NDC11Code": "31722-0632-31",
"ProductNDC": "31722-632",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseltamivir Phosphate",
"NonProprietaryName": "Oseltamivir Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209438",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "OSELTAMIVIR PHOSPHATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2018-03-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180223",
"SamplePackage": "N",
"IndicationAndUsage": "Oseltamivir phosphate is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2)Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.(1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).",
"Description": "Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as: Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide and black iron oxide. The 75 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide. Each capsule is printed with blue ink, which includes shellac, propylene glycol, strong ammonia solution and FD&C Blue No. 2 as the colorant. The botanical source for pregelatinized starch is maize starch. Oseltamivir phosphate USP is a white to off-white powder with the chemical name [3R-(3α,4β,5α)]-Ethyl 4-(acetyl amino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The molecular formula is C16H28N2O4.H3PO4. The relative molecular mass is 410.40 for oseltamivir phosphate salt. The structural formula is as follows:."
},
{
"NDCCode": "43598-410-25",
"PackageDescription": "5 POUCH in 1 CARTON (43598-410-25) / 5 VIAL in 1 POUCH (43598-410-05) / 3 mL in 1 VIAL",
"NDC11Code": "43598-0410-25",
"ProductNDC": "43598-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levalbuterol Inhalation",
"NonProprietaryName": "Levalbuterol Inhalation 0.63mg/3ml",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078171",
"LabelerName": "Dr. Reddy�s Laboratories, Inc.",
"SubstanceName": "LEVALBUTEROL",
"StrengthNumber": ".63",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140916",
"SamplePackage": "N",
"IndicationAndUsage": "Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.",
"Description": "Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg (0.0103%) of Levalbuterol (as 0.36 mg of levalbuterol HCl) or 0.63 mg (0.021%) of levalbuterol (as 0.73 mg of levalbuterol HCl) or 1.25 mg (0.042%) of levalbuterol (as 1.44 mg of levalbuterol HCl), edetate disodium as a chelating agent, sodium chloride to adjust tonicity, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5)."
},
{
"NDCCode": "70121-2625-5",
"PackageDescription": "1 KIT in 1 CARTON (70121-2625-5) * 2 mL in 1 VIAL (70121-1350-1) * 2 mL in 1 SYRINGE (70121-2624-2) ",
"NDC11Code": "70121-2625-05",
"ProductNDC": "70121-2625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "KIT",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250908",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218586",
"LabelerName": "Amneal Pharmaceuticals LLC",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250908",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone for extended-release injectable suspension is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. (1.2).",
"Description": "Risperidone for extended-release injectable suspension contains risperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.48 g/mol. The structural formula is. Risperidone, USP is soluble in methylene chloride, sparingly soluble in alcohol and practically insoluble in water. Risperidone for Extended-Release Injectable Suspension is a combination of extended-release microspheres for injection and diluent for parenteral use. The extended-release microspheres formulation is a sterile, white to off white, free-flowing powder that is available in dosage strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg risperidone, USP per vial. Risperidone, USP is micro-encapsulated in 7525 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres. The diluent for parenteral use is a clear, colorless solution. Composition of the diluent includes 1 mg/mL citric acid anhydrous; 1.25 mg/mL disodium hydrogen phosphate dihydrate; 1 mg/mL polysorbate 20; 23 mg/mL sodium carboxymethyl cellulose; 6 mg/mL sodium chloride; 0.55 mg/mL sodium hydroxide and water for injection. The microspheres are suspended in the diluent prior to injection. Risperidone for extended-release injectable suspension is provided as a single-dose pack, consisting of a vial containing the microspheres, a pre-filled syringe containing the diluent, a vial adapter and two Terumo SurGuard 3 Needles (a 21 G TW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration)."
},
{
"NDCCode": "70121-2626-5",
"PackageDescription": "1 KIT in 1 CARTON (70121-2626-5) * 2 mL in 1 SYRINGE (70121-2624-2) * 2 mL in 1 VIAL (70121-1351-1) ",
"NDC11Code": "70121-2626-05",
"ProductNDC": "70121-2626",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "KIT",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20250908",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218586",
"LabelerName": "Amneal Pharmaceuticals LLC",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250908",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone for extended-release injectable suspension is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. (1.2).",
"Description": "Risperidone for extended-release injectable suspension contains risperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.48 g/mol. The structural formula is. Risperidone, USP is soluble in methylene chloride, sparingly soluble in alcohol and practically insoluble in water. Risperidone for Extended-Release Injectable Suspension is a combination of extended-release microspheres for injection and diluent for parenteral use. The extended-release microspheres formulation is a sterile, white to off white, free-flowing powder that is available in dosage strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg risperidone, USP per vial. Risperidone, USP is micro-encapsulated in 7525 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres. The diluent for parenteral use is a clear, colorless solution. Composition of the diluent includes 1 mg/mL citric acid anhydrous; 1.25 mg/mL disodium hydrogen phosphate dihydrate; 1 mg/mL polysorbate 20; 23 mg/mL sodium carboxymethyl cellulose; 6 mg/mL sodium chloride; 0.55 mg/mL sodium hydroxide and water for injection. The microspheres are suspended in the diluent prior to injection. Risperidone for extended-release injectable suspension is provided as a single-dose pack, consisting of a vial containing the microspheres, a pre-filled syringe containing the diluent, a vial adapter and two Terumo SurGuard 3 Needles (a 21 G TW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration)."
