{
"NDC": [
{
"NDCCode": "67457-790-05",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (67457-790-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-790-00) ",
"NDC11Code": "67457-0790-05",
"ProductNDC": "67457-790",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170724",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203308",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170724",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) . Levetiracetam injection is indicated for adjunctive therapy for the treatment of: oMyoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) oPrimary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) . Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible (1.4) .",
"Description": "Levetiracetam injection, USP is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to almost white powder. It is very soluble in water, soluble in acetonitrile and practically insoluble in hexane. Levetiracetam injection, USP contains 100 mg of levetiracetam, USP per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, USP, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection, USP must be diluted prior to intravenous infusion [see Dosage and Administration (2.6)]."
},
{
"NDCCode": "59088-790-05",
"PackageDescription": "57 g in 1 TUBE (59088-790-05) ",
"NDC11Code": "59088-0790-05",
"ProductNDC": "59088-790",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diabecin Hr",
"NonProprietaryName": "Lidocaine Hcl, Benzalkonium Chloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250610",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "DIMETHICONE; LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE",
"StrengthNumber": "50; 41.2; 1.3",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250610",
"SamplePackage": "N",
"IndicationAndUsage": "Diabecin HR Cream is indicated for the temporary relief of pain and itching associated with minor skin irritations. It combines the anesthetic properties of Lidocaine, and the antiseptic effects of Benzalkonium Chloride to provide effective care for damaged skin.",
"Description": "Diabecin HR Cream contains 41.2 mg of Lidocaine HCl per gram, and 1.3 mg of Benzalkonium Chloride per gram in a vehicle of Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Aqua (Purified Water), Arnica Montana Flower Extract, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Carbomer, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Cyclopentasiloxane, Dimethicone, Disodium EDTA, DL-alpha Tocopheryl Acetate, GenRx® Complex (Proprietary Blend), Glycerin, Glyceryl Acrylate/Acrylic Acid Copolymer, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Methylsilanol Mannuronate, Panthenol, PEG-100 Stearate, Peucedanum Ostruthium (Masterwort) Leaf Extract, Phenoxyethanol, Propylene Glycol, Retinyl Palmitate, Sodium Lauroyl Sarcosinate, Stearic Acid, Tetrahexyldecyl Ascorbate, Triethanolamine, Vitis Vinifera (Grape) Seed Extract, Xanthan Gum, Zea Mays (Corn) Starch."
},
{
"NDCCode": "70512-790-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (70512-790-05) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "70512-0790-05",
"ProductNDC": "70512-790",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20240415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218204",
"LabelerName": "SOLA Pharmaceuticals, LLC",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240415",
"SamplePackage": "N",
"IndicationAndUsage": "Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.",
"Description": "Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-Benzoyl-2, 3-dihydro-1H pyrrolizine-1-carboxylic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure. Ketorolac tromethamine ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution is a racemic mixture of R-(+) and S-(-) -ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of ketorolac tromethamine ophthalmic solution is 290 mOsmol/kg. Each mL of ketorolac tromethamine ophthalmic solution contains: Active:ketorolac tromethamine 0.5%. Preservative:benzalkonium chloride 0.01%. Inactives:edetate disodium 0.1%; octoxynol 40; water for injection; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH."
},
{
"NDCCode": "74588-790-05",
"PackageDescription": "18927 mL in 1 DRUM (74588-790-05) ",
"NDC11Code": "74588-0790-05",
"ProductNDC": "74588-790",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hygienex Hand Sanitizer",
"ProprietaryNameSuffix": "Eucalyptus Refreshing Gel",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Global Impact Innovation LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "72",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "76125-790-05",
"PackageDescription": "1 VIAL in 1 CARTON (76125-790-05) > 50 mL in 1 VIAL (76125-790-06) ",
"NDC11Code": "76125-0790-05",
"ProductNDC": "76125-790",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Albuked",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19760826",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101138",
"LabelerName": "KEDRION BIOPHARMA, INC.",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "2.5",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2020-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19760826",
"SamplePackage": "N",
"IndicationAndUsage": "Emergency Treatment of Hypovolemic Shock. Albuked 5 is iso-oncotic with normal plasma and on intravenous infusion will expand the circulating blood volume by an amount approximately equal to the volume infused. In conditions associated mainly with a volume deficit, albumin is best administered as a 5% solution (Albuked 5); but where there is an oncotic deficit, Albumin (Human) 25%, USP (Albuked 25) may be preferred. This is also an important consideration where the treatment of the shock state has been delayed. If Albuked 25 is used, appropriate additional crystalloid should be administered.(1). Crystalloid solutions in volumes several times greater than that of Albuked 5 may be effective in treating shock in younger individuals who have no preexisting illness at the time of the incident. Older patients, especially those with preexisting debilitating conditions, or those in whom the shock is caused by a medical disorder, or where the state of shock has existed for some time before active therapy could be instituted, may not tolerate hypoalbuminemia as well.(1). Removal of ascitic fluid from a patient with cirrhosis may cause changes in cardiovascular function and even result in hypovolemic shock. In such circumstances, the use of albumin infusion may be required to support the blood volume.(1). Burn Therapy. An optimal therapeutic regimen with respect to the administration of colloids, crystalloids, and water following extensive burns has not been established. During the first 24 hours after sustaining thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours, albumin can be used to maintain plasma colloid osmotic pressure. Albuked 25 may be preferred for this purpose.(1). Cardiopulmonary Bypass(1). With the relatively small priming volume required with modern pumps, preoperative dilution of the blood using albumin and crystalloid has been shown to be safe and well-tolerated. Although the limit to which the hematocrit and plasma protein concentration can be safely lowered has not been defined, it is common practice to adjust the albumin and crystalloid pump prime to achieve a hematocrit of 20% and a plasma albumin concentration of 2.5 g per 100 mL in the patient. Acute Liver Failure(1). In the uncommon situation of rapid loss of liver function, with or without coma, administration of albumin may serve the double purpose of supporting the colloid osmotic pressure of the plasma as well as binding excess plasma bilirubin. Sequestration of Protein Rich Fluids(2). This occurs in such conditions as acute peritonitis, pancreatitis, mediastinitis, and extensive cellulitis. The magnitude of loss into the third space may require treatment of reduced volume or oncotic activity with an infusion of albumin. Situations in Which Albumin Administration is Not Warranted(1). In chronic nephrosis, infused albumin is promptly excreted by the kidneys with no relief of the chronic edema or effect on the underlying renal lesion. It is of occasional use in the rapid “priming” diuresis of nephrosis. Similarly, in hypoproteinemic states associated with chronic cirrhosis, malabsorption, protein losing enteropathies, pancreatic insufficiency, and undernutrition, the infusion of albumin as a source of protein nutrition is not justified.",
"Description": "Albumin (Human) 5%, USP (Albuked 5) is made from large pools of human venous plasma by the Cohn cold ethanol fractionation process. Part of the fractionation may be performed by another licensed manufacturer. It is prepared in accordance with the applicable requirements established by the U.S. Food and Drug Administration. Albuked 5 is a 5% sterile solution of albumin in an aqueous diluent. The preparation is stabilized with 0.004 M sodium caprylate and 0.004 M acetyltryptophan. The aluminum content of the product is not more than 200 µg/L. The approximate sodium content of the product is 145 mEq/L. Albuked 5 is clear, slightly viscous, almost colorless to yellow, amber or green. Each vial of Albuked 5 is heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents.(8-11) The production steps from Pooled Plasma to Effluent IV-1 in the Albuked 5 manufacturing process have been shown to decrease TSE infectivity of that experimental model agent (a total of ≥7.0 logs). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed."
