{
"NDC": [
{
"NDCCode": "39822-9993-4",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 BOX (39822-9993-4) > 20 mL in 1 VIAL, SINGLE-USE (39822-9993-3)",
"NDC11Code": "39822-9993-04",
"ProductNDC": "39822-9993",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin, Tazobactam",
"NonProprietaryName": "Piperacillin, Tazobactam",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170214",
"EndMarketingDate": "20171130",
"MarketingCategoryName": "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE",
"LabelerName": "X-GEN Pharmaceuticals, Inc.",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "3; .375",
"StrengthUnit": "g/20mL; g/20mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "63275-9993-4",
"PackageDescription": "25 g in 1 BOTTLE, PLASTIC (63275-9993-4) ",
"NDC11Code": "63275-9993-04",
"ProductNDC": "63275-9993",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bupivacaine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20100128",
"EndMarketingDate": "20231001",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "B&B Pharmaceuticals, Inc.",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "28-JAN-10",
"EndMarketingDatePackage": "01-OCT-23"
},
{
"NDCCode": "65044-9993-3",
"PackageDescription": "25 VIAL in 1 TRAY (65044-9993-3) > 4.5 mL in 1 VIAL (65044-9993-3)",
"NDC11Code": "65044-9993-03",
"ProductNDC": "65044-9993",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diluent For Allergenic Extract - Sterile Albumin Saline With Phenol",
"NonProprietaryName": "Albumin Saline With Phenol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19790801",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103888",
"LabelerName": "Hollister-Stier Laboratories LLC",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "71092-9993-4",
"PackageDescription": "1000 g in 1 CONTAINER (71092-9993-4)",
"NDC11Code": "71092-9993-04",
"ProductNDC": "71092-9993",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20161222",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Triova Pharmaceuticals, LLC",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "39822-0125-4",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 BOX (39822-0125-4) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (39822-0125-3) ",
"NDC11Code": "39822-0125-04",
"ProductNDC": "39822-0125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin, Tazobactam",
"NonProprietaryName": "Piperacillin, Tazobactam",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207847",
"LabelerName": "X-GEN Pharmaceuticals, Inc.",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "3; .375",
"StrengthUnit": "g/1; g/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170201",
"SamplePackage": "N"
},
{
"NDCCode": "39822-0500-4",
"PackageDescription": "25 VIAL in 1 CARTON (39822-0500-4) > 1 mL in 1 VIAL (39822-0500-1) ",
"NDC11Code": "39822-0500-04",
"ProductNDC": "39822-0500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20150629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203110",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-03-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150629",
"SamplePackage": "N",
"IndicationAndUsage": "Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.",
"Description": "Hydralazine Hydrochloride Injection, USP is an antihypertensive available in a 1 mL vial for intravenous and intramuscular administration. Each milliliter of the sterile, nonpyrogenic colorless solution contains Hydralazine Hydrochloride USP, 20 mg, Propylene Glycol USP, 103.6 mg, and Water for Injection q.s. The pH of the solution is 3.4 - 4.4. pH may be adjusted with Hydrochloric Acid and/or Sodium Hydroxide. Hydralazine Hydrochloride is 1-Hydrazinophthalazine monohydrochloride, and its structural formula is. Molecular Formula C 8H 8N 4HCl. Hydralazine Hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64."
},
{
"NDCCode": "39822-2180-1",
"PackageDescription": "1 VIAL in 1 CARTON (39822-2180-1) > 4 mL in 1 VIAL",
"NDC11Code": "39822-2180-01",
"ProductNDC": "39822-2180",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206177",
"LabelerName": "X-GEN Pharmaceuticals, Inc.",
"SubstanceName": "DOCETAXEL",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-09-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170417",
"SamplePackage": "N"
},
{
"NDCCode": "0404-9993-02",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 BAG (0404-9993-02) / 2 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00404-9993-02",
"ProductNDC": "0404-9993",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adenosine",
"NonProprietaryName": "Adenosine Injection, Solution",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077133",
"LabelerName": "Henry Schein, Inc.",
"SubstanceName": "ADENOSINE",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230628",
"SamplePackage": "N",
"IndicationAndUsage": "Intravenous adenosine injection is indicated for the following. Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine injection administration. It is important to be sure the adenosine injection solution actually reaches the systemic circulation (see DOSAGE AND ADMINISTRATION). Adenosine injection does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine injection administration.",
"Description": "Adenosine is an endogenous nucleoside occurring in all cells of the body. It is chemically 6-amino-9-ß-D-ribofuranosyl-9-H-purine and has the following structural formula:. Adenosine is a white crystalline powder. It is soluble in water and practically insoluble in alcohol. Solubility increases by warming and lowering the pH. Adenosine is not chemically related to other antiarrhythmic drugs. Adenosine Injection is a sterile, nonpyrogenic solution for rapid bolus intravenous injection. Each mL contains 3 mg adenosine and 9 mg sodium chloride in water for injection. The pH of the solution is between 4.5 and 7.5."
},
{
"NDCCode": "11822-9993-1",
"PackageDescription": "1 TUBE in 1 CARTON (11822-9993-1) / 113 g in 1 TUBE",
"NDC11Code": "11822-9993-01",
"ProductNDC": "11822-9993",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rite Aid Ultra Strength Muscle Rub",
"NonProprietaryName": "Methyl Salicylate 30.0%, Camphor 4.0%, Menthol 10.0%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE",
"StrengthNumber": "40; 100; 300",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230301",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves the minor aches and pains of muscles and joints associated with: 1 simple backache, 2 arthritis, 3 strains, 4 bruises, 5 sprains."
},
{
"NDCCode": "50436-9993-2",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (50436-9993-2)",
"NDC11Code": "50436-9993-02",
"ProductNDC": "50436-9993",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Savella",
"NonProprietaryName": "Milnacipran Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090417",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022256",
"LabelerName": "Unit Dose Services",
"SubstanceName": "MILNACIPRAN HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"IndicationAndUsage": "Savella is indicated for the management of fibromyalgia. Savella is not approved for use in pediatric patients [see Use in Specific Populations (8.4)].",
"Description": "Milnacipran hydrochloride is a selective norepinephrine and serotonin reuptake inhibitor; it inhibits norepinephrine uptake with greater potency than serotonin. It is a racemic mixture with the chemical name: (±)-[1R(S),2S(R)]-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride. The structural formula is:. Milnacipran hydrochloride is a white to off-white crystalline powder with a melting point of 179°C. It is freely soluble in water, methanol, ethanol, chloroform, and methylene chloride and sparingly soluble in diethyl ether. It has an empirical formula of C15H23ClN2O and a molecular weight of 282.8 g/mol. Savella is available for oral administration as film-coated tablets containing 12.5 mg, 25 mg, 50 mg, and 100 mg milnacipran hydrochloride. Each tablet also contains dibasic calcium phosphate, povidone, carboxymethylcellulose calcium, colloidal silicon dioxide, magnesium stearate, and talc as inactive ingredients. The film coat contains the following additional inactive ingredients:. 12.5 mg. FD&C Blue #2 Aluminum Lake, polyvinyl alcohol, polyethylene glycol, titanium dioxide. 25 mg. Polyvinyl alcohol, polyethylene glycol, titanium dioxide. 50 mg. Polyvinyl alcohol, polyethylene glycol, titanium dioxide. 100 mg. FD&C Red #40 Aluminum Lake, polyvinyl alcohol, polyethylene glycol, titanium dioxide."
