{
"NDC": [
{
"NDCCode": "0264-9376-88",
"PackageDescription": "5 AMPULE in 1 CARTON (0264-9376-88) > 5 mL in 1 AMPULE",
"NDC11Code": "00264-9376-88",
"ProductNDC": "0264-9376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INFILTRATION",
"StartMarketingDate": "20180803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208474",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE ANHYDROUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2022-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180803",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine HCl Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.",
"Description": "Lidocaine HCl Injection, USP is a sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONS for specific uses. Lidocaine HCl Injection, USP solution contains lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine HCl (C14H22N2O HCl) has the following structural formula. Lidocaine HCl Injection, USP solution is for single dose usage, and is Methyl Paraben Free (Preservative-Free). Lidocaine HCl Injection, USP is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. The pH of this solution is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid."
},
{
"NDCCode": "0264-9375-88",
"PackageDescription": "10 mL in 1 AMPULE (0264-9375-88) ",
"NDC11Code": "00264-9375-88",
"ProductNDC": "0264-9375",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160809",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019635",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "9",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Active",
"LastUpdate": "2022-03-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160809",
"SamplePackage": "N",
"IndicationAndUsage": "0.9% Sodium Chloride Injection USP is indicated as pharmaceutic aid and diluent for the infusion of compatible drug additives. Refer to prescribing information accompanying additive drugs.",
"Description": "Each 1 mL of 0.9% Sodium Chloride Injection USP contains. Sodium Chloride USP 9 mgWater for Injection USP qs. pH: 5.6 (4.5-7.0). Calculated Osmolarity: 0.308 mOsmol/mL. pH adjusted with Hydrochloric Acid NF. Concentration of Electrolytes (mEq/liter): Sodium 154 Chloride 154. 0.9% Sodium Chloride Injection USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP."
},
{
"NDCCode": "0264-9378-05",
"PackageDescription": "5 AMPULE in 1 CARTON (0264-9378-05) / 5 mL in 1 AMPULE (0264-9378-88) ",
"NDC11Code": "00264-9378-05",
"ProductNDC": "0264-9378",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hcl And Epinephrine",
"NonProprietaryName": "Lidocaine Hcl And Epinephrine",
"DosageFormName": "INJECTION",
"RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
"StartMarketingDate": "20210908",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208475",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE",
"StrengthNumber": "15; .005",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210908",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine hydrochloride and epinephrine injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of lidocaine hydrochloride and epinephrine injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP contains lidocaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for lidocaine hydrochloride and epinephrine injection is by injection, for infiltration, nerve block, epidural and caudal use. Lidocaine hydrochloride and epinephrine injection is a single-dose solution that is Methylparaben (preservative) free. Lidocaine hydrochloride is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride monohydrate and has the molecular weight of 288.8 g/mol. Lidocaine hydrochloride molecular formula is C14H22N2OHClH2O, and has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine bitartrate is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl alcohol (+) tartrate (1:1) salt and has the molecular weight 333.3 g/mol. Epinephrine bitartrate molecular formula is C9H13NO3C4H6O6 and has the following structural formula. Lidocaine hydrochloride and epinephrine injection is a sterile, nonpyrogenic, isotonic, clear, colorless and preservative-free solution. Each mL contains 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer. The pH of these solutions is adjusted to approximately 4.5 (3.3 to 5.5) with sodium hydroxide and hydrochloric acid. Filled under nitrogen. * Quantity is equivalent to 16 mg/mL Lidocaine Hydrochloride, USP (Monohydrate). ** Quantity is equivalent to 0.00909 mg/mL of Epinephrine Bitartrate, USP."
},
{
"NDCCode": "0264-9379-88",
"PackageDescription": "10 AMPULE in 1 CARTON (0264-9379-88) / 2 mL in 1 AMPULE",
"NDC11Code": "00264-9379-88",
"ProductNDC": "0264-9379",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupivacaine Hydrochloride With Dextrose",
"NonProprietaryName": "Bupivacaine Hydrochloride With Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "SUBARACHNOID",
"StartMarketingDate": "20190402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209087",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-05-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190402",
"SamplePackage": "N",
"IndicationAndUsage": "Bupivacaine Hydrochloride in Dextrose Injection, USP is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia).",
"Description": "Bupivacaine Hydrochloride in Dextrose Injection, USP is an amide-local anesthetic and sterile hyperbaric aqueous solution. The route of administration for Bupivacaine Hydrochloride in Dextrose Injection, USP is by subarachnoid injection. Bupivacaine Hydrochloride contains bupivacaine hydrochloride, as the active pharmaceutical ingredient and also contains Dextrose, as baricity agent. Bupivacaine Hydrochloride (monohydrate) chemical name is 2-piperidinecarboxamide, 1-butyl-N-(2,6- dimethylphenyl)-, monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. Bupivacaine Hydrochloride (monohydrate) has a molecular formula of C18H28N2O·HCl·H2O and molecular weight of 342.90 g/mol and has the following structural formula. Dextrose chemical name is D-glucopyranose. Dextrose (anhydrous) has a molecular formula of C6H12O6, molecular weight of 180.16 g/mol and has the following structural formula. Bupivacaine Hydrochloride in Dextrose Injection, USP is a clear and colorless sterile hyperbaric solution. Each mL of Bupivacaine Hydrochloride in Dextrose Injection, USP contains 7.5 mg bupivacaine hydrochloride (anhydrous) (equivalent to 7.9 mg of bupivacaine hydrochloride monohydrate), 82.5 mg dextrose (anhydrous) as baricity agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. Bupivacaine Hydrochloride in Dextrose Injection, USP pH is between 4.0 and 6.5. The specific gravity of Bupivacaine Hydrochloride in Dextrose Injection, USP is between 1.030 and 1.035 at 25°C and 1.03 at 37°C. Bupivacaine Hydrochloride in Dextrose Injection, USP does not contain any preservatives."