},
{
"NDCCode": "76420-790-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE, PLASTIC (76420-790-05) ",
"NDC11Code": "76420-0790-05",
"ProductNDC": "76420-790",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204989",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240330",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin capsules, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1of 4.72±0.10 and a pK a2of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400 mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide."
},
{
"NDCCode": "67457-192-05",
"PackageDescription": "10 AMPULE in 1 CARTON (67457-192-05) > 5 mL in 1 AMPULE (67457-192-00)",
"NDC11Code": "67457-0192-05",
"ProductNDC": "67457-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enlon Plus",
"NonProprietaryName": "Edrophonium Chloride And Atropine Sulfate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19911106",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019678",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "EDROPHONIUM CHLORIDE; ATROPINE SULFATE",
"StrengthNumber": "10; .14",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "67457-198-05",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (67457-198-05) / 5 mL in 1 VIAL, GLASS (67457-198-99) ",
"NDC11Code": "67457-0198-05",
"ProductNDC": "67457-198",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ultiva",
"NonProprietaryName": "Remifentanil Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19961106",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020630",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "REMIFENTANIL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19961106",
"EndMarketingDatePackage": "20241031",
"SamplePackage": "N",
"IndicationAndUsage": "ULTIVA is indicated for intravenous (IV) administration: 1 As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures., 2 For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting., 3 As an analgesic component of monitored anesthesia care in adult patients.",
"Description": "ULTIVA (remifentanil hydrochloride) for injection is an opioid agonist. The chemical name is 3-[4-methoxycarbonyl-4-[(1-oxopropyl)phenylamino]-1-piperidine]propanoic acid methyl ester, hydrochloride salt. The molecular weight is 412.91. Its molecular formula is C20H28N2O5HCl, and it has the following chemical structure. ULTIVA is a sterile, nonpyrogenic, preservative-free, white to off-white lyophilized powder for intravenous (IV) administration after reconstitution and dilution. Each vial contains 1 mg, 2 mg, or 5 mg of remifentanil base; 15 mg glycine; and hydrochloric acid to buffer the solutions to a nominal pH of 3 after reconstitution. When reconstituted as directed, solutions of ULTIVA are clear and colorless and contain remifentanil hydrochloride (HCl) equivalent to 1 mg/mL of remifentanil base. The pH of reconstituted solutions of ULTIVA ranges from 2.5 to 3.5. Remifentanil hydrochloride has a pKa of 7.07. Remifentanil hydrochloride has an n-octanol:water partition coefficient of 17.9 at pH 7.3."
},
{
"NDCCode": "67457-210-05",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (67457-210-05) > 5 mL in 1 VIAL, GLASS",
"NDC11Code": "67457-0210-05",
"ProductNDC": "67457-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cidofovir",
"NonProprietaryName": "Cidofovir Anhydrous",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201276",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "CIDOFOVIR",
"StrengthNumber": "75",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2021-07-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130603",
"SamplePackage": "N",
"IndicationAndUsage": "Cidofovir is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). THE SAFETY AND EFFICACY OF CIDOFOVIR INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (SUCH AS PNEUMONITIS OR GASTROENTERITIS), CONGENITAL OR NEONATAL CMV DISEASE, OR CMV DISEASE IN NON-HIV-INFECTED INDIVIDUALS.",
"Description": "The chemical name of cidofovir is 1-[(S)-3-hydroxy-2-(phosphonomethoxy)propyl]cytosine dihydrate (HPMPC), with the molecular formula of C8H14N3O6P2H2O and a molecular weight of 315.22 (279.19 for anhydrous). The chemical structure is. Cidofovir, USP is a white crystalline powder with an aqueous solubility of ≥ 170 mg/mL at pH 6 to 8 and a log P (octanol/aqueous buffer, pH 7.1) value of -3.3. Cidofovir injection, USP is a sterile, hypertonic aqueous solution for intravenous infusion only. The solution is clear and colorless. It is supplied in clear glass vials, each containing 375 mg of anhydrous cidofovir in 5 mL aqueous solution at a concentration of 75 mg/mL. The formulation is pH-adjusted to 7.4 with sodium hydroxide and/or hydrochloric acid and contains no preservatives. The appropriate volume of cidofovir injection must be removed from the single-dose vial and diluted prior to administration (see DOSAGE AND ADMINISTRATION)."
},
{
"NDCCode": "67457-220-05",
"PackageDescription": "6 VIAL, GLASS in 1 CARTON (67457-220-05) / 5 mL in 1 VIAL, GLASS",
"NDC11Code": "67457-0220-05",
"ProductNDC": "67457-220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosulfan Blue",
"NonProprietaryName": "Isosulfan Blue",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20130314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090874",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "ISOSULFAN BLUE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130314",
"SamplePackage": "N",
"IndicationAndUsage": "Isosulfan blue injection 1% upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; lymph node response to therapeutic modalities (1.1).",
"Description": "The chemical name of isosulfan blue injection 1% is N-[4- [[4-(diethylamino)phenyl] (2,5-disulfophenyl) methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide, inner salt, sodium salt. Its structural formula is. ISOSULFAN BLUE. Isosulfan blue injection 1% is a clear dark blue, sterile, non-pyrogenic aqueous solution for subcutaneous administration. Phosphate buffer in sterile, pyrogen free water is added in sufficient quantity to yield a final pH of 6.8 to 7.4. Each mL of solution contains 10 mg isosulfan blue, 6.6 mg sodium monohydrogen phosphate and 2.7 mg potassium dihydrogen phosphate. Each mL of isosulfan blue injection contains 2 mg of sodium and less than 5 mg of phosphorus. The solution contains no preservative. Isosulfan blue injection 1% is a contrast agent for the delineation of lymphatic vessels."
},
{
"NDCCode": "67457-228-05",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (67457-228-05) / 5 mL in 1 VIAL, MULTI-DOSE (67457-228-00) ",
"NDC11Code": "67457-0228-05",
"ProductNDC": "67457-228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rocuronium Bromide",
"NonProprietaryName": "Rocuronium Bromide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079199",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "ROCURONIUM BROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120206",
"SamplePackage": "N",
"IndicationAndUsage": "Rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17ß-(acetyloxy)-3α-hydroxy-2ß-(4-morpholinyl)-5α-androstan-16ß-yl]-1-(2-propenyl) pyrrolidinium bromide. The structural formula is. The chemical formula is C32H53BrN2O4 with a molecular weight of 609.70. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous injection only. Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate. The aqueous solution is adjusted to isotonicity with sodium chloride (3.10 mg/mL) and to a pH of 4 with acetic acid and/or sodium hydroxide."
