{
"NDC": [
{
"NDCCode": "42023-157-89",
"PackageDescription": "1 VIAL in 1 CARTON (42023-157-89) > 50 mL in 1 VIAL",
"NDC11Code": "42023-0157-89",
"ProductNDC": "42023-157",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ethacrynate Sodium",
"NonProprietaryName": "Ethacrynate Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205473",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "ETHACRYNATE SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/50mL",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-02-21",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231"
},
{
"NDCCode": "42023-157-01",
"PackageDescription": "1 VIAL in 1 CARTON (42023-157-01) / 50 mL in 1 VIAL",
"NDC11Code": "42023-0157-01",
"ProductNDC": "42023-157",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ethacrynate Sodium",
"NonProprietaryName": "Ethacrynate Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205473",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "ETHACRYNATE SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/50mL",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150730",
"SamplePackage": "N",
"IndicationAndUsage": "Ethacrynate sodium is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. 1. Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. 2. Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. 3. Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. 4. Intravenous ethacrynate sodium is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable.",
"Description": "Ethacrynic acid is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2- methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of 303.14. Ethacrynic acid is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene. Its empirical formula is C13H12Cl2O4 and its structural formula is. Ethacrynate sodium, the sodium salt of ethacrynic acid, is soluble in water at 25°C to the extent of about 7 percent. Solutions of the sodium salt are relatively stable at about pH 7 at room temperature for short periods, but as the pH or temperature increases the solutions are less stable. The molecular weight of ethacrynate sodium is 325.12. Its empirical formula is C13H11Cl2NaO4 and its structural formula is. Intravenous Ethacrynate Sodium is a sterile freeze-dried powder and is supplied in a vial containing: Ethacrynate sodium equivalent to ethacrynic acid...... 50 mg Inactive ingredient: Mannitol......................62.5 mg."
},
{
"NDCCode": "42023-157-99",
"PackageDescription": "1 VIAL in 1 CARTON (42023-157-99) > 50 mL in 1 VIAL",
"NDC11Code": "42023-0157-99",
"ProductNDC": "42023-157",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ethacrynate Sodium",
"NonProprietaryName": "Ethacrynate Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160923",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205473",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "ETHACRYNATE SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/50mL",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-14",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Ethacrynate sodium is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. : 1 1.Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome., 2 2.Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema., 3 3.Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome., 4 4.Intravenous ethacrynate sodium is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable.",
"Description": "Ethacrynic acid is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2- methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of 303.14. Ethacrynic acid is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene. Its empirical formula is C13H12Cl2O4 and its structural formula is. Ethacrynate sodium, the sodium salt of ethacrynic acid, is soluble in water at 25°C to the extent of about 7 percent. Solutions of the sodium salt are relatively stable at about pH 7 at room temperature for short periods, but as the pH or temperature increases the solutions are less stable. The molecular weight of ethacrynate sodium is 325.12. Its empirical formula is C13H11Cl2NaO4 and its structural formula is. Intravenous Ethacrynate Sodium is a sterile freeze-dried powder and is supplied in a vial containing: Ethacrynate sodium equivalent to ethacrynic acid...... 50 mg Inactive ingredient: Mannitol......................62.5 mg."
},
{
"NDCCode": "42023-129-89",
"PackageDescription": "1 VIAL in 1 CARTON (42023-129-89) / 5 mL in 1 VIAL",
"NDC11Code": "42023-0129-89",
"ProductNDC": "42023-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluphenazine Decanoate",
"NonProprietaryName": "Fluphenazine Decanoate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20180626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203732",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "FLUPHENAZINE DECANOATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180626",
"SamplePackage": "N",
"IndicationAndUsage": "Fluphenazine Decanoate Injection is a long-acting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy (e.g., chronic schizophrenics). Fluphenazine Decanoate Injection has not been shown effective in the management of behavioral complications in patients with mental retardation.",
"Description": "Fluphenazine decanoate is the decanoate ester of a trifluoromethyl phenothiazine derivative. It is a highly potent behavior modifier with a markedly extended duration of effect and has the following structural formula. Fluphenazine Decanoate Injection, USP is available as a clear, pale yellow solution for intramuscular (IM) or subcutaneous (SC) use providing 25 mg fluphenazine decanoate per mL in a sesame oil vehicle with 12 mg benzyl alcohol as a preservative."
},
{
"NDCCode": "42023-168-89",
"PackageDescription": "1 VIAL in 1 CARTON (42023-168-89) / 30 mL in 1 VIAL",
"NDC11Code": "42023-0168-89",
"ProductNDC": "42023-168",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adrenalin",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20201204",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204640",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201204",
"SamplePackage": "N",
"IndicationAndUsage": "Adrenalin® is a non-selective alpha and beta adrenergic agonist indicated for: 1 Emergency treatment of allergic reactions (Type 1), including anaphylaxis (1.1), 2 To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock (1.2).",
"Description": "Adrenalin (epinephrine injection, USP) is a clear, colorless, sterile solution containing 1 mg/mL epinephrine, packaged as 30 mL of solution in a multiple dose amber glass vial. In the 30 mL vial, each 1 mL of Adrenalin solution contains 1 mg epinephrine, 6.15 mg sodium chloride, 0.457 mg sodium metabisulfite, 0.920 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, 5.18 mg of 4% hydrochloric acid to adjust pH, 5.25 mg chlorobutanol as a preservative and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2-(methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is. The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin."
},
{
"NDCCode": "42023-182-89",
"PackageDescription": "1 VIAL in 1 CARTON (42023-182-89) / 2.5 mL in 1 VIAL",
"NDC11Code": "42023-0182-89",
"ProductNDC": "42023-182",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Argatroban",
"NonProprietaryName": "Argatroban",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091665",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "ARGATROBAN",
"StrengthNumber": "250",
"StrengthUnit": "mg/2.5mL",
"Pharm_Classes": "Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150601",
"SamplePackage": "N",
"IndicationAndUsage": "Argatroban is a direct thrombin inhibitor indicated: 1 For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) (1.1), 2 As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) (1.2).",
"Description": "Argatroban is a synthetic direct thrombin inhibitor and the chemical name is 1-[5-[(aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8-quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid, monohydrate. Argatroban has 4 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately 65:35. The molecular formula of argatroban is C23H36N6O5S∙H2O. Its molecular weight is 526.66 g/mol. The structural formula is. Argatroban is a white, odorless crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in ethanol, and insoluble in acetone, ethyl acetate, and ether. Argatroban Injection, USP is a sterile clear, colorless to pale yellow, slightly viscous solution in a single-use amber vial containing 250 mg/2.5 mL of argatroban. Each mL of sterile, nonpyrogenic solution contains 100 mg argatroban, 300 mg D-sorbitol, and 400 mg dehydrated alcohol in water for injection."
},
{
"NDCCode": "42023-221-85",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 PACKAGE (42023-221-85) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-221-89) ",
"NDC11Code": "42023-0221-85",
"ProductNDC": "42023-221",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ertapenem",
"NonProprietaryName": "Ertapenem Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20181101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021337",
"LabelerName": "ENDO USA, Inc.",
"SubstanceName": "ERTAPENEM SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Carbapenems [CS], Penem Antibacterial [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181101",
"SamplePackage": "N",
"IndicationAndUsage": "Ertapenem for injection is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria: 1 Complicated intra-abdominal infections. (1.1), 2 Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis. (1.2), 3 Community-acquired pneumonia. (1.3), 4 Complicated urinary tract infections including pyelonephritis. (1.4), 5 Acute pelvic infections including postpartum endomyometritis, septic abortion and post-surgical gynecologic infections. (1.5).",
"Description": "Ertapenem for injection is a sterile, synthetic, parenteral, 1-β methyl-carbapenem that is structurally related to beta-lactam antibiotics. Chemically, ertapenem for injection is described as [4R-[3(3S*,5S*),4α,5β,6β(R*)]]-3-[[5-[[(3-carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monosodium salt. Its molecular weight is 497.50. The empirical formula is C22H24N3O7SNa, and its structural formula is. Ertapenem sodium is a white to off-white hygroscopic, weakly crystalline powder. It is soluble in water and 0.9% sodium chloride solution, practically insoluble in ethanol, and insoluble in isopropyl acetate and tetrahydrofuran. Ertapenem for injection is supplied as sterile, white to yellowish off-white lyophilized powder for intravenous infusion after reconstitution with appropriate diluent [see Dosage and Administration (2.7)] and transfer to 50 mL 0.9% Sodium Chloride Injection or for intramuscular injection following reconstitution with 1% lidocaine hydrochloride. Each single-dose vial contains 1 gram ertapenem equivalent to 1.046 grams ertapenem sodium. The sodium content is approximately 137 mg (approximately 6.0 mEq). Each vial of ertapenem for injection contains the following inactive ingredients: 175 mg sodium bicarbonate and sodium hydroxide to adjust pH to 7.5."