},
{
"NDCCode": "70121-2627-5",
"PackageDescription": "1 KIT in 1 CARTON (70121-2627-5) * 2 mL in 1 VIAL (70121-1352-1) * 2 mL in 1 SYRINGE (70121-2624-2) ",
"NDC11Code": "70121-2627-05",
"ProductNDC": "70121-2627",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "KIT",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20250908",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218586",
"LabelerName": "Amneal Pharmaceuticals LLC",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250908",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone for extended-release injectable suspension is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. (1.2).",
"Description": "Risperidone for extended-release injectable suspension contains risperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.48 g/mol. The structural formula is. Risperidone, USP is soluble in methylene chloride, sparingly soluble in alcohol and practically insoluble in water. Risperidone for Extended-Release Injectable Suspension is a combination of extended-release microspheres for injection and diluent for parenteral use. The extended-release microspheres formulation is a sterile, white to off white, free-flowing powder that is available in dosage strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg risperidone, USP per vial. Risperidone, USP is micro-encapsulated in 7525 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres. The diluent for parenteral use is a clear, colorless solution. Composition of the diluent includes 1 mg/mL citric acid anhydrous; 1.25 mg/mL disodium hydrogen phosphate dihydrate; 1 mg/mL polysorbate 20; 23 mg/mL sodium carboxymethyl cellulose; 6 mg/mL sodium chloride; 0.55 mg/mL sodium hydroxide and water for injection. The microspheres are suspended in the diluent prior to injection. Risperidone for extended-release injectable suspension is provided as a single-dose pack, consisting of a vial containing the microspheres, a pre-filled syringe containing the diluent, a vial adapter and two Terumo SurGuard 3 Needles (a 21 G TW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration)."
},
{
"NDCCode": "70121-2628-5",
"PackageDescription": "1 KIT in 1 CARTON (70121-2628-5) * 2 mL in 1 VIAL (70121-1353-1) * 2 mL in 1 SYRINGE (70121-2624-2) ",
"NDC11Code": "70121-2628-05",
"ProductNDC": "70121-2628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "KIT",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20250908",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218586",
"LabelerName": "Amneal Pharmaceuticals LLC",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250908",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone for extended-release injectable suspension is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. (1.2).",
"Description": "Risperidone for extended-release injectable suspension contains risperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.48 g/mol. The structural formula is. Risperidone, USP is soluble in methylene chloride, sparingly soluble in alcohol and practically insoluble in water. Risperidone for Extended-Release Injectable Suspension is a combination of extended-release microspheres for injection and diluent for parenteral use. The extended-release microspheres formulation is a sterile, white to off white, free-flowing powder that is available in dosage strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg risperidone, USP per vial. Risperidone, USP is micro-encapsulated in 7525 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres. The diluent for parenteral use is a clear, colorless solution. Composition of the diluent includes 1 mg/mL citric acid anhydrous; 1.25 mg/mL disodium hydrogen phosphate dihydrate; 1 mg/mL polysorbate 20; 23 mg/mL sodium carboxymethyl cellulose; 6 mg/mL sodium chloride; 0.55 mg/mL sodium hydroxide and water for injection. The microspheres are suspended in the diluent prior to injection. Risperidone for extended-release injectable suspension is provided as a single-dose pack, consisting of a vial containing the microspheres, a pre-filled syringe containing the diluent, a vial adapter and two Terumo SurGuard 3 Needles (a 21 G TW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration)."
},
{
"NDCCode": "71288-410-85",
"PackageDescription": "10 SYRINGE in 1 CARTON (71288-410-85) / .6 mL in 1 SYRINGE (71288-410-84) ",
"NDC11Code": "71288-0410-85",
"ProductNDC": "71288-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enoxaparin Sodium",
"NonProprietaryName": "Enoxaparin Sodium",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20191201",
"EndMarketingDate": "20260331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206834",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "ENOXAPARIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191201",
"EndMarketingDatePackage": "20260330",
"SamplePackage": "N",
"IndicationAndUsage": "Enoxaparin Sodium Injection is a low molecular weight heparin (LMWH) indicated for: : 1 Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1) , 2 Inpatient treatment of acute DVT with or without pulmonary embolism (1.2) , 3 Outpatient treatment of acute DVT without pulmonary embolism (1.2) , 4 Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) (1.3) , 5 Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) (1.4) .",
"Description": "Enoxaparin Sodium Injection, USP is an aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5. Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6-anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4,500 daltons. The molecular weight distribution is. STRUCTURAL FORMULA. Enoxaparin Sodium Injection, USP 100 mg per mL Concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1,000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. Enoxaparin Sodium Injection, USP 150 mg per mL Concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1,500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. The Enoxaparin Sodium Injection, USP prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection [see Dosage and Administration (2) and How Supplied/Storage and Handling (16)]."