},
{
"NDCCode": "67457-259-05",
"PackageDescription": "6 VIAL, GLASS in 1 CARTON (67457-259-05) > 5 mL in 1 VIAL, GLASS (67457-259-00)",
"NDC11Code": "67457-0259-05",
"ProductNDC": "67457-259",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosulfan Blue",
"NonProprietaryName": "Isosulfan Blue",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20130314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090874",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "ISOSULFAN BLUE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2017-10-19"
},
{
"NDCCode": "67457-288-05",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (67457-288-05) > 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "67457-0288-05",
"ProductNDC": "67457-288",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pentostatin",
"NonProprietaryName": "Pentostatin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140919",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203554",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "PENTOSTATIN",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140919",
"SamplePackage": "N",
"IndicationAndUsage": "Pentostatin for injection is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms.",
"Description": "Pentostatin for injection is supplied as a sterile, apyrogenic, lyophilized powder in single-dose vials for intravenous administration. Each vial contains 10 mg of pentostatin and 50 mg of Mannitol, USP. The pH of the final product is maintained between 7.0 and 8.5 by addition of sodium hydroxide or hydrochloric acid. Pentostatin, also known as 2’-deoxycoformycin (DCF), is a potent inhibitor of the enzyme adenosine deaminase and is isolated from fermentation cultures of Streptomyces antibioticus. Pentostatin is known chemically as (R)-3-(2-deoxy-ß-D-erythropentofuranosyl)3,6,7,8 tetrahydroimidazo[4,5d][1,3]diazepin-8-ol with a molecular formula of C11H16N4O4 and a molecular weight of 268.27. The molecular structure of pentostatin is. Pentostatin is a white to off-white solid, freely soluble in distilled water."
},
{
"NDCCode": "67457-311-05",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (67457-311-05) > 5 mL in 1 SYRINGE, GLASS (67457-311-00) ",
"NDC11Code": "67457-0311-05",
"ProductNDC": "67457-311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fulvestrant",
"NonProprietaryName": "Fulvestrant",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20190909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208811",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "FULVESTRANT",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Estrogen Receptor Antagonist [EPC], Estrogen Receptor Antagonists [MoA], Selective Estrogen Receptor Modulators [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190909",
"SamplePackage": "N"
},
{
"NDCCode": "67457-326-05",
"PackageDescription": "20 mL in 1 VIAL, SINGLE-DOSE (67457-326-05) ",
"NDC11Code": "67457-0326-05",
"ProductNDC": "67457-326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bendamustine Hydrochloride",
"NonProprietaryName": "Bendamustine Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204104",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "BENDAMUSTINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Alkylating Activity [MoA],Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-02-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180426",
"SamplePackage": "N"
},
{
"NDCCode": "67457-341-05",
"PackageDescription": "1 VIAL in 1 CARTON (67457-341-05) / 100 mL in 1 VIAL",
"NDC11Code": "67457-0341-05",
"ProductNDC": "67457-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20131205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065432",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131205",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, USP 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. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
"Description": "Vancomycin Hydrochloride for Injection, USP is an off white to light tan colored lyophilized powder, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package containing the equivalent of 5 grams of vancomycin base. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL, it forms a clear, colorless or light to dark tan solution with the pH of the solution is between 2.5 and 4.5. It may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,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-[(2R)-4-methyl-2-(methylamino)]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9] oxadiazacyclohexadecino[4,5-m][10,2,16]benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (See DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package.) FURTHER DILUTION IS REQUIRED. NOT FOR DIRECT INFUSION."
},
{
"NDCCode": "67457-400-05",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 CARTON (67457-400-05) / 30 mL in 1 VIAL, MULTI-DOSE (67457-400-31) ",
"NDC11Code": "67457-0400-05",
"ProductNDC": "67457-400",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyanocobalamine",
"NonProprietaryName": "Cyanocobalamine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20170706",
"EndMarketingDate": "20260331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204829",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "CYANOCOBALAMIN",
"StrengthNumber": "1000",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Vitamin B 12 [CS], Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170706",
"EndMarketingDatePackage": "20260331",
"SamplePackage": "N",
"IndicationAndUsage": "Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions: 1 Addisonian (pernicious) anemia, 2 Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy, 3 Fish tapeworm infestation, 4 Malignancy of pancreas or bowel, 5 Folic acid deficiency.",
"Description": "Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1,000 mcg cyanocobalamin, Sodium Chloride 0.9%. Benzyl Alcohol 1.5%, is present as a preservative. Sodium acetate and Glacial acetic acid are present as buffers. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5 to 7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder or purplish crystalline powder. Sparingly soluble in water and soluble in alcohol, practically insoluble in acetone, in chloroform and in ether. It is stable to autoclaving for short periods at 121°C. The vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is 1355.4. The structural formula is represented below."
},
{
"NDCCode": "67457-418-05",
"PackageDescription": "25 VIAL in 1 CARTON (67457-418-05) / 5 mL in 1 VIAL (67457-418-00) ",
"NDC11Code": "67457-0418-05",
"ProductNDC": "67457-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone Sodium Phosphate",
"NonProprietaryName": "Dexamethasone Sodium Phosphate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE",
"StartMarketingDate": "20200415",
"EndMarketingDate": "20261031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040803",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "DEXAMETHASONE SODIUM PHOSPHATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200415",
"EndMarketingDatePackage": "20261031",
"SamplePackage": "N",
"IndicationAndUsage": "A. By intravenous or intramuscular injection when oral therapy is not feasible. 1. Endocrine disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Acute and subacute bursitis. Epicondylitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Psoriatic arthritis. Ankylosing spondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Acute rheumatic carditis. 4. Dermatologic Diseases. Pemphigus. Severe erythema multiforme. (Stevens-Johnson Syndrome). Exfoliative dermatitis. Bullous dermatitis herpetiformis. Severe seborrheic dermatitis. Severe psoriasis. Mycosis fungoides. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Seasonal or perennial allergic rhinitis. Drug hypersensitivity reactions. Urticarial transfusion reactions. Acute noninfectious laryngeal edema (epinephrine is the drug of first choice). 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye, such as. Herpes zoster ophthalmicus. Iritis, iridocyclitis. Chorioretinitis. Diffuse posterior uveitis and choroiditis. Optic neuritis. Sympathetic ophthalmia. Anterior segment inflammation. Allergic conjunctivitis. Keratitis. Allergic corneal marginal ulcers. 7. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis (systemic therapy). Regional enteritis (systemic therapy). 8. Respiratory Diseases. Symptomatic sarcoidosis. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Loeffler's syndrome not manageable by other means. Aspiration pneumonitis. 9. Hematologic Disorders. Acquired (autoimmune) hemolytic anemia. Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated). Secondary thrombocytopenia in adults. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 10. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 11. Edematous States. To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 12. Miscellaneous. Tuberculosis meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement. 13. Diagnostic testing of adrenocortical hyperfunction. 14. Cerebral Edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Use in cerebral edema is not a substitute for careful neurosurgical evaluation and definitive management such as neurosurgery or other specific therapy. B. By intra-articular or soft tissue injection. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Synovitis of osteoarthritis. Rheumatoid arthritis. Acute and subacute bursitis. Acute gouty arthritis. Epicondylitis. Acute nonspecific tenosynovitis. Post-traumatic osteoarthritis. C. By intralesional injection. Keloids. Localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis). Discoid lupus erythematosus. Necrobiosis lipoidica diabeticorum. Alopecia areata. May also be useful in cystic tumors of an aponeurosis or tendon (ganglia).",
"Description": "Dexamethasone sodium phosphate, a synthetic adrenocortical steroid, is a white or slightly yellow, crystalline powder. It is freely soluble in water and is exceedingly hygroscopic. The molecular weight is 516.41. It is designated chemically as 9-fluoro-11β,17-dihydroxy-16α-methyl-21-(phosphonooxy)pregna-1,4-diene-3,20-dione disodium salt. The empirical formula is C22H28FNa2O8P and the structural formula is. Dexamethasone sodium phosphate injection, USP is a sterile solution of dexamethasone sodium phosphate, and is supplied in 4 mg/ mL and 10 mg /mL. Dexamethasone sodium phosphate injection, USP 4 mg/mL is a sterile solution for intravenous, intramuscular, intra-articular, intralesional and soft tissue administration. Each mL contains:. Active: Dexamethasone sodium phosphate 4.4 mg (equivalent to dexamethasone phosphate 4 mg). Preservatives: Methylparaben 1.5 mg; Propylparaben 0.2 mg. Inactives: Edetate Disodium 0.11 mg; Sodium Citrate Anhydrous 10 mg; Citric Acid and/or Sodium Hydroxide q.s to adjust pH 7.0 to 8.5 and Water for Injection q.s to 1 mL. Dexamethasone sodium phosphate injection, USP 10 mg/mL is a sterile solution for intravenous or intramuscular use only. Each mL contains:. Actives: Dexamethasone sodium phosphate 11 mg (equivalent to dexamethasone phosphate 10 mg). Preservatives: Methylparaben 1.5 mg; Propylparaben 0.2 mg. Inactives: Edetate Disodium 0.11 mg; Sodium Citrate Anhydrous 10 mg; Citric Acid and/or Sodium Hydroxide q.s to adjust pH 7.0 to 8.5 and Water for Injection q.s to 1 mL."
