{
"NDC": [
{
"NDCCode": "68462-755-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (68462-755-25) / 1 mL in 1 VIAL, SINGLE-DOSE (68462-755-01) ",
"NDC11Code": "68462-0755-25",
"ProductNDC": "68462-755",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20231019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217789",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231019",
"SamplePackage": "N"
},
{
"NDCCode": "25021-755-05",
"PackageDescription": "25 VIAL in 1 CARTON (25021-755-05) / 5 mL in 1 VIAL",
"NDC11Code": "25021-0755-05",
"ProductNDC": "25021-755",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251015",
"EndMarketingDate": "20270731",
"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": "20270731",
"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": "43744-755-25",
"PackageDescription": "25 g in 1 DRUM (43744-755-25)",
"NDC11Code": "43744-0755-25",
"ProductNDC": "43744-755",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Potassium Iodide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110307",
"EndMarketingDate": "20110308",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "POTASSIUM IODIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20110308"
},
{
"NDCCode": "57218-755-01",
"PackageDescription": "25 kg in 1 DRUM (57218-755-01) ",
"NDC11Code": "57218-0755-01",
"ProductNDC": "57218-755",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Pyrilamine Maleate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20170602",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Malladi Drugs & Pharmaceuticals Limited",
"SubstanceName": "PYRILAMINE MALEATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-23",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "02-JUN-17"
},
{
"NDCCode": "62935-753-75",
"PackageDescription": "1 KIT in 1 CARTON (62935-753-75) * .25 mL in 1 SYRINGE (62935-754-74) * .25 mL in 1 SYRINGE (62935-755-75) ",
"NDC11Code": "62935-0753-75",
"ProductNDC": "62935-753",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eligard",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20020515",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021343",
"LabelerName": "TOLMAR Inc.",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020515",
"SamplePackage": "N",
"IndicationAndUsage": "ELIGARD® is indicated for the palliative treatment of advanced prostate cancer.",
"Description": "ELIGARD® is a sterile polymeric matrix formulation of leuprolide acetate, a GnRH agonist, for subcutaneous injection. It is designed to deliver leuprolide acetate at a controlled rate over a one-, three-, four- or six-month therapeutic period. Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH) that, when given continuously, inhibits pituitary gonadotropin secretion and suppresses testicular and ovarian steroidogenesis. The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula. ELIGARD® is prefilled and supplied in two separate, sterile syringes whose contents are mixed immediately prior to administration. The two syringes are joined and the single dose product is mixed until it is homogenous. ELIGARD® is administered subcutaneously, where it forms a solid drug delivery depot. One syringe contains the ATRIGEL® Delivery System and the other contains leuprolide acetate. ATRIGEL® is a polymeric (non-gelatin containing) delivery system consisting of a biodegradable poly (DL-lactide-co-glycolide) (PLGH or PLG) polymer formulation dissolved in a biocompatible solvent, N-methyl-2-pyrrolidone (NMP). Refer to Table 6 for the delivery system composition and reconstituted product formulation for each ELIGARD® product. Table 6. ELIGARD® Delivery System Composition and Reconstituted Product Formulation."
},
{
"NDCCode": "69423-755-25",
"PackageDescription": "1 TUBE in 1 CARTON (69423-755-25) / 70 g in 1 TUBE",
"NDC11Code": "69423-0755-25",
"ProductNDC": "69423-755",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crest Pro-health",
"ProprietaryNameSuffix": "Densify Pro Intensive Repair",
"NonProprietaryName": "Stannous Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20230210",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "STANNOUS FLUORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230210",
"SamplePackage": "N",
"IndicationAndUsage": "aids in the prevention of cavities. builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact."
},
{
"NDCCode": "68462-146-45",
"PackageDescription": "4 BOTTLE in 1 BOX (68462-146-45) > 25 TABLET in 1 BOTTLE (68462-146-25)",
"NDC11Code": "68462-0146-45",
"ProductNDC": "68462-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20050303",
"MarketingCategoryName": "UNAPPROVED OTHER",
"LabelerName": "Glenmark Generics Inc., USA",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2014-07-07"
},
{
"NDCCode": "68462-486-19",
"PackageDescription": "1 JAR in 1 CARTON (68462-486-19) / 25 g in 1 JAR",
"NDC11Code": "68462-0486-19",
"ProductNDC": "68462-486",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin And Benzoyl Peroxide",
"NonProprietaryName": "Clindamycin And Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209252",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE",
"StrengthNumber": "10; 50",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190314",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin and Benzoyl Peroxide Gel is indicated for the topical treatment of acne vulgaris.",
"Description": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has a molecular weight of 504.96 g/mol and its chemical name is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L-threo-α-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and Benzoyl Peroxide Gel, 1%/5% also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23 g/mol. Each gram of Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer homopolymer type C, docusate sodium, edetate disodium, sodium hydroxide and purified water."
},
{
"NDCCode": "68462-532-28",
"PackageDescription": "1 BOTTLE in 1 CARTON (68462-532-28) / 25 mL in 1 BOTTLE",
"NDC11Code": "68462-0532-28",
"ProductNDC": "68462-532",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180418",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210190",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180418",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate topical solution is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.",
"Description": "Clobetasol Propionate Topical Solution USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate USP is 21-Chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione17-propionate, and it has the following structural formula. Clobetasol propionate USP has the empirical formula C25H32ClFO5 and a molecular weight of 466.97. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Topical Solution USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a solution base composed of isopropyl alcohol, carbomer homopolymer type B, sodium hydroxide and purified water."