},
{
"NDCCode": "71335-2733-1",
"PackageDescription": "30 mL in 1 BOTTLE (71335-2733-1) ",
"NDC11Code": "71335-2733-01",
"ProductNDC": "71335-2733",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20150313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079059",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250729",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone is an atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2) , 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone oral solution contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)- 1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone is also available as a 1 mg/mL oral solution. Risperidone Oral Solution contains the following inactive ingredients: benzoic acid, sodium hydroxide, sorbitol solution, tartaric acid, and purified water."
},
{
"NDCCode": "72288-247-41",
"PackageDescription": "396 g in 1 JAR (72288-247-41) ",
"NDC11Code": "72288-0247-41",
"ProductNDC": "72288-247",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Advanced Healing",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170827",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Amazon.com Services LLC",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "410",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170827",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily protects minor cuts, scrapes, burns. temporarily protects and helps relieve chapped and cracked skin and lips. helps protect from the drying effects of wind and cold weather."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>52584-410-31</NDCCode>
<PackageDescription>1 AMPULE in 1 BAG (52584-410-31) > 2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>52584-0410-31</NDC11Code>
<ProductNDC>52584-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Digoxin</ProprietaryName>
<NonProprietaryName>Digoxin</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20100701</StartMarketingDate>
<EndMarketingDate>20241130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083391</ApplicationNumber>
<LabelerName>General Injectables and Vaccines, Inc</LabelerName>
<SubstanceName>DIGOXIN</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cardiac Glycoside [EPC], Cardiac Glycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100701</StartMarketingDatePackage>
<EndMarketingDatePackage>20241130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Heart Failure in Adults. Digoxin is indicated for the treatment of mild to moderate heart failure in adults. Digoxin increases left ventricular ejection fraction and imporves heart failure symptoms, as evidenced by improves heart failure symptoms, as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. 1.2 Atrial Fibrillation in Adults. Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”). Digoxin has the chemical name: 3β-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide, and the following structural formula. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Injection is a sterile solution for slow intravenous or deep intramuscular injection. Each mL contains digoxin 250 mcg (0.25 mg), alcohol 0.1 mL, propylene glycol 0.4 mL, dibasic sodium phosphate, anhydrous 3 mg and citric acid, anhydrous 0.8 mg in Water for Injection. pH 6.7-7.3; citric acid and/or sodium phosphate added, if necessary, for pH adjustment. Dilution is not required.</Description>
</NDC>
<NDC>
<NDCCode>52584-290-31</NDCCode>
<PackageDescription>1 CARTRIDGE in 1 BAG (52584-290-31) > 1 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>52584-0290-31</NDC11Code>
<ProductNDC>52584-290</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diphenhydramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20100301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040140</ApplicationNumber>
<LabelerName>General Injectables and Vaccines</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-11-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52584-397-31</NDCCode>
<PackageDescription>1 AMPULE in 1 BAG (52584-397-31) > 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>52584-0397-31</NDC11Code>
<ProductNDC>52584-397</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorpromazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlorpromazine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20180702</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083329</ApplicationNumber>
<LabelerName>General Injectables and Vaccines, Inc.</LabelerName>
<SubstanceName>CHLORPROMAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180702</StartMarketingDatePackage>
<EndMarketingDatePackage>20240731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of schizophrenia; to control nausea and vomiting; for relief of restlessness and apprehension before surgery; for acute intermittent porphyria; as an adjunct in the treatment of tetanus; to control the manifestations of the manic type of manic-depressive illness; for relief of intractable hiccups; for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance.</IndicationAndUsage>
<Description>Chlorpromazine HCl is chemically designated as 2-Chloro-10-[3-(dimethylamino)propyl]-phenothiazine monohydrochloride and has the following structural formula. Chlorpromazine Hydrochloride Injection, USP is a sterile aqueous solution intended for deep intramuscular use. Each mL contains chlorpromazine hydrochloride 25 mg, ascorbic acid 2 mg, sodium metabisulfite 1 mg, sodium sulfite 1 mg and sodium chloride 6 mg in Water for Injection. pH is 3.4-5.4.</Description>
</NDC>
<NDC>
<NDCCode>52584-495-31</NDCCode>
<PackageDescription>1 AMPULE in 1 BAG (52584-495-31) > 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>52584-0495-31</NDC11Code>
<ProductNDC>52584-495</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20100801</StartMarketingDate>
<EndMarketingDate>20240630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083312</ApplicationNumber>
<LabelerName>General Injectables & Vaccines, Inc</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100801</StartMarketingDatePackage>