},
{
"NDCCode": "67457-482-05",
"PackageDescription": "1 VIAL in 1 CARTON (67457-482-05) > 5 mL in 1 VIAL",
"NDC11Code": "67457-0482-05",
"ProductNDC": "67457-482",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vinorelbine",
"NonProprietaryName": "Vinorelbine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200148",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "VINORELBINE TARTRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-10-03"
},
{
"NDCCode": "67457-513-05",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (67457-513-05) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "67457-0513-05",
"ProductNDC": "67457-513",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dactinomycin",
"NonProprietaryName": "Dactinomycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203385",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "DACTINOMYCIN",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Actinomycin [EPC], Nucleic Acid Synthesis Inhibitors [MoA], Protein Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N"
},
{
"NDCCode": "67457-518-05",
"PackageDescription": "1 VIAL in 1 CARTON (67457-518-05) > 10 mL in 1 VIAL",
"NDC11Code": "67457-0518-05",
"ProductNDC": "67457-518",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mitomycin",
"NonProprietaryName": "Mitomycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202670",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "MITOMYCIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N"
},
{
"NDCCode": "67457-573-05",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (67457-573-05) > 5 mL in 1 VIAL, MULTI-DOSE (67457-573-00)",
"NDC11Code": "67457-0573-05",
"ProductNDC": "67457-573",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rocuronium Bromide",
"NonProprietaryName": "Rocuronium Bromide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140929",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079199",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "ROCURONIUM BROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-11-21",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "67457-586-05",
"PackageDescription": "6 VIAL, GLASS in 1 CARTON (67457-586-05) > 5 mL in 1 VIAL, GLASS (67457-586-00)",
"NDC11Code": "67457-0586-05",
"ProductNDC": "67457-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosulfan Blue",
"NonProprietaryName": "Isosulfan Blue",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090874",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "ISOSULFAN BLUE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-06-26",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "67457-603-99",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (67457-603-99) / 4 mL in 1 VIAL, MULTI-DOSE (67457-603-05) ",
"NDC11Code": "67457-0603-99",
"ProductNDC": "67457-603",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heparin Sodium",
"NonProprietaryName": "Heparin Sodium",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20180614",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203851",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "HEPARIN SODIUM",
"StrengthNumber": "10000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180614",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "Heparin sodium injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism; , 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; , 3 Atrial fibrillation with embolization; , 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); , 5 Prevention of clotting in arterial and cardiac surgery; , 6 Prophylaxis and treatment of peripheral arterial embolism. , 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .",
"Description": "Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated O-sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of heparin sodium, USP (representative subunits):. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Heparin Sodium Injection, USP preserved with Benzyl Alcohol is available in the following concentrations/mL:. pH 5.0 to 7.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment."
},
{
"NDCCode": "67457-622-05",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (67457-622-05) / 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "67457-0622-05",
"ProductNDC": "67457-622",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRA-ARTICULAR; INTRAMUSCULAR",
"StartMarketingDate": "20230508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212567",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230508",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N",
"IndicationAndUsage": "Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension, USP is indicated for intramuscular use as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "Triamcinolone Acetonide Injectable Suspension, USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRADERMAL INJECTION. Each mL of the sterile, off-white colored, aqueous suspension provides 40 mg triamcinolone acetonide USP, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. Triamcinolone acetonide, USP occurs as a white or almost white crystalline powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol."
},
{
"NDCCode": "67457-662-05",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (67457-662-05) > 4 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "67457-0662-05",
"ProductNDC": "67457-662",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topotecan",
"NonProprietaryName": "Topotecan",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180409",
"EndMarketingDate": "20220228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206074",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "TOPOTECAN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180409",
"EndMarketingDatePackage": "20220228",
"SamplePackage": "N"
},
{
"NDCCode": "67457-699-05",
"PackageDescription": "10 VIAL in 1 CARTON (67457-699-05) > 5 mL in 1 VIAL (67457-699-00) ",
"NDC11Code": "67457-0699-05",
"ProductNDC": "67457-699",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atracurium Besylate",
"NonProprietaryName": "Atracurium Besylate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20171019",
"EndMarketingDate": "20190831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206001",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "ATRACURIUM BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171019",
"EndMarketingDatePackage": "20190831",
"SamplePackage": "N"
},
{
"NDCCode": "67457-778-05",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (67457-778-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-778-00) ",
"NDC11Code": "67457-0778-05",
"ProductNDC": "67457-778",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20171231",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206607",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "80; 16",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171231",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "Sulfamethoxazole and trimethoprim injection is a combination of sulfamethoxazole, a sulfonamide antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor antibacterial, indicated in adults and pediatric patients two months of age and older for treatment of infections caused by designated, susceptible bacteria. : 1 Pneumocystis jirovecii Pneumonia (1.1), 2 Shigellosis (1.2), 3 Urinary Tract Infections (1.3).",
"Description": "Sulfamethoxazole and trimethoprim injection USP, a sterile, clear, colorless or slightly yellow solution for intravenous infusion only, is a combination of sulfamethoxazole, a sulfonamide antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor antibacterial. Each mL contains 16 mg trimethoprim, USP and 80 mg sulfamethoxazole, USP compounded with propylene glycol 400 mg (38.6% v/v and 40.0% w/v); dehydrated alcohol 100 mg (12.3% v/v and 10.0% w/v); diethanolamine 3 mg (0.3% v/v and 0.3% w/v); benzyl alcohol 10 mg (1.0% v/v and 1.0% w/v) as a preservative; sodium metabisulfite 1 mg (0.1% w/v) as an antioxidant; water for injection q.s.; air replaced with nitrogen; pH adjusted with sodium hydroxide and/or hydrochloric acid if necessary. pH 9.5 to 10.5. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula."