},
{
"NDCCode": "68462-536-70",
"PackageDescription": "24 PACKET in 1 CARTON (68462-536-70) / .25 g in 1 PACKET (68462-536-01) ",
"NDC11Code": "68462-0536-70",
"ProductNDC": "68462-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imiquimod",
"NonProprietaryName": "Imiquimod",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201994",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "IMIQUIMOD",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Increased Cytokine Activity [PE], Increased Cytokine Production [PE], Interferon Inducers [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120306",
"SamplePackage": "N",
"IndicationAndUsage": "Imiquimod cream is indicated for the topical treatment of: 1 Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on the face or scalp in immunocompetent adults. (1.1), 2 Biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults with a maximum tumor diameter of 2.0 cm on trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured. (1.2), 3 External genital and perianal warts (EGW) in immunocompetent patients 12 years of age and older. (1.3).",
"Description": "Imiquimod cream USP is an immune response modifier for topical administration. Each gram contains 50 mg of imiquimod, USP in an off-white oil-in-water vanishing cream base consisting of benzyl alcohol, cetyl alcohol, glycerin, isostearic acid, methylparaben, polysorbate 60, propylparaben, purified water, sorbitan monostearate, stearyl alcohol, white petrolatum and xanthan gum. Chemically, imiquimod, USP is 1-(2-methylpropyl)-1 H-imidazo[4,5-c]quinolin-4-amine. Imiquimod, USP has a molecular formula of C14H16N4 and a molecular weight of 240.3 g/mol. Its structural formula is."
},
{
"NDCCode": "68462-621-02",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (68462-621-02) / 2 mL in 1 VIAL, SINGLE-DOSE (68462-621-54) ",
"NDC11Code": "68462-0621-02",
"ProductNDC": "68462-621",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosphenytoin Sodium",
"NonProprietaryName": "Fosphenytoin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20231013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214926",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "FOSPHENYTOIN SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231013",
"SamplePackage": "N",
"IndicationAndUsage": "Fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection can also be substituted, short-term, for oral phenytoin. Fosphenytoin sodium injection should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].",
"Description": "Fosphenytoin sodium injection, USP is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium USP is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE. The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. Fosphenytoin sodium injection, USP is marketed in 2 mL vials containing a total of 100 mg PE/2mL (50 mg PE/mL) and 10 mL vials containing a total of 500 mg PE/10mL (50 mg PE/mL), for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. Fosphenytoin sodium injection, USP is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS) (12 mg/mL), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. Fosphenytoin sodium injection, USP is a clear, colorless to pale yellow, sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is. The molecular weight of fosphenytoin is 406.24."
},
{
"NDCCode": "68462-621-54",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (68462-621-54) / 2 mL in 1 VIAL, SINGLE-DOSE (68462-621-02) ",
"NDC11Code": "68462-0621-54",
"ProductNDC": "68462-621",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosphenytoin Sodium",
"NonProprietaryName": "Fosphenytoin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20231013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214926",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "FOSPHENYTOIN SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231013",
"SamplePackage": "N",
"IndicationAndUsage": "Fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection can also be substituted, short-term, for oral phenytoin. Fosphenytoin sodium injection should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].",
"Description": "Fosphenytoin sodium injection, USP is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium USP is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE. The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. Fosphenytoin sodium injection, USP is marketed in 2 mL vials containing a total of 100 mg PE/2mL (50 mg PE/mL) and 10 mL vials containing a total of 500 mg PE/10mL (50 mg PE/mL), for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. Fosphenytoin sodium injection, USP is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS) (12 mg/mL), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. Fosphenytoin sodium injection, USP is a clear, colorless to pale yellow, sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is. The molecular weight of fosphenytoin is 406.24."
},
{
"NDCCode": "68462-639-45",
"PackageDescription": "4 BOTTLE in 1 CARTON (68462-639-45) / 25 TABLET in 1 BOTTLE (68462-639-25) ",
"NDC11Code": "68462-0639-45",
"ProductNDC": "68462-639",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20170919",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206391",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2025-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170919",
"SamplePackage": "N",
"IndicationAndUsage": "Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "Nitroglycerin Sublingual Tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin; as well as calcium stearate, croscarmellose sodium, silica dimethyl silylate and lactose monohydrate. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. Molecular weight: 227.09 g/mol."
},
{
"NDCCode": "68462-728-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (68462-728-25) / 5 mL in 1 VIAL, SINGLE-DOSE (68462-728-05) ",
"NDC11Code": "68462-0728-25",
"ProductNDC": "68462-728",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Phosphates",
"NonProprietaryName": "Sodium Phosphates",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220683",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
"StrengthNumber": "276; 268",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260223",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium phosphates injection, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.",
"Description": "Sodium phosphates injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water."
},
{
"NDCCode": "68462-729-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (68462-729-25) / 15 mL in 1 VIAL, SINGLE-DOSE (68462-729-15) ",
"NDC11Code": "68462-0729-25",
"ProductNDC": "68462-729",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Phosphates",
"NonProprietaryName": "Sodium Phosphates",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220683",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
"StrengthNumber": "276; 268",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260223",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium phosphates injection, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.",
"Description": "Sodium phosphates injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water."
},
{
"NDCCode": "68462-730-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (68462-730-25) / 50 mL in 1 VIAL, SINGLE-DOSE (68462-730-50) ",
"NDC11Code": "68462-0730-25",
"ProductNDC": "68462-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Phosphates",
"NonProprietaryName": "Sodium Phosphates",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220683",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
"StrengthNumber": "276; 268",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260223",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium phosphates injection, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.",
"Description": "Sodium phosphates injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water."