},
{
"NDCCode": "0264-1909-55",
"PackageDescription": "12 CARTON in 1 CASE (0264-1909-55) > 1 CONTAINER in 1 CARTON > 250 mL in 1 CONTAINER",
"NDC11Code": "00264-1909-55",
"ProductNDC": "0264-1909",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nephramine",
"NonProprietaryName": "Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Cysteine, And Sodium Bisulfite",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19780224",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017766",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; CYSTEINE HYDROCHLORIDE",
"StrengthNumber": ".25; .56; .88; .64; .88; .88; .4; .2; .64; .014",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19780224",
"SamplePackage": "N"
},
{
"NDCCode": "0264-9350-55",
"PackageDescription": "6 CARTON in 1 CASE (0264-9350-55) > 1 CONTAINER in 1 CARTON > 750 mL in 1 CONTAINER",
"NDC11Code": "00264-9350-55",
"ProductNDC": "0264-9350",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Freamine Hbc",
"NonProprietaryName": "Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Glycine, Cysteine, And Sodium Bisulfite",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19710924",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016822",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; GLYCINE; CYSTEINE HYDROCHLORIDE",
"StrengthNumber": ".76; 1.37; .41; .25; .32; .2; .09; .88; .4; .58; .16; .63; .33; .33; .014",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-10-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19710924",
"SamplePackage": "N"
},
{
"NDCCode": "67877-264-01",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-264-01) ",
"NDC11Code": "67877-0264-01",
"ProductNDC": "67877-264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203197",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120501",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine is indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration.Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to off-white crystalline powder, which is slightly soluble in water.Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl cellulose, sodium lauryl sulfate, crosspovidone, sugar spheres, hypromellose phthalates, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow. The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, black iron oxide (for 20 mg and 30 mg strengths), titanium dioxide and purified water."
},
{
"NDCCode": "67877-264-10",
"PackageDescription": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-264-10) ",
"NDC11Code": "67877-0264-10",
"ProductNDC": "67877-264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203197",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120501",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine is indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration.Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to off-white crystalline powder, which is slightly soluble in water.Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl cellulose, sodium lauryl sulfate, crosspovidone, sugar spheres, hypromellose phthalates, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow. The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, black iron oxide (for 20 mg and 30 mg strengths), titanium dioxide and purified water."
},
{
"NDCCode": "67877-264-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-264-30) ",
"NDC11Code": "67877-0264-30",
"ProductNDC": "67877-264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203197",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120501",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine is indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration.Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to off-white crystalline powder, which is slightly soluble in water.Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl cellulose, sodium lauryl sulfate, crosspovidone, sugar spheres, hypromellose phthalates, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow. The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, black iron oxide (for 20 mg and 30 mg strengths), titanium dioxide and purified water."
},
{
"NDCCode": "67877-264-90",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-264-90) ",
"NDC11Code": "67877-0264-90",
"ProductNDC": "67877-264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203197",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120501",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine is indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration.Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to off-white crystalline powder, which is slightly soluble in water.Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl cellulose, sodium lauryl sulfate, crosspovidone, sugar spheres, hypromellose phthalates, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow. The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, black iron oxide (for 20 mg and 30 mg strengths), titanium dioxide and purified water."
},
{
"NDCCode": "0143-9376-01",
"PackageDescription": "1 VIAL in 1 BOX, UNIT-DOSE (0143-9376-01) / 5 mL in 1 VIAL",
"NDC11Code": "00143-9376-01",
"ProductNDC": "0143-9376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etoposide",
"NonProprietaryName": "Etoposide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19960501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074290",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "ETOPOSIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": "Etoposide Injection, USP is indicated in the management of the following neoplasms.",
"Description": "Etoposide (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. It is 4'-demethylepipodophyllotoxin 9-[4,6-0-(R)-ethylidene-β-D-glucopyranoside]. It is very soluble in methanol and chloroform, slightly soluble in ethanol and sparingly soluble in water and ether. It is made more miscible with water by means of organic solvents. It has a molecular weight of 588.58 and a molecular formula of C29H32O13. Etoposide Injection, USP is available for intravenous use as 20 mg/mL solution in 100 mg (5 mL), 500 mg (25 mL), and 1 g (50 mL) sterile, multiple-dose vials. The pH of the clear, nearly colorless to yellow liquid is 3 to 4. Each mL contains 20 mg etoposide USP, 2 mg citric acid, 30 mg benzyl alcohol, 80 mg modified polysorbate 80/tween 80, 650 mg polyethylene glycol 300, and 30.5 percent (v/v) alcohol. The structural formula is."
},
{
"NDCCode": "0220-9376-62",
"PackageDescription": "7 SUPPOSITORY in 1 BOX (0220-9376-62) ",
"NDC11Code": "00220-9376-62",
"ProductNDC": "0220-9376",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Yeastcalm",
"NonProprietaryName": "Sodium Borate,calendula Officinalis Flowering Top,candida Albicans,goldenseal",
"DosageFormName": "SUPPOSITORY",
"RouteName": "VAGINAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoires Boirdon",
"SubstanceName": "GOLDENSEAL; CALENDULA OFFICINALIS FLOWERING TOP; SODIUM BORATE; CANDIDA ALBICANS",
"StrengthNumber": "5; 1; 14; 30",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211001",
"SamplePackage": "N",
"IndicationAndUsage": "Uses*. : 1 if this is the first time you have vaginal itching and discomfort, see your doctor to find out if you have a vaginal yeast infection, 2 temporarily relieves symptoms of vaginal yeast infection (candidiasis) such as:."
},
{
"NDCCode": "33992-9376-5",
"PackageDescription": "1 BOTTLE in 1 CARTON (33992-9376-5) > 15 mL in 1 BOTTLE",
"NDC11Code": "33992-9376-05",
"ProductNDC": "33992-9376",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Assured Original Relief Eye",
"NonProprietaryName": "Tetrahydrozoline Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20130228",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "GREENBRIER INTERNATIONAL, INC.",
"SubstanceName": "TETRAHYDROZOLINE HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Directions: 1 put 1 to 2 drops in the affected eye(s) up to 4 times daily , 2 children under 6 years of age: ask a doctor."