},
{
"NDCCode": "42023-146-25",
"PackageDescription": "25 VIAL in 1 CARTON (42023-146-25) / 2 mL in 1 VIAL",
"NDC11Code": "42023-0146-25",
"ProductNDC": "42023-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmedetomidine Hydrochloride",
"NonProprietaryName": "Dexmedetomidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203972",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140819",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmedetomidine hydrochloride injection is a alpha2-adrenergic receptor agonist indicated for: 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride injection by continuous infusion not to exceed 24 hours. (1.1), 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2).",
"Description": "Dexmedetomidine Injection, USP is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2 HCl and the structural formula is. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Injection, USP is intended to be used after dilution. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 118 mcg of dexmedetomidine hydrochloride (equivalent to 100 mcg or 0.1 mg of dexmedetomidine) and 9 mg of sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine) and 9 mg sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers."
},
{
"NDCCode": "42023-186-20",
"PackageDescription": "20 VIAL in 1 CARTON (42023-186-20) / 50 mL in 1 VIAL",
"NDC11Code": "42023-0186-20",
"ProductNDC": "42023-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmedetomidine Hydrochloride",
"NonProprietaryName": "Dexmedetomidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208266",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201204",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmedetomidine hydrochloride injection is a alpha2-adrenergic receptor agonist indicated for: 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride injection by continuous infusion not to exceed 24 hours. (1.1), 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2).",
"Description": "Dexmedetomidine Injection, USP is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2 HCl and the structural formula is. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Injection, USP is intended to be used after dilution. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 118 mcg of dexmedetomidine hydrochloride (equivalent to 100 mcg or 0.1 mg of dexmedetomidine) and 9 mg of sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine) and 9 mg sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers."
},
{
"NDCCode": "42023-187-10",
"PackageDescription": "10 VIAL in 1 CARTON (42023-187-10) / 100 mL in 1 VIAL",
"NDC11Code": "42023-0187-10",
"ProductNDC": "42023-187",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmedetomidine Hydrochloride",
"NonProprietaryName": "Dexmedetomidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208266",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201204",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmedetomidine hydrochloride injection is a alpha2-adrenergic receptor agonist indicated for: 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride injection by continuous infusion not to exceed 24 hours. (1.1), 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2).",
"Description": "Dexmedetomidine Injection, USP is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2 HCl and the structural formula is. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Injection, USP is intended to be used after dilution. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 118 mcg of dexmedetomidine hydrochloride (equivalent to 100 mcg or 0.1 mg of dexmedetomidine) and 9 mg of sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine) and 9 mg sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers."
},
{
"NDCCode": "42571-314-89",
"PackageDescription": "10 CARTON in 1 CARTON (42571-314-89) / 1 VIAL, GLASS in 1 CARTON (42571-314-88) / 10 mL in 1 VIAL, GLASS",
"NDC11Code": "42571-0314-89",
"ProductNDC": "42571-314",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tranexamic Acid",
"NonProprietaryName": "Tranexamic Acid",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206713",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "TRANEXAMIC ACID",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170801",
"SamplePackage": "N",
"IndicationAndUsage": "Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.",
"Description": "Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid, USP is a white crystalline powder. The structural formula is. Molecular Formula: C 8H 15NO 2Molecular Weight: 157.2. Each mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid, USP and Water for Injection to 1 mL. The aqueous solution for injection has a pH of 6.5 to 8.0."
},
{
"NDCCode": "24357-011-13",
"PackageDescription": "1 KIT in 1 CARTON (24357-011-13) * 1 mL in 1 VIAL (42023-159-25) * 1 mL in 1 PACKET (68599-5804-1) ",
"NDC11Code": "24357-0011-13",
"ProductNDC": "24357-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrine Professional",
"NonProprietaryName": "Epinephrine And Isopropyl Alcohol",
"DosageFormName": "KIT",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20190701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204200",
"LabelerName": "Focus Health Group",
"Status": "Active",
"LastUpdate": "2026-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190701",
"SamplePackage": "N"
},
{
"NDCCode": "24357-012-12",
"PackageDescription": "1 KIT in 1 CARTON (24357-012-12) * 1 mL in 1 PACKET (68599-5804-1) * 1 mL in 1 VIAL (42023-159-01) ",
"NDC11Code": "24357-0012-12",
"ProductNDC": "24357-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrine Professional Ems",
"NonProprietaryName": "Epinephrine Convenience Kit",
"DosageFormName": "KIT",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20190701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204200",
"LabelerName": "Focus Health Group",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190701",
"SamplePackage": "N"
},
{
"NDCCode": "24357-811-20",
"PackageDescription": "1 KIT in 1 KIT (24357-811-20) * 1 mL in 1 VIAL, GLASS (42023-159-25) ",
"NDC11Code": "24357-0811-20",
"ProductNDC": "24357-811",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrinesnap-v",
"NonProprietaryName": "Epinephrine Convenience Kit",
"DosageFormName": "KIT",
"StartMarketingDate": "20170505",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "FOCUS HEALTH GROUP",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170505",
"SamplePackage": "N",
"IndicationAndUsage": "Adrenalin® is available as a single-use 1 mL vial and a multiple-use 30 mL vial for intramuscular and subcutaneous use. Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. The signs and symptoms associated with anaphylaxis include flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with hypotension, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, airway swelling, laryngospasm, bronchospasm, pruritus, urticaria or angioedema, swelling of the eyelids, lips, and tongue.",
"Description": "Adrenalin® (epinephrine injection, USP) is a clear, colorless, sterile solution containing 1 mg/mL (1:1000) epinephrine, packaged as 1 mL of solution in a singleuse clear glass vial or 30 mL of solution in a multiple-dose amber glass vial. In the 1 mL vial, each 1 mL of Adrenalin® solution contains 1 mg epinephrine, 7.3 mg sodium chloride, 0.457 mg sodium metabisulfite, 1 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, hydrochloric acid to adjust pH, and water for injection. In the 30 mL vial, each 1 mL of Adrenalin® solution contains 1 mg epinephrine, 6.15 mg sodium chloride, 0.457 mg sodium metabisulfite, 0.920 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, hydrochloric acid to adjust pH, 5.25 mg chlorobutanol as a preservative and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2-(methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is:. The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin."
},
{
"NDCCode": "42023-104-01",
"PackageDescription": "1 VIAL in 1 CARTON (42023-104-01) / 1 mL in 1 VIAL",
"NDC11Code": "42023-0104-01",
"ProductNDC": "42023-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aplisol",
"NonProprietaryName": "Tuberculin Purified Protein Derivative",
"DosageFormName": "INJECTION",
"RouteName": "INTRADERMAL",
"StartMarketingDate": "20080425",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103782",
"LabelerName": "ENDO USA, Inc.",
"SubstanceName": "TUBERCULIN PURIFIED PROTEIN DERIVATIVE",
"StrengthNumber": "5",
"StrengthUnit": "[iU]/.1mL",
"Pharm_Classes": "Antigens, Bacterial [CS], Cell-mediated Immunity [PE], Skin Test Antigen [EPC], Tuberculosis Skin Test [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080425",
"SamplePackage": "N",
"IndicationAndUsage": "Tuberculin PPD is indicated as an aid in the detection of infection with Mycobacterium tuberculosis. The standard tuberculin test employs the intradermal (Mantoux) test using a 5 TU dose of tuberculin PPD.7 The 0.1 mL test dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 TU dose which has been clinically utilized and standardized with PPD-S. Tuberculin skin testing is not contraindicated for persons who have been vaccinated with BCG and the skin-test results of such persons are used to support or exclude the diagnosis of M. tuberculosis infections.4 HIV infection is a strong risk factor for the development of TB disease in persons having TB infection. All HIV-infected persons should receive a PPD-tuberculin skin test.3.",
"Description": "Aplisol (tuberculin PPD, diluted) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The solution is stabilized with polysorbate (Tween) 80, buffered with potassium and sodium phosphates and contains approximately 0.25% phenol as a preservative. This product is ready for immediate use without further dilution. The purified protein fraction is isolated from culture media filtrates of a human strain of Mycobacterium tuberculosis by the method of F.B. Seibert.1,2 Tuberculin PPD, diluted, is prepared from Tuberculin PPD which is clinically bioequivalent in potency to the standard PPD-S* (5 TU** per 0.1mL) of the U.S. Public Health Service, National Centers for Disease Control. The potency of each lot of tuberculin PPD, diluted is determined in sensitized guinea pigs."