},
{
"NDCCode": "68462-756-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (68462-756-25) / 1 mL in 1 VIAL, SINGLE-DOSE (68462-756-01) ",
"NDC11Code": "68462-0756-25",
"ProductNDC": "68462-756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20231019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217789",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231019",
"SamplePackage": "N"
},
{
"NDCCode": "68462-757-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (68462-757-25) / 2 mL in 1 VIAL, SINGLE-DOSE (68462-757-02) ",
"NDC11Code": "68462-0757-25",
"ProductNDC": "68462-757",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20240201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217789",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "60",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240201",
"SamplePackage": "N"
},
{
"NDCCode": "68462-758-25",
"PackageDescription": "5 TRAY in 1 CARTON (68462-758-25) / 5 AMPULE in 1 TRAY (68462-758-05) / 1 mL in 1 AMPULE",
"NDC11Code": "68462-0758-25",
"ProductNDC": "68462-758",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phytonadione",
"NonProprietaryName": "Phytonadione",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20241210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217386",
"LabelerName": "GLENMARK PHARMACEUTICALS INC",
"SubstanceName": "PHYTONADIONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241210",
"SamplePackage": "N",
"IndicationAndUsage": "Phytonadione Injectable Emulsion is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. Phytonadione Injectable Emulsion is indicated in: anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives; prophylaxis and therapy of hemorrhagic disease of the newborn; hypoprothrombinemia due to antibacterial therapy; hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.",
"Description": "Phytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is practically insoluble in water, sparingly soluble in ethanol and miscible with fatty oils. It has a molecular weight of 450.70.Phytonadione is 2-Methyl-3’,7’,11’,15’-tetramethyl-hexadec-2’-en-1-yl-naphthalene-1,4 dione. Its empirical formula is C31H46O2 and its structural formula is. Phytonadione Injectable Emulsion, USP is a yellow, sterile, nonpyrogenic aqueous dispersion available for injection by the intravenous, intramuscular and subcutaneous routes. Each milliliter contains phytonadione, USP 10 mg, polyoxyl 35 castor oil 70 mg, dextrose monohydrate 37.5 mg in water for injection; benzyl alcohol 9 mg added as preservative. May contain hydrochloric acid for pH adjustment. pH is 6.3 (5.0 to 7.0). Phytonadione is oxygen sensitive."
},
{
"NDCCode": "68462-777-35",
"PackageDescription": "25 VIAL in 1 CARTON (68462-777-35) / 10 mL in 1 VIAL (68462-777-10) ",
"NDC11Code": "68462-0777-35",
"ProductNDC": "68462-777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropivacaine Hydrochloride",
"NonProprietaryName": "Ropivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION",
"StartMarketingDate": "20251008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219883",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251008",
"SamplePackage": "N",
"IndicationAndUsage": "Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.",
"Description": "Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection,USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W.328.89. At 25 °C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C."
},
{
"NDCCode": "68462-778-55",
"PackageDescription": "25 VIAL in 1 CARTON (68462-778-55) / 20 mL in 1 VIAL (68462-778-20) ",
"NDC11Code": "68462-0778-55",
"ProductNDC": "68462-778",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropivacaine Hydrochloride",
"NonProprietaryName": "Ropivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION; PERINEURAL",
"StartMarketingDate": "20251008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219883",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251008",
"SamplePackage": "N",
"IndicationAndUsage": "Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.",
"Description": "Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection,USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W.328.89. At 25 °C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C."
},
{
"NDCCode": "68462-786-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (68462-786-25) / 5 mL in 1 VIAL, SINGLE-DOSE (68462-786-05) ",
"NDC11Code": "68462-0786-25",
"ProductNDC": "68462-786",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphates",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260312",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220373",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE",
"StrengthNumber": "224; 236",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260312",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium phosphates injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.",
"Description": "Potassium phosphates injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial.Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water.Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water.Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate.Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0.This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)].The osmolarity is 7.4 mOsmol/mL (calc).The solution is administered after dilution or admixing by the intravenous route."
},
{
"NDCCode": "68462-787-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (68462-787-25) / 15 mL in 1 VIAL, SINGLE-DOSE (68462-787-15) ",
"NDC11Code": "68462-0787-25",
"ProductNDC": "68462-787",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphates",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260312",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220373",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE",
"StrengthNumber": "224; 236",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260312",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium phosphates injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.",
"Description": "Potassium phosphates injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial.Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water.Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water.Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate.Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0.This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)].The osmolarity is 7.4 mOsmol/mL (calc).The solution is administered after dilution or admixing by the intravenous route."
},
{
"NDCCode": "68462-788-25",
"PackageDescription": "25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68462-788-25) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (68462-788-50) ",
"NDC11Code": "68462-0788-25",
"ProductNDC": "68462-788",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphates",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260312",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220373",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE",
"StrengthNumber": "224; 236",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260312",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium phosphates injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.",
"Description": "Potassium phosphates injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial.Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water.Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water.Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate.Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0.This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)].The osmolarity is 7.4 mOsmol/mL (calc).The solution is administered after dilution or admixing by the intravenous route."