<EndMarketingDatePackage>20240630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride injection is indicated for the following conditions: 1 Amelioration of allergic reactions to blood or plasma., 2 In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled., 3 For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated., 4 For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused., 5 Active treatment of motion sickness., 6 Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery., 7 As an adjunct to analgesics for the control of postoperative pain., 8 Preoperative, postoperative, and obstetric (during labor) sedation., 9 Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.</IndicationAndUsage>
<Description>Promethazine hydrochloride injection, USP is a sterile, pyrogen-free solution for deep intramuscular or intravenous administration. Promethazine hydrochloride (10H-Phenothiazine-10-ethanamine,N,N,a-trimethyl-, monohydrochloride, (±)-) is a racemic compound and has the following structural formula. Each mL contains promethazine hydrochloride, either 25 mg or 50 mg, edetate disodium 0.1 mg, calcium chloride 0.04 mg, sodium metabisulfite 0.25 mg and phenol 5 mg in Water for Injection. pH 4.0 to 5.5; buffered with acetic acid-sodium acetate. Promethazine hydrochloride injection is a clear, colorless solution. The product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.</Description>
</NDC>
<NDC>
<NDCCode>52584-496-31</NDCCode>
<PackageDescription>1 AMPULE in 1 BAG (52584-496-31) > 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>52584-0496-31</NDC11Code>
<ProductNDC>52584-496</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20100801</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083312</ApplicationNumber>
<LabelerName>General Injectables & Vaccines, Inc</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100801</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride injection is indicated for the following conditions: 1 Amelioration of allergic reactions to blood or plasma., 2 In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled., 3 For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated., 4 For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused., 5 Active treatment of motion sickness., 6 Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery., 7 As an adjunct to analgesics for the control of postoperative pain., 8 Preoperative, postoperative, and obstetric (during labor) sedation., 9 Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.</IndicationAndUsage>
<Description>Promethazine hydrochloride injection, USP is a sterile, pyrogen-free solution for deep intramuscular or intravenous administration. Promethazine hydrochloride (10H-Phenothiazine-10-ethanamine,N,N,a-trimethyl-, monohydrochloride, (±)-) is a racemic compound and has the following structural formula. Each mL contains promethazine hydrochloride, either 25 mg or 50 mg, edetate disodium 0.1 mg, calcium chloride 0.04 mg, sodium metabisulfite 0.25 mg and phenol 5 mg in Water for Injection. pH 4.0 to 5.5; buffered with acetic acid-sodium acetate. Promethazine hydrochloride injection is a clear, colorless solution. The product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.</Description>
</NDC>
<NDC>
<NDCCode>10356-410-31</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (10356-410-31)</PackageDescription>
<NDC11Code>10356-0410-31</NDC11Code>
<ProductNDC>10356-410</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nivea Body Natural Tone</ProprietaryName>
<NonProprietaryName>Octinoxate, Avobenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080105</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Beiersdorf Inc</LabelerName>
<SubstanceName>OCTINOXATE; AVOBENZONE</SubstanceName>
<StrengthNumber>1.8; .3</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-03-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>66129-410-31</NDCCode>
<PackageDescription>50 g in 1 TUBE (66129-410-31)</PackageDescription>
<NDC11Code>66129-0410-31</NDC11Code>
<ProductNDC>66129-410</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Idole Skin Lightening</ProprietaryName>
<NonProprietaryName>Hydroquinone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part358A</ApplicationNumber>
<LabelerName>International Beauty Exchange</LabelerName>
<SubstanceName>HYDROQUINONE; OCTINOXATE</SubstanceName>
<StrengthNumber>1; .25</StrengthNumber>
<StrengthUnit>g/50g; g/50g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the gradual fading of dark areas in the skin such as freckles, age and liver spots.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73069-410-31</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BOX (73069-410-31) > 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0410-31</NDC11Code>
<ProductNDC>73069-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-pigmentation</ProprietaryName>
<NonProprietaryName>Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>79043-410-90</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (79043-410-90) * 236.6 mL in 1 BOTTLE * 29.6 mL in 1 BOTTLE (28595-225-31) </PackageDescription>
<NDC11Code>79043-0410-90</NDC11Code>
<ProductNDC>79043-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocort</ProprietaryName>
<NonProprietaryName>Hydrocortisone Lotion Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230610</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Scite Pharma</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocortisone Lotion is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Topical corticosteroids constitute a class of primarily synthetic steroids used a anti-inflammatory and antipruritic agents. Hydrocortisone is a member of this class. Chemically hydrocortisone is pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy, (11Β)-. Its structural formula is. Each mL of ALA-SCALP (Hydrocortisone Lotion USP), 2% contains 20 mg of hydrocortisone USP in a vehicle of isopropyl alcohol, polysorbate 20, purified water, propylene glycol, and benzalkonium chloride.</Description>
</NDC>
<NDC>
<NDCCode>52584-103-01</NDCCode>
<PackageDescription>1 AMPULE in 1 BAG (52584-103-01) > 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>52584-0103-01</NDC11Code>