},
{
"NDCCode": "42023-104-05",
"PackageDescription": "1 VIAL in 1 CARTON (42023-104-05) / 5 mL in 1 VIAL",
"NDC11Code": "42023-0104-05",
"ProductNDC": "42023-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aplisol",
"NonProprietaryName": "Tuberculin Purified Protein Derivative",
"DosageFormName": "INJECTION",
"RouteName": "INTRADERMAL",
"StartMarketingDate": "20080425",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103782",
"LabelerName": "ENDO USA, Inc.",
"SubstanceName": "TUBERCULIN PURIFIED PROTEIN DERIVATIVE",
"StrengthNumber": "5",
"StrengthUnit": "[iU]/.1mL",
"Pharm_Classes": "Antigens, Bacterial [CS], Cell-mediated Immunity [PE], Skin Test Antigen [EPC], Tuberculosis Skin Test [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080425",
"SamplePackage": "N",
"IndicationAndUsage": "Tuberculin PPD is indicated as an aid in the detection of infection with Mycobacterium tuberculosis. The standard tuberculin test employs the intradermal (Mantoux) test using a 5 TU dose of tuberculin PPD.7 The 0.1 mL test dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 TU dose which has been clinically utilized and standardized with PPD-S. Tuberculin skin testing is not contraindicated for persons who have been vaccinated with BCG and the skin-test results of such persons are used to support or exclude the diagnosis of M. tuberculosis infections.4 HIV infection is a strong risk factor for the development of TB disease in persons having TB infection. All HIV-infected persons should receive a PPD-tuberculin skin test.3.",
"Description": "Aplisol (tuberculin PPD, diluted) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The solution is stabilized with polysorbate (Tween) 80, buffered with potassium and sodium phosphates and contains approximately 0.25% phenol as a preservative. This product is ready for immediate use without further dilution. The purified protein fraction is isolated from culture media filtrates of a human strain of Mycobacterium tuberculosis by the method of F.B. Seibert.1,2 Tuberculin PPD, diluted, is prepared from Tuberculin PPD which is clinically bioequivalent in potency to the standard PPD-S* (5 TU** per 0.1mL) of the U.S. Public Health Service, National Centers for Disease Control. The potency of each lot of tuberculin PPD, diluted is determined in sensitized guinea pigs."
},
{
"NDCCode": "42023-105-01",
"PackageDescription": "1 VIAL in 1 CARTON (42023-105-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "42023-0105-01",
"ProductNDC": "42023-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brevital Sodium",
"NonProprietaryName": "Methohexital Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; RECTAL",
"StartMarketingDate": "20071101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA011559",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "METHOHEXITAL SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20071101",
"SamplePackage": "N",
"IndicationAndUsage": "BREVITAL can be used in adults as follows. 1. For intravenous induction of anesthesia prior to the use of other general anesthetic agents. 2. For intravenous induction of anesthesia and as an adjunct to subpotent inhalational anesthetic agents (such as nitrous oxide in oxygen) for short surgical procedures; BREVITAL may be given by infusion or intermittent injection. 3. For use along with other parenteral agents, usually narcotic analgesics, to supplement subpotent inhalational anesthetic agents (such as nitrous oxide in oxygen) for longer surgical procedures. 4. As intravenous anesthesia for short surgical, diagnostic, or therapeutic procedures associated with minimal painful stimuli (see WARNINGS). 5. As an agent for inducing a hypnotic state. BREVITAL can be used in pediatric patients older than 1 month as follows. 1. For rectal or intramuscular induction of anesthesia prior to the use of other general anesthetic agents. 2. For rectal or intramuscular induction of anesthesia and as an adjunct to subpotent inhalational anesthetic agents for short surgical procedures. 3. As rectal or intramuscular anesthesia for short surgical, diagnostic, or therapeutic procedures associated with minimal painful stimuli.",
"Description": "BREVITAL® (methohexital sodium, USP) for injection, is 2,4,6 (1H, 3H, 5H)-Pyrimidinetrione, 1-methyl-5-(1-methyl-2-pentynyl)-5-(2-propenyl)-, (±)-, monosodium salt and has the empirical formula C14H17N2NaO3. Its molecular weight is 284.29. The structural formula is as follows. Methohexital sodium is a rapid, ultrashort-acting barbiturate anesthetic. Methohexital sodium for injection is a freeze-dried, sterile, nonpyrogenic mixture of methohexital sodium with 6% anhydrous sodium carbonate added as a buffer. It contains not less than 90% and not more than 110% of the labeled amount of methohexital sodium. It occurs as a white, freeze-dried plug that is freely soluble in water. This product is oxygen sensitive. The pH of the 1% solution is between 10 and 11; the pH of the 0.2% solution in 5% dextrose is between 9.5 and 10.5. Methohexital sodium may be administered by direct intravenous injection or continuous intravenous drip, intramuscular or rectal routes (see PRECAUTIONS/Pediatric Use). Reconstituting instructions vary depending on the route of administration (see DOSAGE AND ADMINISTRATION)."
},
{
"NDCCode": "42023-106-01",
"PackageDescription": "1 VIAL in 1 CARTON (42023-106-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "42023-0106-01",
"ProductNDC": "42023-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brevital Sodium",
"NonProprietaryName": "Methohexital Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; RECTAL",
"StartMarketingDate": "20071101",
"EndMarketingDate": "20210131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA011559",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "METHOHEXITAL SODIUM",
"StrengthNumber": "2.5",
"StrengthUnit": "g/1",
"Pharm_Classes": "Barbiturate [EPC],Barbiturates [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2021-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20071101",
"EndMarketingDatePackage": "20210131",
"SamplePackage": "N"
},
{
"NDCCode": "42023-107-01",
"PackageDescription": "1 VIAL in 1 CARTON (42023-107-01) / 2 mL in 1 VIAL",
"NDC11Code": "42023-0107-01",
"ProductNDC": "42023-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Coly-mycin",
"ProprietaryNameSuffix": "M",
"NonProprietaryName": "Colistimethate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20071101",
"EndMarketingDate": "20270531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050108",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "COLISTIMETHATE SODIUM",
"StrengthNumber": "150",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20071101",
"EndMarketingDatePackage": "20270531",
"SamplePackage": "N",
"IndicationAndUsage": "Coly-Mycin M Parenteral is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa. This antibiotic is not indicated for infections due to Proteus or Neisseria. Coly-Mycin M Parenteral has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa. Coly-Mycin M Parenteral may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Coly-Mycin M and other antibacterial drugs, Coly-Mycin M should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Coly-Mycin® M Parenteral (Colistimethate for Injection, USP) is a sterile parenteral antibiotic product which, when reconstituted (see Reconstitution), is suitable for intramuscular or intravenous administration. Each vial contains colistimethate sodium or pentasodium colistinmethanesulfonate (150 mg colistin base activity). Colistimethate sodium is a polypeptide antibiotic with an approximate molecular weight of 1750. The empirical formula is C58H105N16Na5O28S5 and the structural formula is represented below."
},
{
"NDCCode": "42023-107-06",
"PackageDescription": "6 VIAL in 1 CARTON (42023-107-06) > 2 mL in 1 VIAL",
"NDC11Code": "42023-0107-06",
"ProductNDC": "42023-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Coly-mycin",
"ProprietaryNameSuffix": "M",
"NonProprietaryName": "Colistimethate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20071101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050108",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "COLISTIMETHATE SODIUM",
"StrengthNumber": "150",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20071101",
"EndMarketingDatePackage": "20221031",
"SamplePackage": "N",
"IndicationAndUsage": "Coly-Mycin M Parenteral is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa. This antibiotic is not indicated for infections due to Proteus or Neisseria. Coly-Mycin M Parenteral has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa. Coly-Mycin M Parenteral may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Coly-Mycin M and other antibacterial drugs, Coly-Mycin M should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Coly-Mycin® M Parenteral (Colistimethate for Injection, USP) is a sterile parenteral antibiotic product which, when reconstituted (see Reconstitution), is suitable for intramuscular or intravenous administration. Each vial contains colistimethate sodium or pentasodium colistinmethanesulfonate (150 mg colistin base activity). Colistimethate sodium is a polypeptide antibiotic with an approximate molecular weight of 1750. The empirical formula is C58H105N16Na5O28S5 and the structural formula is represented below."
},
{
"NDCCode": "42023-108-01",
"PackageDescription": "5 mL in 1 BOTTLE, DROPPER (42023-108-01)",
"NDC11Code": "42023-0108-01",
"ProductNDC": "42023-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Coly-mycin S",
"NonProprietaryName": "Colistin Sulfate, Neomycin Sulfate, Thonzonium Bromide And Hydrocortisone Acetate",
"DosageFormName": "SUSPENSION",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20071101",
"EndMarketingDate": "20170618",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050356",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "COLISTIN SULFATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE; HYDROCORTISONE ACETATE",
"StrengthNumber": "3; 3.3; .5; 10",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-06-21"
},
{
"NDCCode": "42023-109-01",
"PackageDescription": "10 mL in 1 BOTTLE, DROPPER (42023-109-01) ",
"NDC11Code": "42023-0109-01",
"ProductNDC": "42023-109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cortisporin-tc",
"NonProprietaryName": "Colistin Sulfate, Neomycin Sulfate, Thonzonium Bromide, And Hydrocortisone Acetate",
"DosageFormName": "SUSPENSION",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20071101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050356",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "COLISTIN SULFATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE; HYDROCORTISONE ACETATE",
"StrengthNumber": "3; 3.3; .5; 10",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20071101",
"SamplePackage": "N"
},
{
"NDCCode": "42023-110-01",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (42023-110-01) ",
"NDC11Code": "42023-0110-01",
"ProductNDC": "42023-110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delestrogen",
"NonProprietaryName": "Estradiol Valerate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20071101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA009402",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "ESTRADIOL VALERATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20071101",
"SamplePackage": "N",
"IndicationAndUsage": "DELESTROGEN (estradiol valerate injection, USP) is indicated in the. 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).",
"Description": "DELESTROGEN® (estradiol valerate injection, USP) contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to yellow. Formulations (per mL): 10 mg estradiol valerate in a vehicle containing 5 mg chlorobutanol (chloral derivative/preservative) and 915 mg sesame oil; 20 mg estradiol valerate in a vehicle containing 224 mg benzyl benzoate, 20 mg benzyl alcohol (preservative) and 730 mg castor oil; 40 mg estradiol valerate in a vehicle containing 447 mg benzyl benzoate, 20 mg benzyl alcohol and 522 mg castor oil. Estradiol valerate is designated chemically as estra-1,3,5(10)-triene-3, 17-diol(17β)-, 17-pentanoate. Graphic formula."
