{
"NDC": [
{
"NDCCode": "72611-756-10",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (72611-756-10) / 5 mL in 1 VIAL, MULTI-DOSE (72611-756-01) ",
"NDC11Code": "72611-0756-10",
"ProductNDC": "72611-756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rocuronium Bromide",
"NonProprietaryName": "Rocuronium Bromide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200327",
"EndMarketingDate": "20250301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205656",
"LabelerName": "Almaject, Inc.",
"SubstanceName": "ROCURONIUM BROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200327",
"EndMarketingDatePackage": "20250301",
"SamplePackage": "N",
"IndicationAndUsage": "Rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2- propenyl)pyrrolidinium bromide. The structural formula is. The chemical formula is C32H53BrN2O4 with a molecular weight of 609.70. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide 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 and to a pH of 4 with acetic acid and/or sodium hydroxide."
},
{
"NDCCode": "72611-700-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (72611-700-01) / 10.8 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "72611-0700-01",
"ProductNDC": "72611-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Caspofungin Acetate",
"NonProprietaryName": "Caspofungin Acetate",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200331",
"EndMarketingDate": "20251101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207092",
"LabelerName": "Almaject, Inc.",
"SubstanceName": "CASPOFUNGIN ACETATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Echinocandin Antifungal [EPC], Lipopeptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200331",
"EndMarketingDatePackage": "20251101",
"SamplePackage": "N",
"IndicationAndUsage": "Caspofungin acetate for injection is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for: : 1 Empirical therapy for presumed fungal infections in febrile, neutropenic patients. (1) , 2 Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. (1) , 3 Treatment of esophageal candidiasis. (1) , 4 Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. (1) .",
"Description": "Caspofungin acetate for injection is a sterile, lyophilized product for intravenous (IV) infusion that contains a semisynthetic lipopeptide (echinocandin) compound synthesized from a fermentation product of Glarea lozoyensis. Caspofungin acetate is an echinocandin antifungal that inhibits the synthesis of β (1,3)-D-glucan, an integral component of the fungal cell wall. Caspofungin acetate is 1-[(4R,5S)-5-[(2-aminoethyl)amino]-N2-(10,12-dimethyl-1-oxotetradecyl)-4-hydroxy-L-ornithine]-5-[(3R)-3-hydroxy-L-ornithine] pneumocandin B0 diacetate (salt). Caspofungin acetate for injection 50 mg vial contains 50 mg of caspofungin equivalent to 55.5 mg of caspofungin acetate. Caspofungin acetate for injection 50 mg vial also contains 39 mg sucrose, 26 mg mannitol, 2 mg glacial acetic acid added as a buffering agent, and sodium hydroxide added as a pH adjuster ingredient. Caspofungin acetate for injection 70 mg vial contains 70 mg of caspofungin equivalent to 77.7 mg of caspofungin acetate. Caspofungin acetate for injection 70 mg vial also contains 54 mg sucrose, 36 mg mannitol, 2.7 mg glacial acetic acid added as a buffering agent, and sodium hydroxide added as a pH adjuster ingredient. Caspofungin acetate is a hygroscopic, white to off-white powder. It is freely soluble in water and methanol, and slightly soluble in ethanol. The pH of a saturated aqueous solution of caspofungin acetate is approximately 6.6. The empirical formula is C52H88N10O152C2H4O2 and the formula weight is 1213.42. The structural formula is:."
},
{
"NDCCode": "72611-702-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (72611-702-01) / 10.8 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "72611-0702-01",
"ProductNDC": "72611-702",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Caspofungin Acetate",
"NonProprietaryName": "Caspofungin Acetate",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200331",
"EndMarketingDate": "20241101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207092",
"LabelerName": "Almaject, Inc.",
"SubstanceName": "CASPOFUNGIN ACETATE",
"StrengthNumber": "7",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Echinocandin Antifungal [EPC], Lipopeptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200331",
"EndMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "Caspofungin acetate for injection is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for: : 1 Empirical therapy for presumed fungal infections in febrile, neutropenic patients. (1) , 2 Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. (1) , 3 Treatment of esophageal candidiasis. (1) , 4 Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. (1) .",
"Description": "Caspofungin acetate for injection is a sterile, lyophilized product for intravenous (IV) infusion that contains a semisynthetic lipopeptide (echinocandin) compound synthesized from a fermentation product of Glarea lozoyensis. Caspofungin acetate is an echinocandin antifungal that inhibits the synthesis of β (1,3)-D-glucan, an integral component of the fungal cell wall. Caspofungin acetate is 1-[(4R,5S)-5-[(2-aminoethyl)amino]-N2-(10,12-dimethyl-1-oxotetradecyl)-4-hydroxy-L-ornithine]-5-[(3R)-3-hydroxy-L-ornithine] pneumocandin B0 diacetate (salt). Caspofungin acetate for injection 50 mg vial contains 50 mg of caspofungin equivalent to 55.5 mg of caspofungin acetate. Caspofungin acetate for injection 50 mg vial also contains 39 mg sucrose, 26 mg mannitol, 2 mg glacial acetic acid added as a buffering agent, and sodium hydroxide added as a pH adjuster ingredient. Caspofungin acetate for injection 70 mg vial contains 70 mg of caspofungin equivalent to 77.7 mg of caspofungin acetate. Caspofungin acetate for injection 70 mg vial also contains 54 mg sucrose, 36 mg mannitol, 2.7 mg glacial acetic acid added as a buffering agent, and sodium hydroxide added as a pH adjuster ingredient. Caspofungin acetate is a hygroscopic, white to off-white powder. It is freely soluble in water and methanol, and slightly soluble in ethanol. The pH of a saturated aqueous solution of caspofungin acetate is approximately 6.6. The empirical formula is C52H88N10O152C2H4O2 and the formula weight is 1213.42. The structural formula is:."
},
{
"NDCCode": "72611-740-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (72611-740-10) / 5 mL in 1 VIAL, SINGLE-DOSE (72611-740-01) ",
"NDC11Code": "72611-0740-10",
"ProductNDC": "72611-740",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200331",
"EndMarketingDate": "20261101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204205",
"LabelerName": "Almaject, Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200331",
"EndMarketingDatePackage": "20261101",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate injection is indicated in the treatment of definite or suspected acute myocardial infarction in hemodynamically stable patients to reduce cardiovascular mortality when used in conjunction with oral metoprolol maintenance therapy.",
"Description": "Metoprolol tartrate USP, is a selective beta1-adrenoreceptor blocking agent, available in 5 mL vials for intravenous administration. Each vial contains a sterile solution of metoprolol tartrate USP, 5 mg, and sodium chloride USP, 45 mg, and water for injection USP. Metoprolol tartrate USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L- (+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether."