},
{
"NDCCode": "55154-9376-5",
"PackageDescription": "5 VIAL in 1 BAG (55154-9376-5) > 2 mL in 1 VIAL",
"NDC11Code": "55154-9376-05",
"ProductNDC": "55154-9376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gentamicin",
"NonProprietaryName": "Gentamicin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20041129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062366",
"LabelerName": "Cardinal Health",
"SubstanceName": "GENTAMICIN SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-05-22",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "68788-9376-1",
"PackageDescription": "100 TABLET in 1 BOTTLE (68788-9376-1) ",
"NDC11Code": "68788-9376-01",
"ProductNDC": "68788-9376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090200",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20141125",
"SamplePackage": "N"
},
{
"NDCCode": "68788-9376-2",
"PackageDescription": "20 TABLET in 1 BOTTLE (68788-9376-2) ",
"NDC11Code": "68788-9376-02",
"ProductNDC": "68788-9376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090200",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20141125",
"SamplePackage": "N"
},
{
"NDCCode": "68788-9376-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (68788-9376-3) ",
"NDC11Code": "68788-9376-03",
"ProductNDC": "68788-9376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090200",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20141125",
"SamplePackage": "N"
},
{
"NDCCode": "68788-9376-4",
"PackageDescription": "40 TABLET in 1 BOTTLE (68788-9376-4) ",
"NDC11Code": "68788-9376-04",
"ProductNDC": "68788-9376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090200",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20141125",
"SamplePackage": "N"
},
{
"NDCCode": "68788-9376-6",
"PackageDescription": "60 TABLET in 1 BOTTLE (68788-9376-6) ",
"NDC11Code": "68788-9376-06",
"ProductNDC": "68788-9376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090200",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20141125",
"SamplePackage": "N"
},
{
"NDCCode": "68788-9376-8",
"PackageDescription": "120 TABLET in 1 BOTTLE (68788-9376-8) ",
"NDC11Code": "68788-9376-08",
"ProductNDC": "68788-9376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090200",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20141125",
"SamplePackage": "N"
},
{
"NDCCode": "68788-9376-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (68788-9376-9) ",
"NDC11Code": "68788-9376-09",
"ProductNDC": "68788-9376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090200",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20141125",
"SamplePackage": "N"
},
{
"NDCCode": "0054-0264-24",
"PackageDescription": "10 CONTAINER in 1 CARTON (0054-0264-24) / 10 TABLET in 1 CONTAINER",
"NDC11Code": "00054-0264-24",
"ProductNDC": "0054-0264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090729",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074597",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090729",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid agonist. Hydromorphone hydrochloride, USP is a white to off-white powder. It is soluble in water and sparingly soluble in alcohol. The chemical name of hydromorphone hydrochloride is 4,5α-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula is. C17H19NO3 ●HCl M.W. 321.80. Each Hydromorphone Hydrochloride Tablet, USP for oral administration, contains 4 mg or 8 mg hydromorphone hydrochloride, USP. In addition, the tablets include lactose anhydrous and magnesium stearate. Hydromorphone Hydrochloride Tablets, USP may contain traces of sodium metabisulfite. Each 5 mL (1 teaspoonful) of Hydromorphone Hydrochloride Oral Solution, USP contains 5 mg of hydromorphone hydrochloride, USP. In addition, other ingredients include FD&C Red No. 40, methyl paraben, propylene glycol, propylparaben, purified water, raspberry blend, saccharin sodium and sorbitol solution. Hydromorphone Hydrochloride Oral Solution, USP may contain traces of sodium metabisulfite."
},
{
"NDCCode": "0054-0264-25",
"PackageDescription": "100 TABLET in 1 BOTTLE (0054-0264-25) ",
"NDC11Code": "00054-0264-25",
"ProductNDC": "0054-0264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090729",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074597",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090729",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid agonist. Hydromorphone hydrochloride, USP is a white to off-white powder. It is soluble in water and sparingly soluble in alcohol. The chemical name of hydromorphone hydrochloride is 4,5α-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula is. C17H19NO3 ●HCl M.W. 321.80. Each Hydromorphone Hydrochloride Tablet, USP for oral administration, contains 4 mg or 8 mg hydromorphone hydrochloride, USP. In addition, the tablets include lactose anhydrous and magnesium stearate. Hydromorphone Hydrochloride Tablets, USP may contain traces of sodium metabisulfite. Each 5 mL (1 teaspoonful) of Hydromorphone Hydrochloride Oral Solution, USP contains 5 mg of hydromorphone hydrochloride, USP. In addition, other ingredients include FD&C Red No. 40, methyl paraben, propylene glycol, propylparaben, purified water, raspberry blend, saccharin sodium and sorbitol solution. Hydromorphone Hydrochloride Oral Solution, USP may contain traces of sodium metabisulfite."
},
{
"NDCCode": "0093-0264-15",
"PackageDescription": "1 TUBE in 1 CARTON (0093-0264-15) / 15 g in 1 TUBE",
"NDC11Code": "00093-0264-15",
"ProductNDC": "0093-0264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19920501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073481",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19920501",
"SamplePackage": "N",
"IndicationAndUsage": "The topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The topical corticosteroids are intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene) bis(oxy)]-,(6α, 11β, 16α)-. It has the following structural formula. C26H32F207 M.W. 494.5. Each gram of Fluocinonide Cream USP, 0.05% (Emulsified Base) contains: 0.5 mg fluocinonide, USP in a water-washable aqueous emollient base of stearyl alcohol, cetyl alcohol, mineral oil, propylene glycol, sorbitan monostearate, polysorbate 60, citric acid monohydrate and purified water. Each gram of Fluocinonide Cream USP, 0.05% contains: 0.5 mg fluocinonide, USP in a specially formulated cream base consisting of stearyl alcohol, polyethylene glycol 8000, propylene glycol, 1,2,6-hexanetriol and citric acid monohydrate. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophilic properties. In this formulation, the active ingredient is totally in solution. Each gram of Fluocinonide Ointment USP, 0.05% contains: 0.5 mg fluocinonide, USP in an ointment base consisting of white petrolatum, castor oil, and sorbitan sesquioleate. It provides the occlusive and emollient effects desirable in an ointment. In this formulation, the active ingredient is totally in solution."