},
{
"NDCCode": "67457-879-05",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (67457-879-05) > 1 SYRINGE in 1 BLISTER PACK (67457-879-00) > .5 mL in 1 SYRINGE",
"NDC11Code": "67457-0879-05",
"ProductNDC": "67457-879",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan",
"NonProprietaryName": "Sumatriptan",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20181106",
"EndMarketingDate": "20210531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090314",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "6",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181106",
"EndMarketingDatePackage": "20210531",
"SamplePackage": "N"
},
{
"NDCCode": "67457-880-05",
"PackageDescription": "5 VIAL in 1 CARTON (67457-880-05) > .5 mL in 1 VIAL (67457-880-00) ",
"NDC11Code": "67457-0880-05",
"ProductNDC": "67457-880",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan",
"NonProprietaryName": "Sumatriptan",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20181106",
"EndMarketingDate": "20210131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090641",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "6",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181106",
"EndMarketingDatePackage": "20210131",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>67457-790-05</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (67457-790-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-790-00) </PackageDescription>
<NDC11Code>67457-0790-05</NDC11Code>
<ProductNDC>67457-790</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170724</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203308</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) . Levetiracetam injection is indicated for adjunctive therapy for the treatment of: oMyoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) oPrimary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) . Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible (1.4) .</IndicationAndUsage>
<Description>Levetiracetam injection, USP is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to almost white powder. It is very soluble in water, soluble in acetonitrile and practically insoluble in hexane. Levetiracetam injection, USP contains 100 mg of levetiracetam, USP per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, USP, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection, USP must be diluted prior to intravenous infusion [see Dosage and Administration (2.6)].</Description>
</NDC>
<NDC>
<NDCCode>59088-790-05</NDCCode>
<PackageDescription>57 g in 1 TUBE (59088-790-05) </PackageDescription>
<NDC11Code>59088-0790-05</NDC11Code>
<ProductNDC>59088-790</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diabecin Hr</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl, Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250610</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>DIMETHICONE; LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>50; 41.2; 1.3</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diabecin HR Cream is indicated for the temporary relief of pain and itching associated with minor skin irritations. It combines the anesthetic properties of Lidocaine, and the antiseptic effects of Benzalkonium Chloride to provide effective care for damaged skin.</IndicationAndUsage>
<Description>Diabecin HR Cream contains 41.2 mg of Lidocaine HCl per gram, and 1.3 mg of Benzalkonium Chloride per gram in a vehicle of Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Aqua (Purified Water), Arnica Montana Flower Extract, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Carbomer, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Cyclopentasiloxane, Dimethicone, Disodium EDTA, DL-alpha Tocopheryl Acetate, GenRx® Complex (Proprietary Blend), Glycerin, Glyceryl Acrylate/Acrylic Acid Copolymer, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Methylsilanol Mannuronate, Panthenol, PEG-100 Stearate, Peucedanum Ostruthium (Masterwort) Leaf Extract, Phenoxyethanol, Propylene Glycol, Retinyl Palmitate, Sodium Lauroyl Sarcosinate, Stearic Acid, Tetrahexyldecyl Ascorbate, Triethanolamine, Vitis Vinifera (Grape) Seed Extract, Xanthan Gum, Zea Mays (Corn) Starch.</Description>
</NDC>
<NDC>
<NDCCode>70512-790-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (70512-790-05) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>70512-0790-05</NDC11Code>
<ProductNDC>70512-790</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20240415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218204</ApplicationNumber>
<LabelerName>SOLA Pharmaceuticals, LLC</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.</IndicationAndUsage>
<Description>Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-Benzoyl-2, 3-dihydro-1H pyrrolizine-1-carboxylic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure. Ketorolac tromethamine ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution is a racemic mixture of R-(+) and S-(-) -ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of ketorolac tromethamine ophthalmic solution is 290 mOsmol/kg. Each mL of ketorolac tromethamine ophthalmic solution contains: Active:ketorolac tromethamine 0.5%. Preservative:benzalkonium chloride 0.01%. Inactives:edetate disodium 0.1%; octoxynol 40; water for injection; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH.</Description>
</NDC>
<NDC>
<NDCCode>74588-790-05</NDCCode>
<PackageDescription>18927 mL in 1 DRUM (74588-790-05) </PackageDescription>
<NDC11Code>74588-0790-05</NDC11Code>
<ProductNDC>74588-790</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hygienex Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>Eucalyptus Refreshing Gel</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Global Impact Innovation LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>72</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76125-790-05</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (76125-790-05) > 50 mL in 1 VIAL (76125-790-06) </PackageDescription>
<NDC11Code>76125-0790-05</NDC11Code>
<ProductNDC>76125-790</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albuked</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19760826</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101138</ApplicationNumber>
<LabelerName>KEDRION BIOPHARMA, INC.</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19760826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Emergency Treatment of Hypovolemic Shock. Albuked 5 is iso-oncotic with normal plasma and on intravenous infusion will expand the circulating blood volume by an amount approximately equal to the volume infused. In conditions associated mainly with a volume deficit, albumin is best administered as a 5% solution (Albuked 5); but where there is an oncotic deficit, Albumin (Human) 25%, USP (Albuked 25) may be preferred. This is also an important consideration where the treatment of the shock state has been delayed. If Albuked 25 is used, appropriate additional crystalloid should be administered.(1). Crystalloid solutions in volumes several times greater than that of Albuked 5 may be effective in treating shock in younger individuals who have no preexisting illness at the time of the incident. Older patients, especially those with preexisting debilitating conditions, or those in whom the shock is caused by a medical disorder, or where the state of shock has existed for some time before active therapy could be instituted, may not tolerate hypoalbuminemia as well.(1). Removal of ascitic fluid from a patient with cirrhosis may cause changes in cardiovascular function and even result in hypovolemic shock. In such circumstances, the use of albumin infusion may be required to support the blood volume.(1). Burn Therapy. An optimal therapeutic regimen with respect to the administration of colloids, crystalloids, and water following extensive burns has not been established. During the first 24 hours after sustaining thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours, albumin can be used to maintain plasma colloid osmotic pressure. Albuked 25 may be preferred for this purpose.(1). Cardiopulmonary Bypass(1). With the relatively small priming volume required with modern pumps, preoperative dilution of the blood using albumin and crystalloid has been shown to be safe and well-tolerated. Although the limit to which the hematocrit and plasma protein concentration can be safely lowered has not been defined, it is common practice to adjust the albumin and crystalloid pump prime to achieve a hematocrit of 20% and a plasma albumin concentration of 2.5 g per 100 mL in the patient. Acute Liver Failure(1). In the uncommon situation of rapid loss of liver function, with or without coma, administration of albumin may serve the double purpose of supporting the colloid osmotic pressure of the plasma as well as binding excess plasma bilirubin. Sequestration of Protein Rich Fluids(2). This occurs in such conditions as acute peritonitis, pancreatitis, mediastinitis, and extensive cellulitis. The magnitude of loss into the third space may require treatment of reduced volume or oncotic activity with an infusion of albumin. Situations in Which Albumin Administration is Not Warranted(1). In chronic nephrosis, infused albumin is promptly excreted by the kidneys with no relief of the chronic edema or effect on the underlying renal lesion. It is of occasional use in the rapid “priming” diuresis of nephrosis. Similarly, in hypoproteinemic states associated with chronic cirrhosis, malabsorption, protein losing enteropathies, pancreatic insufficiency, and undernutrition, the infusion of albumin as a source of protein nutrition is not justified.</IndicationAndUsage>