},
{
"NDCCode": "72611-749-10",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (72611-749-10) / 10 mL in 1 VIAL, MULTI-DOSE (72611-749-01) ",
"NDC11Code": "72611-0749-10",
"ProductNDC": "72611-749",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Midazolam",
"NonProprietaryName": "Midazolam",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20200414",
"EndMarketingDate": "20260401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090850",
"LabelerName": "Almaject, Inc.",
"SubstanceName": "MIDAZOLAM HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2026-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200414",
"EndMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "Midazolam Injection is indicated: : 1 intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;, 2 intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;, 3 intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);, 4 continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting. .",
"Description": "Midazolam hydrochloride is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 5 mg midazolam compounded with 0.8% sodium chloride and 0.01% edetate disodium, with 1% benzyl alcohol as preservative; the pH is adjusted to 2.9 to 3.5 with hydrochloric acid and, if necessary, sodium hydroxide. Midazolam is a white or yellowish crystalline powder, insoluble in water. The hydrochloride salt of midazolam, which is formed in situ, is soluble in aqueous solutions. Chemically, midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine hydrochloride. Midazolam hydrochloride has the empirical formula C18H13ClFN3HCl, a calculated molecular weight of 362.25 and the following structural formula:. Under the acidic conditions required to solubilize midazolam in the product, midazolam is present as an equilibrium mixture (shown below) of the closed ring form shown above and an open-ring structure formed by the acid-catalyzed ring opening of the 4,5-double bond of the diazepine ring. The amount of open-ring form is dependent upon the pH of the solution. At the specified pH of the product, the solution may contain up to about 25% of the open-ring compound. At the physiologic conditions under which the product is absorbed (pH of 5 to 8) into the systemic circulation, any open-ring form present reverts to the physiologically active, lipophilic, closed-ring form (midazolam) and is absorbed as such. The following chart plots the percentage of midazolam present as the open-ring form as a function of pH in aqueous solutions. As indicated in the graph, the amount of open-ring compound present in solution is sensitive to changes in pH over the pH range specified for the product: 3.0 to 3.6 for the 5 mg/mL concentration. Above pH 5, at least 99% of the mixture is present in the closed-ring form."
},
{
"NDCCode": "72611-757-10",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (72611-757-10) / 10 mL in 1 VIAL, MULTI-DOSE (72611-757-01) ",
"NDC11Code": "72611-0757-10",
"ProductNDC": "72611-757",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rocuronium Bromide",
"NonProprietaryName": "Rocuronium Bromide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200327",
"EndMarketingDate": "20250301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205656",
"LabelerName": "Almaject, Inc.",
"SubstanceName": "ROCURONIUM BROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200327",
"EndMarketingDatePackage": "20250301",
"SamplePackage": "N",
"IndicationAndUsage": "Rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2- propenyl)pyrrolidinium bromide. The structural formula is. The chemical formula is C32H53BrN2O4 with a molecular weight of 609.70. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide 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 and to a pH of 4 with acetic acid and/or sodium hydroxide."
},
{
"NDCCode": "72611-760-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (72611-760-10) / 10 mL in 1 VIAL, SINGLE-DOSE (72611-760-01) ",
"NDC11Code": "72611-0760-10",
"ProductNDC": "72611-760",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tranexamic Acid",
"NonProprietaryName": "Tranexamic Acid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207239",
"LabelerName": "Almaject, Inc.",
"SubstanceName": "TRANEXAMIC ACID",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-10-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210301",
"SamplePackage": "N",
"IndicationAndUsage": "Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.",
"Description": "Tranexamic acid, USP is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid, USP is a white crystalline powder. The structural formula is. Empirical Formula: C8H15NO2 Molecular Weight: 157.2. Each mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid, USP and Water for Injection to 1 mL. The aqueous solution for injection has a pH of 6.5 to 8.0."
},
{
"NDCCode": "72611-761-10",
"PackageDescription": "10 VIAL in 1 CARTON (72611-761-10) / 10 mL in 1 VIAL (72611-761-01) ",
"NDC11Code": "72611-0761-10",
"ProductNDC": "72611-761",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200508",
"EndMarketingDate": "20250201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205694",
"LabelerName": "Almaject, Inc.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200508",
"EndMarketingDatePackage": "20250201",
"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 a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 gram vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. 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 Amycolatopasis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-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-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-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 1,485.74. Vancomycin hydrochloride has the following structural formula:."
},
{
"NDCCode": "72611-765-10",
"PackageDescription": "10 VIAL in 1 CARTON (72611-765-10) / 20 mL in 1 VIAL (72611-765-01) ",
"NDC11Code": "72611-0765-10",
"ProductNDC": "72611-765",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200508",
"EndMarketingDate": "20241201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205694",
"LabelerName": "Almaject, Inc.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/20mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200508",
"EndMarketingDatePackage": "20241201",
"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 a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 gram vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. 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 Amycolatopasis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-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-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-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 1,485.74. Vancomycin hydrochloride has the following structural formula:."
},
{
"NDCCode": "72611-779-02",
"PackageDescription": "1 KIT in 1 CARTON (72611-779-02) * 10 mL in 1 VIAL, SINGLE-DOSE (72611-772-01) * 10 mL in 1 VIAL, SINGLE-DOSE (72611-776-01) ",
"NDC11Code": "72611-0779-02",
"ProductNDC": "72611-779",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Melphalan Hydrochloride",
"NonProprietaryName": "Melphalan Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20190518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204817",
"LabelerName": "Almaject, Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20201101",
"SamplePackage": "N",
"IndicationAndUsage": "Melphalan hydrochloride for injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.",
"Description": "Melphalan, also known as L-phenylalanine mustard, phenylalanine mustard, L-PAM, or L-sarcolysin, is a phenylalanine derivative of nitrogen mustard. Melphalan is a bifunctional alkylating agent that is active against selected human neoplastic diseases. It is known chemically as 4-[bis(2-chloroethyl)amino]-L-phenylalanine. The molecular formula is C13H18Cl2N2O2 and the molecular weight is 305.20. The structural formula is. Melphalan is the active L-isomer of the compound and was first synthesized in 1953 by Bergel and Stock; the D-isomer, known as medphalan, is less active against certain animal tumors, and the dose needed to produce effects on chromosomes is larger than that required with the L-isomer. The racemic (DL-) form is known as merphalan or sarcolysin. Melphalan is practically insoluble in water and has a pKa1 of ~ 2.5. Melphalan hydrochloride for injection is supplied as a sterile, nonpyrogenic, freeze-dried powder. Each single-dose vial contains melphalan hydrochloride equivalent to 50 mg melphalan and 20 mg povidone. Melphalan hydrochloride for injection is reconstituted using the sterile diluent provided. Each vial of sterile diluent contains sodium citrate 0.2 g, propylene glycol 6.0 mL, ethanol (96%) 0.52 mL, and Water for Injection to a total of 10 mL. Melphalan hydrochloride for injection is administered intravenously."