},
{
"NDCCode": "42023-111-01",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (42023-111-01) ",
"NDC11Code": "42023-0111-01",
"ProductNDC": "42023-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delestrogen",
"NonProprietaryName": "Estradiol Valerate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20071101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA009402",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "ESTRADIOL VALERATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20071101",
"SamplePackage": "N",
"IndicationAndUsage": "DELESTROGEN (estradiol valerate injection, USP) is indicated in the. 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).",
"Description": "DELESTROGEN® (estradiol valerate injection, USP) contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to yellow. Formulations (per mL): 10 mg estradiol valerate in a vehicle containing 5 mg chlorobutanol (chloral derivative/preservative) and 915 mg sesame oil; 20 mg estradiol valerate in a vehicle containing 224 mg benzyl benzoate, 20 mg benzyl alcohol (preservative) and 730 mg castor oil; 40 mg estradiol valerate in a vehicle containing 447 mg benzyl benzoate, 20 mg benzyl alcohol and 522 mg castor oil. Estradiol valerate is designated chemically as estra-1,3,5(10)-triene-3, 17-diol(17β)-, 17-pentanoate. Graphic formula."
},
{
"NDCCode": "42023-112-01",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (42023-112-01) ",
"NDC11Code": "42023-0112-01",
"ProductNDC": "42023-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delestrogen",
"NonProprietaryName": "Estradiol Valerate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20071101",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA009402",
"LabelerName": "ENDO USA, Inc.",
"SubstanceName": "ESTRADIOL VALERATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20071101",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "DELESTROGEN (estradiol valerate injection, USP) is indicated in the. 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).",
"Description": "DELESTROGEN® (estradiol valerate injection, USP) contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to yellow. Formulations (per mL): 10 mg estradiol valerate in a vehicle containing 5 mg chlorobutanol (chloral derivative/preservative) and 915 mg sesame oil; 20 mg estradiol valerate in a vehicle containing 224 mg benzyl benzoate, 20 mg benzyl alcohol (preservative) and 730 mg castor oil; 40 mg estradiol valerate in a vehicle containing 447 mg benzyl benzoate, 20 mg benzyl alcohol and 522 mg castor oil. Estradiol valerate is designated chemically as estra-1,3,5(10)-triene-3, 17-diol(17β)-, 17-pentanoate. Graphic formula."
},
{
"NDCCode": "42023-113-10",
"PackageDescription": "10 VIAL in 1 CARTON (42023-113-10) / 20 mL in 1 VIAL",
"NDC11Code": "42023-0113-10",
"ProductNDC": "42023-113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketalar",
"NonProprietaryName": "Ketamine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20071001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016812",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "KETAMINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20071001",
"SamplePackage": "N",
"IndicationAndUsage": "KETALAR (ketamine hydrochloride) injection is indicated: 1 as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation., 2 for the induction of anesthesia prior to the administration of other general anesthetic agents., 3 as a supplement to other anesthetic agents.",
"Description": "KETALAR (ketamine hydrochloride) injection, for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine hydrochloride, USP is a white crystalline powder and has a molecular formula of C13H16ClNOHCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is (±)-2-(o-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride. The chemical structure of ketamine hydrochloride is. It is formulated as a slightly acidic (pH 3.5-5.5) sterile solution for intravenous or intramuscular injection. Each milliliter (mL) of the multiple-dose vials contain either 10 mg ketamine base (equivalent to 11.53 mg ketamine hydrochloride), 50 mg ketamine base (equivalent to 57.67 mg ketamine hydrochloride) or 100 mg ketamine base (equivalent to 115.33 mg ketamine hydrochloride) and not more than 0.10 mg/mL benzethonium chloride added as a preservative in water for injection. The 10 mg/mL solution has been made isotonic with 6.60 mg sodium chloride."
},
{
"NDCCode": "42023-114-10",
"PackageDescription": "10 VIAL in 1 CARTON (42023-114-10) / 10 mL in 1 VIAL",
"NDC11Code": "42023-0114-10",
"ProductNDC": "42023-114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketalar",
"NonProprietaryName": "Ketamine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20071001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016812",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "KETAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20071001",
"SamplePackage": "N",
"IndicationAndUsage": "KETALAR (ketamine hydrochloride) injection is indicated: 1 as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation., 2 for the induction of anesthesia prior to the administration of other general anesthetic agents., 3 as a supplement to other anesthetic agents.",
"Description": "KETALAR (ketamine hydrochloride) injection, for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine hydrochloride, USP is a white crystalline powder and has a molecular formula of C13H16ClNOHCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is (±)-2-(o-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride. The chemical structure of ketamine hydrochloride is. It is formulated as a slightly acidic (pH 3.5-5.5) sterile solution for intravenous or intramuscular injection. Each milliliter (mL) of the multiple-dose vials contain either 10 mg ketamine base (equivalent to 11.53 mg ketamine hydrochloride), 50 mg ketamine base (equivalent to 57.67 mg ketamine hydrochloride) or 100 mg ketamine base (equivalent to 115.33 mg ketamine hydrochloride) and not more than 0.10 mg/mL benzethonium chloride added as a preservative in water for injection. The 10 mg/mL solution has been made isotonic with 6.60 mg sodium chloride."
},
{
"NDCCode": "42023-115-10",
"PackageDescription": "10 VIAL in 1 CARTON (42023-115-10) / 5 mL in 1 VIAL",
"NDC11Code": "42023-0115-10",
"ProductNDC": "42023-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketalar",
"NonProprietaryName": "Ketamine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20071001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016812",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "KETAMINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20071001",
"SamplePackage": "N",
"IndicationAndUsage": "KETALAR (ketamine hydrochloride) injection is indicated: 1 as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation., 2 for the induction of anesthesia prior to the administration of other general anesthetic agents., 3 as a supplement to other anesthetic agents.",
"Description": "KETALAR (ketamine hydrochloride) injection, for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine hydrochloride, USP is a white crystalline powder and has a molecular formula of C13H16ClNOHCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is (±)-2-(o-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride. The chemical structure of ketamine hydrochloride is. It is formulated as a slightly acidic (pH 3.5-5.5) sterile solution for intravenous or intramuscular injection. Each milliliter (mL) of the multiple-dose vials contain either 10 mg ketamine base (equivalent to 11.53 mg ketamine hydrochloride), 50 mg ketamine base (equivalent to 57.67 mg ketamine hydrochloride) or 100 mg ketamine base (equivalent to 115.33 mg ketamine hydrochloride) and not more than 0.10 mg/mL benzethonium chloride added as a preservative in water for injection. The 10 mg/mL solution has been made isotonic with 6.60 mg sodium chloride."
},
{
"NDCCode": "42023-116-01",
"PackageDescription": "1 VIAL in 1 CARTON (42023-116-01) > 10 mL in 1 VIAL",
"NDC11Code": "42023-0116-01",
"ProductNDC": "42023-116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pitocin",
"NonProprietaryName": "Oxytocin",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20080201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018261",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "OXYTOCIN",
"StrengthNumber": "10",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20080201",
"EndMarketingDatePackage": "20210831",
"SamplePackage": "N",
"IndicationAndUsage": "Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, Pitocin is not indicated for elective induction of labor.",
"Description": "Pitocin (oxytocin injection, USP) is a sterile, clear, colorless aqueous solution of synthetic oxytocin, for intravenous infusion or intramuscular injection. Pitocin is a nonapeptide found in pituitary extracts from mammals. It is standardized to contain 10 units of oxytocic hormone/mL and contains 0.5% Chlorobutanol, a chloroform derivative as a preservative, 1.65 mg acetic acid and 0.16 mg ammonium acetate as buffers, and with the pH adjusted with acetic acid to achieve a targeted pH of 3.5. Pitocin may contain up to 16% of total impurities. The hormone is prepared synthetically to avoid possible contamination with vasopressin (ADH) and other small polypeptides with biologic activity. Pitocin has the empirical formula C43H66N12O12S2 (molecular weight 1007.19). The structural formula is as follows:."