},
{
"NDCCode": "39822-0127-5",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 BOX (39822-0127-5) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE",
"NDC11Code": "39822-0127-05",
"ProductNDC": "39822-0127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin, Tazobactam",
"NonProprietaryName": "Piperacillin, Tazobactam",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207847",
"LabelerName": "X-GEN Pharmaceuticals, Inc.",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "4; .5",
"StrengthUnit": "g/1; g/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-02-13"
},
{
"NDCCode": "39822-0127-6",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 BOX (39822-0127-6) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (39822-0127-5) ",
"NDC11Code": "39822-0127-06",
"ProductNDC": "39822-0127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin, Tazobactam",
"NonProprietaryName": "Piperacillin, Tazobactam",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207847",
"LabelerName": "X-GEN Pharmaceuticals, Inc.",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "4; .5",
"StrengthUnit": "g/1; g/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170201",
"SamplePackage": "N"
},
{
"NDCCode": "39822-0139-7",
"PackageDescription": "1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (39822-0139-7) ",
"NDC11Code": "39822-0139-07",
"ProductNDC": "39822-0139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin, Tazobactam",
"NonProprietaryName": "Piperacillin, Tazobactam",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207848",
"LabelerName": "X-GEN Pharmaceuticals, Inc.",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "36; 4.5",
"StrengthUnit": "g/1; g/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180212",
"SamplePackage": "N"
},
{
"NDCCode": "39822-0151-1",
"PackageDescription": "1 VIAL in 1 CARTON (39822-0151-1) / 1 mL in 1 VIAL",
"NDC11Code": "39822-0151-01",
"ProductNDC": "39822-0151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Liothyronine Sodium",
"NonProprietaryName": "Liothyronine Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076923",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "LIOTHYRONINE SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Triiodothyronine [CS], l-Triiodothyronine [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050817",
"SamplePackage": "N",
"IndicationAndUsage": "Liothyronine sodium injection (T 3) is indicated in the treatment of myxedema coma/precoma. Liothyronine sodium injection (T 3) can be used in patients allergic to desiccated thyroid or thyroid extract derived from pork or beef.",
"Description": "Thyroid hormone drugs are natural or synthetic preparations containing tetraiodothyronine (T 4, levothyroxine) sodium or triiodothyronine (T 3, liothyronine) sodium or both. T 4 and T 3 are produced in the human thyroid gland by the iodination and coupling of the amino acid tyrosine. T 4 contains four iodine atoms and is formed by the coupling of two molecules of diiodotyrosine (DIT). T 3 contains three atoms of iodine and is formed by the coupling of one molecule of DIT with one molecule of monoiodotyrosine (MIT). Both hormones are stored in the thyroid colloid as thyroglobulin and released into the circulation. The major source of T 3 has been shown to be peripheral deiodination of T 4. T 3 is bound less firmly than T 4 in the serum, enters peripheral tissues more readily, and binds to specific nuclear receptor(s) to initiate hormonal, metabolic effects. T 4 is the prohormone which is deiodinated to T 3 for hormone activity. Thyroid hormone preparations belong to two categories: (1) natural hormonal preparations derived from animal thyroid, and (2) synthetic preparations. Natural preparations include desiccated thyroid and thyroglobulin. Desiccated thyroid is derived from domesticated animals that are used for food by man (either beef or hog thyroid), and thyroglobulin is derived from thyroid glands of the hog. Liothyronine sodium injection (T 3) contains liothyronine (L-triiodothyronine or L-T 3), a synthetic form of a natural thyroid hormone, as the sodium salt. The structural and empirical formulas and molecular weight of liothyronine sodium are given below. In euthyroid patients, 25 mcg of liothyronine is equivalent to approximately 1 grain of desiccated thyroid or thyroglobulin and 0.1 mg of L-thyroxine. Each mL of liothyronine sodium injection (T 3) in amber glass vials contains, in sterile non-pyrogenic aqueous solution, liothyronine sodium equivalent to 10 mcg of liothyronine; alcohol, 6.8% by volume; anhydrous citric acid, 0.175 mg; ammonia, 2.19 mg, as ammonium hydroxide; Water for Injection, USP."
},
{
"NDCCode": "39822-0190-1",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (39822-0190-1) / 5 mL in 1 VIAL, GLASS",
"NDC11Code": "39822-0190-01",
"ProductNDC": "39822-0190",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetazolamide",
"NonProprietaryName": "Acetazolamide",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20081210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040784",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "ACETAZOLAMIDE SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090301",
"SamplePackage": "N",
"IndicationAndUsage": "For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure.",
"Description": "Acetazolamide, an inhibitor of the enzyme carbonic anhydrase, is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2-yl)-acetamide and has the following structural formula:. Acetazolamide for injection, USP is available for intravenous use, and is supplied as a sterile powder requiring reconstitution. Each vial contains an amount of acetazolamide sodium equivalent to 500 mg of acetazolamide. The bulk solution is adjusted to pH 9.6 using sodium hydroxide and, if necessary, hydrochloric acid prior to lyophilization."
},
{
"NDCCode": "39822-0350-2",
"PackageDescription": "10 VIAL in 1 CARTON (39822-0350-2) > 2 mL in 1 VIAL (39822-0350-1) ",
"NDC11Code": "39822-0350-02",
"ProductNDC": "39822-0350",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lincomycin",
"NonProprietaryName": "Lincomycin Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL",
"StartMarketingDate": "20150705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201746",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "LINCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2022-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150705",
"SamplePackage": "N",
"IndicationAndUsage": "Lincomycin Injection, USP is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the BOXED WARNING, before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy. Lincomycin injection may be administered concomitantly with other antimicrobial agents when indicated. Lincomycin is not indicated in the treatment of minor bacterial infections or viral infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Lincomycin and other antibacterial drugs, Lincomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Lincomycin Injection, USP is a sterile solution containing lincomycin hydrochloride which is the monohydrated salt of lincomycin, a lincosamide antibacterial produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae). The chemical name for lincomycin hydrochloride is Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrolidinecarboxamido)-1-thio-D-erythro-α-D-galacto-octopyranoside monohydrochloride monohydrate. The molecular formula of lincomycin hydrochloride is C 18H 34N 2O 6SHClH 2O and the molecular weight is 461.01. The structural formula is represented below. Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory. Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone. Lincomycin Injection contains lincomycin hydrochloride in a sterile, clear, colorless solution with benzyl alcohol used as a preservative 9.45 mg/mL, and water for injection. Lincomycin Injection is a sterile solution for intramuscular and intravenous use. Lincomycin injection is supplied in 2 mL and 10 mL multiple-dose vials containing the equivalent of 300 mg/mL of lincomycin (equivalent to 340 mg/mL of lincomycin hydrochloride, USP)."
},
{
"NDCCode": "39822-0353-6",
"PackageDescription": "10 mL in 1 VIAL (39822-0353-6) ",
"NDC11Code": "39822-0353-06",
"ProductNDC": "39822-0353",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lincomycin",
"NonProprietaryName": "Lincomycin Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL",
"StartMarketingDate": "20150705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201746",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "LINCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2022-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150705",
"SamplePackage": "N",
"IndicationAndUsage": "Lincomycin Injection, USP is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the BOXED WARNING, before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy. Lincomycin injection may be administered concomitantly with other antimicrobial agents when indicated. Lincomycin is not indicated in the treatment of minor bacterial infections or viral infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Lincomycin and other antibacterial drugs, Lincomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Lincomycin Injection, USP is a sterile solution containing lincomycin hydrochloride which is the monohydrated salt of lincomycin, a lincosamide antibacterial produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae). The chemical name for lincomycin hydrochloride is Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrolidinecarboxamido)-1-thio-D-erythro-α-D-galacto-octopyranoside monohydrochloride monohydrate. The molecular formula of lincomycin hydrochloride is C 18H 34N 2O 6SHClH 2O and the molecular weight is 461.01. The structural formula is represented below. Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory. Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone. Lincomycin Injection contains lincomycin hydrochloride in a sterile, clear, colorless solution with benzyl alcohol used as a preservative 9.45 mg/mL, and water for injection. Lincomycin Injection is a sterile solution for intramuscular and intravenous use. Lincomycin injection is supplied in 2 mL and 10 mL multiple-dose vials containing the equivalent of 300 mg/mL of lincomycin (equivalent to 340 mg/mL of lincomycin hydrochloride, USP)."
},
{
"NDCCode": "39822-0412-1",
"PackageDescription": "1 VIAL in 1 CARTON (39822-0412-1) / 30 mL in 1 VIAL",
"NDC11Code": "39822-0412-01",
"ProductNDC": "39822-0412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobramycin",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20010817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065013",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "TOBRAMYCIN SULFATE",
"StrengthNumber": "1.2",
"StrengthUnit": "g/30mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010817",
"SamplePackage": "N",
"IndicationAndUsage": "Tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below. - Septicemia in the neonate, child, and adult caused by P. aeruginosa, E. coli, and Klebsiella sp. - Lower respiratory tract infections caused by P. aeruginosa, Klebsiella sp, Enterobacter sp, Serratia sp, E. coli, and S. aureus (penicillinase and non-penicillinase-producing strains). - Serious central-nervous-system infections (meningitis) caused by susceptible organisms. - Intra-abdominal infections, including peritonitis, caused by E. coli, Klebsiella sp, and Enterobacter sp. - Skin, bone, and skin-structure infections caused by P. aeruginosa,Proteus sp, E. coli, Klebsiella sp, Enterobacter sp, and S. aureus. - Complicated and recurrent urinary tract infections caused by P. aeruginosa, Proteus sp (indole-positive and indole-negative), E. coli, Klebsiella sp, Enterobacter sp, Serratia sp, S. aureus, Providencia sp, and Citrobacter sp. Aminoglycosides, including tobramycin sulfate, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Tobramycin may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use. Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. If susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. In patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin sulfate may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with tobramycin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the WARNINGSbox above. To reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Tobramycin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived from the actinomycete Streptomyces tenebrarius. Tobramycin for injection, USP is supplied as a sterile dry powder and is intended for reconstitution with 30 mL of sterile water for injection, USP. Sulfuric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH. Each vial contains tobramycin sulfate equivalent to 1200 mg of tobramycin. After reconstitution, the solution will contain 40 mg of tobramycin per mL. The product contains no preservative or sodium bisulfite. Tobramycin sulfate is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)- O-[2,6-diamino-2,3,6-trideoxy-α-D- ribo-hexopyranosyl-(1→6)-2-deoxy-L-streptamine, sulfate (2:5)(salt) and has the chemical formula (C 18H 37N 5O 9) 25H 2SO 4. The molecular weight is 1,425.39. The structural formula for tobramycin is as follows:. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion (see DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package)."