},
{
"NDCCode": "72611-874-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (72611-874-10) / 5 mL in 1 VIAL, SINGLE-DOSE (72611-874-01) ",
"NDC11Code": "72611-0874-10",
"ProductNDC": "72611-874",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Regadenoson",
"NonProprietaryName": "Regadenoson",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207320",
"LabelerName": "Almaject, Inc.",
"SubstanceName": "REGADENOSON",
"StrengthNumber": ".08",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adenosine Receptor Agonists [MoA], Pharmacologic Cardiac Stress Test Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230703",
"SamplePackage": "N",
"IndicationAndUsage": "Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.",
"Description": "Regadenoson is an A2A adenosine receptor agonist that is a coronary vasodilator [see Clinical Pharmacology (12.1)]. Regadenoson is chemically described as adenosine, 2- [4-[(methylamino) carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its structural formula is. The molecular formula for regadenoson is C15H18N8O5.H2O and its molecular weight is 408.37.Regadenoson injection is a sterile, nonpyrogenic solution for intravenous injection. The solution is clear and colorless. Each 1 mL in the 5 mL vial contains 0.08 mg of regadenoson, 10.9 mg dibasic sodium phosphate dihydrate, 5.4 mg monobasic sodium phosphate monohydrate, 150 mg propylene glycol, 1 mg edetate disodium dihydrate, and Water for Injection, with pH between 6.3 and 7.7."
},
{
"NDCCode": "80425-0245-1",
"PackageDescription": "1 KIT in 1 CARTON (80425-0245-1) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18) * .9 mL in 1 PACKET (67777-419-02) * 5 mL in 1 POUCH * 10 AMPULE in 1 CARTON (55150-158-72) / 2 mL in 1 AMPULE * 1 mL in 1 VIAL, SINGLE-DOSE (72611-722-01) ",
"NDC11Code": "80425-0245-01",
"ProductNDC": "80425-0245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorocaine Lm Kit",
"NonProprietaryName": "Ketorolac Tromethamine, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine",
"DosageFormName": "KIT",
"RouteName": "EPIDURAL; INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL",
"StartMarketingDate": "20230512",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Advanced Rx Pharmacy of Tennessee, LLC",
"Status": "Active",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230512",
"SamplePackage": "N"
},
{
"NDCCode": "10135-756-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (10135-756-10) ",
"NDC11Code": "10135-0756-10",
"ProductNDC": "10135-756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071173",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220801",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol tablets, USP are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets, USP are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets, USP are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets, USP are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets, USP should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.",
"Description": "Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4’—fluorobutyrophenone and it has the following structural formula. Haloperidol is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, pregelatinized starch. In addition, the 1 mg, 5 mg and 10 mg tablets contain D&C Yellow No. 10 Aluminum Lake. The 5 mg and 10 mg tablets contain FD&C Blue No. 1 Aluminum Lake, 20 mg tablets contain FD&C Red No. 40 Aluminum Lake."
},
{
"NDCCode": "12634-756-00",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (12634-756-00)",
"NDC11Code": "12634-0756-00",
"ProductNDC": "12634-756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091184",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"IndicationAndUsage": "Metformin hydrochloride tablets USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets USP are oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride ( N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients corn starch, povidone and magnesium stearate. In addition, the coating for each tablet contains hypromellose, talc, titanium dioxide, polyethylene glycol, and propylene glycol."
},
{
"NDCCode": "12634-756-61",
"PackageDescription": "10 TABLET, FILM COATED in 1 BLISTER PACK (12634-756-61)",
"NDC11Code": "12634-0756-61",
"ProductNDC": "12634-756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091184",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"IndicationAndUsage": "Metformin hydrochloride tablets USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets USP are oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride ( N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients corn starch, povidone and magnesium stearate. In addition, the coating for each tablet contains hypromellose, talc, titanium dioxide, polyethylene glycol, and propylene glycol."
},
{
"NDCCode": "13517-756-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (13517-756-10) ",
"NDC11Code": "13517-0756-10",
"ProductNDC": "13517-756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190321",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "e5 Pharma, LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190321",
"SamplePackage": "N"
},
{
"NDCCode": "16571-756-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (16571-756-10) ",
"NDC11Code": "16571-0756-10",
"ProductNDC": "16571-756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram",
"NonProprietaryName": "Escitalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078777",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230610",
"SamplePackage": "N",
"IndicationAndUsage": "Escitalopram tablets are indicated for the treatment of: 1 major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older., 2 generalized anxiety disorder (GAD) in adults.",
"Description": "Escitalopram Tablets, USP are an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate, USP occurs as a fine, white to off-white powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram oxalate is available as tablets. Escitalopram Tablets, USP are film-coated, round tablets containing escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: butylated hydroxyanisole, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The film coating contains hydroxypropyl cellulose, hypromellose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "24909-756-10",
"PackageDescription": "100 mL in 1 BOTTLE (24909-756-10) ",
"NDC11Code": "24909-0756-10",
"ProductNDC": "24909-756",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cbd Clinic Relax Massage",
"NonProprietaryName": "Camphor",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191215",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Aidance Skincare & Topical Solutions, LLC",
"SubstanceName": "CAMPHOR (NATURAL)",
"StrengthNumber": "3",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191215",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pain of muscles and joints associated with: simple backache arthritis strains bruises sprains."
},
{
"NDCCode": "25021-756-10",
"PackageDescription": "10 VIAL in 1 CARTON (25021-756-10) / 10 mL in 1 VIAL",
"NDC11Code": "25021-0756-10",
"ProductNDC": "25021-756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251015",
"EndMarketingDate": "20270331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219935",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20251015",
"EndMarketingDatePackage": "20270331",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidine Injection is indicated for use in hospitalized adults, or as an alternative to oral famotidine in adults, for the treatment of: : 1 active duodenal ulcer (DU). , 2 active gastric ulcer (GU). , 3 symptomatic nonerosive gastroesophageal reflux disease (GERD). , 4 erosive esophagitis due to GERD, diagnosed by endoscopy. , 5 treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). , 6 reduction of the risk of duodenal ulcer recurrence. .",
"Description": "The active ingredient in Famotidine Injection is a histamine H2-receptor antagonist. Famotidine, USP is N'-(aminosulfonyl)-3-[[[2-[ ( diaminomethylene )amino ]-4 thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.45. Its structural formula is:. Famotidine, USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. Famotidine Injection is supplied as a premixed, ready-to-use, sterile solution for intravenous injection. Each mL contains 4 mg of famotidine and the following inactive ingredients: L-aspartic acid 1.6 mg, mannitol 8 mg, sodium chloride 7 mg, and Water for Injection q.s. 1 mL. The multiple-dose vials of 10 mL and 50 mL also contain benzyl alcohol 0.36% (3.6 mg per mL) added as a preservative. The pH ranges for all three concentrations range from 5.7 to 6.4 and may have been adjusted with sodium hydroxide."
