{
"NDC": [
{
"NDCCode": "59651-395-39",
"PackageDescription": "3000 TABLET in 1 BAG (59651-395-39) ",
"NDC11Code": "59651-0395-39",
"ProductNDC": "59651-395",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"StartMarketingDate": "20210713",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-06-14",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "13-JUL-21"
},
{
"NDCCode": "59651-395-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (59651-395-01) ",
"NDC11Code": "59651-0395-01",
"ProductNDC": "59651-395",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214099",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210713",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen tablets treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen USP, is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)- butanoic acid, and its structural formula is. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol and in 96% ethanol, practically insoluble in acetone, insoluble in chloroform, dissolves in dilute mineral acids and in dilute solutions of alkali hydroxides. Inactive Ingredients. Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "59651-395-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (59651-395-05) ",
"NDC11Code": "59651-0395-05",
"ProductNDC": "59651-395",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214099",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210713",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen tablets treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen USP, is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)- butanoic acid, and its structural formula is. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol and in 96% ethanol, practically insoluble in acetone, insoluble in chloroform, dissolves in dilute mineral acids and in dilute solutions of alkali hydroxides. Inactive Ingredients. Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "59651-395-99",
"PackageDescription": "1000 TABLET in 1 BOTTLE (59651-395-99) ",
"NDC11Code": "59651-0395-99",
"ProductNDC": "59651-395",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214099",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210713",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen tablets treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen USP, is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)- butanoic acid, and its structural formula is. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol and in 96% ethanol, practically insoluble in acetone, insoluble in chloroform, dissolves in dilute mineral acids and in dilute solutions of alkali hydroxides. Inactive Ingredients. Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "59651-034-39",
"PackageDescription": "35000 TABLET, EXTENDED RELEASE in 1 BAG (59651-034-39) ",
"NDC11Code": "59651-0034-39",
"ProductNDC": "59651-034",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"StartMarketingDate": "20161109",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2023-12-29",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "18-NOV-22"
},
{
"NDCCode": "59651-282-39",
"PackageDescription": "3000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-282-39) ",
"NDC11Code": "59651-0282-39",
"ProductNDC": "59651-282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090778",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-05-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20131211",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are 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 delayed-release capsules are selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride USP is a white to brownish-white solid, 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 USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include crospovidone, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, sugar spheres, talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution."
},
{
"NDCCode": "59651-324-39",
"PackageDescription": "3000 TABLET, FILM COATED in 1 BAG (59651-324-39) ",
"NDC11Code": "59651-0324-39",
"ProductNDC": "59651-324",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20200610",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-01-27",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "10-JUN-20"
},
{
"NDCCode": "59651-337-39",
"PackageDescription": "3000 TABLET, FILM COATED in 1 BAG (59651-337-39) ",
"NDC11Code": "59651-0337-39",
"ProductNDC": "59651-337",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2021-11-18",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "01-MAY-20"
},
{
"NDCCode": "59651-440-39",
"PackageDescription": "3000 TABLET, DELAYED RELEASE in 1 BAG (59651-440-39) ",
"NDC11Code": "59651-0440-39",
"ProductNDC": "59651-440",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"StartMarketingDate": "20230712",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM DIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-07-02",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "12-JUL-23"
},
{
"NDCCode": "59651-627-39",
"PackageDescription": "3000 CAPSULE in 1 BAG (59651-627-39) ",
"NDC11Code": "59651-0627-39",
"ProductNDC": "59651-627",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "20190402",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2022-04-22",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "15-APR-21"
},
{
"NDCCode": "59651-866-39",
"PackageDescription": "3000 TABLET, FILM COATED in 1 BAG (59651-866-39) ",
"NDC11Code": "59651-0866-39",
"ProductNDC": "59651-866",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20240209",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "09-FEB-24"
},
{
"NDCCode": "59651-890-39",
"PackageDescription": "3000 CAPSULE, LIQUID FILLED in 1 BAG (59651-890-39) ",
"NDC11Code": "59651-0890-39",
"ProductNDC": "59651-890",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"StartMarketingDate": "20230914",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2023-10-10",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "14-SEP-23"
},
{
"NDCCode": "59651-976-39",
"PackageDescription": "3000 TABLET, FILM COATED in 1 BAG (59651-976-39) ",
"NDC11Code": "59651-0976-39",
"ProductNDC": "59651-976",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20250327",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-04-17",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "27-MAR-25"
},
{
"NDCCode": "59088-210-16",
"PackageDescription": "227 g in 1 JAR (59088-210-16) ",
"NDC11Code": "59088-0210-16",
"ProductNDC": "59088-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Urea 39.5% With 2% Salicylic Acid",
"NonProprietaryName": "Urea, Salicylic Acid",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230324",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "UREA; SALICYLIC ACID",
"StrengthNumber": "39.5; 2",
"StrengthUnit": "g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2023-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230324",
"SamplePackage": "N",
"IndicationAndUsage": "For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dermatitis, psoriasis, soothes rough and dry skin, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.",
"Description": "Urea 39.5% Cream with 2% Salicylic Acid is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin space. Each gram contains 395 mg of urea, 20 mg of Salicylic Acid in vehicle consisting of: Aqua (Purified Water), Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Dimethicone, Disodium EDTA, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylparaben, Simethicone, Sodium Hydroxide, Squalane, Stearic Acid. Urea is a diamide of carbonic acid with the following chemical structure."