},
{
"NDCCode": "68462-789-25",
"PackageDescription": "25 VIAL, PLASTIC in 1 CARTON (68462-789-25) / 10 mL in 1 VIAL, PLASTIC (68462-789-10) ",
"NDC11Code": "68462-0789-25",
"ProductNDC": "68462-789",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcium Gluconate",
"NonProprietaryName": "Calcium Gluconate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260504",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218840",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "CALCIUM GLUCONATE MONOHYDRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260504",
"SamplePackage": "N",
"IndicationAndUsage": "Calcium Gluconate Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia.Limitations of Use The safety of Calcium Gluconate Injection for long term use has not been established.",
"Description": "Calcium Gluconate Injection, USP is a sterile, preservative-free, nonpyrogenic, supersaturated solution of calcium gluconate, a form of calcium, for intravenous use. Calcium Gluconate is calcium D-gluconate (1:2) monohydrate. The structural formula is. Molecular formula: C12H22CaO14 H2O Molecular weight: 448.39 Solubility in water: 3.5 g/100 mL at 25°C. Calcium Gluconate Injection, USP is available as 1,000 mg per 10 mL (100 mg per mL) or 5,000 mg per 50 mL (100 mg per mL) in a single-dose vial, or 10,000 mg per 100 mL (100 mg per mL) in a pharmacy bulk package. Each mL of Calcium Gluconate Injection, USP contains 100 mg of calcium gluconate (equivalent to 94 mg of calcium gluconate and 4.5 mg of calcium saccharate tetrahydrate), hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and sterile water for injection, q.s. It contains no antimicrobial agent. Each mL of Calcium Gluconate Injection, USP contains 9.3 mg (0.465 mEq) of elemental calcium."
},
{
"NDCCode": "68462-790-25",
"PackageDescription": "25 VIAL, PLASTIC in 1 CARTON (68462-790-25) / 50 mL in 1 VIAL, PLASTIC (68462-790-50) ",
"NDC11Code": "68462-0790-25",
"ProductNDC": "68462-790",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcium Gluconate",
"NonProprietaryName": "Calcium Gluconate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260504",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218840",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "CALCIUM GLUCONATE MONOHYDRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260504",
"SamplePackage": "N",
"IndicationAndUsage": "Calcium Gluconate Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia.Limitations of Use The safety of Calcium Gluconate Injection for long term use has not been established.",
"Description": "Calcium Gluconate Injection, USP is a sterile, preservative-free, nonpyrogenic, supersaturated solution of calcium gluconate, a form of calcium, for intravenous use. Calcium Gluconate is calcium D-gluconate (1:2) monohydrate. The structural formula is. Molecular formula: C12H22CaO14 H2O Molecular weight: 448.39 Solubility in water: 3.5 g/100 mL at 25°C. Calcium Gluconate Injection, USP is available as 1,000 mg per 10 mL (100 mg per mL) or 5,000 mg per 50 mL (100 mg per mL) in a single-dose vial, or 10,000 mg per 100 mL (100 mg per mL) in a pharmacy bulk package. Each mL of Calcium Gluconate Injection, USP contains 100 mg of calcium gluconate (equivalent to 94 mg of calcium gluconate and 4.5 mg of calcium saccharate tetrahydrate), hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and sterile water for injection, q.s. It contains no antimicrobial agent. Each mL of Calcium Gluconate Injection, USP contains 9.3 mg (0.465 mEq) of elemental calcium."
},
{
"NDCCode": "68462-793-55",
"PackageDescription": "25 VIAL in 1 CARTON (68462-793-55) / 20 mL in 1 VIAL (68462-793-20) ",
"NDC11Code": "68462-0793-55",
"ProductNDC": "68462-793",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropivacaine Hydrochloride",
"NonProprietaryName": "Ropivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION",
"StartMarketingDate": "20250807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219883",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250807",
"SamplePackage": "N",
"IndicationAndUsage": "Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.",
"Description": "Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection,USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W.328.89. At 25 °C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C."
},
{
"NDCCode": "68462-794-62",
"PackageDescription": "25 VIAL in 1 CARTON (68462-794-62) / 30 mL in 1 VIAL (68462-794-30) ",
"NDC11Code": "68462-0794-62",
"ProductNDC": "68462-794",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropivacaine Hydrochloride",
"NonProprietaryName": "Ropivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION; PERINEURAL",
"StartMarketingDate": "20250807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219883",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250807",
"SamplePackage": "N",
"IndicationAndUsage": "Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.",
"Description": "Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection,USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W.328.89. At 25 °C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C."
},
{
"NDCCode": "68462-795-55",
"PackageDescription": "25 VIAL in 1 CARTON (68462-795-55) / 20 mL in 1 VIAL (68462-795-20) ",
"NDC11Code": "68462-0795-55",
"ProductNDC": "68462-795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropivacaine Hydrochloride",
"NonProprietaryName": "Ropivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION; PERINEURAL",
"StartMarketingDate": "20250807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219883",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250807",
"SamplePackage": "N",
"IndicationAndUsage": "Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.",
"Description": "Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection,USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W.328.89. At 25 °C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C."