},
{
"NDCCode": "31722-756-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (31722-756-10) ",
"NDC11Code": "31722-0756-10",
"ProductNDC": "31722-756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"NonProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219869",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "100; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260527",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium and hydrochlorothiazide tablet is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2).",
"Description": "Losartan potassium and hydrochlorothiazide tablets 50 mg/12.5 mg, 100 mg/12.5 mg and 100 mg/25 mg combine an angiotensin II receptor blocker acting on the AT 1receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol, monopotassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to almost white crystalline powder with a molecular weight of 461.00. It is freely soluble in water and in methanol, slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 2H-1,2,4-benzothiadiazine-7-sulphonamide-6-chloro-3,4-dihydro-1,1-dioxide. Its molecular formula is C 7H 8ClN 3O 4S 2and its structural formula is:. Hydrochlorothiazide, USP is a white or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, freely soluble in sodium hydroxide solution, n-butylamine and in dimethylformamide, sparingly soluble in methanol, insoluble in ether, chloroform and in dilute mineral acids. Losartan potassium and hydrochlorothiazide tablets are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contains 50 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contains 100 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contains 100 mg of losartan potassium, USP and 25 mg of hydrochlorothiazide, USP. Inactive ingredients are colloidal silicon dioxide, D&C yellow #10 aluminum lake (for 50 mg/12.5 mg and 100 mg/25 mg strength tablets only), hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and titanium dioxide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contains 8.48 mg (0.216 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium. FDA dissolution test specifications differ from USP."
},
{
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"ProductNDC": "43598-756",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212795",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "LORATADINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2023-07-14",
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"StartMarketingDatePackage": "20230714",
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"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
},
{
"NDCCode": "43598-756-30",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (43598-756-30) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "43598-0756-30",
"ProductNDC": "43598-756",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
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"StartMarketingDate": "20210519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212795",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "LORATADINE",
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"StrengthUnit": "mg/1",
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"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
},
{
"NDCCode": "49035-756-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (49035-756-10) ",
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"ProductNDC": "49035-756",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Fiber Therapy",
"NonProprietaryName": "Methylcellulose",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170830",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Wal-Mart Stores,Inc.,",
"SubstanceName": "METHYLCELLULOSE (4000 MPA.S)",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-10-28",
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"IndicationAndUsage": "helps restore and maintain regularity and relieves constipation (irregularity). in the treatment of constipation associated with other bowel disorders when recommended by a doctor."
},
{
"NDCCode": "65841-756-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (65841-756-10) ",
"NDC11Code": "65841-0756-10",
"ProductNDC": "65841-756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Galantamine",
"NonProprietaryName": "Galantamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111010",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078898",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "GALANTAMINE HYDROBROMIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20111010",
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},
{
"NDCCode": "65841-756-30",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (65841-756-30) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "65841-0756-30",
"ProductNDC": "65841-756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Galantamine",
"NonProprietaryName": "Galantamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111010",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078898",
"LabelerName": "Cadila Healthcare Limited",
"SubstanceName": "GALANTAMINE HYDROBROMIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20111010",
"SamplePackage": "N"
},
{
"NDCCode": "65841-756-77",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (65841-756-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "65841-0756-77",
"ProductNDC": "65841-756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Galantamine",
"NonProprietaryName": "Galantamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111010",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078898",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "GALANTAMINE HYDROBROMIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20111010",
"SamplePackage": "N"
},
{
"NDCCode": "67457-756-10",
"PackageDescription": "1 KIT in 1 KIT (67457-756-10) * 6 mL in 1 VIAL (67457-754-10) * 2 mL in 1 SYRINGE (67457-755-02) ",
"NDC11Code": "67457-0756-10",
"ProductNDC": "67457-756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Octreotide Acetate",
"NonProprietaryName": "Octreotide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "20260128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216589",
"LabelerName": "Mylan Institutional LLC",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260128",
"SamplePackage": "N",
"IndicationAndUsage": "Octreotide acetate for injectable suspension 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with octreotide acetate injection has been shown to be effective and tolerated.",
"Description": "Octreotide is the acetate salt of a cyclic octapeptide. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Octreotide is known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxy-methyl) propyl]-, cyclic (2→7)-disulfide; [R-(R*,R*)]. The molecular weight of octreotide is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is. Octreotide acetate for injectable suspension is available in a single-dose vial containing the sterile drug product, which when mixed with diluent, becomes a suspension that is given as a monthly intragluteal injection. The octreotide is uniformly distributed within the microspheres which are made of a biodegradable glucose star polymer, D,L-lactic and glycolic acids copolymer. Sterile mannitol is added to the microspheres to improve suspendability. Octreotide acetate for injectable suspension is available as: sterile 6 mL single-dose vials in 3 strengths delivering 10 mg, 20 mg, or 30 mg octreotide-free peptide. Each single-dose vial of octreotide acetate for injectable suspension delivers."
},
{
"NDCCode": "68094-756-62",
"PackageDescription": "3 TRAY in 1 CASE (68094-756-62) > 10 CUP, UNIT-DOSE in 1 TRAY > 4 mL in 1 CUP, UNIT-DOSE (68094-756-59) ",
"NDC11Code": "68094-0756-62",
"ProductNDC": "68094-756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20121023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070434",
"LabelerName": "Precision Dose Inc.",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2022-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20121023",
"SamplePackage": "N",
"IndicationAndUsage": "Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.",
"Description": "Each mL of Oral Solution for oral administration contains. Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is a white to slightly yellow, crystalline powder. It is practically insoluble in water; freely soluble in acetone, dimethylformamide and in solutions of alkali hydroxides; soluble in methanol; sparingly soluble in alcohol; slightly soluble in ether; very slightly soluble in chloroform. The CAS Registry Number is 54-31-9. The structural formula is as follows. Furosemide Oral Solution USP is also available for oral administration containing either 10 mg per mL or 40 mg per 5 mL. The oral solution contains the following inactive ingredients: D and C Yellow No. 10, FD and C Yellow No. 6, flavors, potassium carbonate 1½ hydrate, propylene glycol, purified water and sorbitol solution. The 10 mg/mL solution is orange flavored and contains prosweet liquid and saccharin sodium. The 40 mg/5 mL solution is pineapple-peach flavored and contains sweet tone."