},
{
"NDCCode": "39822-0412-6",
"PackageDescription": "6 VIAL in 1 CARTON (39822-0412-6) / 30 mL in 1 VIAL",
"NDC11Code": "39822-0412-06",
"ProductNDC": "39822-0412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobramycin",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20010817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065013",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "TOBRAMYCIN SULFATE",
"StrengthNumber": "1.2",
"StrengthUnit": "g/30mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010817",
"SamplePackage": "N",
"IndicationAndUsage": "Tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below. - Septicemia in the neonate, child, and adult caused by P. aeruginosa, E. coli, and Klebsiella sp. - Lower respiratory tract infections caused by P. aeruginosa, Klebsiella sp, Enterobacter sp, Serratia sp, E. coli, and S. aureus (penicillinase and non-penicillinase-producing strains). - Serious central-nervous-system infections (meningitis) caused by susceptible organisms. - Intra-abdominal infections, including peritonitis, caused by E. coli, Klebsiella sp, and Enterobacter sp. - Skin, bone, and skin-structure infections caused by P. aeruginosa,Proteus sp, E. coli, Klebsiella sp, Enterobacter sp, and S. aureus. - Complicated and recurrent urinary tract infections caused by P. aeruginosa, Proteus sp (indole-positive and indole-negative), E. coli, Klebsiella sp, Enterobacter sp, Serratia sp, S. aureus, Providencia sp, and Citrobacter sp. Aminoglycosides, including tobramycin sulfate, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Tobramycin may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use. Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. If susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. In patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin sulfate may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with tobramycin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the WARNINGSbox above. To reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Tobramycin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived from the actinomycete Streptomyces tenebrarius. Tobramycin for injection, USP is supplied as a sterile dry powder and is intended for reconstitution with 30 mL of sterile water for injection, USP. Sulfuric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH. Each vial contains tobramycin sulfate equivalent to 1200 mg of tobramycin. After reconstitution, the solution will contain 40 mg of tobramycin per mL. The product contains no preservative or sodium bisulfite. Tobramycin sulfate is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)- O-[2,6-diamino-2,3,6-trideoxy-α-D- ribo-hexopyranosyl-(1→6)-2-deoxy-L-streptamine, sulfate (2:5)(salt) and has the chemical formula (C 18H 37N 5O 9) 25H 2SO 4. The molecular weight is 1,425.39. The structural formula for tobramycin is as follows:. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion (see DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package)."
},
{
"NDCCode": "39822-0460-2",
"PackageDescription": "10 VIAL in 1 CARTON (39822-0460-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "39822-0460-02",
"ProductNDC": "39822-0460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215324",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "1.25",
"StrengthUnit": "g/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"Description": "Vancomycin hydrochloride for injection, USP, contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride, USP is (S a)- (3 S,6 R,7 R,22 R,23 S,26 S,36 R,38a R)-44-[[2- O-(3-Amino-2,3,6-trideoxy-3- C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro- 2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2 R)-4- methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22 H-8,11:18,21-dietheno-23,36- (iminomethano)-13,16:31,35-dimetheno-1 H,16 H-[l,6,9]oxadiazacyclohexadecino[4,5- m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride, USP has the following structural formula:. Vancomycin hydrochloride for injection, USP is a sterile off-white to light tan colored lyophilized plug or powder for injection. Vancomycin hydrochloride for injection, USP is supplied in single-dose vials, containing 1.28 g or 1.54 g of vancomycin hydrochloride, USP equivalent to 1.25 g or 1.5 g of vancomycin base. The lyophilized powder is reconstituted with sterile water for injection, USP which forms a clear, colorless or light to dark tan solution and subsequently diluted prior to intravenous administration [see Dosage and Administration (2.5)]."
},
{
"NDCCode": "39822-0470-2",
"PackageDescription": "10 VIAL in 1 CARTON (39822-0470-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "39822-0470-02",
"ProductNDC": "39822-0470",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215324",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"Description": "Vancomycin hydrochloride for injection, USP, contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride, USP is (S a)- (3 S,6 R,7 R,22 R,23 S,26 S,36 R,38a R)-44-[[2- O-(3-Amino-2,3,6-trideoxy-3- C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro- 2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2 R)-4- methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22 H-8,11:18,21-dietheno-23,36- (iminomethano)-13,16:31,35-dimetheno-1 H,16 H-[l,6,9]oxadiazacyclohexadecino[4,5- m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride, USP has the following structural formula:. Vancomycin hydrochloride for injection, USP is a sterile off-white to light tan colored lyophilized plug or powder for injection. Vancomycin hydrochloride for injection, USP is supplied in single-dose vials, containing 1.28 g or 1.54 g of vancomycin hydrochloride, USP equivalent to 1.25 g or 1.5 g of vancomycin base. The lyophilized powder is reconstituted with sterile water for injection, USP which forms a clear, colorless or light to dark tan solution and subsequently diluted prior to intravenous administration [see Dosage and Administration (2.5)]."
},
{
"NDCCode": "39822-0650-1",
"PackageDescription": "1 VIAL in 1 CARTON (39822-0650-1) / 50 mL in 1 VIAL",
"NDC11Code": "39822-0650-01",
"ProductNDC": "39822-0650",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nelarabine",
"NonProprietaryName": "Nelarabine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216510",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "NELARABINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250217",
"SamplePackage": "N",
"IndicationAndUsage": "Nelarabine injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.",
"Description": "Nelarabine is a prodrug of the cytotoxic deoxyguanosine analogue, 9-β- D-arabinofuranosylguanine (ara-G). The chemical name for nelarabine is 2-amino-9-β- D-arabinofuranosyl-6-methoxy-9 H-purine. It has the molecular formula C 11H 15N 5O 5 and a molecular weight of 297.27. Nelarabine has the following structural formula:. Nelarabine is slightly soluble to soluble in water and melts with decomposition between 209°C and 217°C. Nelarabine injection is supplied as a clear, colorless, sterile solution in glass single-dose vials. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride (4.5 mg per mL) in Water for Injection, USP. Nelarabine injection is intended for intravenous infusion. Hydrochloric acid and sodium hydroxide may have been used to adjust the pH. The solution pH ranges from 5.0 to 7.0."
},
{
"NDCCode": "39822-0650-6",
"PackageDescription": "6 VIAL in 1 CARTON (39822-0650-6) / 50 mL in 1 VIAL",
"NDC11Code": "39822-0650-06",
"ProductNDC": "39822-0650",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nelarabine",
"NonProprietaryName": "Nelarabine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216510",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "NELARABINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250217",
"SamplePackage": "N",
"IndicationAndUsage": "Nelarabine injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.",
"Description": "Nelarabine is a prodrug of the cytotoxic deoxyguanosine analogue, 9-β- D-arabinofuranosylguanine (ara-G). The chemical name for nelarabine is 2-amino-9-β- D-arabinofuranosyl-6-methoxy-9 H-purine. It has the molecular formula C 11H 15N 5O 5 and a molecular weight of 297.27. Nelarabine has the following structural formula:. Nelarabine is slightly soluble to soluble in water and melts with decomposition between 209°C and 217°C. Nelarabine injection is supplied as a clear, colorless, sterile solution in glass single-dose vials. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride (4.5 mg per mL) in Water for Injection, USP. Nelarabine injection is intended for intravenous infusion. Hydrochloric acid and sodium hydroxide may have been used to adjust the pH. The solution pH ranges from 5.0 to 7.0."