<ProductNDC>52584-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinephrine</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180702</StartMarketingDate>
<EndMarketingDate>20230731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205029</ApplicationNumber>
<LabelerName>General Injectables and Vaccines, Inc.</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180702</StartMarketingDatePackage>
<EndMarketingDatePackage>20230731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52584-353-05</NDCCode>
<PackageDescription>1 VIAL in 1 BAG (52584-353-05) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>52584-0353-05</NDC11Code>
<ProductNDC>52584-353</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lincomycin</ProprietaryName>
<NonProprietaryName>Lincomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL</RouteName>
<StartMarketingDate>20201106</StartMarketingDate>
<EndMarketingDate>20230731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201746</ApplicationNumber>
<LabelerName>General Injectables and Vaccines, INC.</LabelerName>
<SubstanceName>LINCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201106</StartMarketingDatePackage>
<EndMarketingDatePackage>20230731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52584-415-10</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BAG (52584-415-10) > 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>52584-0415-10</NDC11Code>
<ProductNDC>52584-415</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neostigmine Methylsulfate</ProprietaryName>
<NonProprietaryName>Neostigmine Methylsulfate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160811</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203629</ApplicationNumber>
<LabelerName>General Injectables and Vaccines, Inc</LabelerName>
<SubstanceName>NEOSTIGMINE METHYLSULFATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-08-31</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52584-482-57</NDCCode>
<PackageDescription>1 VIAL in 1 BAG (52584-482-57) > 50 mL in 1 VIAL</PackageDescription>
<NDC11Code>52584-0482-57</NDC11Code>
<ProductNDC>52584-482</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xylocaine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INFILTRATION; PERINEURAL</RouteName>
<StartMarketingDate>20110912</StartMarketingDate>
<EndMarketingDate>20231231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA006488</ApplicationNumber>
<LabelerName>General Injectables & Vaccines, Inc</LabelerName>
<SubstanceName>EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
<StrengthNumber>.01; 10</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110912</StartMarketingDatePackage>
<EndMarketingDatePackage>20230731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52584-616-03</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (52584-616-03) > 3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>52584-0616-03</NDC11Code>
<ProductNDC>52584-616</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amiodarone Hydrochloride</ProprietaryName>
<NonProprietaryName>Amiodarone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075761</ApplicationNumber>
<LabelerName>General Injectables and Vaccines, Inc.</LabelerName>
<SubstanceName>AMIODARONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-08-31</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52584-795-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (52584-795-01) > 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>52584-0795-01</NDC11Code>
<ProductNDC>52584-795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20120410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074802</ApplicationNumber>
<LabelerName>General Injectables & Vaccines, Inc</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-08-31</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0573-0720-12</NDCCode>
<PackageDescription>1 CYLINDER in 1 BLISTER PACK (0573-0720-12) / 4 g in 1 CYLINDER</PackageDescription>
<NDC11Code>00573-0720-12</NDC11Code>
<ProductNDC>0573-0720</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chapstick Medicated</ProprietaryName>
<NonProprietaryName>Camphor, Menthol, Petrolatum, Phenol</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180610</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; PETROLATUM; PHENOL</SubstanceName>
<StrengthNumber>10; 6; 410; 5</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent and temporarily protects chafed, chapped or cracked lips. temporary relief of pain associated with fever blisters and cold sores. helps prevent and protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0573-0720-51</NDCCode>
<PackageDescription>4 g in 1 CYLINDER (0573-0720-51) </PackageDescription>
<NDC11Code>00573-0720-51</NDC11Code>
<ProductNDC>0573-0720</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chapstick Medicated</ProprietaryName>
<NonProprietaryName>Camphor, Menthol, Petrolatum, Phenol</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180610</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; PETROLATUM; PHENOL</SubstanceName>
<StrengthNumber>10; 6; 410; 5</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent and temporarily protects chafed, chapped or cracked lips. temporary relief of pain associated with fever blisters and cold sores. helps prevent and protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0573-0720-70</NDCCode>
<PackageDescription>2 CYLINDER in 1 BLISTER PACK (0573-0720-70) / 4 g in 1 CYLINDER</PackageDescription>
<NDC11Code>00573-0720-70</NDC11Code>
<ProductNDC>0573-0720</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chapstick Medicated</ProprietaryName>
<NonProprietaryName>Camphor, Menthol, Petrolatum, Phenol</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180610</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; PETROLATUM; PHENOL</SubstanceName>
<StrengthNumber>10; 6; 410; 5</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent and temporarily protects chafed, chapped or cracked lips. temporary relief of pain associated with fever blisters and cold sores. helps prevent and protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0615-8197-30</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8197-30) / 5 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00615-8197-30</NDC11Code>