},
{
"NDCCode": "42023-116-02",
"PackageDescription": "25 VIAL in 1 CARTON (42023-116-02) / 10 mL in 1 VIAL",
"NDC11Code": "42023-0116-02",
"ProductNDC": "42023-116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pitocin",
"NonProprietaryName": "Oxytocin",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20080201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018261",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "OXYTOCIN",
"StrengthNumber": "10",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [CS]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080201",
"SamplePackage": "N",
"IndicationAndUsage": "Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, Pitocin is not indicated for elective induction of labor.",
"Description": "Pitocin (oxytocin injection, USP) is a sterile, clear, colorless aqueous solution of synthetic oxytocin, for intravenous infusion or intramuscular injection. Pitocin is a nonapeptide found in pituitary extracts from mammals. It is standardized to contain 10 units of oxytocic hormone/mL and contains 0.5% Chlorobutanol, a chloroform derivative as a preservative, 1.65 mg acetic acid and 0.16 mg ammonium acetate as buffers, and with the pH adjusted with acetic acid to achieve a targeted pH of 3.5. Pitocin may contain up to 16% of total impurities. The hormone is prepared synthetically to avoid possible contamination with vasopressin (ADH) and other small polypeptides with biologic activity. Pitocin has the empirical formula C43H66N12O12S2 (molecular weight 1007.19). The structural formula is as follows:."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>42023-157-89</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (42023-157-89) > 50 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0157-89</NDC11Code>
<ProductNDC>42023-157</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ethacrynate Sodium</ProprietaryName>
<NonProprietaryName>Ethacrynate Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205473</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ETHACRYNATE SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-02-21</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42023-157-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (42023-157-01) / 50 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0157-01</NDC11Code>
<ProductNDC>42023-157</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ethacrynate Sodium</ProprietaryName>
<NonProprietaryName>Ethacrynate Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150730</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205473</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>ETHACRYNATE SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150730</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ethacrynate sodium is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. 1. Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. 2. Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. 3. Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. 4. Intravenous ethacrynate sodium is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable.</IndicationAndUsage>
<Description>Ethacrynic acid is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2- methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of 303.14. Ethacrynic acid is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene. Its empirical formula is C13H12Cl2O4 and its structural formula is. Ethacrynate sodium, the sodium salt of ethacrynic acid, is soluble in water at 25°C to the extent of about 7 percent. Solutions of the sodium salt are relatively stable at about pH 7 at room temperature for short periods, but as the pH or temperature increases the solutions are less stable. The molecular weight of ethacrynate sodium is 325.12. Its empirical formula is C13H11Cl2NaO4 and its structural formula is. Intravenous Ethacrynate Sodium is a sterile freeze-dried powder and is supplied in a vial containing: Ethacrynate sodium equivalent to ethacrynic acid...... 50 mg Inactive ingredient: Mannitol......................62.5 mg.</Description>
</NDC>
<NDC>
<NDCCode>42023-157-99</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (42023-157-99) > 50 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0157-99</NDC11Code>
<ProductNDC>42023-157</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ethacrynate Sodium</ProprietaryName>
<NonProprietaryName>Ethacrynate Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160923</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205473</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ETHACRYNATE SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-14</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ethacrynate sodium is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. : 1 1.Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome., 2 2.Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema., 3 3.Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome., 4 4.Intravenous ethacrynate sodium is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable.</IndicationAndUsage>
<Description>Ethacrynic acid is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2- methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of 303.14. Ethacrynic acid is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene. Its empirical formula is C13H12Cl2O4 and its structural formula is. Ethacrynate sodium, the sodium salt of ethacrynic acid, is soluble in water at 25°C to the extent of about 7 percent. Solutions of the sodium salt are relatively stable at about pH 7 at room temperature for short periods, but as the pH or temperature increases the solutions are less stable. The molecular weight of ethacrynate sodium is 325.12. Its empirical formula is C13H11Cl2NaO4 and its structural formula is. Intravenous Ethacrynate Sodium is a sterile freeze-dried powder and is supplied in a vial containing: Ethacrynate sodium equivalent to ethacrynic acid...... 50 mg Inactive ingredient: Mannitol......................62.5 mg.</Description>
</NDC>
<NDC>
<NDCCode>42023-129-89</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (42023-129-89) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0129-89</NDC11Code>
<ProductNDC>42023-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluphenazine Decanoate</ProprietaryName>
<NonProprietaryName>Fluphenazine Decanoate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203732</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>FLUPHENAZINE DECANOATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluphenazine Decanoate Injection is a long-acting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy (e.g., chronic schizophrenics). Fluphenazine Decanoate Injection has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Fluphenazine decanoate is the decanoate ester of a trifluoromethyl phenothiazine derivative. It is a highly potent behavior modifier with a markedly extended duration of effect and has the following structural formula. Fluphenazine Decanoate Injection, USP is available as a clear, pale yellow solution for intramuscular (IM) or subcutaneous (SC) use providing 25 mg fluphenazine decanoate per mL in a sesame oil vehicle with 12 mg benzyl alcohol as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>42023-168-89</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (42023-168-89) / 30 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0168-89</NDC11Code>
<ProductNDC>42023-168</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adrenalin</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20201204</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204640</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adrenalin® is a non-selective alpha and beta adrenergic agonist indicated for: 1 Emergency treatment of allergic reactions (Type 1), including anaphylaxis (1.1), 2 To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock (1.2).</IndicationAndUsage>
<Description>Adrenalin (epinephrine injection, USP) is a clear, colorless, sterile solution containing 1 mg/mL epinephrine, packaged as 30 mL of solution in a multiple dose amber glass vial. In the 30 mL vial, each 1 mL of Adrenalin solution contains 1 mg epinephrine, 6.15 mg sodium chloride, 0.457 mg sodium metabisulfite, 0.920 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, 5.18 mg of 4% hydrochloric acid to adjust pH, 5.25 mg chlorobutanol as a preservative and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2-(methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is. The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin.</Description>
</NDC>
<NDC>
<NDCCode>42023-182-89</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (42023-182-89) / 2.5 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0182-89</NDC11Code>
<ProductNDC>42023-182</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Argatroban</ProprietaryName>
<NonProprietaryName>Argatroban</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091665</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>ARGATROBAN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Argatroban is a direct thrombin inhibitor indicated: 1 For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) (1.1), 2 As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) (1.2).</IndicationAndUsage>
<Description>Argatroban is a synthetic direct thrombin inhibitor and the chemical name is 1-[5-[(aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8-quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid, monohydrate. Argatroban has 4 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately 65:35. The molecular formula of argatroban is C23H36N6O5S∙H2O. Its molecular weight is 526.66 g/mol. The structural formula is. Argatroban is a white, odorless crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in ethanol, and insoluble in acetone, ethyl acetate, and ether. Argatroban Injection, USP is a sterile clear, colorless to pale yellow, slightly viscous solution in a single-use amber vial containing 250 mg/2.5 mL of argatroban. Each mL of sterile, nonpyrogenic solution contains 100 mg argatroban, 300 mg D-sorbitol, and 400 mg dehydrated alcohol in water for injection.</Description>
</NDC>
<NDC>
<NDCCode>42023-221-85</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 PACKAGE (42023-221-85) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-221-89) </PackageDescription>
<NDC11Code>42023-0221-85</NDC11Code>
<ProductNDC>42023-221</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ertapenem</ProprietaryName>
<NonProprietaryName>Ertapenem Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20181101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021337</ApplicationNumber>
<LabelerName>ENDO USA, Inc.</LabelerName>
<SubstanceName>ERTAPENEM SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ertapenem for injection is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria: 1 Complicated intra-abdominal infections. (1.1), 2 Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis. (1.2), 3 Community-acquired pneumonia. (1.3), 4 Complicated urinary tract infections including pyelonephritis. (1.4), 5 Acute pelvic infections including postpartum endomyometritis, septic abortion and post-surgical gynecologic infections. (1.5).</IndicationAndUsage>