},
{
"NDCCode": "71205-756-10",
"PackageDescription": "10 TABLET in 1 BOTTLE, PLASTIC (71205-756-10) ",
"NDC11Code": "71205-0756-10",
"ProductNDC": "71205-756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211011",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072926",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230223",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Lorazepam, USP, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a nearly white powder almost insoluble in water. Each lorazepam tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "76420-756-10",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (76420-756-10) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "76420-0756-10",
"ProductNDC": "76420-756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION; PERINEURAL",
"StartMarketingDate": "20171030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207182",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-06-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240620",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine hydrochloride injection is indicated for production of local or regional anesthesia by infiltration techniques, such as percutaneous injection, and by peripheral nerve block techniques such as brachial plexus and intercostal, when the accepted procedures for these techniques as described in standard textbooks are observed.",
"Description": "Lidocaine hydrochloride injection, USP is sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONS AND USAGEsection for specific uses. Lidocaine hydrochloride injection, USP contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular weight 270.8. Lidocaine hydrochloride (C 14H 22N 2O HCl) has the following structural formula:. Lidocaine hydrochloride USP is a white, odorless, crystalline powder. Lidocaine hydrochloride injection, USP is a sterile, nonpyrogenic, clear, colorless, isotonic solution containing sodium chloride. Each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of the solution is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>72611-756-10</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (72611-756-10) / 5 mL in 1 VIAL, MULTI-DOSE (72611-756-01) </PackageDescription>
<NDC11Code>72611-0756-10</NDC11Code>
<ProductNDC>72611-756</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rocuronium Bromide</ProprietaryName>
<NonProprietaryName>Rocuronium Bromide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200327</StartMarketingDate>
<EndMarketingDate>20250301</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205656</ApplicationNumber>
<LabelerName>Almaject, Inc.</LabelerName>
<SubstanceName>ROCURONIUM BROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200327</StartMarketingDatePackage>
<EndMarketingDatePackage>20250301</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2- propenyl)pyrrolidinium bromide. The structural formula is. The chemical formula is C32H53BrN2O4 with a molecular weight of 609.70. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide 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 and to a pH of 4 with acetic acid and/or sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>72611-700-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (72611-700-01) / 10.8 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>72611-0700-01</NDC11Code>
<ProductNDC>72611-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Caspofungin Acetate</ProprietaryName>
<NonProprietaryName>Caspofungin Acetate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200331</StartMarketingDate>
<EndMarketingDate>20251101</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207092</ApplicationNumber>
<LabelerName>Almaject, Inc.</LabelerName>
<SubstanceName>CASPOFUNGIN ACETATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Echinocandin Antifungal [EPC], Lipopeptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200331</StartMarketingDatePackage>
<EndMarketingDatePackage>20251101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Caspofungin acetate for injection is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for: : 1 Empirical therapy for presumed fungal infections in febrile, neutropenic patients. (1) , 2 Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. (1) , 3 Treatment of esophageal candidiasis. (1) , 4 Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. (1) .</IndicationAndUsage>
<Description>Caspofungin acetate for injection is a sterile, lyophilized product for intravenous (IV) infusion that contains a semisynthetic lipopeptide (echinocandin) compound synthesized from a fermentation product of Glarea lozoyensis. Caspofungin acetate is an echinocandin antifungal that inhibits the synthesis of β (1,3)-D-glucan, an integral component of the fungal cell wall. Caspofungin acetate is 1-[(4R,5S)-5-[(2-aminoethyl)amino]-N2-(10,12-dimethyl-1-oxotetradecyl)-4-hydroxy-L-ornithine]-5-[(3R)-3-hydroxy-L-ornithine] pneumocandin B0 diacetate (salt). Caspofungin acetate for injection 50 mg vial contains 50 mg of caspofungin equivalent to 55.5 mg of caspofungin acetate. Caspofungin acetate for injection 50 mg vial also contains 39 mg sucrose, 26 mg mannitol, 2 mg glacial acetic acid added as a buffering agent, and sodium hydroxide added as a pH adjuster ingredient. Caspofungin acetate for injection 70 mg vial contains 70 mg of caspofungin equivalent to 77.7 mg of caspofungin acetate. Caspofungin acetate for injection 70 mg vial also contains 54 mg sucrose, 36 mg mannitol, 2.7 mg glacial acetic acid added as a buffering agent, and sodium hydroxide added as a pH adjuster ingredient. Caspofungin acetate is a hygroscopic, white to off-white powder. It is freely soluble in water and methanol, and slightly soluble in ethanol. The pH of a saturated aqueous solution of caspofungin acetate is approximately 6.6. The empirical formula is C52H88N10O152C2H4O2 and the formula weight is 1213.42. The structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>72611-702-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (72611-702-01) / 10.8 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>72611-0702-01</NDC11Code>
<ProductNDC>72611-702</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Caspofungin Acetate</ProprietaryName>
<NonProprietaryName>Caspofungin Acetate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200331</StartMarketingDate>
<EndMarketingDate>20241101</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207092</ApplicationNumber>
<LabelerName>Almaject, Inc.</LabelerName>
<SubstanceName>CASPOFUNGIN ACETATE</SubstanceName>
<StrengthNumber>7</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Echinocandin Antifungal [EPC], Lipopeptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200331</StartMarketingDatePackage>
<EndMarketingDatePackage>20241101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Caspofungin acetate for injection is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for: : 1 Empirical therapy for presumed fungal infections in febrile, neutropenic patients. (1) , 2 Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. (1) , 3 Treatment of esophageal candidiasis. (1) , 4 Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. (1) .</IndicationAndUsage>
<Description>Caspofungin acetate for injection is a sterile, lyophilized product for intravenous (IV) infusion that contains a semisynthetic lipopeptide (echinocandin) compound synthesized from a fermentation product of Glarea lozoyensis. Caspofungin acetate is an echinocandin antifungal that inhibits the synthesis of β (1,3)-D-glucan, an integral component of the fungal cell wall. Caspofungin acetate is 1-[(4R,5S)-5-[(2-aminoethyl)amino]-N2-(10,12-dimethyl-1-oxotetradecyl)-4-hydroxy-L-ornithine]-5-[(3R)-3-hydroxy-L-ornithine] pneumocandin B0 diacetate (salt). Caspofungin acetate for injection 50 mg vial contains 50 mg of caspofungin equivalent to 55.5 mg of caspofungin acetate. Caspofungin acetate for injection 50 mg vial also contains 39 mg sucrose, 26 mg mannitol, 2 mg glacial acetic acid added as a buffering agent, and sodium hydroxide added as a pH adjuster ingredient. Caspofungin acetate for injection 70 mg vial contains 70 mg of caspofungin equivalent to 77.7 mg of caspofungin acetate. Caspofungin acetate for injection 70 mg vial also contains 54 mg sucrose, 36 mg mannitol, 2.7 mg glacial acetic acid added as a buffering agent, and sodium hydroxide added as a pH adjuster ingredient. Caspofungin acetate is a hygroscopic, white to off-white powder. It is freely soluble in water and methanol, and slightly soluble in ethanol. The pH of a saturated aqueous solution of caspofungin acetate is approximately 6.6. The empirical formula is C52H88N10O152C2H4O2 and the formula weight is 1213.42. The structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>72611-740-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (72611-740-10) / 5 mL in 1 VIAL, SINGLE-DOSE (72611-740-01) </PackageDescription>
<NDC11Code>72611-0740-10</NDC11Code>
<ProductNDC>72611-740</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200331</StartMarketingDate>
<EndMarketingDate>20261101</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204205</ApplicationNumber>
<LabelerName>Almaject, Inc.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200331</StartMarketingDatePackage>
<EndMarketingDatePackage>20261101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate injection is indicated in the treatment of definite or suspected acute myocardial infarction in hemodynamically stable patients to reduce cardiovascular mortality when used in conjunction with oral metoprolol maintenance therapy.</IndicationAndUsage>