},
{
"NDCCode": "68462-951-65",
"PackageDescription": "25 VIAL in 1 CARTON (68462-951-65) / 50 mL in 1 VIAL (68462-951-50) ",
"NDC11Code": "68462-0951-65",
"ProductNDC": "68462-951",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Bicarbonate",
"NonProprietaryName": "Sodium Bicarbonate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219701",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "84",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Alkalinizing Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250807",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium bicarbonate injection is contraindicated in patients who are losing chloride by vomiting or from continuous gastrointestinal suction, and in patients receiving diuretics known to produce a hypochloremic alkalosis.",
"Description": "Intravenous sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses the clinical manifestations of acidosis.Sodium bicarbonate in water dissociates to provide sodium (Na+) and bicarbonate (HCO3-) ions. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Bicarbonate (HCO3-) is a normal constituent of body fluids and the normal plasma level ranges from 24 to 31 mEq/liter. Plasma concentration is regulated by the kidney through acidification of the urine when there is a deficit or by alkalinization of the urine when there is an excess. Bicarbonate anion is considered \"labile\" since at a proper concentration of hydrogen ion (H+) it may be converted to carbonic acid (H2CO3) and thence to its volatile form, carbon dioxide (CO2) excreted by the lung. Normally a ratio of 1:20 (carbonic acid: bicarbonate) is present in the extracellular fluid. In a healthy adult with normal kidney function, practically all the glomerular filtered bicarbonate ion is reabsorbed; less than 1% is excreted in the urine."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>68462-755-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (68462-755-25) / 1 mL in 1 VIAL, SINGLE-DOSE (68462-755-01) </PackageDescription>
<NDC11Code>68462-0755-25</NDC11Code>
<ProductNDC>68462-755</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20231019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217789</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>25021-755-05</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (25021-755-05) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0755-05</NDC11Code>
<ProductNDC>25021-755</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251015</StartMarketingDate>
<EndMarketingDate>20270731</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>20270731</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>43744-755-25</NDCCode>
<PackageDescription>25 g in 1 DRUM (43744-755-25)</PackageDescription>
<NDC11Code>43744-0755-25</NDC11Code>
<ProductNDC>43744-755</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Potassium Iodide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110307</StartMarketingDate>
<EndMarketingDate>20110308</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>POTASSIUM IODIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20110308</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57218-755-01</NDCCode>
<PackageDescription>25 kg in 1 DRUM (57218-755-01) </PackageDescription>
<NDC11Code>57218-0755-01</NDC11Code>
<ProductNDC>57218-755</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Pyrilamine Maleate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20170602</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Malladi Drugs & Pharmaceuticals Limited</LabelerName>
<SubstanceName>PYRILAMINE MALEATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-23</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>02-JUN-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>62935-753-75</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (62935-753-75) * .25 mL in 1 SYRINGE (62935-754-74) * .25 mL in 1 SYRINGE (62935-755-75) </PackageDescription>
<NDC11Code>62935-0753-75</NDC11Code>
<ProductNDC>62935-753</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eligard</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20020515</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021343</ApplicationNumber>
<LabelerName>TOLMAR Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELIGARD® is indicated for the palliative treatment of advanced prostate cancer.</IndicationAndUsage>
<Description>ELIGARD® is a sterile polymeric matrix formulation of leuprolide acetate, a GnRH agonist, for subcutaneous injection. It is designed to deliver leuprolide acetate at a controlled rate over a one-, three-, four- or six-month therapeutic period. Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH) that, when given continuously, inhibits pituitary gonadotropin secretion and suppresses testicular and ovarian steroidogenesis. The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula. ELIGARD® is prefilled and supplied in two separate, sterile syringes whose contents are mixed immediately prior to administration. The two syringes are joined and the single dose product is mixed until it is homogenous. ELIGARD® is administered subcutaneously, where it forms a solid drug delivery depot. One syringe contains the ATRIGEL® Delivery System and the other contains leuprolide acetate. ATRIGEL® is a polymeric (non-gelatin containing) delivery system consisting of a biodegradable poly (DL-lactide-co-glycolide) (PLGH or PLG) polymer formulation dissolved in a biocompatible solvent, N-methyl-2-pyrrolidone (NMP). Refer to Table 6 for the delivery system composition and reconstituted product formulation for each ELIGARD® product. Table 6. ELIGARD® Delivery System Composition and Reconstituted Product Formulation.</Description>
</NDC>
<NDC>
<NDCCode>69423-755-25</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (69423-755-25) / 70 g in 1 TUBE</PackageDescription>
<NDC11Code>69423-0755-25</NDC11Code>
<ProductNDC>69423-755</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Crest Pro-health</ProprietaryName>
<ProprietaryNameSuffix>Densify Pro Intensive Repair</ProprietaryNameSuffix>
<NonProprietaryName>Stannous Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20230210</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>STANNOUS FLUORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>aids in the prevention of cavities. builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68462-146-45</NDCCode>
<PackageDescription>4 BOTTLE in 1 BOX (68462-146-45) > 25 TABLET in 1 BOTTLE (68462-146-25)</PackageDescription>
<NDC11Code>68462-0146-45</NDC11Code>
<ProductNDC>68462-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitroglycerin</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED OTHER</MarketingCategoryName>
<LabelerName>Glenmark Generics Inc., USA</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-07-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>68462-486-19</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (68462-486-19) / 25 g in 1 JAR</PackageDescription>
<NDC11Code>68462-0486-19</NDC11Code>
<ProductNDC>68462-486</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin And Benzoyl Peroxide</ProprietaryName>
<NonProprietaryName>Clindamycin And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209252</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>10; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin and Benzoyl Peroxide Gel is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has a molecular weight of 504.96 g/mol and its chemical name is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L-threo-α-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and Benzoyl Peroxide Gel, 1%/5% also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23 g/mol. Each gram of Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer homopolymer type C, docusate sodium, edetate disodium, sodium hydroxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>68462-532-28</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68462-532-28) / 25 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>68462-0532-28</NDC11Code>