<Description>Albumin (Human) 5%, USP (Albuked 5) is made from large pools of human venous plasma by the Cohn cold ethanol fractionation process. Part of the fractionation may be performed by another licensed manufacturer. It is prepared in accordance with the applicable requirements established by the U.S. Food and Drug Administration. Albuked 5 is a 5% sterile solution of albumin in an aqueous diluent. The preparation is stabilized with 0.004 M sodium caprylate and 0.004 M acetyltryptophan. The aluminum content of the product is not more than 200 µg/L. The approximate sodium content of the product is 145 mEq/L. Albuked 5 is clear, slightly viscous, almost colorless to yellow, amber or green. Each vial of Albuked 5 is heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents.(8-11) The production steps from Pooled Plasma to Effluent IV-1 in the Albuked 5 manufacturing process have been shown to decrease TSE infectivity of that experimental model agent (a total of ≥7.0 logs). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
</NDC>
<NDC>
<NDCCode>76420-790-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (76420-790-05) </PackageDescription>
<NDC11Code>76420-0790-05</NDC11Code>
<ProductNDC>76420-790</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204989</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1of 4.72±0.10 and a pK a2of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400 mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>67457-192-05</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (67457-192-05) > 5 mL in 1 AMPULE (67457-192-00)</PackageDescription>
<NDC11Code>67457-0192-05</NDC11Code>
<ProductNDC>67457-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enlon Plus</ProprietaryName>
<NonProprietaryName>Edrophonium Chloride And Atropine Sulfate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19911106</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019678</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>EDROPHONIUM CHLORIDE; ATROPINE SULFATE</SubstanceName>
<StrengthNumber>10; .14</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67457-198-05</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (67457-198-05) / 5 mL in 1 VIAL, GLASS (67457-198-99) </PackageDescription>
<NDC11Code>67457-0198-05</NDC11Code>
<ProductNDC>67457-198</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ultiva</ProprietaryName>
<NonProprietaryName>Remifentanil Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19961106</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020630</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>REMIFENTANIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19961106</StartMarketingDatePackage>
<EndMarketingDatePackage>20241031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ULTIVA is indicated for intravenous (IV) administration: 1 As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures., 2 For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting., 3 As an analgesic component of monitored anesthesia care in adult patients.</IndicationAndUsage>
<Description>ULTIVA (remifentanil hydrochloride) for injection is an opioid agonist. The chemical name is 3-[4-methoxycarbonyl-4-[(1-oxopropyl)phenylamino]-1-piperidine]propanoic acid methyl ester, hydrochloride salt. The molecular weight is 412.91. Its molecular formula is C20H28N2O5HCl, and it has the following chemical structure. ULTIVA is a sterile, nonpyrogenic, preservative-free, white to off-white lyophilized powder for intravenous (IV) administration after reconstitution and dilution. Each vial contains 1 mg, 2 mg, or 5 mg of remifentanil base; 15 mg glycine; and hydrochloric acid to buffer the solutions to a nominal pH of 3 after reconstitution. When reconstituted as directed, solutions of ULTIVA are clear and colorless and contain remifentanil hydrochloride (HCl) equivalent to 1 mg/mL of remifentanil base. The pH of reconstituted solutions of ULTIVA ranges from 2.5 to 3.5. Remifentanil hydrochloride has a pKa of 7.07. Remifentanil hydrochloride has an n-octanol:water partition coefficient of 17.9 at pH 7.3.</Description>
</NDC>
<NDC>
<NDCCode>67457-210-05</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (67457-210-05) > 5 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>67457-0210-05</NDC11Code>
<ProductNDC>67457-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cidofovir</ProprietaryName>
<NonProprietaryName>Cidofovir Anhydrous</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201276</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>CIDOFOVIR</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-07-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cidofovir is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). THE SAFETY AND EFFICACY OF CIDOFOVIR INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (SUCH AS PNEUMONITIS OR GASTROENTERITIS), CONGENITAL OR NEONATAL CMV DISEASE, OR CMV DISEASE IN NON-HIV-INFECTED INDIVIDUALS.</IndicationAndUsage>
<Description>The chemical name of cidofovir is 1-[(S)-3-hydroxy-2-(phosphonomethoxy)propyl]cytosine dihydrate (HPMPC), with the molecular formula of C8H14N3O6P2H2O and a molecular weight of 315.22 (279.19 for anhydrous). The chemical structure is. Cidofovir, USP is a white crystalline powder with an aqueous solubility of ≥ 170 mg/mL at pH 6 to 8 and a log P (octanol/aqueous buffer, pH 7.1) value of -3.3. Cidofovir injection, USP is a sterile, hypertonic aqueous solution for intravenous infusion only. The solution is clear and colorless. It is supplied in clear glass vials, each containing 375 mg of anhydrous cidofovir in 5 mL aqueous solution at a concentration of 75 mg/mL. The formulation is pH-adjusted to 7.4 with sodium hydroxide and/or hydrochloric acid and contains no preservatives. The appropriate volume of cidofovir injection must be removed from the single-dose vial and diluted prior to administration (see DOSAGE AND ADMINISTRATION).</Description>
</NDC>
<NDC>
<NDCCode>67457-220-05</NDCCode>
<PackageDescription>6 VIAL, GLASS in 1 CARTON (67457-220-05) / 5 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>67457-0220-05</NDC11Code>
<ProductNDC>67457-220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosulfan Blue</ProprietaryName>
<NonProprietaryName>Isosulfan Blue</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20130314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090874</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>ISOSULFAN BLUE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isosulfan blue injection 1% upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; lymph node response to therapeutic modalities (1.1).</IndicationAndUsage>
<Description>The chemical name of isosulfan blue injection 1% is N-[4- [[4-(diethylamino)phenyl] (2,5-disulfophenyl) methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide, inner salt, sodium salt. Its structural formula is. ISOSULFAN BLUE. Isosulfan blue injection 1% is a clear dark blue, sterile, non-pyrogenic aqueous solution for subcutaneous administration. Phosphate buffer in sterile, pyrogen free water is added in sufficient quantity to yield a final pH of 6.8 to 7.4. Each mL of solution contains 10 mg isosulfan blue, 6.6 mg sodium monohydrogen phosphate and 2.7 mg potassium dihydrogen phosphate. Each mL of isosulfan blue injection contains 2 mg of sodium and less than 5 mg of phosphorus. The solution contains no preservative. Isosulfan blue injection 1% is a contrast agent for the delineation of lymphatic vessels.</Description>
</NDC>
<NDC>
<NDCCode>67457-228-05</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (67457-228-05) / 5 mL in 1 VIAL, MULTI-DOSE (67457-228-00) </PackageDescription>
<NDC11Code>67457-0228-05</NDC11Code>
<ProductNDC>67457-228</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rocuronium Bromide</ProprietaryName>
<NonProprietaryName>Rocuronium Bromide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079199</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>ROCURONIUM BROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17ß-(acetyloxy)-3α-hydroxy-2ß-(4-morpholinyl)-5α-androstan-16ß-yl]-1-(2-propenyl) pyrrolidinium bromide. The structural formula is. The chemical formula is C32H53BrN2O4 with a molecular weight of 609.70. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous injection only. Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate. The aqueous solution is adjusted to isotonicity with sodium chloride (3.10 mg/mL) and to a pH of 4 with acetic acid and/or sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>67457-259-05</NDCCode>
<PackageDescription>6 VIAL, GLASS in 1 CARTON (67457-259-05) > 5 mL in 1 VIAL, GLASS (67457-259-00)</PackageDescription>
<NDC11Code>67457-0259-05</NDC11Code>
<ProductNDC>67457-259</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosulfan Blue</ProprietaryName>
<NonProprietaryName>Isosulfan Blue</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20130314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090874</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>ISOSULFAN BLUE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>67457-288-05</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (67457-288-05) > 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>67457-0288-05</NDC11Code>
<ProductNDC>67457-288</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pentostatin</ProprietaryName>
<NonProprietaryName>Pentostatin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140919</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203554</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>PENTOSTATIN</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pentostatin for injection is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms.</IndicationAndUsage>