<Description>Metoprolol tartrate USP, is a selective beta1-adrenoreceptor blocking agent, available in 5 mL vials for intravenous administration. Each vial contains a sterile solution of metoprolol tartrate USP, 5 mg, and sodium chloride USP, 45 mg, and water for injection USP. Metoprolol tartrate USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L- (+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether.</Description>
</NDC>
<NDC>
<NDCCode>72611-749-10</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (72611-749-10) / 10 mL in 1 VIAL, MULTI-DOSE (72611-749-01) </PackageDescription>
<NDC11Code>72611-0749-10</NDC11Code>
<ProductNDC>72611-749</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Midazolam</ProprietaryName>
<NonProprietaryName>Midazolam</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20200414</StartMarketingDate>
<EndMarketingDate>20260401</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090850</ApplicationNumber>
<LabelerName>Almaject, Inc.</LabelerName>
<SubstanceName>MIDAZOLAM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200414</StartMarketingDatePackage>
<EndMarketingDatePackage>20260401</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Midazolam Injection is indicated: : 1 intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;, 2 intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;, 3 intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);, 4 continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting. .</IndicationAndUsage>
<Description>Midazolam hydrochloride is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 5 mg midazolam compounded with 0.8% sodium chloride and 0.01% edetate disodium, with 1% benzyl alcohol as preservative; the pH is adjusted to 2.9 to 3.5 with hydrochloric acid and, if necessary, sodium hydroxide. Midazolam is a white or yellowish crystalline powder, insoluble in water. The hydrochloride salt of midazolam, which is formed in situ, is soluble in aqueous solutions. Chemically, midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine hydrochloride. Midazolam hydrochloride has the empirical formula C18H13ClFN3HCl, a calculated molecular weight of 362.25 and the following structural formula:. Under the acidic conditions required to solubilize midazolam in the product, midazolam is present as an equilibrium mixture (shown below) of the closed ring form shown above and an open-ring structure formed by the acid-catalyzed ring opening of the 4,5-double bond of the diazepine ring. The amount of open-ring form is dependent upon the pH of the solution. At the specified pH of the product, the solution may contain up to about 25% of the open-ring compound. At the physiologic conditions under which the product is absorbed (pH of 5 to 8) into the systemic circulation, any open-ring form present reverts to the physiologically active, lipophilic, closed-ring form (midazolam) and is absorbed as such. The following chart plots the percentage of midazolam present as the open-ring form as a function of pH in aqueous solutions. As indicated in the graph, the amount of open-ring compound present in solution is sensitive to changes in pH over the pH range specified for the product: 3.0 to 3.6 for the 5 mg/mL concentration. Above pH 5, at least 99% of the mixture is present in the closed-ring form.</Description>
</NDC>
<NDC>
<NDCCode>72611-757-10</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (72611-757-10) / 10 mL in 1 VIAL, MULTI-DOSE (72611-757-01) </PackageDescription>
<NDC11Code>72611-0757-10</NDC11Code>
<ProductNDC>72611-757</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rocuronium Bromide</ProprietaryName>
<NonProprietaryName>Rocuronium Bromide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200327</StartMarketingDate>
<EndMarketingDate>20250301</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205656</ApplicationNumber>
<LabelerName>Almaject, Inc.</LabelerName>
<SubstanceName>ROCURONIUM BROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200327</StartMarketingDatePackage>
<EndMarketingDatePackage>20250301</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2- propenyl)pyrrolidinium bromide. The structural formula is. The chemical formula is C32H53BrN2O4 with a molecular weight of 609.70. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide 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 and to a pH of 4 with acetic acid and/or sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>72611-760-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (72611-760-10) / 10 mL in 1 VIAL, SINGLE-DOSE (72611-760-01) </PackageDescription>
<NDC11Code>72611-0760-10</NDC11Code>
<ProductNDC>72611-760</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tranexamic Acid</ProprietaryName>
<NonProprietaryName>Tranexamic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207239</ApplicationNumber>
<LabelerName>Almaject, Inc.</LabelerName>
<SubstanceName>TRANEXAMIC ACID</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.</IndicationAndUsage>
<Description>Tranexamic acid, USP is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid, USP is a white crystalline powder. The structural formula is. Empirical Formula: C8H15NO2 Molecular Weight: 157.2. Each mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid, USP and Water for Injection to 1 mL. The aqueous solution for injection has a pH of 6.5 to 8.0.</Description>
</NDC>
<NDC>
<NDCCode>72611-761-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (72611-761-10) / 10 mL in 1 VIAL (72611-761-01) </PackageDescription>
<NDC11Code>72611-0761-10</NDC11Code>
<ProductNDC>72611-761</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>20200508</StartMarketingDate>
<EndMarketingDate>20250201</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205694</ApplicationNumber>
<LabelerName>Almaject, Inc.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200508</StartMarketingDatePackage>
<EndMarketingDatePackage>20250201</EndMarketingDatePackage>
<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 a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 gram vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. 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 Amycolatopasis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-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-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-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 1,485.74. Vancomycin hydrochloride has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>72611-765-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (72611-765-10) / 20 mL in 1 VIAL (72611-765-01) </PackageDescription>
<NDC11Code>72611-0765-10</NDC11Code>
<ProductNDC>72611-765</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>20200508</StartMarketingDate>
<EndMarketingDate>20241201</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205694</ApplicationNumber>
<LabelerName>Almaject, Inc.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/20mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200508</StartMarketingDatePackage>
<EndMarketingDatePackage>20241201</EndMarketingDatePackage>
<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 a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 gram vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. 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 Amycolatopasis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-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-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-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 1,485.74. Vancomycin hydrochloride has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>72611-779-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (72611-779-02) * 10 mL in 1 VIAL, SINGLE-DOSE (72611-772-01) * 10 mL in 1 VIAL, SINGLE-DOSE (72611-776-01) </PackageDescription>
<NDC11Code>72611-0779-02</NDC11Code>
<ProductNDC>72611-779</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Melphalan Hydrochloride</ProprietaryName>
<NonProprietaryName>Melphalan Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20190518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204817</ApplicationNumber>
<LabelerName>Almaject, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Melphalan hydrochloride for injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.</IndicationAndUsage>
<Description>Melphalan, also known as L-phenylalanine mustard, phenylalanine mustard, L-PAM, or L-sarcolysin, is a phenylalanine derivative of nitrogen mustard. Melphalan is a bifunctional alkylating agent that is active against selected human neoplastic diseases. It is known chemically as 4-[bis(2-chloroethyl)amino]-L-phenylalanine. The molecular formula is C13H18Cl2N2O2 and the molecular weight is 305.20. The structural formula is. Melphalan is the active L-isomer of the compound and was first synthesized in 1953 by Bergel and Stock; the D-isomer, known as medphalan, is less active against certain animal tumors, and the dose needed to produce effects on chromosomes is larger than that required with the L-isomer. The racemic (DL-) form is known as merphalan or sarcolysin. Melphalan is practically insoluble in water and has a pKa1 of ~ 2.5. Melphalan hydrochloride for injection is supplied as a sterile, nonpyrogenic, freeze-dried powder. Each single-dose vial contains melphalan hydrochloride equivalent to 50 mg melphalan and 20 mg povidone. Melphalan hydrochloride for injection is reconstituted using the sterile diluent provided. Each vial of sterile diluent contains sodium citrate 0.2 g, propylene glycol 6.0 mL, ethanol (96%) 0.52 mL, and Water for Injection to a total of 10 mL. Melphalan hydrochloride for injection is administered intravenously.</Description>