},
{
"NDCCode": "39822-0706-2",
"PackageDescription": "10 VIAL in 1 BOX (39822-0706-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (39822-0706-1) ",
"NDC11Code": "39822-0706-02",
"ProductNDC": "39822-0706",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Streptomycin",
"NonProprietaryName": "Streptomycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "19980630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064210",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "STREPTOMYCIN SULFATE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Antimycobacterial [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980630",
"SamplePackage": "N",
"IndicationAndUsage": "Streptomycin is indicated for the treatment of individuals with moderate to severe infections caused by susceptibile strains of microorganisms in the specific conditions listed below. 1. Mycobacterium tuberculosis: The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and the Center for Disease Control recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH or rifampin resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. In the past when the national rate of primary drug resistance to isoniazid was known to be less than 4% and was either stable or declining, therapy with two and three drug regimens was considered adequate. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered. Streptomycin is also indicated for therapy of tuberculosis when one or more of the above drugs is contraindicated because of toxicity or intolerance. The management of tuberculosis has become more complex as a consequence of increasing rates of drug resistance and concomitant HIV infection. Additional consultation from experts in the treatment of tuberculosis may be desirable in those settings. 2. Non-tuberculosis infections: The use of streptomycin should be limited to the treatment of infections caused by bacteria which have been shown to be susceptible to the antibacterial effects of streptomycin and which are not amenable to therapy with less potentially toxic agents. a. Yersinia pestis (plague), b. Francisella tularensis (tularemia), c. Brucella, d. Calymmatobacterium granulomatis (donovanosis, granuloma inguinale), e. H. ducreyi (chancroid), f. H. influenzae (in respiratory, endocardial, and meningeal infections-concomitantly with another antibacterial agent), g. K. pneumoniae pneumonia (concomitantly with another antibacterial agent), h. E.coli, Proteus, A. aerogenes, K. pneumoniae, and Enterococcus faecalis in urinary tract infections, i. Streptococcus viridans, Enterococcus faecalis (in endocardial infections - concomitantly with penicillin), j. Gram-negative bacillary bacteremia (concomitantly with another antibacterial agent). To reduce the development of drug-resistant bacteria and maintain the effectiveness of streptomycin and other antibacterial drugs, streptomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Streptomycin is a water-soluble aminoglycoside derived from Streptomyces griseus. It is marketed as the sulfate salt of streptomycin. The chemical name of streptomycin sulfate is D-Streptamine, O-2-deoxy-2-(methylamino)- α-L-glucopyranosyl-(1→2)- O-5-deoxy-3- C-formyl- α-L-lyxofuranosyl-(1→4)- N,N1-bis(aminoiminomethyl)-,sulfate (2:3) (salt). The molecular formula for Streptomycin Sulfate is (C 21H 39N 7O 12) 2 3H 2SO 4 and the molecular weight is 1457.41. It has the following structural formula:. Streptomycin for Injection, equivalent to 1 gram streptomycin/vial, is supplied as a sterile nonpyrogenic lyophilized cake for intramuscular use after reconstitution. The lyophilized cake may reduce to a powder during shipping. After reconstitution, the pH range for Streptomycin for Injection should be between 4.5 and 7 in a solution containing 200 mg of streptomycin activity per mL. *Each vial of Streptomycin for Injection contains streptomycin sulfate equivalent to 1 gram of streptomycin."
},
{
"NDCCode": "39822-1000-1",
"PackageDescription": "10 VIAL in 1 CARTON (39822-1000-1) / 10 mL in 1 VIAL",
"NDC11Code": "39822-1000-01",
"ProductNDC": "39822-1000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tranexamic Acid",
"NonProprietaryName": "Tranexamic Acid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201580",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "TRANEXAMIC ACID",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120518",
"SamplePackage": "N",
"IndicationAndUsage": "Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.",
"Description": "Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid is a white crystalline powder. The structural formula is. Each mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid and Water for Injection to 1 mL. The aqueous solution for injection has a pH of 6.5 to 8.0."
},
{
"NDCCode": "39822-1030-2",
"PackageDescription": "3 VIAL in 1 CARTON (39822-1030-2) / 2 mL in 1 VIAL (39822-1030-1) ",
"NDC11Code": "39822-1030-02",
"ProductNDC": "39822-1030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen Lysine",
"NonProprietaryName": "Ibuprofen Lysine",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202402",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "IBUPROFEN LYSINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160408",
"SamplePackage": "N",
"IndicationAndUsage": "Ibuprofen Lysine Injection is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. The clinical trial was conducted among infants with an asymptomatic PDA. However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.",
"Description": "Ibuprofen Lysine Injection is a clear sterile preservative-free solution of the L-lysine salt of (±)-ibuprofen which is the active ingredient. (±)-Ibuprofen is a nonsteroidal anti-inflammatory agent (NSAID). L-lysine is used to create a water-soluble drug product salt suitable for intravenous administration. Each mL of Ibuprofen Lysine Injection contains 17.1 mg of ibuprofen lysine (equivalent to 10 mg of (±)-ibuprofen) in Water for Injection, USP. The pH is adjusted to 7.0 with sodium hydroxide or hydrochloric acid. The structural formula is. Ibuprofen Lysine Injection is designated chemically as α-methyl-4-(2-methyl propyl) benzeneacetic acid lysine salt. Its molecular weight is 352.48. Its empirical formula is C 19H 32N 2O 4. It occurs as a white crystalline solid which is soluble in water and slightly soluble in ethanol."
},
{
"NDCCode": "39822-1077-1",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (39822-1077-1) / 20 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "39822-1077-01",
"ProductNDC": "39822-1077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Voriconazole",
"NonProprietaryName": "Voriconazole",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170309",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208562",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "VORICONAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170409",
"SamplePackage": "N",
"IndicationAndUsage": "Voriconazole for injection is an azole antifungal indicated for use in the treatment of adults and pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight with: 1 Invasive aspergillosis ( 1.1) , 2 Candidemia in non-neutropenics and other deep tissue Candida infections ( 1.2) , 3 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy ( 1.3) .",
"Description": "Voriconazole for injection, an azole antifungal is available as a sterile lyophilized cake or powder for solution for intravenous infusion. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1 H-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C 16H 14F 3N 5O and a molecular weight of 349.3. Voriconazole drug substance is a white or almost white powder. Voriconazole for injection is a white to off white lyophilized cake or powder containing nominally 200 mg voriconazole and 3200 mg hydroxypropyl β-cyclodextrin (HPβCD) in a 30 mL Type I clear glass vial. Voriconazole for injection is intended for administration by intravenous infusion. It is an unpreserved product in a single dose vial. Vials containing 200 mg lyophilized voriconazole are intended for reconstitution with Water for Injection to produce a solution containing 10 mg/mL Voriconazole for injection and 160 mg/mL of hydroxypropyl β-cyclodextrin (HPβCD). The resultant solution is further diluted prior to administration as an intravenous infusion [see Dosage and Administration (2)]."
},
{
"NDCCode": "39822-1100-1",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (39822-1100-1) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "39822-1100-01",
"ProductNDC": "39822-1100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Folic Acid",
"NonProprietaryName": "Folic Acid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20191117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202522",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "FOLIC ACID",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191117",
"SamplePackage": "N",
"IndicationAndUsage": "Folic Acid Injection, USP alone is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid as may be seen in tropical or nontropical sprue, in anemias of nutritional origin, pregnancy, infancy or childhood.",
"Description": "Folic Acid Injection, USP is a sterile, nonpyrogenic solution of sodium folate (prepared by the addition of sodium hydroxide to folic acid) in Water for Injection, USP intended for intramuscular (IM), intravenous (IV) or subcutaneous (SC) use. Folic acid is a complex organic compound present in liver, yeast and other substances, which may be prepared synthetically. It is a yellow or yellowish orange, odorless crystalline powder. It is very slightly soluble in water, insoluble in alcohol, chloroform, ether; readily dissolves in dilute solutions of alkali hydroxides and carbonates. It is chemically designated as: L-Glutamic acid, N-[4-[[(2-amino-1-4-dihydro-4-oxo-6-pteridinyl) methyl] amino]benzoyl]-, and has the following structural formula. C 19H 19N 7O 6 ; M.W. 441.40. Each mL contains: Sodium folate (equivalent to 5 mg folic acid); edetate disodium 2 mg; benzyl alcohol 15 mg (added as preservative); Water for Injection, USP q.s. Sodium hydroxide for pH adjustment (8.0 to 11.0)."