<Description>Ertapenem for injection is a sterile, synthetic, parenteral, 1-β methyl-carbapenem that is structurally related to beta-lactam antibiotics. Chemically, ertapenem for injection is described as [4R-[3(3S*,5S*),4α,5β,6β(R*)]]-3-[[5-[[(3-carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monosodium salt. Its molecular weight is 497.50. The empirical formula is C22H24N3O7SNa, and its structural formula is. Ertapenem sodium is a white to off-white hygroscopic, weakly crystalline powder. It is soluble in water and 0.9% sodium chloride solution, practically insoluble in ethanol, and insoluble in isopropyl acetate and tetrahydrofuran. Ertapenem for injection is supplied as sterile, white to yellowish off-white lyophilized powder for intravenous infusion after reconstitution with appropriate diluent [see Dosage and Administration (2.7)] and transfer to 50 mL 0.9% Sodium Chloride Injection or for intramuscular injection following reconstitution with 1% lidocaine hydrochloride. Each single-dose vial contains 1 gram ertapenem equivalent to 1.046 grams ertapenem sodium. The sodium content is approximately 137 mg (approximately 6.0 mEq). Each vial of ertapenem for injection contains the following inactive ingredients: 175 mg sodium bicarbonate and sodium hydroxide to adjust pH to 7.5.</Description>
</NDC>
<NDC>
<NDCCode>42023-146-25</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (42023-146-25) / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0146-25</NDC11Code>
<ProductNDC>42023-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmedetomidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmedetomidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203972</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexmedetomidine hydrochloride injection is a alpha2-adrenergic receptor agonist indicated for: 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride injection by continuous infusion not to exceed 24 hours. (1.1), 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2).</IndicationAndUsage>
<Description>Dexmedetomidine Injection, USP is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2 HCl and the structural formula is. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Injection, USP is intended to be used after dilution. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 118 mcg of dexmedetomidine hydrochloride (equivalent to 100 mcg or 0.1 mg of dexmedetomidine) and 9 mg of sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine) and 9 mg sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers.</Description>
</NDC>
<NDC>
<NDCCode>42023-186-20</NDCCode>
<PackageDescription>20 VIAL in 1 CARTON (42023-186-20) / 50 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0186-20</NDC11Code>
<ProductNDC>42023-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmedetomidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmedetomidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208266</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexmedetomidine hydrochloride injection is a alpha2-adrenergic receptor agonist indicated for: 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride injection by continuous infusion not to exceed 24 hours. (1.1), 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2).</IndicationAndUsage>
<Description>Dexmedetomidine Injection, USP is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2 HCl and the structural formula is. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Injection, USP is intended to be used after dilution. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 118 mcg of dexmedetomidine hydrochloride (equivalent to 100 mcg or 0.1 mg of dexmedetomidine) and 9 mg of sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine) and 9 mg sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers.</Description>
</NDC>
<NDC>
<NDCCode>42023-187-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (42023-187-10) / 100 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0187-10</NDC11Code>
<ProductNDC>42023-187</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmedetomidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmedetomidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208266</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexmedetomidine hydrochloride injection is a alpha2-adrenergic receptor agonist indicated for: 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride injection by continuous infusion not to exceed 24 hours. (1.1), 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2).</IndicationAndUsage>
<Description>Dexmedetomidine Injection, USP is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2 HCl and the structural formula is. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Injection, USP is intended to be used after dilution. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 118 mcg of dexmedetomidine hydrochloride (equivalent to 100 mcg or 0.1 mg of dexmedetomidine) and 9 mg of sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine) and 9 mg sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers.</Description>
</NDC>
<NDC>
<NDCCode>42571-314-89</NDCCode>
<PackageDescription>10 CARTON in 1 CARTON (42571-314-89) / 1 VIAL, GLASS in 1 CARTON (42571-314-88) / 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>42571-0314-89</NDC11Code>
<ProductNDC>42571-314</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tranexamic Acid</ProprietaryName>
<NonProprietaryName>Tranexamic Acid</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206713</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>TRANEXAMIC ACID</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.</IndicationAndUsage>
<Description>Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid, USP is a white crystalline powder. The structural formula is. Molecular Formula: C 8H 15NO 2Molecular Weight: 157.2. Each mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid, USP and Water for Injection to 1 mL. The aqueous solution for injection has a pH of 6.5 to 8.0.</Description>
</NDC>
<NDC>
<NDCCode>24357-011-13</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (24357-011-13) * 1 mL in 1 VIAL (42023-159-25) * 1 mL in 1 PACKET (68599-5804-1) </PackageDescription>
<NDC11Code>24357-0011-13</NDC11Code>
<ProductNDC>24357-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinephrine Professional</ProprietaryName>
<NonProprietaryName>Epinephrine And Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204200</ApplicationNumber>
<LabelerName>Focus Health Group</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24357-012-12</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (24357-012-12) * 1 mL in 1 PACKET (68599-5804-1) * 1 mL in 1 VIAL (42023-159-01) </PackageDescription>
<NDC11Code>24357-0012-12</NDC11Code>
<ProductNDC>24357-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinephrine Professional Ems</ProprietaryName>
<NonProprietaryName>Epinephrine Convenience Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204200</ApplicationNumber>
<LabelerName>Focus Health Group</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24357-811-20</NDCCode>
<PackageDescription>1 KIT in 1 KIT (24357-811-20) * 1 mL in 1 VIAL, GLASS (42023-159-25) </PackageDescription>
<NDC11Code>24357-0811-20</NDC11Code>
<ProductNDC>24357-811</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinephrinesnap-v</ProprietaryName>
<NonProprietaryName>Epinephrine Convenience Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20170505</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>FOCUS HEALTH GROUP</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adrenalin® is available as a single-use 1 mL vial and a multiple-use 30 mL vial for intramuscular and subcutaneous use. Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. The signs and symptoms associated with anaphylaxis include flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with hypotension, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, airway swelling, laryngospasm, bronchospasm, pruritus, urticaria or angioedema, swelling of the eyelids, lips, and tongue.</IndicationAndUsage>
<Description>Adrenalin® (epinephrine injection, USP) is a clear, colorless, sterile solution containing 1 mg/mL (1:1000) epinephrine, packaged as 1 mL of solution in a singleuse clear glass vial or 30 mL of solution in a multiple-dose amber glass vial. In the 1 mL vial, each 1 mL of Adrenalin® solution contains 1 mg epinephrine, 7.3 mg sodium chloride, 0.457 mg sodium metabisulfite, 1 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, hydrochloric acid to adjust pH, and water for injection. In the 30 mL vial, each 1 mL of Adrenalin® solution contains 1 mg epinephrine, 6.15 mg sodium chloride, 0.457 mg sodium metabisulfite, 0.920 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, hydrochloric acid to adjust pH, 5.25 mg chlorobutanol as a preservative and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2-(methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is:. The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin.</Description>
</NDC>
<NDC>
<NDCCode>42023-104-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (42023-104-01) / 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0104-01</NDC11Code>
<ProductNDC>42023-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aplisol</ProprietaryName>
<NonProprietaryName>Tuberculin Purified Protein Derivative</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRADERMAL</RouteName>
<StartMarketingDate>20080425</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103782</ApplicationNumber>
<LabelerName>ENDO USA, Inc.</LabelerName>
<SubstanceName>TUBERCULIN PURIFIED PROTEIN DERIVATIVE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>[iU]/.1mL</StrengthUnit>
<Pharm_Classes>Antigens, Bacterial [CS], Cell-mediated Immunity [PE], Skin Test Antigen [EPC], Tuberculosis Skin Test [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tuberculin PPD is indicated as an aid in the detection of infection with Mycobacterium tuberculosis. The standard tuberculin test employs the intradermal (Mantoux) test using a 5 TU dose of tuberculin PPD.7 The 0.1 mL test dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 TU dose which has been clinically utilized and standardized with PPD-S. Tuberculin skin testing is not contraindicated for persons who have been vaccinated with BCG and the skin-test results of such persons are used to support or exclude the diagnosis of M. tuberculosis infections.4 HIV infection is a strong risk factor for the development of TB disease in persons having TB infection. All HIV-infected persons should receive a PPD-tuberculin skin test.3.</IndicationAndUsage>
<Description>Aplisol (tuberculin PPD, diluted) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The solution is stabilized with polysorbate (Tween) 80, buffered with potassium and sodium phosphates and contains approximately 0.25% phenol as a preservative. This product is ready for immediate use without further dilution. The purified protein fraction is isolated from culture media filtrates of a human strain of Mycobacterium tuberculosis by the method of F.B. Seibert.1,2 Tuberculin PPD, diluted, is prepared from Tuberculin PPD which is clinically bioequivalent in potency to the standard PPD-S* (5 TU** per 0.1mL) of the U.S. Public Health Service, National Centers for Disease Control. The potency of each lot of tuberculin PPD, diluted is determined in sensitized guinea pigs.</Description>
</NDC>
<NDC>
<NDCCode>42023-104-05</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (42023-104-05) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0104-05</NDC11Code>
<ProductNDC>42023-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aplisol</ProprietaryName>
<NonProprietaryName>Tuberculin Purified Protein Derivative</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRADERMAL</RouteName>