<ProductNDC>68462-532</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180418</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210190</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate topical solution is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.</IndicationAndUsage>
<Description>Clobetasol Propionate Topical Solution USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate USP is 21-Chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione17-propionate, and it has the following structural formula. Clobetasol propionate USP has the empirical formula C25H32ClFO5 and a molecular weight of 466.97. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Topical Solution USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a solution base composed of isopropyl alcohol, carbomer homopolymer type B, sodium hydroxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>68462-536-70</NDCCode>
<PackageDescription>24 PACKET in 1 CARTON (68462-536-70) / .25 g in 1 PACKET (68462-536-01) </PackageDescription>
<NDC11Code>68462-0536-70</NDC11Code>
<ProductNDC>68462-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imiquimod</ProprietaryName>
<NonProprietaryName>Imiquimod</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201994</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>IMIQUIMOD</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Increased Cytokine Activity [PE], Increased Cytokine Production [PE], Interferon Inducers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Imiquimod cream is indicated for the topical treatment of: 1 Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on the face or scalp in immunocompetent adults. (1.1), 2 Biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults with a maximum tumor diameter of 2.0 cm on trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured. (1.2), 3 External genital and perianal warts (EGW) in immunocompetent patients 12 years of age and older. (1.3).</IndicationAndUsage>
<Description>Imiquimod cream USP is an immune response modifier for topical administration. Each gram contains 50 mg of imiquimod, USP in an off-white oil-in-water vanishing cream base consisting of benzyl alcohol, cetyl alcohol, glycerin, isostearic acid, methylparaben, polysorbate 60, propylparaben, purified water, sorbitan monostearate, stearyl alcohol, white petrolatum and xanthan gum. Chemically, imiquimod, USP is 1-(2-methylpropyl)-1 H-imidazo[4,5-c]quinolin-4-amine. Imiquimod, USP has a molecular formula of C14H16N4 and a molecular weight of 240.3 g/mol. Its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>68462-621-02</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (68462-621-02) / 2 mL in 1 VIAL, SINGLE-DOSE (68462-621-54) </PackageDescription>
<NDC11Code>68462-0621-02</NDC11Code>
<ProductNDC>68462-621</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosphenytoin Sodium</ProprietaryName>
<NonProprietaryName>Fosphenytoin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20231013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214926</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
<SubstanceName>FOSPHENYTOIN SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection can also be substituted, short-term, for oral phenytoin. Fosphenytoin sodium injection should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>Fosphenytoin sodium injection, USP is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium USP is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE. The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. Fosphenytoin sodium injection, USP is marketed in 2 mL vials containing a total of 100 mg PE/2mL (50 mg PE/mL) and 10 mL vials containing a total of 500 mg PE/10mL (50 mg PE/mL), for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. Fosphenytoin sodium injection, USP is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS) (12 mg/mL), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. Fosphenytoin sodium injection, USP is a clear, colorless to pale yellow, sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is. The molecular weight of fosphenytoin is 406.24.</Description>
</NDC>
<NDC>
<NDCCode>68462-621-54</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (68462-621-54) / 2 mL in 1 VIAL, SINGLE-DOSE (68462-621-02) </PackageDescription>
<NDC11Code>68462-0621-54</NDC11Code>
<ProductNDC>68462-621</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosphenytoin Sodium</ProprietaryName>
<NonProprietaryName>Fosphenytoin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20231013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214926</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
<SubstanceName>FOSPHENYTOIN SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection can also be substituted, short-term, for oral phenytoin. Fosphenytoin sodium injection should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>Fosphenytoin sodium injection, USP is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium USP is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE. The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. Fosphenytoin sodium injection, USP is marketed in 2 mL vials containing a total of 100 mg PE/2mL (50 mg PE/mL) and 10 mL vials containing a total of 500 mg PE/10mL (50 mg PE/mL), for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. Fosphenytoin sodium injection, USP is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS) (12 mg/mL), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. Fosphenytoin sodium injection, USP is a clear, colorless to pale yellow, sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is. The molecular weight of fosphenytoin is 406.24.</Description>
</NDC>
<NDC>
<NDCCode>68462-639-45</NDCCode>
<PackageDescription>4 BOTTLE in 1 CARTON (68462-639-45) / 25 TABLET in 1 BOTTLE (68462-639-25) </PackageDescription>
<NDC11Code>68462-0639-45</NDC11Code>
<ProductNDC>68462-639</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitroglycerin</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20170919</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206391</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
<Description>Nitroglycerin Sublingual Tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin; as well as calcium stearate, croscarmellose sodium, silica dimethyl silylate and lactose monohydrate. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. Molecular weight: 227.09 g/mol.</Description>
</NDC>
<NDC>
<NDCCode>68462-728-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (68462-728-25) / 5 mL in 1 VIAL, SINGLE-DOSE (68462-728-05) </PackageDescription>
<NDC11Code>68462-0728-25</NDC11Code>
<ProductNDC>68462-728</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Phosphates</ProprietaryName>
<NonProprietaryName>Sodium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220683</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE</SubstanceName>
<StrengthNumber>276; 268</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium phosphates injection, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.</IndicationAndUsage>
<Description>Sodium phosphates injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>68462-729-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (68462-729-25) / 15 mL in 1 VIAL, SINGLE-DOSE (68462-729-15) </PackageDescription>
<NDC11Code>68462-0729-25</NDC11Code>
<ProductNDC>68462-729</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Phosphates</ProprietaryName>
<NonProprietaryName>Sodium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220683</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE</SubstanceName>