<ProductNDC>0615-8197</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077493</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180301</StartMarketingDatePackage>
<EndMarketingDatePackage>20230731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3) .</IndicationAndUsage>
<Description>Risperidone is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone Tablets, USP, are for oral administration and are available in 0.25 mg (dark yellow), 0.5 mg (brownish red), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (white) strengths. Risperidone tablets contain the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and tartaric acid. The 0.25 mg tablets also contain Opadry II yellow 85F12383, for purposes of coating, which contains the following: iron oxide yellow, polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide. The 0.5 mg tablets also contain Opadry II red 85F15362, for purposes of coating, which contains the following: iron oxide red, polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide. The 1 mg and 4 mg tablets also contain Opadry II white 85F18422, for purposes of coating, which contains the following: polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide. The 2 mg tablets also contain Opadry II red 85F15404, for purposes of coating, which contains the following: calcium carbonate, calcium sulfate, iron oxide red, polyethylene glycol 3350, polyvinyl alcohol, and talc. The 3 mg tablets also contain Opadry II yellow 03B12447, for purposes of coating, which contains the following: hypromellose 2910 6cP, iron oxide red, iron oxide yellow, polyethylene glycol 400, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>31722-630-31</NDCCode>
<PackageDescription>10 CAPSULE in 1 CARTON (31722-630-31) </PackageDescription>
<NDC11Code>31722-0630-31</NDC11Code>
<ProductNDC>31722-630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oseltamivir Phosphate</ProprietaryName>
<NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209438</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2018-03-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oseltamivir phosphate is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2)Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.(1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).</IndicationAndUsage>
<Description>Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as: Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide and black iron oxide. The 75 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide. Each capsule is printed with blue ink, which includes shellac, propylene glycol, strong ammonia solution and FD&C Blue No. 2 as the colorant. The botanical source for pregelatinized starch is maize starch. Oseltamivir phosphate USP is a white to off-white powder with the chemical name [3R-(3α,4β,5α)]-Ethyl 4-(acetyl amino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The molecular formula is C16H28N2O4.H3PO4. The relative molecular mass is 410.40 for oseltamivir phosphate salt. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>31722-631-31</NDCCode>
<PackageDescription>10 CAPSULE in 1 CARTON (31722-631-31) </PackageDescription>
<NDC11Code>31722-0631-31</NDC11Code>
<ProductNDC>31722-631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oseltamivir Phosphate</ProprietaryName>
<NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209438</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2018-03-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oseltamivir phosphate is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2)Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.(1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).</IndicationAndUsage>
<Description>Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as: Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide and black iron oxide. The 75 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide. Each capsule is printed with blue ink, which includes shellac, propylene glycol, strong ammonia solution and FD&C Blue No. 2 as the colorant. The botanical source for pregelatinized starch is maize starch. Oseltamivir phosphate USP is a white to off-white powder with the chemical name [3R-(3α,4β,5α)]-Ethyl 4-(acetyl amino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The molecular formula is C16H28N2O4.H3PO4. The relative molecular mass is 410.40 for oseltamivir phosphate salt. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>31722-632-31</NDCCode>
<PackageDescription>10 CAPSULE in 1 CARTON (31722-632-31) </PackageDescription>
<NDC11Code>31722-0632-31</NDC11Code>
<ProductNDC>31722-632</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oseltamivir Phosphate</ProprietaryName>
<NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209438</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2018-03-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oseltamivir phosphate is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2)Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.(1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).</IndicationAndUsage>
<Description>Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as: Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide and black iron oxide. The 75 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide. Each capsule is printed with blue ink, which includes shellac, propylene glycol, strong ammonia solution and FD&C Blue No. 2 as the colorant. The botanical source for pregelatinized starch is maize starch. Oseltamivir phosphate USP is a white to off-white powder with the chemical name [3R-(3α,4β,5α)]-Ethyl 4-(acetyl amino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The molecular formula is C16H28N2O4.H3PO4. The relative molecular mass is 410.40 for oseltamivir phosphate salt. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>43598-410-25</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (43598-410-25) / 5 VIAL in 1 POUCH (43598-410-05) / 3 mL in 1 VIAL</PackageDescription>
<NDC11Code>43598-0410-25</NDC11Code>