},
{
"NDCCode": "0093-0264-30",
"PackageDescription": "1 TUBE in 1 CARTON (0093-0264-30) / 30 g in 1 TUBE",
"NDC11Code": "00093-0264-30",
"ProductNDC": "0093-0264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19920501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073481",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19920501",
"SamplePackage": "N",
"IndicationAndUsage": "The topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The topical corticosteroids are intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene) bis(oxy)]-,(6α, 11β, 16α)-. It has the following structural formula. C26H32F207 M.W. 494.5. Each gram of Fluocinonide Cream USP, 0.05% (Emulsified Base) contains: 0.5 mg fluocinonide, USP in a water-washable aqueous emollient base of stearyl alcohol, cetyl alcohol, mineral oil, propylene glycol, sorbitan monostearate, polysorbate 60, citric acid monohydrate and purified water. Each gram of Fluocinonide Cream USP, 0.05% contains: 0.5 mg fluocinonide, USP in a specially formulated cream base consisting of stearyl alcohol, polyethylene glycol 8000, propylene glycol, 1,2,6-hexanetriol and citric acid monohydrate. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophilic properties. In this formulation, the active ingredient is totally in solution. Each gram of Fluocinonide Ointment USP, 0.05% contains: 0.5 mg fluocinonide, USP in an ointment base consisting of white petrolatum, castor oil, and sorbitan sesquioleate. It provides the occlusive and emollient effects desirable in an ointment. In this formulation, the active ingredient is totally in solution."
},
{
"NDCCode": "0093-0264-92",
"PackageDescription": "1 TUBE in 1 CARTON (0093-0264-92) / 60 g in 1 TUBE",
"NDC11Code": "00093-0264-92",
"ProductNDC": "0093-0264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19920501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073481",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19920501",
"SamplePackage": "N",
"IndicationAndUsage": "The topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The topical corticosteroids are intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene) bis(oxy)]-,(6α, 11β, 16α)-. It has the following structural formula. C26H32F207 M.W. 494.5. Each gram of Fluocinonide Cream USP, 0.05% (Emulsified Base) contains: 0.5 mg fluocinonide, USP in a water-washable aqueous emollient base of stearyl alcohol, cetyl alcohol, mineral oil, propylene glycol, sorbitan monostearate, polysorbate 60, citric acid monohydrate and purified water. Each gram of Fluocinonide Cream USP, 0.05% contains: 0.5 mg fluocinonide, USP in a specially formulated cream base consisting of stearyl alcohol, polyethylene glycol 8000, propylene glycol, 1,2,6-hexanetriol and citric acid monohydrate. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophilic properties. In this formulation, the active ingredient is totally in solution. Each gram of Fluocinonide Ointment USP, 0.05% contains: 0.5 mg fluocinonide, USP in an ointment base consisting of white petrolatum, castor oil, and sorbitan sesquioleate. It provides the occlusive and emollient effects desirable in an ointment. In this formulation, the active ingredient is totally in solution."
},
{
"NDCCode": "0168-0264-15",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0264-15) / 15 g in 1 TUBE",
"NDC11Code": "00168-0264-15",
"ProductNDC": "0168-0264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alclometasone Dipropionate",
"NonProprietaryName": "Alclometasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20050718",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076884",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "ALCLOMETASONE DIPROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050718",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Alclometasone dipropionate ointment is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use). Since the safety and efficacy of alclometasone dipropionate ointment have not been established in pediatric patients below 1 year of age, the use in this age-group is not recommended.",
"Description": "Alclometasone dipropionate ointment contains alclometasone dipropionate (7α-chloro-11β ,17,21-trihydroxy-16α -methylpregna-1,4-diene-3,20-dione 17,21-dipropionate), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, alclometasone dipropionate is C28H37ClO7. It has the following structural formula:. Alclometasone dipropionate has the molecular weight of 521. It is a white powder, insoluble in water, slightly soluble in propylene glycol, and moderately soluble in hexylene glycol. Each gram of alclometasone dipropionate ointment contains 0.5 mg of alclometasone dipropionate in an ointment base of hexylene glycol, white wax, propylene glycol stearate, and white petrolatum."
},
{
"NDCCode": "0168-0264-45",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0264-45) / 45 g in 1 TUBE",
"NDC11Code": "00168-0264-45",
"ProductNDC": "0168-0264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alclometasone Dipropionate",
"NonProprietaryName": "Alclometasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20050718",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076884",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "ALCLOMETASONE DIPROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050718",
"EndMarketingDatePackage": "20240731",
"SamplePackage": "N",
"IndicationAndUsage": "Alclometasone dipropionate ointment is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use). Since the safety and efficacy of alclometasone dipropionate ointment have not been established in pediatric patients below 1 year of age, the use in this age-group is not recommended.",
"Description": "Alclometasone dipropionate ointment contains alclometasone dipropionate (7α-chloro-11β ,17,21-trihydroxy-16α -methylpregna-1,4-diene-3,20-dione 17,21-dipropionate), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, alclometasone dipropionate is C28H37ClO7. It has the following structural formula:. Alclometasone dipropionate has the molecular weight of 521. It is a white powder, insoluble in water, slightly soluble in propylene glycol, and moderately soluble in hexylene glycol. Each gram of alclometasone dipropionate ointment contains 0.5 mg of alclometasone dipropionate in an ointment base of hexylene glycol, white wax, propylene glycol stearate, and white petrolatum."
},
{
"NDCCode": "0168-0264-60",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0264-60) / 60 g in 1 TUBE",
"NDC11Code": "00168-0264-60",
"ProductNDC": "0168-0264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alclometasone Dipropionate",
"NonProprietaryName": "Alclometasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20050718",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076884",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "ALCLOMETASONE DIPROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050718",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "Alclometasone dipropionate ointment is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use). Since the safety and efficacy of alclometasone dipropionate ointment have not been established in pediatric patients below 1 year of age, the use in this age-group is not recommended.",
"Description": "Alclometasone dipropionate ointment contains alclometasone dipropionate (7α-chloro-11β ,17,21-trihydroxy-16α -methylpregna-1,4-diene-3,20-dione 17,21-dipropionate), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, alclometasone dipropionate is C28H37ClO7. It has the following structural formula:. Alclometasone dipropionate has the molecular weight of 521. It is a white powder, insoluble in water, slightly soluble in propylene glycol, and moderately soluble in hexylene glycol. Each gram of alclometasone dipropionate ointment contains 0.5 mg of alclometasone dipropionate in an ointment base of hexylene glycol, white wax, propylene glycol stearate, and white petrolatum."