</NDC>
<NDC>
<NDCCode>72611-874-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (72611-874-10) / 5 mL in 1 VIAL, SINGLE-DOSE (72611-874-01) </PackageDescription>
<NDC11Code>72611-0874-10</NDC11Code>
<ProductNDC>72611-874</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Regadenoson</ProprietaryName>
<NonProprietaryName>Regadenoson</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230703</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207320</ApplicationNumber>
<LabelerName>Almaject, Inc.</LabelerName>
<SubstanceName>REGADENOSON</SubstanceName>
<StrengthNumber>.08</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adenosine Receptor Agonists [MoA], Pharmacologic Cardiac Stress Test Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.</IndicationAndUsage>
<Description>Regadenoson is an A2A adenosine receptor agonist that is a coronary vasodilator [see Clinical Pharmacology (12.1)]. Regadenoson is chemically described as adenosine, 2- [4-[(methylamino) carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its structural formula is. The molecular formula for regadenoson is C15H18N8O5.H2O and its molecular weight is 408.37.Regadenoson injection is a sterile, nonpyrogenic solution for intravenous injection. The solution is clear and colorless. Each 1 mL in the 5 mL vial contains 0.08 mg of regadenoson, 10.9 mg dibasic sodium phosphate dihydrate, 5.4 mg monobasic sodium phosphate monohydrate, 150 mg propylene glycol, 1 mg edetate disodium dihydrate, and Water for Injection, with pH between 6.3 and 7.7.</Description>
</NDC>
<NDC>
<NDCCode>80425-0245-1</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (80425-0245-1) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18) * .9 mL in 1 PACKET (67777-419-02) * 5 mL in 1 POUCH * 10 AMPULE in 1 CARTON (55150-158-72) / 2 mL in 1 AMPULE * 1 mL in 1 VIAL, SINGLE-DOSE (72611-722-01) </PackageDescription>
<NDC11Code>80425-0245-01</NDC11Code>
<ProductNDC>80425-0245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorocaine Lm Kit</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL</RouteName>
<StartMarketingDate>20230512</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Advanced Rx Pharmacy of Tennessee, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10135-756-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (10135-756-10) </PackageDescription>
<NDC11Code>10135-0756-10</NDC11Code>
<ProductNDC>10135-756</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071173</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol tablets, USP are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets, USP are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets, USP are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets, USP are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets, USP should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
<Description>Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4’—fluorobutyrophenone and it has the following structural formula. Haloperidol is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, pregelatinized starch. In addition, the 1 mg, 5 mg and 10 mg tablets contain D&C Yellow No. 10 Aluminum Lake. The 5 mg and 10 mg tablets contain FD&C Blue No. 1 Aluminum Lake, 20 mg tablets contain FD&C Red No. 40 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>12634-756-00</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (12634-756-00)</PackageDescription>
<NDC11Code>12634-0756-00</NDC11Code>
<ProductNDC>12634-756</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091184</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metformin hydrochloride tablets USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets USP are oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride ( N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients corn starch, povidone and magnesium stearate. In addition, the coating for each tablet contains hypromellose, talc, titanium dioxide, polyethylene glycol, and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>12634-756-61</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BLISTER PACK (12634-756-61)</PackageDescription>
<NDC11Code>12634-0756-61</NDC11Code>
<ProductNDC>12634-756</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091184</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metformin hydrochloride tablets USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets USP are oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride ( N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients corn starch, povidone and magnesium stearate. In addition, the coating for each tablet contains hypromellose, talc, titanium dioxide, polyethylene glycol, and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>13517-756-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (13517-756-10) </PackageDescription>
<NDC11Code>13517-0756-10</NDC11Code>
<ProductNDC>13517-756</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190321</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>e5 Pharma, LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16571-756-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (16571-756-10) </PackageDescription>
<NDC11Code>16571-0756-10</NDC11Code>
<ProductNDC>16571-756</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078777</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Escitalopram tablets are indicated for the treatment of: 1 major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older., 2 generalized anxiety disorder (GAD) in adults.</IndicationAndUsage>
<Description>Escitalopram Tablets, USP are an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate, USP occurs as a fine, white to off-white powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram oxalate is available as tablets. Escitalopram Tablets, USP are film-coated, round tablets containing escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: butylated hydroxyanisole, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The film coating contains hydroxypropyl cellulose, hypromellose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>24909-756-10</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (24909-756-10) </PackageDescription>
<NDC11Code>24909-0756-10</NDC11Code>
<ProductNDC>24909-756</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cbd Clinic Relax Massage</ProprietaryName>
<NonProprietaryName>Camphor</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Aidance Skincare & Topical Solutions, LLC</LabelerName>
<SubstanceName>CAMPHOR (NATURAL)</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pain of muscles and joints associated with: simple backache arthritis strains bruises sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>25021-756-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (25021-756-10) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0756-10</NDC11Code>
<ProductNDC>25021-756</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251015</StartMarketingDate>
<EndMarketingDate>20270331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219935</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20251015</StartMarketingDatePackage>
<EndMarketingDatePackage>20270331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidine Injection is indicated for use in hospitalized adults, or as an alternative to oral famotidine in adults, for the treatment of: : 1 active duodenal ulcer (DU). , 2 active gastric ulcer (GU). , 3 symptomatic nonerosive gastroesophageal reflux disease (GERD). , 4 erosive esophagitis due to GERD, diagnosed by endoscopy. , 5 treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). , 6 reduction of the risk of duodenal ulcer recurrence. .</IndicationAndUsage>
<Description>The active ingredient in Famotidine Injection is a histamine H2-receptor antagonist. Famotidine, USP is N'-(aminosulfonyl)-3-[[[2-[ ( diaminomethylene )amino ]-4 thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.45. Its structural formula is:. Famotidine, USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. Famotidine Injection is supplied as a premixed, ready-to-use, sterile solution for intravenous injection. Each mL contains 4 mg of famotidine and the following inactive ingredients: L-aspartic acid 1.6 mg, mannitol 8 mg, sodium chloride 7 mg, and Water for Injection q.s. 1 mL. The multiple-dose vials of 10 mL and 50 mL also contain benzyl alcohol 0.36% (3.6 mg per mL) added as a preservative. The pH ranges for all three concentrations range from 5.7 to 6.4 and may have been adjusted with sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>31722-756-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (31722-756-10) </PackageDescription>
<NDC11Code>31722-0756-10</NDC11Code>
<ProductNDC>31722-756</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Losartan Potassium And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219869</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>100; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium and hydrochlorothiazide tablet is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2).</IndicationAndUsage>