<ProductNDC>43598-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levalbuterol Inhalation</ProprietaryName>
<NonProprietaryName>Levalbuterol Inhalation 0.63mg/3ml</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078171</ApplicationNumber>
<LabelerName>Dr. Reddy�s Laboratories, Inc.</LabelerName>
<SubstanceName>LEVALBUTEROL</SubstanceName>
<StrengthNumber>.63</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
<Description>Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg (0.0103%) of Levalbuterol (as 0.36 mg of levalbuterol HCl) or 0.63 mg (0.021%) of levalbuterol (as 0.73 mg of levalbuterol HCl) or 1.25 mg (0.042%) of levalbuterol (as 1.44 mg of levalbuterol HCl), edetate disodium as a chelating agent, sodium chloride to adjust tonicity, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5).</Description>
</NDC>
<NDC>
<NDCCode>70121-2625-5</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (70121-2625-5) * 2 mL in 1 VIAL (70121-1350-1) * 2 mL in 1 SYRINGE (70121-2624-2) </PackageDescription>
<NDC11Code>70121-2625-05</NDC11Code>
<ProductNDC>70121-2625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250908</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218586</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone for extended-release injectable suspension is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. (1.2).</IndicationAndUsage>
<Description>Risperidone for extended-release injectable suspension contains risperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.48 g/mol. The structural formula is. Risperidone, USP is soluble in methylene chloride, sparingly soluble in alcohol and practically insoluble in water. Risperidone for Extended-Release Injectable Suspension is a combination of extended-release microspheres for injection and diluent for parenteral use. The extended-release microspheres formulation is a sterile, white to off white, free-flowing powder that is available in dosage strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg risperidone, USP per vial. Risperidone, USP is micro-encapsulated in 7525 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres. The diluent for parenteral use is a clear, colorless solution. Composition of the diluent includes 1 mg/mL citric acid anhydrous; 1.25 mg/mL disodium hydrogen phosphate dihydrate; 1 mg/mL polysorbate 20; 23 mg/mL sodium carboxymethyl cellulose; 6 mg/mL sodium chloride; 0.55 mg/mL sodium hydroxide and water for injection. The microspheres are suspended in the diluent prior to injection. Risperidone for extended-release injectable suspension is provided as a single-dose pack, consisting of a vial containing the microspheres, a pre-filled syringe containing the diluent, a vial adapter and two Terumo SurGuard 3 Needles (a 21 G TW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration).</Description>
</NDC>
<NDC>
<NDCCode>70121-2626-5</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (70121-2626-5) * 2 mL in 1 SYRINGE (70121-2624-2) * 2 mL in 1 VIAL (70121-1351-1) </PackageDescription>
<NDC11Code>70121-2626-05</NDC11Code>
<ProductNDC>70121-2626</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20250908</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218586</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone for extended-release injectable suspension is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. (1.2).</IndicationAndUsage>
<Description>Risperidone for extended-release injectable suspension contains risperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.48 g/mol. The structural formula is. Risperidone, USP is soluble in methylene chloride, sparingly soluble in alcohol and practically insoluble in water. Risperidone for Extended-Release Injectable Suspension is a combination of extended-release microspheres for injection and diluent for parenteral use. The extended-release microspheres formulation is a sterile, white to off white, free-flowing powder that is available in dosage strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg risperidone, USP per vial. Risperidone, USP is micro-encapsulated in 7525 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres. The diluent for parenteral use is a clear, colorless solution. Composition of the diluent includes 1 mg/mL citric acid anhydrous; 1.25 mg/mL disodium hydrogen phosphate dihydrate; 1 mg/mL polysorbate 20; 23 mg/mL sodium carboxymethyl cellulose; 6 mg/mL sodium chloride; 0.55 mg/mL sodium hydroxide and water for injection. The microspheres are suspended in the diluent prior to injection. Risperidone for extended-release injectable suspension is provided as a single-dose pack, consisting of a vial containing the microspheres, a pre-filled syringe containing the diluent, a vial adapter and two Terumo SurGuard 3 Needles (a 21 G TW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration).</Description>
</NDC>
<NDC>
<NDCCode>70121-2627-5</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (70121-2627-5) * 2 mL in 1 VIAL (70121-1352-1) * 2 mL in 1 SYRINGE (70121-2624-2) </PackageDescription>
<NDC11Code>70121-2627-05</NDC11Code>
<ProductNDC>70121-2627</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20250908</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218586</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone for extended-release injectable suspension is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. (1.2).</IndicationAndUsage>
<Description>Risperidone for extended-release injectable suspension contains risperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.48 g/mol. The structural formula is. Risperidone, USP is soluble in methylene chloride, sparingly soluble in alcohol and practically insoluble in water. Risperidone for Extended-Release Injectable Suspension is a combination of extended-release microspheres for injection and diluent for parenteral use. The extended-release microspheres formulation is a sterile, white to off white, free-flowing powder that is available in dosage strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg risperidone, USP per vial. Risperidone, USP is micro-encapsulated in 7525 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres. The diluent for parenteral use is a clear, colorless solution. Composition of the diluent includes 1 mg/mL citric acid anhydrous; 1.25 mg/mL disodium hydrogen phosphate dihydrate; 1 mg/mL polysorbate 20; 23 mg/mL sodium carboxymethyl cellulose; 6 mg/mL sodium chloride; 0.55 mg/mL sodium hydroxide and water for injection. The microspheres are suspended in the diluent prior to injection. Risperidone for extended-release injectable suspension is provided as a single-dose pack, consisting of a vial containing the microspheres, a pre-filled syringe containing the diluent, a vial adapter and two Terumo SurGuard 3 Needles (a 21 G TW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration).</Description>