},
{
"NDCCode": "0264-1009-90",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-1009-90) / 100 mL in 1 CONTAINER",
"NDC11Code": "00264-1009-90",
"ProductNDC": "0264-1009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209705",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240513",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (greater than or equal to 16 years of age) with the following seizure types when oral administration is temporarily not feasible: 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures (1.3).",
"Description": "Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port container. This container closure is not made with natural rubber latex, PVC or DEHP. 500 mg/100 mL: One 100 mL fill container contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL fill container contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL fill container contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition. Each is covered by a tamperproof barrier. Refer to the DIRECTIONS FOR USE of the container to properly identify the ports. No vapor barrier is necessary."
}
]
}
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<NDCList>
<NDC>
<NDCCode>0264-9376-88</NDCCode>
<PackageDescription>5 AMPULE in 1 CARTON (0264-9376-88) > 5 mL in 1 AMPULE</PackageDescription>
<NDC11Code>00264-9376-88</NDC11Code>
<ProductNDC>0264-9376</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INFILTRATION</RouteName>
<StartMarketingDate>20180803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208474</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine HCl Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.</IndicationAndUsage>
<Description>Lidocaine HCl Injection, USP is a sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONS for specific uses. Lidocaine HCl Injection, USP solution contains lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine HCl (C14H22N2O HCl) has the following structural formula. Lidocaine HCl Injection, USP solution is for single dose usage, and is Methyl Paraben Free (Preservative-Free). Lidocaine HCl Injection, USP is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. The pH of this solution is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid.</Description>
</NDC>
<NDC>
<NDCCode>0264-9375-88</NDCCode>
<PackageDescription>10 mL in 1 AMPULE (0264-9375-88) </PackageDescription>
<NDC11Code>00264-9375-88</NDC11Code>
<ProductNDC>0264-9375</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Chloride</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160809</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019635</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-03-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>0.9% Sodium Chloride Injection USP is indicated as pharmaceutic aid and diluent for the infusion of compatible drug additives. Refer to prescribing information accompanying additive drugs.</IndicationAndUsage>
<Description>Each 1 mL of 0.9% Sodium Chloride Injection USP contains. Sodium Chloride USP 9 mgWater for Injection USP qs. pH: 5.6 (4.5-7.0). Calculated Osmolarity: 0.308 mOsmol/mL. pH adjusted with Hydrochloric Acid NF. Concentration of Electrolytes (mEq/liter): Sodium 154 Chloride 154. 0.9% Sodium Chloride Injection USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP.</Description>
</NDC>
<NDC>
<NDCCode>0264-9378-05</NDCCode>
<PackageDescription>5 AMPULE in 1 CARTON (0264-9378-05) / 5 mL in 1 AMPULE (0264-9378-88) </PackageDescription>
<NDC11Code>00264-9378-05</NDC11Code>
<ProductNDC>0264-9378</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl And Epinephrine</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL</RouteName>
<StartMarketingDate>20210908</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208475</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>15; .005</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine hydrochloride and epinephrine injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of lidocaine hydrochloride and epinephrine injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP contains lidocaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for lidocaine hydrochloride and epinephrine injection is by injection, for infiltration, nerve block, epidural and caudal use. Lidocaine hydrochloride and epinephrine injection is a single-dose solution that is Methylparaben (preservative) free. Lidocaine hydrochloride is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride monohydrate and has the molecular weight of 288.8 g/mol. Lidocaine hydrochloride molecular formula is C14H22N2OHClH2O, and has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine bitartrate is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl alcohol (+) tartrate (1:1) salt and has the molecular weight 333.3 g/mol. Epinephrine bitartrate molecular formula is C9H13NO3C4H6O6 and has the following structural formula. Lidocaine hydrochloride and epinephrine injection is a sterile, nonpyrogenic, isotonic, clear, colorless and preservative-free solution. Each mL contains 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer. The pH of these solutions is adjusted to approximately 4.5 (3.3 to 5.5) with sodium hydroxide and hydrochloric acid. Filled under nitrogen. * Quantity is equivalent to 16 mg/mL Lidocaine Hydrochloride, USP (Monohydrate). ** Quantity is equivalent to 0.00909 mg/mL of Epinephrine Bitartrate, USP.</Description>
</NDC>
<NDC>
<NDCCode>0264-9379-88</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (0264-9379-88) / 2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>00264-9379-88</NDC11Code>
<ProductNDC>0264-9379</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupivacaine Hydrochloride With Dextrose</ProprietaryName>
<NonProprietaryName>Bupivacaine Hydrochloride With Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBARACHNOID</RouteName>
<StartMarketingDate>20190402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209087</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupivacaine Hydrochloride in Dextrose Injection, USP is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia).</IndicationAndUsage>
<Description>Bupivacaine Hydrochloride in Dextrose Injection, USP is an amide-local anesthetic and sterile hyperbaric aqueous solution. The route of administration for Bupivacaine Hydrochloride in Dextrose Injection, USP is by subarachnoid injection. Bupivacaine Hydrochloride contains bupivacaine hydrochloride, as the active pharmaceutical ingredient and also contains Dextrose, as baricity agent. Bupivacaine Hydrochloride (monohydrate) chemical name is 2-piperidinecarboxamide, 1-butyl-N-(2,6- dimethylphenyl)-, monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. Bupivacaine Hydrochloride (monohydrate) has a molecular formula of C18H28N2O·HCl·H2O and molecular weight of 342.90 g/mol and has the following structural formula. Dextrose chemical name is D-glucopyranose. Dextrose (anhydrous) has a molecular formula of C6H12O6, molecular weight of 180.16 g/mol and has the following structural formula. Bupivacaine Hydrochloride in Dextrose Injection, USP is a clear and colorless sterile hyperbaric solution. Each mL of Bupivacaine Hydrochloride in Dextrose Injection, USP contains 7.5 mg bupivacaine hydrochloride (anhydrous) (equivalent to 7.9 mg of bupivacaine hydrochloride monohydrate), 82.5 mg dextrose (anhydrous) as baricity agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. Bupivacaine Hydrochloride in Dextrose Injection, USP pH is between 4.0 and 6.5. The specific gravity of Bupivacaine Hydrochloride in Dextrose Injection, USP is between 1.030 and 1.035 at 25°C and 1.03 at 37°C. Bupivacaine Hydrochloride in Dextrose Injection, USP does not contain any preservatives.</Description>
</NDC>
<NDC>
<NDCCode>0264-1909-55</NDCCode>
<PackageDescription>12 CARTON in 1 CASE (0264-1909-55) > 1 CONTAINER in 1 CARTON > 250 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-1909-55</NDC11Code>