<StartMarketingDate>20080425</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103782</ApplicationNumber>
<LabelerName>ENDO USA, Inc.</LabelerName>
<SubstanceName>TUBERCULIN PURIFIED PROTEIN DERIVATIVE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>[iU]/.1mL</StrengthUnit>
<Pharm_Classes>Antigens, Bacterial [CS], Cell-mediated Immunity [PE], Skin Test Antigen [EPC], Tuberculosis Skin Test [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tuberculin PPD is indicated as an aid in the detection of infection with Mycobacterium tuberculosis. The standard tuberculin test employs the intradermal (Mantoux) test using a 5 TU dose of tuberculin PPD.7 The 0.1 mL test dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 TU dose which has been clinically utilized and standardized with PPD-S. Tuberculin skin testing is not contraindicated for persons who have been vaccinated with BCG and the skin-test results of such persons are used to support or exclude the diagnosis of M. tuberculosis infections.4 HIV infection is a strong risk factor for the development of TB disease in persons having TB infection. All HIV-infected persons should receive a PPD-tuberculin skin test.3.</IndicationAndUsage>
<Description>Aplisol (tuberculin PPD, diluted) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The solution is stabilized with polysorbate (Tween) 80, buffered with potassium and sodium phosphates and contains approximately 0.25% phenol as a preservative. This product is ready for immediate use without further dilution. The purified protein fraction is isolated from culture media filtrates of a human strain of Mycobacterium tuberculosis by the method of F.B. Seibert.1,2 Tuberculin PPD, diluted, is prepared from Tuberculin PPD which is clinically bioequivalent in potency to the standard PPD-S* (5 TU** per 0.1mL) of the U.S. Public Health Service, National Centers for Disease Control. The potency of each lot of tuberculin PPD, diluted is determined in sensitized guinea pigs.</Description>
</NDC>
<NDC>
<NDCCode>42023-105-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (42023-105-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>42023-0105-01</NDC11Code>
<ProductNDC>42023-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brevital Sodium</ProprietaryName>
<NonProprietaryName>Methohexital Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; RECTAL</RouteName>
<StartMarketingDate>20071101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA011559</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>METHOHEXITAL SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BREVITAL can be used in adults as follows. 1. For intravenous induction of anesthesia prior to the use of other general anesthetic agents. 2. For intravenous induction of anesthesia and as an adjunct to subpotent inhalational anesthetic agents (such as nitrous oxide in oxygen) for short surgical procedures; BREVITAL may be given by infusion or intermittent injection. 3. For use along with other parenteral agents, usually narcotic analgesics, to supplement subpotent inhalational anesthetic agents (such as nitrous oxide in oxygen) for longer surgical procedures. 4. As intravenous anesthesia for short surgical, diagnostic, or therapeutic procedures associated with minimal painful stimuli (see WARNINGS). 5. As an agent for inducing a hypnotic state. BREVITAL can be used in pediatric patients older than 1 month as follows. 1. For rectal or intramuscular induction of anesthesia prior to the use of other general anesthetic agents. 2. For rectal or intramuscular induction of anesthesia and as an adjunct to subpotent inhalational anesthetic agents for short surgical procedures. 3. As rectal or intramuscular anesthesia for short surgical, diagnostic, or therapeutic procedures associated with minimal painful stimuli.</IndicationAndUsage>
<Description>BREVITAL® (methohexital sodium, USP) for injection, is 2,4,6 (1H, 3H, 5H)-Pyrimidinetrione, 1-methyl-5-(1-methyl-2-pentynyl)-5-(2-propenyl)-, (±)-, monosodium salt and has the empirical formula C14H17N2NaO3. Its molecular weight is 284.29. The structural formula is as follows. Methohexital sodium is a rapid, ultrashort-acting barbiturate anesthetic. Methohexital sodium for injection is a freeze-dried, sterile, nonpyrogenic mixture of methohexital sodium with 6% anhydrous sodium carbonate added as a buffer. It contains not less than 90% and not more than 110% of the labeled amount of methohexital sodium. It occurs as a white, freeze-dried plug that is freely soluble in water. This product is oxygen sensitive. The pH of the 1% solution is between 10 and 11; the pH of the 0.2% solution in 5% dextrose is between 9.5 and 10.5. Methohexital sodium may be administered by direct intravenous injection or continuous intravenous drip, intramuscular or rectal routes (see PRECAUTIONS/Pediatric Use). Reconstituting instructions vary depending on the route of administration (see DOSAGE AND ADMINISTRATION).</Description>
</NDC>
<NDC>
<NDCCode>42023-106-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (42023-106-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>42023-0106-01</NDC11Code>
<ProductNDC>42023-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brevital Sodium</ProprietaryName>
<NonProprietaryName>Methohexital Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; RECTAL</RouteName>
<StartMarketingDate>20071101</StartMarketingDate>
<EndMarketingDate>20210131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA011559</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>METHOHEXITAL SODIUM</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC],Barbiturates [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20071101</StartMarketingDatePackage>
<EndMarketingDatePackage>20210131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42023-107-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (42023-107-01) / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0107-01</NDC11Code>
<ProductNDC>42023-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Coly-mycin</ProprietaryName>
<ProprietaryNameSuffix>M</ProprietaryNameSuffix>
<NonProprietaryName>Colistimethate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20071101</StartMarketingDate>
<EndMarketingDate>20270531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050108</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>COLISTIMETHATE SODIUM</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20071101</StartMarketingDatePackage>
<EndMarketingDatePackage>20270531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Coly-Mycin M Parenteral is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa. This antibiotic is not indicated for infections due to Proteus or Neisseria. Coly-Mycin M Parenteral has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa. Coly-Mycin M Parenteral may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Coly-Mycin M and other antibacterial drugs, Coly-Mycin M should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Coly-Mycin® M Parenteral (Colistimethate for Injection, USP) is a sterile parenteral antibiotic product which, when reconstituted (see Reconstitution), is suitable for intramuscular or intravenous administration. Each vial contains colistimethate sodium or pentasodium colistinmethanesulfonate (150 mg colistin base activity). Colistimethate sodium is a polypeptide antibiotic with an approximate molecular weight of 1750. The empirical formula is C58H105N16Na5O28S5 and the structural formula is represented below.</Description>
</NDC>
<NDC>
<NDCCode>42023-107-06</NDCCode>
<PackageDescription>6 VIAL in 1 CARTON (42023-107-06) > 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0107-06</NDC11Code>
<ProductNDC>42023-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Coly-mycin</ProprietaryName>
<ProprietaryNameSuffix>M</ProprietaryNameSuffix>
<NonProprietaryName>Colistimethate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20071101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050108</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>COLISTIMETHATE SODIUM</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071101</StartMarketingDatePackage>
<EndMarketingDatePackage>20221031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Coly-Mycin M Parenteral is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa. This antibiotic is not indicated for infections due to Proteus or Neisseria. Coly-Mycin M Parenteral has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa. Coly-Mycin M Parenteral may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Coly-Mycin M and other antibacterial drugs, Coly-Mycin M should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Coly-Mycin® M Parenteral (Colistimethate for Injection, USP) is a sterile parenteral antibiotic product which, when reconstituted (see Reconstitution), is suitable for intramuscular or intravenous administration. Each vial contains colistimethate sodium or pentasodium colistinmethanesulfonate (150 mg colistin base activity). Colistimethate sodium is a polypeptide antibiotic with an approximate molecular weight of 1750. The empirical formula is C58H105N16Na5O28S5 and the structural formula is represented below.</Description>
</NDC>
<NDC>
<NDCCode>42023-108-01</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, DROPPER (42023-108-01)</PackageDescription>
<NDC11Code>42023-0108-01</NDC11Code>
<ProductNDC>42023-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Coly-mycin S</ProprietaryName>
<NonProprietaryName>Colistin Sulfate, Neomycin Sulfate, Thonzonium Bromide And Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20071101</StartMarketingDate>
<EndMarketingDate>20170618</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050356</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>COLISTIN SULFATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE; HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>3; 3.3; .5; 10</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-06-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>42023-109-01</NDCCode>
<PackageDescription>10 mL in 1 BOTTLE, DROPPER (42023-109-01) </PackageDescription>
<NDC11Code>42023-0109-01</NDC11Code>
<ProductNDC>42023-109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cortisporin-tc</ProprietaryName>
<NonProprietaryName>Colistin Sulfate, Neomycin Sulfate, Thonzonium Bromide, And Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20071101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050356</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>COLISTIN SULFATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE; HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>3; 3.3; .5; 10</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42023-110-01</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (42023-110-01) </PackageDescription>
<NDC11Code>42023-0110-01</NDC11Code>
<ProductNDC>42023-110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delestrogen</ProprietaryName>
<NonProprietaryName>Estradiol Valerate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20071101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA009402</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>ESTRADIOL VALERATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DELESTROGEN (estradiol valerate injection, USP) is indicated in the. 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).</IndicationAndUsage>