<StrengthNumber>276; 268</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium phosphates injection, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.</IndicationAndUsage>
<Description>Sodium phosphates injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>68462-730-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (68462-730-25) / 50 mL in 1 VIAL, SINGLE-DOSE (68462-730-50) </PackageDescription>
<NDC11Code>68462-0730-25</NDC11Code>
<ProductNDC>68462-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Phosphates</ProprietaryName>
<NonProprietaryName>Sodium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220683</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE</SubstanceName>
<StrengthNumber>276; 268</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium phosphates injection, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.</IndicationAndUsage>
<Description>Sodium phosphates injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>68462-756-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (68462-756-25) / 1 mL in 1 VIAL, SINGLE-DOSE (68462-756-01) </PackageDescription>
<NDC11Code>68462-0756-25</NDC11Code>
<ProductNDC>68462-756</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20231019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217789</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68462-757-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (68462-757-25) / 2 mL in 1 VIAL, SINGLE-DOSE (68462-757-02) </PackageDescription>
<NDC11Code>68462-0757-25</NDC11Code>
<ProductNDC>68462-757</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20240201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217789</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68462-758-25</NDCCode>
<PackageDescription>5 TRAY in 1 CARTON (68462-758-25) / 5 AMPULE in 1 TRAY (68462-758-05) / 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>68462-0758-25</NDC11Code>
<ProductNDC>68462-758</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phytonadione</ProprietaryName>
<NonProprietaryName>Phytonadione</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20241210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217386</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC</LabelerName>
<SubstanceName>PHYTONADIONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phytonadione Injectable Emulsion is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. Phytonadione Injectable Emulsion is indicated in: anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives; prophylaxis and therapy of hemorrhagic disease of the newborn; hypoprothrombinemia due to antibacterial therapy; hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.</IndicationAndUsage>
<Description>Phytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is practically insoluble in water, sparingly soluble in ethanol and miscible with fatty oils. It has a molecular weight of 450.70.Phytonadione is 2-Methyl-3’,7’,11’,15’-tetramethyl-hexadec-2’-en-1-yl-naphthalene-1,4 dione. Its empirical formula is C31H46O2 and its structural formula is. Phytonadione Injectable Emulsion, USP is a yellow, sterile, nonpyrogenic aqueous dispersion available for injection by the intravenous, intramuscular and subcutaneous routes. Each milliliter contains phytonadione, USP 10 mg, polyoxyl 35 castor oil 70 mg, dextrose monohydrate 37.5 mg in water for injection; benzyl alcohol 9 mg added as preservative. May contain hydrochloric acid for pH adjustment. pH is 6.3 (5.0 to 7.0). Phytonadione is oxygen sensitive.</Description>
</NDC>
<NDC>
<NDCCode>68462-777-35</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (68462-777-35) / 10 mL in 1 VIAL (68462-777-10) </PackageDescription>
<NDC11Code>68462-0777-35</NDC11Code>
<ProductNDC>68462-777</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION</RouteName>
<StartMarketingDate>20251008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219883</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.</IndicationAndUsage>
<Description>Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection,USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W.328.89. At 25 °C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>68462-778-55</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (68462-778-55) / 20 mL in 1 VIAL (68462-778-20) </PackageDescription>
<NDC11Code>68462-0778-55</NDC11Code>
<ProductNDC>68462-778</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; PERINEURAL</RouteName>
<StartMarketingDate>20251008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219883</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.</IndicationAndUsage>
<Description>Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection,USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W.328.89. At 25 °C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>68462-786-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (68462-786-25) / 5 mL in 1 VIAL, SINGLE-DOSE (68462-786-05) </PackageDescription>
<NDC11Code>68462-0786-25</NDC11Code>
<ProductNDC>68462-786</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260312</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220373</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
<SubstanceName>MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE</SubstanceName>
<StrengthNumber>224; 236</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium phosphates injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.</IndicationAndUsage>
<Description>Potassium phosphates injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial.Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water.Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water.Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate.Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0.This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)].The osmolarity is 7.4 mOsmol/mL (calc).The solution is administered after dilution or admixing by the intravenous route.</Description>
</NDC>
<NDC>
<NDCCode>68462-787-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (68462-787-25) / 15 mL in 1 VIAL, SINGLE-DOSE (68462-787-15) </PackageDescription>
<NDC11Code>68462-0787-25</NDC11Code>
<ProductNDC>68462-787</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260312</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220373</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
<SubstanceName>MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE</SubstanceName>
<StrengthNumber>224; 236</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium phosphates injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.</IndicationAndUsage>
<Description>Potassium phosphates injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial.Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water.Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water.Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate.Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0.This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)].The osmolarity is 7.4 mOsmol/mL (calc).The solution is administered after dilution or admixing by the intravenous route.</Description>
</NDC>
<NDC>
<NDCCode>68462-788-25</NDCCode>
<PackageDescription>25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68462-788-25) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (68462-788-50) </PackageDescription>
<NDC11Code>68462-0788-25</NDC11Code>
<ProductNDC>68462-788</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260312</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220373</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
<SubstanceName>MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE</SubstanceName>
<StrengthNumber>224; 236</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium phosphates injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.</IndicationAndUsage>