<ProductNDC>0264-1909</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nephramine</ProprietaryName>
<NonProprietaryName>Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Cysteine, And Sodium Bisulfite</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19780224</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017766</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; CYSTEINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.25; .56; .88; .64; .88; .88; .4; .2; .64; .014</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19780224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0264-9350-55</NDCCode>
<PackageDescription>6 CARTON in 1 CASE (0264-9350-55) > 1 CONTAINER in 1 CARTON > 750 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-9350-55</NDC11Code>
<ProductNDC>0264-9350</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Freamine Hbc</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Glycine, Cysteine, And Sodium Bisulfite</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19710924</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016822</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; GLYCINE; CYSTEINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.76; 1.37; .41; .25; .32; .2; .09; .88; .4; .58; .16; .63; .33; .33; .014</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-10-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19710924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67877-264-01</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-264-01) </PackageDescription>
<NDC11Code>67877-0264-01</NDC11Code>
<ProductNDC>67877-264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203197</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine is indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration.Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to off-white crystalline powder, which is slightly soluble in water.Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl cellulose, sodium lauryl sulfate, crosspovidone, sugar spheres, hypromellose phthalates, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow. The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, black iron oxide (for 20 mg and 30 mg strengths), titanium dioxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>67877-264-10</NDCCode>
<PackageDescription>1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-264-10) </PackageDescription>
<NDC11Code>67877-0264-10</NDC11Code>
<ProductNDC>67877-264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203197</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine is indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration.Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to off-white crystalline powder, which is slightly soluble in water.Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl cellulose, sodium lauryl sulfate, crosspovidone, sugar spheres, hypromellose phthalates, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow. The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, black iron oxide (for 20 mg and 30 mg strengths), titanium dioxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>67877-264-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-264-30) </PackageDescription>
<NDC11Code>67877-0264-30</NDC11Code>
<ProductNDC>67877-264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203197</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine is indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration.Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to off-white crystalline powder, which is slightly soluble in water.Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl cellulose, sodium lauryl sulfate, crosspovidone, sugar spheres, hypromellose phthalates, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow. The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, black iron oxide (for 20 mg and 30 mg strengths), titanium dioxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>67877-264-90</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-264-90) </PackageDescription>
<NDC11Code>67877-0264-90</NDC11Code>
<ProductNDC>67877-264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203197</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine is indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration.Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to off-white crystalline powder, which is slightly soluble in water.Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl cellulose, sodium lauryl sulfate, crosspovidone, sugar spheres, hypromellose phthalates, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow. The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, black iron oxide (for 20 mg and 30 mg strengths), titanium dioxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>0143-9376-01</NDCCode>
<PackageDescription>1 VIAL in 1 BOX, UNIT-DOSE (0143-9376-01) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>00143-9376-01</NDC11Code>
<ProductNDC>0143-9376</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etoposide</ProprietaryName>
<NonProprietaryName>Etoposide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19960501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074290</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ETOPOSIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Etoposide Injection, USP is indicated in the management of the following neoplasms.</IndicationAndUsage>
<Description>Etoposide (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. It is 4'-demethylepipodophyllotoxin 9-[4,6-0-(R)-ethylidene-β-D-glucopyranoside]. It is very soluble in methanol and chloroform, slightly soluble in ethanol and sparingly soluble in water and ether. It is made more miscible with water by means of organic solvents. It has a molecular weight of 588.58 and a molecular formula of C29H32O13. Etoposide Injection, USP is available for intravenous use as 20 mg/mL solution in 100 mg (5 mL), 500 mg (25 mL), and 1 g (50 mL) sterile, multiple-dose vials. The pH of the clear, nearly colorless to yellow liquid is 3 to 4. Each mL contains 20 mg etoposide USP, 2 mg citric acid, 30 mg benzyl alcohol, 80 mg modified polysorbate 80/tween 80, 650 mg polyethylene glycol 300, and 30.5 percent (v/v) alcohol. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>0220-9376-62</NDCCode>
<PackageDescription>7 SUPPOSITORY in 1 BOX (0220-9376-62) </PackageDescription>
<NDC11Code>00220-9376-62</NDC11Code>
<ProductNDC>0220-9376</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Yeastcalm</ProprietaryName>
<NonProprietaryName>Sodium Borate,calendula Officinalis Flowering Top,candida Albicans,goldenseal</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Laboratoires Boirdon</LabelerName>
<SubstanceName>GOLDENSEAL; CALENDULA OFFICINALIS FLOWERING TOP; SODIUM BORATE; CANDIDA ALBICANS</SubstanceName>
<StrengthNumber>5; 1; 14; 30</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses*. : 1 if this is the first time you have vaginal itching and discomfort, see your doctor to find out if you have a vaginal yeast infection, 2 temporarily relieves symptoms of vaginal yeast infection (candidiasis) such as:.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>33992-9376-5</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (33992-9376-5) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>33992-9376-05</NDC11Code>
<ProductNDC>33992-9376</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Assured Original Relief Eye</ProprietaryName>
<NonProprietaryName>Tetrahydrozoline Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20130228</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>GREENBRIER INTERNATIONAL, INC.</LabelerName>
<SubstanceName>TETRAHYDROZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions: 1 put 1 to 2 drops in the affected eye(s) up to 4 times daily , 2 children under 6 years of age: ask a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55154-9376-5</NDCCode>