<Description>Pentostatin for injection is supplied as a sterile, apyrogenic, lyophilized powder in single-dose vials for intravenous administration. Each vial contains 10 mg of pentostatin and 50 mg of Mannitol, USP. The pH of the final product is maintained between 7.0 and 8.5 by addition of sodium hydroxide or hydrochloric acid. Pentostatin, also known as 2’-deoxycoformycin (DCF), is a potent inhibitor of the enzyme adenosine deaminase and is isolated from fermentation cultures of Streptomyces antibioticus. Pentostatin is known chemically as (R)-3-(2-deoxy-ß-D-erythropentofuranosyl)3,6,7,8 tetrahydroimidazo[4,5d][1,3]diazepin-8-ol with a molecular formula of C11H16N4O4 and a molecular weight of 268.27. The molecular structure of pentostatin is. Pentostatin is a white to off-white solid, freely soluble in distilled water.</Description>
</NDC>
<NDC>
<NDCCode>67457-311-05</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (67457-311-05) > 5 mL in 1 SYRINGE, GLASS (67457-311-00) </PackageDescription>
<NDC11Code>67457-0311-05</NDC11Code>
<ProductNDC>67457-311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fulvestrant</ProprietaryName>
<NonProprietaryName>Fulvestrant</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20190909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208811</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>FULVESTRANT</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Antagonist [EPC], Estrogen Receptor Antagonists [MoA], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67457-326-05</NDCCode>
<PackageDescription>20 mL in 1 VIAL, SINGLE-DOSE (67457-326-05) </PackageDescription>
<NDC11Code>67457-0326-05</NDC11Code>
<ProductNDC>67457-326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bendamustine Hydrochloride</ProprietaryName>
<NonProprietaryName>Bendamustine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204104</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>BENDAMUSTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA],Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-02-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67457-341-05</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (67457-341-05) / 100 mL in 1 VIAL</PackageDescription>
<NDC11Code>67457-0341-05</NDC11Code>
<ProductNDC>67457-341</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>20131205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065432</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, USP 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. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Injection, USP is an off white to light tan colored lyophilized powder, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package containing the equivalent of 5 grams of vancomycin base. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL, it forms a clear, colorless or light to dark tan solution with the pH of the solution is between 2.5 and 4.5. It may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,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-[(2R)-4-methyl-2-(methylamino)]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9] oxadiazacyclohexadecino[4,5-m][10,2,16]benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (See DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package.) FURTHER DILUTION IS REQUIRED. NOT FOR DIRECT INFUSION.</Description>
</NDC>
<NDC>
<NDCCode>67457-400-05</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 CARTON (67457-400-05) / 30 mL in 1 VIAL, MULTI-DOSE (67457-400-31) </PackageDescription>
<NDC11Code>67457-0400-05</NDC11Code>
<ProductNDC>67457-400</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyanocobalamine</ProprietaryName>
<NonProprietaryName>Cyanocobalamine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20170706</StartMarketingDate>
<EndMarketingDate>20260331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204829</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Vitamin B 12 [CS], Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170706</StartMarketingDatePackage>
<EndMarketingDatePackage>20260331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions: 1 Addisonian (pernicious) anemia, 2 Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy, 3 Fish tapeworm infestation, 4 Malignancy of pancreas or bowel, 5 Folic acid deficiency.</IndicationAndUsage>
<Description>Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1,000 mcg cyanocobalamin, Sodium Chloride 0.9%. Benzyl Alcohol 1.5%, is present as a preservative. Sodium acetate and Glacial acetic acid are present as buffers. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5 to 7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder or purplish crystalline powder. Sparingly soluble in water and soluble in alcohol, practically insoluble in acetone, in chloroform and in ether. It is stable to autoclaving for short periods at 121°C. The vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is 1355.4. The structural formula is represented below.</Description>
</NDC>
<NDC>
<NDCCode>67457-418-05</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (67457-418-05) / 5 mL in 1 VIAL (67457-418-00) </PackageDescription>
<NDC11Code>67457-0418-05</NDC11Code>
<ProductNDC>67457-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
<NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE</RouteName>
<StartMarketingDate>20200415</StartMarketingDate>
<EndMarketingDate>20261031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040803</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200415</StartMarketingDatePackage>
<EndMarketingDatePackage>20261031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>A. By intravenous or intramuscular injection when oral therapy is not feasible. 1. Endocrine disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Acute and subacute bursitis. Epicondylitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Psoriatic arthritis. Ankylosing spondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Acute rheumatic carditis. 4. Dermatologic Diseases. Pemphigus. Severe erythema multiforme. (Stevens-Johnson Syndrome). Exfoliative dermatitis. Bullous dermatitis herpetiformis. Severe seborrheic dermatitis. Severe psoriasis. Mycosis fungoides. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Seasonal or perennial allergic rhinitis. Drug hypersensitivity reactions. Urticarial transfusion reactions. Acute noninfectious laryngeal edema (epinephrine is the drug of first choice). 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye, such as. Herpes zoster ophthalmicus. Iritis, iridocyclitis. Chorioretinitis. Diffuse posterior uveitis and choroiditis. Optic neuritis. Sympathetic ophthalmia. Anterior segment inflammation. Allergic conjunctivitis. Keratitis. Allergic corneal marginal ulcers. 7. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis (systemic therapy). Regional enteritis (systemic therapy). 8. Respiratory Diseases. Symptomatic sarcoidosis. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Loeffler's syndrome not manageable by other means. Aspiration pneumonitis. 9. Hematologic Disorders. Acquired (autoimmune) hemolytic anemia. Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated). Secondary thrombocytopenia in adults. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 10. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 11. Edematous States. To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 12. Miscellaneous. Tuberculosis meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement. 13. Diagnostic testing of adrenocortical hyperfunction. 14. Cerebral Edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Use in cerebral edema is not a substitute for careful neurosurgical evaluation and definitive management such as neurosurgery or other specific therapy. B. By intra-articular or soft tissue injection. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Synovitis of osteoarthritis. Rheumatoid arthritis. Acute and subacute bursitis. Acute gouty arthritis. Epicondylitis. Acute nonspecific tenosynovitis. Post-traumatic osteoarthritis. C. By intralesional injection. Keloids. Localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis). Discoid lupus erythematosus. Necrobiosis lipoidica diabeticorum. Alopecia areata. May also be useful in cystic tumors of an aponeurosis or tendon (ganglia).</IndicationAndUsage>
<Description>Dexamethasone sodium phosphate, a synthetic adrenocortical steroid, is a white or slightly yellow, crystalline powder. It is freely soluble in water and is exceedingly hygroscopic. The molecular weight is 516.41. It is designated chemically as 9-fluoro-11β,17-dihydroxy-16α-methyl-21-(phosphonooxy)pregna-1,4-diene-3,20-dione disodium salt. The empirical formula is C22H28FNa2O8P and the structural formula is. Dexamethasone sodium phosphate injection, USP is a sterile solution of dexamethasone sodium phosphate, and is supplied in 4 mg/ mL and 10 mg /mL. Dexamethasone sodium phosphate injection, USP 4 mg/mL is a sterile solution for intravenous, intramuscular, intra-articular, intralesional and soft tissue administration. Each mL contains:. Active: Dexamethasone sodium phosphate 4.4 mg (equivalent to dexamethasone phosphate 4 mg). Preservatives: Methylparaben 1.5 mg; Propylparaben 0.2 mg. Inactives: Edetate Disodium 0.11 mg; Sodium Citrate Anhydrous 10 mg; Citric Acid and/or Sodium Hydroxide q.s to adjust pH 7.0 to 8.5 and Water for Injection q.s to 1 mL. Dexamethasone sodium phosphate injection, USP 10 mg/mL is a sterile solution for intravenous or intramuscular use only. Each mL contains:. Actives: Dexamethasone sodium phosphate 11 mg (equivalent to dexamethasone phosphate 10 mg). Preservatives: Methylparaben 1.5 mg; Propylparaben 0.2 mg. Inactives: Edetate Disodium 0.11 mg; Sodium Citrate Anhydrous 10 mg; Citric Acid and/or Sodium Hydroxide q.s to adjust pH 7.0 to 8.5 and Water for Injection q.s to 1 mL.</Description>
</NDC>
<NDC>