<Description>Potassium phosphates injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial.Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water.Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water.Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate.Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0.This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)].The osmolarity is 7.4 mOsmol/mL (calc).The solution is administered after dilution or admixing by the intravenous route.</Description>
</NDC>
<NDC>
<NDCCode>68462-789-25</NDCCode>
<PackageDescription>25 VIAL, PLASTIC in 1 CARTON (68462-789-25) / 10 mL in 1 VIAL, PLASTIC (68462-789-10) </PackageDescription>
<NDC11Code>68462-0789-25</NDC11Code>
<ProductNDC>68462-789</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcium Gluconate</ProprietaryName>
<NonProprietaryName>Calcium Gluconate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260504</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218840</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
<SubstanceName>CALCIUM GLUCONATE MONOHYDRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcium Gluconate Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia.Limitations of Use The safety of Calcium Gluconate Injection for long term use has not been established.</IndicationAndUsage>
<Description>Calcium Gluconate Injection, USP is a sterile, preservative-free, nonpyrogenic, supersaturated solution of calcium gluconate, a form of calcium, for intravenous use. Calcium Gluconate is calcium D-gluconate (1:2) monohydrate. The structural formula is. Molecular formula: C12H22CaO14 H2O Molecular weight: 448.39 Solubility in water: 3.5 g/100 mL at 25°C. Calcium Gluconate Injection, USP is available as 1,000 mg per 10 mL (100 mg per mL) or 5,000 mg per 50 mL (100 mg per mL) in a single-dose vial, or 10,000 mg per 100 mL (100 mg per mL) in a pharmacy bulk package. Each mL of Calcium Gluconate Injection, USP contains 100 mg of calcium gluconate (equivalent to 94 mg of calcium gluconate and 4.5 mg of calcium saccharate tetrahydrate), hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and sterile water for injection, q.s. It contains no antimicrobial agent. Each mL of Calcium Gluconate Injection, USP contains 9.3 mg (0.465 mEq) of elemental calcium.</Description>
</NDC>
<NDC>
<NDCCode>68462-790-25</NDCCode>
<PackageDescription>25 VIAL, PLASTIC in 1 CARTON (68462-790-25) / 50 mL in 1 VIAL, PLASTIC (68462-790-50) </PackageDescription>
<NDC11Code>68462-0790-25</NDC11Code>
<ProductNDC>68462-790</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcium Gluconate</ProprietaryName>
<NonProprietaryName>Calcium Gluconate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260504</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218840</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
<SubstanceName>CALCIUM GLUCONATE MONOHYDRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcium Gluconate Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia.Limitations of Use The safety of Calcium Gluconate Injection for long term use has not been established.</IndicationAndUsage>
<Description>Calcium Gluconate Injection, USP is a sterile, preservative-free, nonpyrogenic, supersaturated solution of calcium gluconate, a form of calcium, for intravenous use. Calcium Gluconate is calcium D-gluconate (1:2) monohydrate. The structural formula is. Molecular formula: C12H22CaO14 H2O Molecular weight: 448.39 Solubility in water: 3.5 g/100 mL at 25°C. Calcium Gluconate Injection, USP is available as 1,000 mg per 10 mL (100 mg per mL) or 5,000 mg per 50 mL (100 mg per mL) in a single-dose vial, or 10,000 mg per 100 mL (100 mg per mL) in a pharmacy bulk package. Each mL of Calcium Gluconate Injection, USP contains 100 mg of calcium gluconate (equivalent to 94 mg of calcium gluconate and 4.5 mg of calcium saccharate tetrahydrate), hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and sterile water for injection, q.s. It contains no antimicrobial agent. Each mL of Calcium Gluconate Injection, USP contains 9.3 mg (0.465 mEq) of elemental calcium.</Description>
</NDC>
<NDC>
<NDCCode>68462-793-55</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (68462-793-55) / 20 mL in 1 VIAL (68462-793-20) </PackageDescription>
<NDC11Code>68462-0793-55</NDC11Code>
<ProductNDC>68462-793</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION</RouteName>
<StartMarketingDate>20250807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219883</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.</IndicationAndUsage>
<Description>Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection,USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W.328.89. At 25 °C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>68462-794-62</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (68462-794-62) / 30 mL in 1 VIAL (68462-794-30) </PackageDescription>
<NDC11Code>68462-0794-62</NDC11Code>
<ProductNDC>68462-794</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; PERINEURAL</RouteName>
<StartMarketingDate>20250807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219883</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.</IndicationAndUsage>
<Description>Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection,USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W.328.89. At 25 °C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>68462-795-55</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (68462-795-55) / 20 mL in 1 VIAL (68462-795-20) </PackageDescription>
<NDC11Code>68462-0795-55</NDC11Code>
<ProductNDC>68462-795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; PERINEURAL</RouteName>
<StartMarketingDate>20250807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219883</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.</IndicationAndUsage>
<Description>Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection,USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W.328.89. At 25 °C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>68462-951-65</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (68462-951-65) / 50 mL in 1 VIAL (68462-951-50) </PackageDescription>
<NDC11Code>68462-0951-65</NDC11Code>
<ProductNDC>68462-951</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Bicarbonate</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219701</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>84</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Alkalinizing Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium bicarbonate injection is contraindicated in patients who are losing chloride by vomiting or from continuous gastrointestinal suction, and in patients receiving diuretics known to produce a hypochloremic alkalosis.</IndicationAndUsage>
<Description>Intravenous sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses the clinical manifestations of acidosis.Sodium bicarbonate in water dissociates to provide sodium (Na+) and bicarbonate (HCO3-) ions. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Bicarbonate (HCO3-) is a normal constituent of body fluids and the normal plasma level ranges from 24 to 31 mEq/liter. Plasma concentration is regulated by the kidney through acidification of the urine when there is a deficit or by alkalinization of the urine when there is an excess. Bicarbonate anion is considered "labile" since at a proper concentration of hydrogen ion (H+) it may be converted to carbonic acid (H2CO3) and thence to its volatile form, carbon dioxide (CO2) excreted by the lung. Normally a ratio of 1:20 (carbonic acid: bicarbonate) is present in the extracellular fluid. In a healthy adult with normal kidney function, practically all the glomerular filtered bicarbonate ion is reabsorbed; less than 1% is excreted in the urine.</Description>
</NDC>
</NDCList>