},
{
"NDCCode": "39822-1410-6",
"PackageDescription": "10 AMPULE in 1 CARTON (39822-1410-6) > 5 mL in 1 AMPULE (39822-1410-5) ",
"NDC11Code": "39822-1410-06",
"ProductNDC": "39822-1410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rezipres",
"NonProprietaryName": "Ephedrine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210614",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213536",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "EPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "4.7",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20211101",
"SamplePackage": "N"
},
{
"NDCCode": "39822-1800-1",
"PackageDescription": "1 VIAL in 1 CARTON (39822-1800-1) / 2 mL in 1 VIAL",
"NDC11Code": "39822-1800-01",
"ProductNDC": "39822-1800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20250828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211072",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250902",
"SamplePackage": "N",
"Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine for injection is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>39822-9993-4</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 BOX (39822-9993-4) > 20 mL in 1 VIAL, SINGLE-USE (39822-9993-3)</PackageDescription>
<NDC11Code>39822-9993-04</NDC11Code>
<ProductNDC>39822-9993</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin, Tazobactam</ProprietaryName>
<NonProprietaryName>Piperacillin, Tazobactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170214</StartMarketingDate>
<EndMarketingDate>20171130</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE</MarketingCategoryName>
<LabelerName>X-GEN Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
<StrengthNumber>3; .375</StrengthNumber>
<StrengthUnit>g/20mL; g/20mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>63275-9993-4</NDCCode>
<PackageDescription>25 g in 1 BOTTLE, PLASTIC (63275-9993-4) </PackageDescription>
<NDC11Code>63275-9993-04</NDC11Code>
<ProductNDC>63275-9993</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20100128</StartMarketingDate>
<EndMarketingDate>20231001</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>B&B Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>28-JAN-10</StartMarketingDatePackage>
<EndMarketingDatePackage>01-OCT-23</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>65044-9993-3</NDCCode>
<PackageDescription>25 VIAL in 1 TRAY (65044-9993-3) > 4.5 mL in 1 VIAL (65044-9993-3)</PackageDescription>
<NDC11Code>65044-9993-03</NDC11Code>
<ProductNDC>65044-9993</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diluent For Allergenic Extract - Sterile Albumin Saline With Phenol</ProprietaryName>
<NonProprietaryName>Albumin Saline With Phenol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19790801</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103888</ApplicationNumber>
<LabelerName>Hollister-Stier Laboratories LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71092-9993-4</NDCCode>
<PackageDescription>1000 g in 1 CONTAINER (71092-9993-4)</PackageDescription>
<NDC11Code>71092-9993-04</NDC11Code>
<ProductNDC>71092-9993</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20161222</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Triova Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>39822-0125-4</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 BOX (39822-0125-4) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (39822-0125-3) </PackageDescription>
<NDC11Code>39822-0125-04</NDC11Code>
<ProductNDC>39822-0125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin, Tazobactam</ProprietaryName>
<NonProprietaryName>Piperacillin, Tazobactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207847</ApplicationNumber>
<LabelerName>X-GEN Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
<StrengthNumber>3; .375</StrengthNumber>
<StrengthUnit>g/1; g/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>39822-0500-4</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (39822-0500-4) > 1 mL in 1 VIAL (39822-0500-1) </PackageDescription>
<NDC11Code>39822-0500-04</NDC11Code>
<ProductNDC>39822-0500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20150629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203110</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.</IndicationAndUsage>
<Description>Hydralazine Hydrochloride Injection, USP is an antihypertensive available in a 1 mL vial for intravenous and intramuscular administration. Each milliliter of the sterile, nonpyrogenic colorless solution contains Hydralazine Hydrochloride USP, 20 mg, Propylene Glycol USP, 103.6 mg, and Water for Injection q.s. The pH of the solution is 3.4 - 4.4. pH may be adjusted with Hydrochloric Acid and/or Sodium Hydroxide. Hydralazine Hydrochloride is 1-Hydrazinophthalazine monohydrochloride, and its structural formula is. Molecular Formula C 8H 8N 4HCl. Hydralazine Hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64.</Description>
</NDC>
<NDC>
<NDCCode>39822-2180-1</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (39822-2180-1) > 4 mL in 1 VIAL</PackageDescription>
<NDC11Code>39822-2180-01</NDC11Code>
<ProductNDC>39822-2180</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206177</ApplicationNumber>
<LabelerName>X-GEN Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DOCETAXEL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-09-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0404-9993-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 BAG (0404-9993-02) / 2 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00404-9993-02</NDC11Code>
<ProductNDC>0404-9993</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adenosine</ProprietaryName>
<NonProprietaryName>Adenosine Injection, Solution</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077133</ApplicationNumber>
<LabelerName>Henry Schein, Inc.</LabelerName>
<SubstanceName>ADENOSINE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Intravenous adenosine injection is indicated for the following. Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine injection administration. It is important to be sure the adenosine injection solution actually reaches the systemic circulation (see DOSAGE AND ADMINISTRATION). Adenosine injection does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine injection administration.</IndicationAndUsage>
<Description>Adenosine is an endogenous nucleoside occurring in all cells of the body. It is chemically 6-amino-9-ß-D-ribofuranosyl-9-H-purine and has the following structural formula:. Adenosine is a white crystalline powder. It is soluble in water and practically insoluble in alcohol. Solubility increases by warming and lowering the pH. Adenosine is not chemically related to other antiarrhythmic drugs. Adenosine Injection is a sterile, nonpyrogenic solution for rapid bolus intravenous injection. Each mL contains 3 mg adenosine and 9 mg sodium chloride in water for injection. The pH of the solution is between 4.5 and 7.5.</Description>
</NDC>
<NDC>
<NDCCode>11822-9993-1</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (11822-9993-1) / 113 g in 1 TUBE</PackageDescription>
<NDC11Code>11822-9993-01</NDC11Code>
<ProductNDC>11822-9993</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rite Aid Ultra Strength Muscle Rub</ProprietaryName>
<NonProprietaryName>Methyl Salicylate 30.0%, Camphor 4.0%, Menthol 10.0%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>40; 100; 300</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves the minor aches and pains of muscles and joints associated with: 1 simple backache, 2 arthritis, 3 strains, 4 bruises, 5 sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50436-9993-2</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (50436-9993-2)</PackageDescription>
<NDC11Code>50436-9993-02</NDC11Code>
<ProductNDC>50436-9993</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Savella</ProprietaryName>
<NonProprietaryName>Milnacipran Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090417</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022256</ApplicationNumber>
<LabelerName>Unit Dose Services</LabelerName>
<SubstanceName>MILNACIPRAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Savella is indicated for the management of fibromyalgia. Savella is not approved for use in pediatric patients [see Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Milnacipran hydrochloride is a selective norepinephrine and serotonin reuptake inhibitor; it inhibits norepinephrine uptake with greater potency than serotonin. It is a racemic mixture with the chemical name: (±)-[1R(S),2S(R)]-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride. The structural formula is:. Milnacipran hydrochloride is a white to off-white crystalline powder with a melting point of 179°C. It is freely soluble in water, methanol, ethanol, chloroform, and methylene chloride and sparingly soluble in diethyl ether. It has an empirical formula of C15H23ClN2O and a molecular weight of 282.8 g/mol. Savella is available for oral administration as film-coated tablets containing 12.5 mg, 25 mg, 50 mg, and 100 mg milnacipran hydrochloride. Each tablet also contains dibasic calcium phosphate, povidone, carboxymethylcellulose calcium, colloidal silicon dioxide, magnesium stearate, and talc as inactive ingredients. The film coat contains the following additional inactive ingredients:. 12.5 mg. FD&C Blue #2 Aluminum Lake, polyvinyl alcohol, polyethylene glycol, titanium dioxide. 25 mg. Polyvinyl alcohol, polyethylene glycol, titanium dioxide. 50 mg. Polyvinyl alcohol, polyethylene glycol, titanium dioxide. 100 mg. FD&C Red #40 Aluminum Lake, polyvinyl alcohol, polyethylene glycol, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>39822-0127-5</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 BOX (39822-0127-5) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>39822-0127-05</NDC11Code>
<ProductNDC>39822-0127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin, Tazobactam</ProprietaryName>
<NonProprietaryName>Piperacillin, Tazobactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207847</ApplicationNumber>
<LabelerName>X-GEN Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
<StrengthNumber>4; .5</StrengthNumber>
<StrengthUnit>g/1; g/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-02-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>39822-0127-6</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 BOX (39822-0127-6) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (39822-0127-5) </PackageDescription>
<NDC11Code>39822-0127-06</NDC11Code>
<ProductNDC>39822-0127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin, Tazobactam</ProprietaryName>
<NonProprietaryName>Piperacillin, Tazobactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207847</ApplicationNumber>