<PackageDescription>5 VIAL in 1 BAG (55154-9376-5) > 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>55154-9376-05</NDC11Code>
<ProductNDC>55154-9376</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gentamicin</ProprietaryName>
<NonProprietaryName>Gentamicin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20041129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062366</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>GENTAMICIN SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-05-22</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68788-9376-1</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68788-9376-1) </PackageDescription>
<NDC11Code>68788-9376-01</NDC11Code>
<ProductNDC>68788-9376</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090200</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-9376-2</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (68788-9376-2) </PackageDescription>
<NDC11Code>68788-9376-02</NDC11Code>
<ProductNDC>68788-9376</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090200</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-9376-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68788-9376-3) </PackageDescription>
<NDC11Code>68788-9376-03</NDC11Code>
<ProductNDC>68788-9376</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090200</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-9376-4</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE (68788-9376-4) </PackageDescription>
<NDC11Code>68788-9376-04</NDC11Code>
<ProductNDC>68788-9376</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090200</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-9376-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68788-9376-6) </PackageDescription>
<NDC11Code>68788-9376-06</NDC11Code>
<ProductNDC>68788-9376</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090200</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-9376-8</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (68788-9376-8) </PackageDescription>
<NDC11Code>68788-9376-08</NDC11Code>
<ProductNDC>68788-9376</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090200</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-9376-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68788-9376-9) </PackageDescription>
<NDC11Code>68788-9376-09</NDC11Code>
<ProductNDC>68788-9376</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090200</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0054-0264-24</NDCCode>
<PackageDescription>10 CONTAINER in 1 CARTON (0054-0264-24) / 10 TABLET in 1 CONTAINER</PackageDescription>
<NDC11Code>00054-0264-24</NDC11Code>
<ProductNDC>0054-0264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090729</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074597</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid agonist. Hydromorphone hydrochloride, USP is a white to off-white powder. It is soluble in water and sparingly soluble in alcohol. The chemical name of hydromorphone hydrochloride is 4,5α-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula is. C17H19NO3 ●HCl M.W. 321.80. Each Hydromorphone Hydrochloride Tablet, USP for oral administration, contains 4 mg or 8 mg hydromorphone hydrochloride, USP. In addition, the tablets include lactose anhydrous and magnesium stearate. Hydromorphone Hydrochloride Tablets, USP may contain traces of sodium metabisulfite. Each 5 mL (1 teaspoonful) of Hydromorphone Hydrochloride Oral Solution, USP contains 5 mg of hydromorphone hydrochloride, USP. In addition, other ingredients include FD&C Red No. 40, methyl paraben, propylene glycol, propylparaben, purified water, raspberry blend, saccharin sodium and sorbitol solution. Hydromorphone Hydrochloride Oral Solution, USP may contain traces of sodium metabisulfite.</Description>
</NDC>
<NDC>
<NDCCode>0054-0264-25</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0054-0264-25) </PackageDescription>
<NDC11Code>00054-0264-25</NDC11Code>
<ProductNDC>0054-0264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090729</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074597</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid agonist. Hydromorphone hydrochloride, USP is a white to off-white powder. It is soluble in water and sparingly soluble in alcohol. The chemical name of hydromorphone hydrochloride is 4,5α-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula is. C17H19NO3 ●HCl M.W. 321.80. Each Hydromorphone Hydrochloride Tablet, USP for oral administration, contains 4 mg or 8 mg hydromorphone hydrochloride, USP. In addition, the tablets include lactose anhydrous and magnesium stearate. Hydromorphone Hydrochloride Tablets, USP may contain traces of sodium metabisulfite. Each 5 mL (1 teaspoonful) of Hydromorphone Hydrochloride Oral Solution, USP contains 5 mg of hydromorphone hydrochloride, USP. In addition, other ingredients include FD&C Red No. 40, methyl paraben, propylene glycol, propylparaben, purified water, raspberry blend, saccharin sodium and sorbitol solution. Hydromorphone Hydrochloride Oral Solution, USP may contain traces of sodium metabisulfite.</Description>
</NDC>
<NDC>
<NDCCode>0093-0264-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0093-0264-15) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00093-0264-15</NDC11Code>
<ProductNDC>0093-0264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19920501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073481</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The topical corticosteroids are intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene) bis(oxy)]-,(6α, 11β, 16α)-. It has the following structural formula. C26H32F207 M.W. 494.5. Each gram of Fluocinonide Cream USP, 0.05% (Emulsified Base) contains: 0.5 mg fluocinonide, USP in a water-washable aqueous emollient base of stearyl alcohol, cetyl alcohol, mineral oil, propylene glycol, sorbitan monostearate, polysorbate 60, citric acid monohydrate and purified water. Each gram of Fluocinonide Cream USP, 0.05% contains: 0.5 mg fluocinonide, USP in a specially formulated cream base consisting of stearyl alcohol, polyethylene glycol 8000, propylene glycol, 1,2,6-hexanetriol and citric acid monohydrate. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophilic properties. In this formulation, the active ingredient is totally in solution. Each gram of Fluocinonide Ointment USP, 0.05% contains: 0.5 mg fluocinonide, USP in an ointment base consisting of white petrolatum, castor oil, and sorbitan sesquioleate. It provides the occlusive and emollient effects desirable in an ointment. In this formulation, the active ingredient is totally in solution.</Description>
</NDC>
<NDC>
<NDCCode>0093-0264-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0093-0264-30) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>00093-0264-30</NDC11Code>
<ProductNDC>0093-0264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19920501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073481</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The topical corticosteroids are intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene) bis(oxy)]-,(6α, 11β, 16α)-. It has the following structural formula. C26H32F207 M.W. 494.5. Each gram of Fluocinonide Cream USP, 0.05% (Emulsified Base) contains: 0.5 mg fluocinonide, USP in a water-washable aqueous emollient base of stearyl alcohol, cetyl alcohol, mineral oil, propylene glycol, sorbitan monostearate, polysorbate 60, citric acid monohydrate and purified water. Each gram of Fluocinonide Cream USP, 0.05% contains: 0.5 mg fluocinonide, USP in a specially formulated cream base consisting of stearyl alcohol, polyethylene glycol 8000, propylene glycol, 1,2,6-hexanetriol and citric acid monohydrate. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophilic properties. In this formulation, the active ingredient is totally in solution. Each gram of Fluocinonide Ointment USP, 0.05% contains: 0.5 mg fluocinonide, USP in an ointment base consisting of white petrolatum, castor oil, and sorbitan sesquioleate. It provides the occlusive and emollient effects desirable in an ointment. In this formulation, the active ingredient is totally in solution.</Description>