<Description>Losartan potassium and hydrochlorothiazide tablets 50 mg/12.5 mg, 100 mg/12.5 mg and 100 mg/25 mg combine an angiotensin II receptor blocker acting on the AT 1receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol, monopotassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to almost white crystalline powder with a molecular weight of 461.00. It is freely soluble in water and in methanol, slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 2H-1,2,4-benzothiadiazine-7-sulphonamide-6-chloro-3,4-dihydro-1,1-dioxide. Its molecular formula is C 7H 8ClN 3O 4S 2and its structural formula is:. Hydrochlorothiazide, USP is a white or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, freely soluble in sodium hydroxide solution, n-butylamine and in dimethylformamide, sparingly soluble in methanol, insoluble in ether, chloroform and in dilute mineral acids. Losartan potassium and hydrochlorothiazide tablets are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contains 50 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contains 100 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contains 100 mg of losartan potassium, USP and 25 mg of hydrochlorothiazide, USP. Inactive ingredients are colloidal silicon dioxide, D&C yellow #10 aluminum lake (for 50 mg/12.5 mg and 100 mg/25 mg strength tablets only), hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and titanium dioxide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contains 8.48 mg (0.216 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium. FDA dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>43598-756-10</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (43598-756-10) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>43598-0756-10</NDC11Code>
<ProductNDC>43598-756</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212795</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-756-30</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (43598-756-30) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>43598-0756-30</NDC11Code>
<ProductNDC>43598-756</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212795</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49035-756-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (49035-756-10) </PackageDescription>
<NDC11Code>49035-0756-10</NDC11Code>
<ProductNDC>49035-756</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Fiber Therapy</ProprietaryName>
<NonProprietaryName>Methylcellulose</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170830</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>Wal-Mart Stores,Inc.,</LabelerName>
<SubstanceName>METHYLCELLULOSE (4000 MPA.S)</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps restore and maintain regularity and relieves constipation (irregularity). in the treatment of constipation associated with other bowel disorders when recommended by a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65841-756-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (65841-756-10) </PackageDescription>
<NDC11Code>65841-0756-10</NDC11Code>
<ProductNDC>65841-756</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Galantamine</ProprietaryName>
<NonProprietaryName>Galantamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111010</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078898</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65841-756-30</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (65841-756-30) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65841-0756-30</NDC11Code>
<ProductNDC>65841-756</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Galantamine</ProprietaryName>
<NonProprietaryName>Galantamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111010</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078898</ApplicationNumber>
<LabelerName>Cadila Healthcare Limited</LabelerName>
<SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65841-756-77</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (65841-756-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65841-0756-77</NDC11Code>
<ProductNDC>65841-756</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Galantamine</ProprietaryName>
<NonProprietaryName>Galantamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111010</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078898</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67457-756-10</NDCCode>
<PackageDescription>1 KIT in 1 KIT (67457-756-10) * 6 mL in 1 VIAL (67457-754-10) * 2 mL in 1 SYRINGE (67457-755-02) </PackageDescription>
<NDC11Code>67457-0756-10</NDC11Code>
<ProductNDC>67457-756</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Octreotide Acetate</ProprietaryName>
<NonProprietaryName>Octreotide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216589</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Octreotide acetate for injectable suspension 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with octreotide acetate injection has been shown to be effective and tolerated.</IndicationAndUsage>
<Description>Octreotide is the acetate salt of a cyclic octapeptide. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Octreotide is known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxy-methyl) propyl]-, cyclic (2→7)-disulfide; [R-(R*,R*)]. The molecular weight of octreotide is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is. Octreotide acetate for injectable suspension is available in a single-dose vial containing the sterile drug product, which when mixed with diluent, becomes a suspension that is given as a monthly intragluteal injection. The octreotide is uniformly distributed within the microspheres which are made of a biodegradable glucose star polymer, D,L-lactic and glycolic acids copolymer. Sterile mannitol is added to the microspheres to improve suspendability. Octreotide acetate for injectable suspension is available as: sterile 6 mL single-dose vials in 3 strengths delivering 10 mg, 20 mg, or 30 mg octreotide-free peptide. Each single-dose vial of octreotide acetate for injectable suspension delivers.</Description>
</NDC>
<NDC>
<NDCCode>68094-756-62</NDCCode>
<PackageDescription>3 TRAY in 1 CASE (68094-756-62) > 10 CUP, UNIT-DOSE in 1 TRAY > 4 mL in 1 CUP, UNIT-DOSE (68094-756-59) </PackageDescription>
<NDC11Code>68094-0756-62</NDC11Code>
<ProductNDC>68094-756</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121023</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070434</ApplicationNumber>
<LabelerName>Precision Dose Inc.</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.</IndicationAndUsage>
<Description>Each mL of Oral Solution for oral administration contains. Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is a white to slightly yellow, crystalline powder. It is practically insoluble in water; freely soluble in acetone, dimethylformamide and in solutions of alkali hydroxides; soluble in methanol; sparingly soluble in alcohol; slightly soluble in ether; very slightly soluble in chloroform. The CAS Registry Number is 54-31-9. The structural formula is as follows. Furosemide Oral Solution USP is also available for oral administration containing either 10 mg per mL or 40 mg per 5 mL. The oral solution contains the following inactive ingredients: D and C Yellow No. 10, FD and C Yellow No. 6, flavors, potassium carbonate 1½ hydrate, propylene glycol, purified water and sorbitol solution. The 10 mg/mL solution is orange flavored and contains prosweet liquid and saccharin sodium. The 40 mg/5 mL solution is pineapple-peach flavored and contains sweet tone.</Description>
</NDC>
<NDC>
<NDCCode>71205-756-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE, PLASTIC (71205-756-10) </PackageDescription>
<NDC11Code>71205-0756-10</NDC11Code>
<ProductNDC>71205-756</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211011</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072926</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Lorazepam, USP, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a nearly white powder almost insoluble in water. Each lorazepam tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
</NDC>
<NDC>
<NDCCode>76420-756-10</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (76420-756-10) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>76420-0756-10</NDC11Code>
<ProductNDC>76420-756</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INFILTRATION; PERINEURAL</RouteName>
<StartMarketingDate>20171030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207182</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine hydrochloride injection is indicated for production of local or regional anesthesia by infiltration techniques, such as percutaneous injection, and by peripheral nerve block techniques such as brachial plexus and intercostal, when the accepted procedures for these techniques as described in standard textbooks are observed.</IndicationAndUsage>
<Description>Lidocaine hydrochloride injection, USP is sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONS AND USAGEsection for specific uses. Lidocaine hydrochloride injection, USP contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular weight 270.8. Lidocaine hydrochloride (C 14H 22N 2O HCl) has the following structural formula:. Lidocaine hydrochloride USP is a white, odorless, crystalline powder. Lidocaine hydrochloride injection, USP is a sterile, nonpyrogenic, clear, colorless, isotonic solution containing sodium chloride. Each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of the solution is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid.</Description>
</NDC>
</NDCList>