<LabelerName>X-GEN Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
<StrengthNumber>4; .5</StrengthNumber>
<StrengthUnit>g/1; g/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>39822-0139-7</NDCCode>
<PackageDescription>1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (39822-0139-7) </PackageDescription>
<NDC11Code>39822-0139-07</NDC11Code>
<ProductNDC>39822-0139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin, Tazobactam</ProprietaryName>
<NonProprietaryName>Piperacillin, Tazobactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207848</ApplicationNumber>
<LabelerName>X-GEN Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
<StrengthNumber>36; 4.5</StrengthNumber>
<StrengthUnit>g/1; g/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>39822-0151-1</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (39822-0151-1) / 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>39822-0151-01</NDC11Code>
<ProductNDC>39822-0151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Liothyronine Sodium</ProprietaryName>
<NonProprietaryName>Liothyronine Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076923</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>LIOTHYRONINE SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Triiodothyronine [CS], l-Triiodothyronine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Liothyronine sodium injection (T 3) is indicated in the treatment of myxedema coma/precoma. Liothyronine sodium injection (T 3) can be used in patients allergic to desiccated thyroid or thyroid extract derived from pork or beef.</IndicationAndUsage>
<Description>Thyroid hormone drugs are natural or synthetic preparations containing tetraiodothyronine (T 4, levothyroxine) sodium or triiodothyronine (T 3, liothyronine) sodium or both. T 4 and T 3 are produced in the human thyroid gland by the iodination and coupling of the amino acid tyrosine. T 4 contains four iodine atoms and is formed by the coupling of two molecules of diiodotyrosine (DIT). T 3 contains three atoms of iodine and is formed by the coupling of one molecule of DIT with one molecule of monoiodotyrosine (MIT). Both hormones are stored in the thyroid colloid as thyroglobulin and released into the circulation. The major source of T 3 has been shown to be peripheral deiodination of T 4. T 3 is bound less firmly than T 4 in the serum, enters peripheral tissues more readily, and binds to specific nuclear receptor(s) to initiate hormonal, metabolic effects. T 4 is the prohormone which is deiodinated to T 3 for hormone activity. Thyroid hormone preparations belong to two categories: (1) natural hormonal preparations derived from animal thyroid, and (2) synthetic preparations. Natural preparations include desiccated thyroid and thyroglobulin. Desiccated thyroid is derived from domesticated animals that are used for food by man (either beef or hog thyroid), and thyroglobulin is derived from thyroid glands of the hog. Liothyronine sodium injection (T 3) contains liothyronine (L-triiodothyronine or L-T 3), a synthetic form of a natural thyroid hormone, as the sodium salt. The structural and empirical formulas and molecular weight of liothyronine sodium are given below. In euthyroid patients, 25 mcg of liothyronine is equivalent to approximately 1 grain of desiccated thyroid or thyroglobulin and 0.1 mg of L-thyroxine. Each mL of liothyronine sodium injection (T 3) in amber glass vials contains, in sterile non-pyrogenic aqueous solution, liothyronine sodium equivalent to 10 mcg of liothyronine; alcohol, 6.8% by volume; anhydrous citric acid, 0.175 mg; ammonia, 2.19 mg, as ammonium hydroxide; Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>39822-0190-1</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (39822-0190-1) / 5 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>39822-0190-01</NDC11Code>
<ProductNDC>39822-0190</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetazolamide</ProprietaryName>
<NonProprietaryName>Acetazolamide</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20081210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040784</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>ACETAZOLAMIDE SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure.</IndicationAndUsage>
<Description>Acetazolamide, an inhibitor of the enzyme carbonic anhydrase, is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2-yl)-acetamide and has the following structural formula:. Acetazolamide for injection, USP is available for intravenous use, and is supplied as a sterile powder requiring reconstitution. Each vial contains an amount of acetazolamide sodium equivalent to 500 mg of acetazolamide. The bulk solution is adjusted to pH 9.6 using sodium hydroxide and, if necessary, hydrochloric acid prior to lyophilization.</Description>
</NDC>
<NDC>
<NDCCode>39822-0350-2</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (39822-0350-2) > 2 mL in 1 VIAL (39822-0350-1) </PackageDescription>
<NDC11Code>39822-0350-02</NDC11Code>
<ProductNDC>39822-0350</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lincomycin</ProprietaryName>
<NonProprietaryName>Lincomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL</RouteName>
<StartMarketingDate>20150705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201746</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>LINCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lincomycin Injection, USP is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the BOXED WARNING, before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy. Lincomycin injection may be administered concomitantly with other antimicrobial agents when indicated. Lincomycin is not indicated in the treatment of minor bacterial infections or viral infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Lincomycin and other antibacterial drugs, Lincomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Lincomycin Injection, USP is a sterile solution containing lincomycin hydrochloride which is the monohydrated salt of lincomycin, a lincosamide antibacterial produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae). The chemical name for lincomycin hydrochloride is Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrolidinecarboxamido)-1-thio-D-erythro-α-D-galacto-octopyranoside monohydrochloride monohydrate. The molecular formula of lincomycin hydrochloride is C 18H 34N 2O 6SHClH 2O and the molecular weight is 461.01. The structural formula is represented below. Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory. Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone. Lincomycin Injection contains lincomycin hydrochloride in a sterile, clear, colorless solution with benzyl alcohol used as a preservative 9.45 mg/mL, and water for injection. Lincomycin Injection is a sterile solution for intramuscular and intravenous use. Lincomycin injection is supplied in 2 mL and 10 mL multiple-dose vials containing the equivalent of 300 mg/mL of lincomycin (equivalent to 340 mg/mL of lincomycin hydrochloride, USP).</Description>
</NDC>
<NDC>
<NDCCode>39822-0353-6</NDCCode>
<PackageDescription>10 mL in 1 VIAL (39822-0353-6) </PackageDescription>
<NDC11Code>39822-0353-06</NDC11Code>
<ProductNDC>39822-0353</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lincomycin</ProprietaryName>
<NonProprietaryName>Lincomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL</RouteName>
<StartMarketingDate>20150705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201746</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>LINCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lincomycin Injection, USP is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the BOXED WARNING, before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy. Lincomycin injection may be administered concomitantly with other antimicrobial agents when indicated. Lincomycin is not indicated in the treatment of minor bacterial infections or viral infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Lincomycin and other antibacterial drugs, Lincomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Lincomycin Injection, USP is a sterile solution containing lincomycin hydrochloride which is the monohydrated salt of lincomycin, a lincosamide antibacterial produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae). The chemical name for lincomycin hydrochloride is Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrolidinecarboxamido)-1-thio-D-erythro-α-D-galacto-octopyranoside monohydrochloride monohydrate. The molecular formula of lincomycin hydrochloride is C 18H 34N 2O 6SHClH 2O and the molecular weight is 461.01. The structural formula is represented below. Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory. Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone. Lincomycin Injection contains lincomycin hydrochloride in a sterile, clear, colorless solution with benzyl alcohol used as a preservative 9.45 mg/mL, and water for injection. Lincomycin Injection is a sterile solution for intramuscular and intravenous use. Lincomycin injection is supplied in 2 mL and 10 mL multiple-dose vials containing the equivalent of 300 mg/mL of lincomycin (equivalent to 340 mg/mL of lincomycin hydrochloride, USP).</Description>
</NDC>
<NDC>
<NDCCode>39822-0412-1</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (39822-0412-1) / 30 mL in 1 VIAL</PackageDescription>
<NDC11Code>39822-0412-01</NDC11Code>
<ProductNDC>39822-0412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobramycin</ProprietaryName>