</NDC>
<NDC>
<NDCCode>0093-0264-92</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0093-0264-92) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>00093-0264-92</NDC11Code>
<ProductNDC>0093-0264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19920501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073481</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The topical corticosteroids are intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene) bis(oxy)]-,(6α, 11β, 16α)-. It has the following structural formula. C26H32F207 M.W. 494.5. Each gram of Fluocinonide Cream USP, 0.05% (Emulsified Base) contains: 0.5 mg fluocinonide, USP in a water-washable aqueous emollient base of stearyl alcohol, cetyl alcohol, mineral oil, propylene glycol, sorbitan monostearate, polysorbate 60, citric acid monohydrate and purified water. Each gram of Fluocinonide Cream USP, 0.05% contains: 0.5 mg fluocinonide, USP in a specially formulated cream base consisting of stearyl alcohol, polyethylene glycol 8000, propylene glycol, 1,2,6-hexanetriol and citric acid monohydrate. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophilic properties. In this formulation, the active ingredient is totally in solution. Each gram of Fluocinonide Ointment USP, 0.05% contains: 0.5 mg fluocinonide, USP in an ointment base consisting of white petrolatum, castor oil, and sorbitan sesquioleate. It provides the occlusive and emollient effects desirable in an ointment. In this formulation, the active ingredient is totally in solution.</Description>
</NDC>
<NDC>
<NDCCode>0168-0264-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0264-15) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0264-15</NDC11Code>
<ProductNDC>0168-0264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alclometasone Dipropionate</ProprietaryName>
<NonProprietaryName>Alclometasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20050718</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076884</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ALCLOMETASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050718</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alclometasone dipropionate ointment is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use). Since the safety and efficacy of alclometasone dipropionate ointment have not been established in pediatric patients below 1 year of age, the use in this age-group is not recommended.</IndicationAndUsage>
<Description>Alclometasone dipropionate ointment contains alclometasone dipropionate (7α-chloro-11β ,17,21-trihydroxy-16α -methylpregna-1,4-diene-3,20-dione 17,21-dipropionate), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, alclometasone dipropionate is C28H37ClO7. It has the following structural formula:. Alclometasone dipropionate has the molecular weight of 521. It is a white powder, insoluble in water, slightly soluble in propylene glycol, and moderately soluble in hexylene glycol. Each gram of alclometasone dipropionate ointment contains 0.5 mg of alclometasone dipropionate in an ointment base of hexylene glycol, white wax, propylene glycol stearate, and white petrolatum.</Description>
</NDC>
<NDC>
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<PackageDescription>1 TUBE in 1 CARTON (0168-0264-45) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0264-45</NDC11Code>
<ProductNDC>0168-0264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alclometasone Dipropionate</ProprietaryName>
<NonProprietaryName>Alclometasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20050718</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076884</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ALCLOMETASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050718</StartMarketingDatePackage>
<EndMarketingDatePackage>20240731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alclometasone dipropionate ointment is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use). Since the safety and efficacy of alclometasone dipropionate ointment have not been established in pediatric patients below 1 year of age, the use in this age-group is not recommended.</IndicationAndUsage>
<Description>Alclometasone dipropionate ointment contains alclometasone dipropionate (7α-chloro-11β ,17,21-trihydroxy-16α -methylpregna-1,4-diene-3,20-dione 17,21-dipropionate), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, alclometasone dipropionate is C28H37ClO7. It has the following structural formula:. Alclometasone dipropionate has the molecular weight of 521. It is a white powder, insoluble in water, slightly soluble in propylene glycol, and moderately soluble in hexylene glycol. Each gram of alclometasone dipropionate ointment contains 0.5 mg of alclometasone dipropionate in an ointment base of hexylene glycol, white wax, propylene glycol stearate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>0168-0264-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0264-60) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0264-60</NDC11Code>
<ProductNDC>0168-0264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alclometasone Dipropionate</ProprietaryName>
<NonProprietaryName>Alclometasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20050718</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076884</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ALCLOMETASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050718</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alclometasone dipropionate ointment is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use). Since the safety and efficacy of alclometasone dipropionate ointment have not been established in pediatric patients below 1 year of age, the use in this age-group is not recommended.</IndicationAndUsage>
<Description>Alclometasone dipropionate ointment contains alclometasone dipropionate (7α-chloro-11β ,17,21-trihydroxy-16α -methylpregna-1,4-diene-3,20-dione 17,21-dipropionate), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, alclometasone dipropionate is C28H37ClO7. It has the following structural formula:. Alclometasone dipropionate has the molecular weight of 521. It is a white powder, insoluble in water, slightly soluble in propylene glycol, and moderately soluble in hexylene glycol. Each gram of alclometasone dipropionate ointment contains 0.5 mg of alclometasone dipropionate in an ointment base of hexylene glycol, white wax, propylene glycol stearate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>0264-1009-90</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-1009-90) / 100 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-1009-90</NDC11Code>
<ProductNDC>0264-1009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209705</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
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<IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (greater than or equal to 16 years of age) with the following seizure types when oral administration is temporarily not feasible: 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures (1.3).</IndicationAndUsage>
<Description>Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port container. This container closure is not made with natural rubber latex, PVC or DEHP. 500 mg/100 mL: One 100 mL fill container contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL fill container contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL fill container contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition. Each is covered by a tamperproof barrier. Refer to the DIRECTIONS FOR USE of the container to properly identify the ports. No vapor barrier is necessary.</Description>
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