<NDCCode>67457-482-05</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (67457-482-05) > 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>67457-0482-05</NDC11Code>
<ProductNDC>67457-482</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vinorelbine</ProprietaryName>
<NonProprietaryName>Vinorelbine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200148</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>VINORELBINE TARTRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-10-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>67457-513-05</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (67457-513-05) > 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>67457-0513-05</NDC11Code>
<ProductNDC>67457-513</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dactinomycin</ProprietaryName>
<NonProprietaryName>Dactinomycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203385</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>DACTINOMYCIN</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Actinomycin [EPC], Nucleic Acid Synthesis Inhibitors [MoA], Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67457-518-05</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (67457-518-05) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>67457-0518-05</NDC11Code>
<ProductNDC>67457-518</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mitomycin</ProprietaryName>
<NonProprietaryName>Mitomycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202670</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>MITOMYCIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67457-573-05</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (67457-573-05) > 5 mL in 1 VIAL, MULTI-DOSE (67457-573-00)</PackageDescription>
<NDC11Code>67457-0573-05</NDC11Code>
<ProductNDC>67457-573</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rocuronium Bromide</ProprietaryName>
<NonProprietaryName>Rocuronium Bromide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140929</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079199</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>ROCURONIUM BROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-21</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67457-586-05</NDCCode>
<PackageDescription>6 VIAL, GLASS in 1 CARTON (67457-586-05) > 5 mL in 1 VIAL, GLASS (67457-586-00)</PackageDescription>
<NDC11Code>67457-0586-05</NDC11Code>
<ProductNDC>67457-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosulfan Blue</ProprietaryName>
<NonProprietaryName>Isosulfan Blue</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090874</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>ISOSULFAN BLUE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-06-26</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67457-603-99</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (67457-603-99) / 4 mL in 1 VIAL, MULTI-DOSE (67457-603-05) </PackageDescription>
<NDC11Code>67457-0603-99</NDC11Code>
<ProductNDC>67457-603</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heparin Sodium</ProprietaryName>
<NonProprietaryName>Heparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180614</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203851</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>HEPARIN SODIUM</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180614</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Heparin sodium injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism; , 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; , 3 Atrial fibrillation with embolization; , 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); , 5 Prevention of clotting in arterial and cardiac surgery; , 6 Prophylaxis and treatment of peripheral arterial embolism. , 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .</IndicationAndUsage>
<Description>Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated O-sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of heparin sodium, USP (representative subunits):. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Heparin Sodium Injection, USP preserved with Benzyl Alcohol is available in the following concentrations/mL:. pH 5.0 to 7.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>67457-622-05</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (67457-622-05) / 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>67457-0622-05</NDC11Code>
<ProductNDC>67457-622</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRA-ARTICULAR; INTRAMUSCULAR</RouteName>
<StartMarketingDate>20230508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212567</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230508</StartMarketingDatePackage>
<EndMarketingDatePackage>20260228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension, USP is indicated for intramuscular use as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>Triamcinolone Acetonide Injectable Suspension, USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRADERMAL INJECTION. Each mL of the sterile, off-white colored, aqueous suspension provides 40 mg triamcinolone acetonide USP, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. Triamcinolone acetonide, USP occurs as a white or almost white crystalline powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>67457-662-05</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (67457-662-05) > 4 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>67457-0662-05</NDC11Code>
<ProductNDC>67457-662</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topotecan</ProprietaryName>
<NonProprietaryName>Topotecan</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180409</StartMarketingDate>
<EndMarketingDate>20220228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206074</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>TOPOTECAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180409</StartMarketingDatePackage>
<EndMarketingDatePackage>20220228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67457-699-05</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (67457-699-05) > 5 mL in 1 VIAL (67457-699-00) </PackageDescription>
<NDC11Code>67457-0699-05</NDC11Code>
<ProductNDC>67457-699</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atracurium Besylate</ProprietaryName>
<NonProprietaryName>Atracurium Besylate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20171019</StartMarketingDate>
<EndMarketingDate>20190831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206001</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>ATRACURIUM BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171019</StartMarketingDatePackage>
<EndMarketingDatePackage>20190831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67457-778-05</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (67457-778-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-778-00) </PackageDescription>
<NDC11Code>67457-0778-05</NDC11Code>
<ProductNDC>67457-778</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20171231</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206607</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>80; 16</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171231</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sulfamethoxazole and trimethoprim injection is a combination of sulfamethoxazole, a sulfonamide antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor antibacterial, indicated in adults and pediatric patients two months of age and older for treatment of infections caused by designated, susceptible bacteria. : 1 Pneumocystis jirovecii Pneumonia (1.1), 2 Shigellosis (1.2), 3 Urinary Tract Infections (1.3).</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim injection USP, a sterile, clear, colorless or slightly yellow solution for intravenous infusion only, is a combination of sulfamethoxazole, a sulfonamide antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor antibacterial. Each mL contains 16 mg trimethoprim, USP and 80 mg sulfamethoxazole, USP compounded with propylene glycol 400 mg (38.6% v/v and 40.0% w/v); dehydrated alcohol 100 mg (12.3% v/v and 10.0% w/v); diethanolamine 3 mg (0.3% v/v and 0.3% w/v); benzyl alcohol 10 mg (1.0% v/v and 1.0% w/v) as a preservative; sodium metabisulfite 1 mg (0.1% w/v) as an antioxidant; water for injection q.s.; air replaced with nitrogen; pH adjusted with sodium hydroxide and/or hydrochloric acid if necessary. pH 9.5 to 10.5. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>67457-879-05</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (67457-879-05) > 1 SYRINGE in 1 BLISTER PACK (67457-879-00) > .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>67457-0879-05</NDC11Code>
<ProductNDC>67457-879</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan</ProprietaryName>
<NonProprietaryName>Sumatriptan</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20181106</StartMarketingDate>
<EndMarketingDate>20210531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090314</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181106</StartMarketingDatePackage>
<EndMarketingDatePackage>20210531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67457-880-05</NDCCode>
<PackageDescription>5 VIAL in 1 CARTON (67457-880-05) > .5 mL in 1 VIAL (67457-880-00) </PackageDescription>
<NDC11Code>67457-0880-05</NDC11Code>
<ProductNDC>67457-880</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan</ProprietaryName>
<NonProprietaryName>Sumatriptan</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20181106</StartMarketingDate>
<EndMarketingDate>20210131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090641</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181106</StartMarketingDatePackage>
<EndMarketingDatePackage>20210131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>