<NonProprietaryName>Tobramycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20010817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065013</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>TOBRAMYCIN SULFATE</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>g/30mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below. - Septicemia in the neonate, child, and adult caused by P. aeruginosa, E. coli, and Klebsiella sp. - Lower respiratory tract infections caused by P. aeruginosa, Klebsiella sp, Enterobacter sp, Serratia sp, E. coli, and S. aureus (penicillinase and non-penicillinase-producing strains). - Serious central-nervous-system infections (meningitis) caused by susceptible organisms. - Intra-abdominal infections, including peritonitis, caused by E. coli, Klebsiella sp, and Enterobacter sp. - Skin, bone, and skin-structure infections caused by P. aeruginosa,Proteus sp, E. coli, Klebsiella sp, Enterobacter sp, and S. aureus. - Complicated and recurrent urinary tract infections caused by P. aeruginosa, Proteus sp (indole-positive and indole-negative), E. coli, Klebsiella sp, Enterobacter sp, Serratia sp, S. aureus, Providencia sp, and Citrobacter sp. Aminoglycosides, including tobramycin sulfate, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Tobramycin may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use. Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. If susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. In patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin sulfate may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with tobramycin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the WARNINGSbox above. To reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Tobramycin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived from the actinomycete Streptomyces tenebrarius. Tobramycin for injection, USP is supplied as a sterile dry powder and is intended for reconstitution with 30 mL of sterile water for injection, USP. Sulfuric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH. Each vial contains tobramycin sulfate equivalent to 1200 mg of tobramycin. After reconstitution, the solution will contain 40 mg of tobramycin per mL. The product contains no preservative or sodium bisulfite. Tobramycin sulfate is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)- O-[2,6-diamino-2,3,6-trideoxy-α-D- ribo-hexopyranosyl-(1→6)-2-deoxy-L-streptamine, sulfate (2:5)(salt) and has the chemical formula (C 18H 37N 5O 9) 25H 2SO 4. The molecular weight is 1,425.39. The structural formula for tobramycin is as follows:. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion (see DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package).</Description>
</NDC>
<NDC>
<NDCCode>39822-0412-6</NDCCode>
<PackageDescription>6 VIAL in 1 CARTON (39822-0412-6) / 30 mL in 1 VIAL</PackageDescription>
<NDC11Code>39822-0412-06</NDC11Code>
<ProductNDC>39822-0412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobramycin</ProprietaryName>
<NonProprietaryName>Tobramycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20010817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065013</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>TOBRAMYCIN SULFATE</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>g/30mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below. - Septicemia in the neonate, child, and adult caused by P. aeruginosa, E. coli, and Klebsiella sp. - Lower respiratory tract infections caused by P. aeruginosa, Klebsiella sp, Enterobacter sp, Serratia sp, E. coli, and S. aureus (penicillinase and non-penicillinase-producing strains). - Serious central-nervous-system infections (meningitis) caused by susceptible organisms. - Intra-abdominal infections, including peritonitis, caused by E. coli, Klebsiella sp, and Enterobacter sp. - Skin, bone, and skin-structure infections caused by P. aeruginosa,Proteus sp, E. coli, Klebsiella sp, Enterobacter sp, and S. aureus. - Complicated and recurrent urinary tract infections caused by P. aeruginosa, Proteus sp (indole-positive and indole-negative), E. coli, Klebsiella sp, Enterobacter sp, Serratia sp, S. aureus, Providencia sp, and Citrobacter sp. Aminoglycosides, including tobramycin sulfate, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Tobramycin may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use. Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. If susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. In patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin sulfate may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with tobramycin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the WARNINGSbox above. To reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Tobramycin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived from the actinomycete Streptomyces tenebrarius. Tobramycin for injection, USP is supplied as a sterile dry powder and is intended for reconstitution with 30 mL of sterile water for injection, USP. Sulfuric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH. Each vial contains tobramycin sulfate equivalent to 1200 mg of tobramycin. After reconstitution, the solution will contain 40 mg of tobramycin per mL. The product contains no preservative or sodium bisulfite. Tobramycin sulfate is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)- O-[2,6-diamino-2,3,6-trideoxy-α-D- ribo-hexopyranosyl-(1→6)-2-deoxy-L-streptamine, sulfate (2:5)(salt) and has the chemical formula (C 18H 37N 5O 9) 25H 2SO 4. The molecular weight is 1,425.39. The structural formula for tobramycin is as follows:. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion (see DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package).</Description>
</NDC>
<NDC>
<NDCCode>39822-0460-2</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (39822-0460-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>39822-0460-02</NDC11Code>
<ProductNDC>39822-0460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215324</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Vancomycin hydrochloride for injection, USP, contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride, USP is (S a)- (3 S,6 R,7 R,22 R,23 S,26 S,36 R,38a R)-44-[[2- O-(3-Amino-2,3,6-trideoxy-3- C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro- 2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2 R)-4- methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22 H-8,11:18,21-dietheno-23,36- (iminomethano)-13,16:31,35-dimetheno-1 H,16 H-[l,6,9]oxadiazacyclohexadecino[4,5- m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride, USP has the following structural formula:. Vancomycin hydrochloride for injection, USP is a sterile off-white to light tan colored lyophilized plug or powder for injection. Vancomycin hydrochloride for injection, USP is supplied in single-dose vials, containing 1.28 g or 1.54 g of vancomycin hydrochloride, USP equivalent to 1.25 g or 1.5 g of vancomycin base. The lyophilized powder is reconstituted with sterile water for injection, USP which forms a clear, colorless or light to dark tan solution and subsequently diluted prior to intravenous administration [see Dosage and Administration (2.5)].</Description>
</NDC>
<NDC>
<NDCCode>39822-0470-2</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (39822-0470-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>39822-0470-02</NDC11Code>
<ProductNDC>39822-0470</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215324</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Vancomycin hydrochloride for injection, USP, contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride, USP is (S a)- (3 S,6 R,7 R,22 R,23 S,26 S,36 R,38a R)-44-[[2- O-(3-Amino-2,3,6-trideoxy-3- C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro- 2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2 R)-4- methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22 H-8,11:18,21-dietheno-23,36- (iminomethano)-13,16:31,35-dimetheno-1 H,16 H-[l,6,9]oxadiazacyclohexadecino[4,5- m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride, USP has the following structural formula:. Vancomycin hydrochloride for injection, USP is a sterile off-white to light tan colored lyophilized plug or powder for injection. Vancomycin hydrochloride for injection, USP is supplied in single-dose vials, containing 1.28 g or 1.54 g of vancomycin hydrochloride, USP equivalent to 1.25 g or 1.5 g of vancomycin base. The lyophilized powder is reconstituted with sterile water for injection, USP which forms a clear, colorless or light to dark tan solution and subsequently diluted prior to intravenous administration [see Dosage and Administration (2.5)].</Description>
</NDC>
<NDC>
<NDCCode>39822-0650-1</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (39822-0650-1) / 50 mL in 1 VIAL</PackageDescription>
<NDC11Code>39822-0650-01</NDC11Code>
<ProductNDC>39822-0650</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nelarabine</ProprietaryName>
<NonProprietaryName>Nelarabine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216510</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>NELARABINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nelarabine injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.</IndicationAndUsage>
<Description>Nelarabine is a prodrug of the cytotoxic deoxyguanosine analogue, 9-β- D-arabinofuranosylguanine (ara-G). The chemical name for nelarabine is 2-amino-9-β- D-arabinofuranosyl-6-methoxy-9 H-purine. It has the molecular formula C 11H 15N 5O 5 and a molecular weight of 297.27. Nelarabine has the following structural formula:. Nelarabine is slightly soluble to soluble in water and melts with decomposition between 209°C and 217°C. Nelarabine injection is supplied as a clear, colorless, sterile solution in glass single-dose vials. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride (4.5 mg per mL) in Water for Injection, USP. Nelarabine injection is intended for intravenous infusion. Hydrochloric acid and sodium hydroxide may have been used to adjust the pH. The solution pH ranges from 5.0 to 7.0.</Description>
</NDC>
<NDC>
<NDCCode>39822-0650-6</NDCCode>
<PackageDescription>6 VIAL in 1 CARTON (39822-0650-6) / 50 mL in 1 VIAL</PackageDescription>
<NDC11Code>39822-0650-06</NDC11Code>
<ProductNDC>39822-0650</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nelarabine</ProprietaryName>
<NonProprietaryName>Nelarabine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216510</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>NELARABINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nelarabine injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.</IndicationAndUsage>
<Description>Nelarabine is a prodrug of the cytotoxic deoxyguanosine analogue, 9-β- D-arabinofuranosylguanine (ara-G). The chemical name for nelarabine is 2-amino-9-β- D-arabinofuranosyl-6-methoxy-9 H-purine. It has the molecular formula C 11H 15N 5O 5 and a molecular weight of 297.27. Nelarabine has the following structural formula:. Nelarabine is slightly soluble to soluble in water and melts with decomposition between 209°C and 217°C. Nelarabine injection is supplied as a clear, colorless, sterile solution in glass single-dose vials. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride (4.5 mg per mL) in Water for Injection, USP. Nelarabine injection is intended for intravenous infusion. Hydrochloric acid and sodium hydroxide may have been used to adjust the pH. The solution pH ranges from 5.0 to 7.0.</Description>
</NDC>
<NDC>
<NDCCode>39822-0706-2</NDCCode>
<PackageDescription>10 VIAL in 1 BOX (39822-0706-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (39822-0706-1) </PackageDescription>
<NDC11Code>39822-0706-02</NDC11Code>
<ProductNDC>39822-0706</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Streptomycin</ProprietaryName>