<Description>DELESTROGEN® (estradiol valerate injection, USP) contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to yellow. Formulations (per mL): 10 mg estradiol valerate in a vehicle containing 5 mg chlorobutanol (chloral derivative/preservative) and 915 mg sesame oil; 20 mg estradiol valerate in a vehicle containing 224 mg benzyl benzoate, 20 mg benzyl alcohol (preservative) and 730 mg castor oil; 40 mg estradiol valerate in a vehicle containing 447 mg benzyl benzoate, 20 mg benzyl alcohol and 522 mg castor oil. Estradiol valerate is designated chemically as estra-1,3,5(10)-triene-3, 17-diol(17β)-, 17-pentanoate. Graphic formula.</Description>
</NDC>
<NDC>
<NDCCode>42023-111-01</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (42023-111-01) </PackageDescription>
<NDC11Code>42023-0111-01</NDC11Code>
<ProductNDC>42023-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delestrogen</ProprietaryName>
<NonProprietaryName>Estradiol Valerate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20071101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA009402</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>ESTRADIOL VALERATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DELESTROGEN (estradiol valerate injection, USP) is indicated in the. 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).</IndicationAndUsage>
<Description>DELESTROGEN® (estradiol valerate injection, USP) contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to yellow. Formulations (per mL): 10 mg estradiol valerate in a vehicle containing 5 mg chlorobutanol (chloral derivative/preservative) and 915 mg sesame oil; 20 mg estradiol valerate in a vehicle containing 224 mg benzyl benzoate, 20 mg benzyl alcohol (preservative) and 730 mg castor oil; 40 mg estradiol valerate in a vehicle containing 447 mg benzyl benzoate, 20 mg benzyl alcohol and 522 mg castor oil. Estradiol valerate is designated chemically as estra-1,3,5(10)-triene-3, 17-diol(17β)-, 17-pentanoate. Graphic formula.</Description>
</NDC>
<NDC>
<NDCCode>42023-112-01</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (42023-112-01) </PackageDescription>
<NDC11Code>42023-0112-01</NDC11Code>
<ProductNDC>42023-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delestrogen</ProprietaryName>
<NonProprietaryName>Estradiol Valerate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20071101</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA009402</ApplicationNumber>
<LabelerName>ENDO USA, Inc.</LabelerName>
<SubstanceName>ESTRADIOL VALERATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20071101</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DELESTROGEN (estradiol valerate injection, USP) is indicated in the. 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).</IndicationAndUsage>
<Description>DELESTROGEN® (estradiol valerate injection, USP) contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to yellow. Formulations (per mL): 10 mg estradiol valerate in a vehicle containing 5 mg chlorobutanol (chloral derivative/preservative) and 915 mg sesame oil; 20 mg estradiol valerate in a vehicle containing 224 mg benzyl benzoate, 20 mg benzyl alcohol (preservative) and 730 mg castor oil; 40 mg estradiol valerate in a vehicle containing 447 mg benzyl benzoate, 20 mg benzyl alcohol and 522 mg castor oil. Estradiol valerate is designated chemically as estra-1,3,5(10)-triene-3, 17-diol(17β)-, 17-pentanoate. Graphic formula.</Description>
</NDC>
<NDC>
<NDCCode>42023-113-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (42023-113-10) / 20 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0113-10</NDC11Code>
<ProductNDC>42023-113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketalar</ProprietaryName>
<NonProprietaryName>Ketamine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20071001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016812</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>KETAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KETALAR (ketamine hydrochloride) injection is indicated: 1 as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation., 2 for the induction of anesthesia prior to the administration of other general anesthetic agents., 3 as a supplement to other anesthetic agents.</IndicationAndUsage>
<Description>KETALAR (ketamine hydrochloride) injection, for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine hydrochloride, USP is a white crystalline powder and has a molecular formula of C13H16ClNOHCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is (±)-2-(o-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride. The chemical structure of ketamine hydrochloride is. It is formulated as a slightly acidic (pH 3.5-5.5) sterile solution for intravenous or intramuscular injection. Each milliliter (mL) of the multiple-dose vials contain either 10 mg ketamine base (equivalent to 11.53 mg ketamine hydrochloride), 50 mg ketamine base (equivalent to 57.67 mg ketamine hydrochloride) or 100 mg ketamine base (equivalent to 115.33 mg ketamine hydrochloride) and not more than 0.10 mg/mL benzethonium chloride added as a preservative in water for injection. The 10 mg/mL solution has been made isotonic with 6.60 mg sodium chloride.</Description>
</NDC>
<NDC>
<NDCCode>42023-114-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (42023-114-10) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0114-10</NDC11Code>
<ProductNDC>42023-114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketalar</ProprietaryName>
<NonProprietaryName>Ketamine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20071001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016812</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>KETAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KETALAR (ketamine hydrochloride) injection is indicated: 1 as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation., 2 for the induction of anesthesia prior to the administration of other general anesthetic agents., 3 as a supplement to other anesthetic agents.</IndicationAndUsage>
<Description>KETALAR (ketamine hydrochloride) injection, for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine hydrochloride, USP is a white crystalline powder and has a molecular formula of C13H16ClNOHCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is (±)-2-(o-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride. The chemical structure of ketamine hydrochloride is. It is formulated as a slightly acidic (pH 3.5-5.5) sterile solution for intravenous or intramuscular injection. Each milliliter (mL) of the multiple-dose vials contain either 10 mg ketamine base (equivalent to 11.53 mg ketamine hydrochloride), 50 mg ketamine base (equivalent to 57.67 mg ketamine hydrochloride) or 100 mg ketamine base (equivalent to 115.33 mg ketamine hydrochloride) and not more than 0.10 mg/mL benzethonium chloride added as a preservative in water for injection. The 10 mg/mL solution has been made isotonic with 6.60 mg sodium chloride.</Description>
</NDC>
<NDC>
<NDCCode>42023-115-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (42023-115-10) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0115-10</NDC11Code>
<ProductNDC>42023-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketalar</ProprietaryName>
<NonProprietaryName>Ketamine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20071001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016812</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>KETAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KETALAR (ketamine hydrochloride) injection is indicated: 1 as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation., 2 for the induction of anesthesia prior to the administration of other general anesthetic agents., 3 as a supplement to other anesthetic agents.</IndicationAndUsage>
<Description>KETALAR (ketamine hydrochloride) injection, for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine hydrochloride, USP is a white crystalline powder and has a molecular formula of C13H16ClNOHCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is (±)-2-(o-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride. The chemical structure of ketamine hydrochloride is. It is formulated as a slightly acidic (pH 3.5-5.5) sterile solution for intravenous or intramuscular injection. Each milliliter (mL) of the multiple-dose vials contain either 10 mg ketamine base (equivalent to 11.53 mg ketamine hydrochloride), 50 mg ketamine base (equivalent to 57.67 mg ketamine hydrochloride) or 100 mg ketamine base (equivalent to 115.33 mg ketamine hydrochloride) and not more than 0.10 mg/mL benzethonium chloride added as a preservative in water for injection. The 10 mg/mL solution has been made isotonic with 6.60 mg sodium chloride.</Description>
</NDC>
<NDC>
<NDCCode>42023-116-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (42023-116-01) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0116-01</NDC11Code>
<ProductNDC>42023-116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pitocin</ProprietaryName>
<NonProprietaryName>Oxytocin</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20080201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018261</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>OXYTOCIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080201</StartMarketingDatePackage>
<EndMarketingDatePackage>20210831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, Pitocin is not indicated for elective induction of labor.</IndicationAndUsage>
<Description>Pitocin (oxytocin injection, USP) is a sterile, clear, colorless aqueous solution of synthetic oxytocin, for intravenous infusion or intramuscular injection. Pitocin is a nonapeptide found in pituitary extracts from mammals. It is standardized to contain 10 units of oxytocic hormone/mL and contains 0.5% Chlorobutanol, a chloroform derivative as a preservative, 1.65 mg acetic acid and 0.16 mg ammonium acetate as buffers, and with the pH adjusted with acetic acid to achieve a targeted pH of 3.5. Pitocin may contain up to 16% of total impurities. The hormone is prepared synthetically to avoid possible contamination with vasopressin (ADH) and other small polypeptides with biologic activity. Pitocin has the empirical formula C43H66N12O12S2 (molecular weight 1007.19). The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>42023-116-02</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (42023-116-02) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0116-02</NDC11Code>
<ProductNDC>42023-116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pitocin</ProprietaryName>
<NonProprietaryName>Oxytocin</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20080201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018261</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>OXYTOCIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, Pitocin is not indicated for elective induction of labor.</IndicationAndUsage>
<Description>Pitocin (oxytocin injection, USP) is a sterile, clear, colorless aqueous solution of synthetic oxytocin, for intravenous infusion or intramuscular injection. Pitocin is a nonapeptide found in pituitary extracts from mammals. It is standardized to contain 10 units of oxytocic hormone/mL and contains 0.5% Chlorobutanol, a chloroform derivative as a preservative, 1.65 mg acetic acid and 0.16 mg ammonium acetate as buffers, and with the pH adjusted with acetic acid to achieve a targeted pH of 3.5. Pitocin may contain up to 16% of total impurities. The hormone is prepared synthetically to avoid possible contamination with vasopressin (ADH) and other small polypeptides with biologic activity. Pitocin has the empirical formula C43H66N12O12S2 (molecular weight 1007.19). The structural formula is as follows:.</Description>
</NDC>
</NDCList>