</NDC>
<NDC>
<NDCCode>70121-2628-5</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (70121-2628-5) * 2 mL in 1 VIAL (70121-1353-1) * 2 mL in 1 SYRINGE (70121-2624-2) </PackageDescription>
<NDC11Code>70121-2628-05</NDC11Code>
<ProductNDC>70121-2628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20250908</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218586</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone for extended-release injectable suspension is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. (1.2).</IndicationAndUsage>
<Description>Risperidone for extended-release injectable suspension contains risperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.48 g/mol. The structural formula is. Risperidone, USP is soluble in methylene chloride, sparingly soluble in alcohol and practically insoluble in water. Risperidone for Extended-Release Injectable Suspension is a combination of extended-release microspheres for injection and diluent for parenteral use. The extended-release microspheres formulation is a sterile, white to off white, free-flowing powder that is available in dosage strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg risperidone, USP per vial. Risperidone, USP is micro-encapsulated in 7525 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres. The diluent for parenteral use is a clear, colorless solution. Composition of the diluent includes 1 mg/mL citric acid anhydrous; 1.25 mg/mL disodium hydrogen phosphate dihydrate; 1 mg/mL polysorbate 20; 23 mg/mL sodium carboxymethyl cellulose; 6 mg/mL sodium chloride; 0.55 mg/mL sodium hydroxide and water for injection. The microspheres are suspended in the diluent prior to injection. Risperidone for extended-release injectable suspension is provided as a single-dose pack, consisting of a vial containing the microspheres, a pre-filled syringe containing the diluent, a vial adapter and two Terumo SurGuard 3 Needles (a 21 G TW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration).</Description>
</NDC>
<NDC>
<NDCCode>71288-410-85</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (71288-410-85) / .6 mL in 1 SYRINGE (71288-410-84) </PackageDescription>
<NDC11Code>71288-0410-85</NDC11Code>
<ProductNDC>71288-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enoxaparin Sodium</ProprietaryName>
<NonProprietaryName>Enoxaparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20191201</StartMarketingDate>
<EndMarketingDate>20260331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206834</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ENOXAPARIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191201</StartMarketingDatePackage>
<EndMarketingDatePackage>20260330</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enoxaparin Sodium Injection is a low molecular weight heparin (LMWH) indicated for: : 1 Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1) , 2 Inpatient treatment of acute DVT with or without pulmonary embolism (1.2) , 3 Outpatient treatment of acute DVT without pulmonary embolism (1.2) , 4 Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) (1.3) , 5 Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) (1.4) .</IndicationAndUsage>
<Description>Enoxaparin Sodium Injection, USP is an aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5. Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6-anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4,500 daltons. The molecular weight distribution is. STRUCTURAL FORMULA. Enoxaparin Sodium Injection, USP 100 mg per mL Concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1,000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. Enoxaparin Sodium Injection, USP 150 mg per mL Concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1,500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. The Enoxaparin Sodium Injection, USP prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection [see Dosage and Administration (2) and How Supplied/Storage and Handling (16)].</Description>
</NDC>
<NDC>
<NDCCode>71335-2733-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (71335-2733-1) </PackageDescription>
<NDC11Code>71335-2733-01</NDC11Code>
<ProductNDC>71335-2733</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079059</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2) , 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
<Description>Risperidone oral solution contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)- 1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone is also available as a 1 mg/mL oral solution. Risperidone Oral Solution contains the following inactive ingredients: benzoic acid, sodium hydroxide, sorbitol solution, tartaric acid, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>72288-247-41</NDCCode>
<PackageDescription>396 g in 1 JAR (72288-247-41) </PackageDescription>
<NDC11Code>72288-0247-41</NDC11Code>
<ProductNDC>72288-247</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Advanced Healing</ProprietaryName>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170827</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Amazon.com Services LLC</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>410</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily protects minor cuts, scrapes, burns. temporarily protects and helps relieve chapped and cracked skin and lips. helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
</NDCList>