<NonProprietaryName>Streptomycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>19980630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064210</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>STREPTOMYCIN SULFATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Antimycobacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Streptomycin is indicated for the treatment of individuals with moderate to severe infections caused by susceptibile strains of microorganisms in the specific conditions listed below. 1. Mycobacterium tuberculosis: The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and the Center for Disease Control recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH or rifampin resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. In the past when the national rate of primary drug resistance to isoniazid was known to be less than 4% and was either stable or declining, therapy with two and three drug regimens was considered adequate. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered. Streptomycin is also indicated for therapy of tuberculosis when one or more of the above drugs is contraindicated because of toxicity or intolerance. The management of tuberculosis has become more complex as a consequence of increasing rates of drug resistance and concomitant HIV infection. Additional consultation from experts in the treatment of tuberculosis may be desirable in those settings. 2. Non-tuberculosis infections: The use of streptomycin should be limited to the treatment of infections caused by bacteria which have been shown to be susceptible to the antibacterial effects of streptomycin and which are not amenable to therapy with less potentially toxic agents. a. Yersinia pestis (plague), b. Francisella tularensis (tularemia), c. Brucella, d. Calymmatobacterium granulomatis (donovanosis, granuloma inguinale), e. H. ducreyi (chancroid), f. H. influenzae (in respiratory, endocardial, and meningeal infections-concomitantly with another antibacterial agent), g. K. pneumoniae pneumonia (concomitantly with another antibacterial agent), h. E.coli, Proteus, A. aerogenes, K. pneumoniae, and Enterococcus faecalis in urinary tract infections, i. Streptococcus viridans, Enterococcus faecalis (in endocardial infections - concomitantly with penicillin), j. Gram-negative bacillary bacteremia (concomitantly with another antibacterial agent). To reduce the development of drug-resistant bacteria and maintain the effectiveness of streptomycin and other antibacterial drugs, streptomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Streptomycin is a water-soluble aminoglycoside derived from Streptomyces griseus. It is marketed as the sulfate salt of streptomycin. The chemical name of streptomycin sulfate is D-Streptamine, O-2-deoxy-2-(methylamino)- α-L-glucopyranosyl-(1→2)- O-5-deoxy-3- C-formyl- α-L-lyxofuranosyl-(1→4)- N,N1-bis(aminoiminomethyl)-,sulfate (2:3) (salt). The molecular formula for Streptomycin Sulfate is (C 21H 39N 7O 12) 2 3H 2SO 4 and the molecular weight is 1457.41. It has the following structural formula:. Streptomycin for Injection, equivalent to 1 gram streptomycin/vial, is supplied as a sterile nonpyrogenic lyophilized cake for intramuscular use after reconstitution. The lyophilized cake may reduce to a powder during shipping. After reconstitution, the pH range for Streptomycin for Injection should be between 4.5 and 7 in a solution containing 200 mg of streptomycin activity per mL. *Each vial of Streptomycin for Injection contains streptomycin sulfate equivalent to 1 gram of streptomycin.</Description>
</NDC>
<NDC>
<NDCCode>39822-1000-1</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (39822-1000-1) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>39822-1000-01</NDC11Code>
<ProductNDC>39822-1000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tranexamic Acid</ProprietaryName>
<NonProprietaryName>Tranexamic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201580</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>TRANEXAMIC ACID</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.</IndicationAndUsage>
<Description>Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid is a white crystalline powder. The structural formula is. Each mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid and Water for Injection to 1 mL. The aqueous solution for injection has a pH of 6.5 to 8.0.</Description>
</NDC>
<NDC>
<NDCCode>39822-1030-2</NDCCode>
<PackageDescription>3 VIAL in 1 CARTON (39822-1030-2) / 2 mL in 1 VIAL (39822-1030-1) </PackageDescription>
<NDC11Code>39822-1030-02</NDC11Code>
<ProductNDC>39822-1030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen Lysine</ProprietaryName>
<NonProprietaryName>Ibuprofen Lysine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202402</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>IBUPROFEN LYSINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ibuprofen Lysine Injection is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. The clinical trial was conducted among infants with an asymptomatic PDA. However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.</IndicationAndUsage>
<Description>Ibuprofen Lysine Injection is a clear sterile preservative-free solution of the L-lysine salt of (±)-ibuprofen which is the active ingredient. (±)-Ibuprofen is a nonsteroidal anti-inflammatory agent (NSAID). L-lysine is used to create a water-soluble drug product salt suitable for intravenous administration. Each mL of Ibuprofen Lysine Injection contains 17.1 mg of ibuprofen lysine (equivalent to 10 mg of (±)-ibuprofen) in Water for Injection, USP. The pH is adjusted to 7.0 with sodium hydroxide or hydrochloric acid. The structural formula is. Ibuprofen Lysine Injection is designated chemically as α-methyl-4-(2-methyl propyl) benzeneacetic acid lysine salt. Its molecular weight is 352.48. Its empirical formula is C 19H 32N 2O 4. It occurs as a white crystalline solid which is soluble in water and slightly soluble in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>39822-1077-1</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (39822-1077-1) / 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>39822-1077-01</NDC11Code>
<ProductNDC>39822-1077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Voriconazole</ProprietaryName>
<NonProprietaryName>Voriconazole</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170309</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208562</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>VORICONAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Voriconazole for injection is an azole antifungal indicated for use in the treatment of adults and pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight with: 1 Invasive aspergillosis ( 1.1) , 2 Candidemia in non-neutropenics and other deep tissue Candida infections ( 1.2) , 3 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy ( 1.3) .</IndicationAndUsage>
<Description>Voriconazole for injection, an azole antifungal is available as a sterile lyophilized cake or powder for solution for intravenous infusion. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1 H-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C 16H 14F 3N 5O and a molecular weight of 349.3. Voriconazole drug substance is a white or almost white powder. Voriconazole for injection is a white to off white lyophilized cake or powder containing nominally 200 mg voriconazole and 3200 mg hydroxypropyl β-cyclodextrin (HPβCD) in a 30 mL Type I clear glass vial. Voriconazole for injection is intended for administration by intravenous infusion. It is an unpreserved product in a single dose vial. Vials containing 200 mg lyophilized voriconazole are intended for reconstitution with Water for Injection to produce a solution containing 10 mg/mL Voriconazole for injection and 160 mg/mL of hydroxypropyl β-cyclodextrin (HPβCD). The resultant solution is further diluted prior to administration as an intravenous infusion [see Dosage and Administration (2)].</Description>
</NDC>
<NDC>
<NDCCode>39822-1100-1</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (39822-1100-1) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>39822-1100-01</NDC11Code>
<ProductNDC>39822-1100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Folic Acid</ProprietaryName>
<NonProprietaryName>Folic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20191117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202522</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>FOLIC ACID</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Folic Acid Injection, USP alone is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid as may be seen in tropical or nontropical sprue, in anemias of nutritional origin, pregnancy, infancy or childhood.</IndicationAndUsage>
<Description>Folic Acid Injection, USP is a sterile, nonpyrogenic solution of sodium folate (prepared by the addition of sodium hydroxide to folic acid) in Water for Injection, USP intended for intramuscular (IM), intravenous (IV) or subcutaneous (SC) use. Folic acid is a complex organic compound present in liver, yeast and other substances, which may be prepared synthetically. It is a yellow or yellowish orange, odorless crystalline powder. It is very slightly soluble in water, insoluble in alcohol, chloroform, ether; readily dissolves in dilute solutions of alkali hydroxides and carbonates. It is chemically designated as: L-Glutamic acid, N-[4-[[(2-amino-1-4-dihydro-4-oxo-6-pteridinyl) methyl] amino]benzoyl]-, and has the following structural formula. C 19H 19N 7O 6 ; M.W. 441.40. Each mL contains: Sodium folate (equivalent to 5 mg folic acid); edetate disodium 2 mg; benzyl alcohol 15 mg (added as preservative); Water for Injection, USP q.s. Sodium hydroxide for pH adjustment (8.0 to 11.0).</Description>
</NDC>
<NDC>
<NDCCode>39822-1410-6</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (39822-1410-6) > 5 mL in 1 AMPULE (39822-1410-5) </PackageDescription>
<NDC11Code>39822-1410-06</NDC11Code>
<ProductNDC>39822-1410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rezipres</ProprietaryName>
<NonProprietaryName>Ephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210614</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213536</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>EPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4.7</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>39822-1800-1</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (39822-1800-1) / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>39822-1800-01</NDC11Code>
<ProductNDC>39822-1800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20250828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211072</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250902</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine for injection is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH.</Description>
</NDC>
</NDCList>