},
{
"NDCCode": "59088-698-16",
"PackageDescription": "227 g in 1 JAR (59088-698-16) ",
"NDC11Code": "59088-0698-16",
"ProductNDC": "59088-698",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Urea 39.5%",
"NonProprietaryName": "Urea",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230120",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "UREA",
"StrengthNumber": "395",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2023-01-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230120",
"SamplePackage": "N",
"IndicationAndUsage": "For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.",
"Description": "Urea 39.5% Cream is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram contains 395 mg of urea in a vehicle consisting of: Aqua (Purified Water), Ceteareth-6, Ceteareth-25, Cetyl Alcohol, Methylparaben, Paraffin, Propylene Glycol, Stearyl Alcohol, Xanthan Gum. Urea is a diamide of carbonic acid with the following chemical structure."
},
{
"NDCCode": "59651-528-47",
"PackageDescription": "1 BOTTLE in 1 CARTON (59651-528-47) / 473 mL in 1 BOTTLE",
"NDC11Code": "59651-0528-47",
"ProductNDC": "59651-528",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20251003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216504",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "125",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251003",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen oral suspension is indicated for: the relief of the signs and symptoms of: : 1 rheumatoid arthritis , 2 osteoarthritis , 3 ankylosing spondylitis , 4 polyarticular juvenile idiopathic arthritis , 5 tendonitis , 6 bursitis , 7 acute gout .",
"Description": "Naproxen oral suspension, USP is available as a light orange-colored, pineapple-orange flavored homogenous suspension containing 125 mg/5 mL of naproxen USP for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. The molecular weight is 230.26. Its molecular formula is C14H14O3, and it has the following chemical structure. Naproxen USP is a white to off-white crystalline powder. It is soluble in chloroform, in dehydrated alcohol, and in alcohol, sparingly soluble in ether, practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The inactive ingredients in naproxen oral suspension USP include art pineapple flavor, benzyl alcohol, FD&C yellow No. 6, fumaric acid, magnesium aluminum silicate, methylparaben, modified food starch (corn), nat orange flavor, noncrystallizing sorbitol solution, propylene glycol, purified water, sodium chloride (39 mg/5 mL, 0.667 mEq), sucrose, and xanthan gum. The pH of the suspension ranges from 2.2 to 3.7."
},
{
"NDCCode": "59651-844-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (59651-844-30) ",
"NDC11Code": "59651-0844-30",
"ProductNDC": "59651-844",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin",
"NonProprietaryName": "Doxepin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216041",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250712",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin tablets is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.",
"Description": "Doxepin tablets are available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride, USP is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C19H21NOHCl. Each Doxepin tablet includes the following inactive ingredients: microcrystalline cellulose, magnesium stearate, pregelatinized starch, povidone."
},
{
"NDCCode": "59651-845-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (59651-845-30) ",
"NDC11Code": "59651-0845-30",
"ProductNDC": "59651-845",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin",
"NonProprietaryName": "Doxepin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216041",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250712",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin tablets is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.",
"Description": "Doxepin tablets are available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride, USP is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C19H21NOHCl. Each Doxepin tablet includes the following inactive ingredients: microcrystalline cellulose, magnesium stearate, pregelatinized starch, povidone."
},
{
"NDCCode": "0006-3083-01",
"PackageDescription": "1 VIAL in 1 CARTON (0006-3083-01) / 2.4 mL in 1 VIAL (0006-3083-99) ",
"NDC11Code": "00006-3083-01",
"ProductNDC": "0006-3083",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Keytruda Qlex",
"NonProprietaryName": "Pembrolizumab And Berahyaluronidase Alfa-pmph",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250919",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761467",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "PEMBROLIZUMAB; BERAHYALURONIDASE ALFA",
"StrengthNumber": "165; 2000",
"StrengthUnit": "mg/mL; U/mL",
"Pharm_Classes": "Endoglycosidase [EPC], Glycoside Hydrolases [CS], Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250919",
"SamplePackage": "N",
"IndicationAndUsage": "KEYTRUDA QLEX is a combination of pembrolizumab, a programmed death receptor-1 (PD-1)-blocking antibody, and berahyaluronidase alfa, an endoglycosidase, indicated:. Melanoma: 1 for the treatment of adult patients with unresectable or metastatic melanoma. (1.1), 2 for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection. (1.1).",
"Description": "KEYTRUDA QLEX is a fixed-combination drug product containing pembrolizumab and berahyaluronidase alfa. Pembrolizumab is a programmed death receptor-1 (PD 1)-blocking antibody. Pembrolizumab is a humanized monoclonal IgG4 kappa antibody with an approximate molecular weight of 149 kDa. Pembrolizumab is produced in recombinant Chinese hamster ovary (CHO) cells. Berahyaluronidase alfa is an endoglycosidase used to enhance dispersion and permeation, which facilitates delivery of increased volume of pembrolizumab that is co-administered subcutaneously. It is produced by mammalian CHO (Chinese Hamster Ovary) cells containing a DNA plasmid encoding a variant of human hyaluronidase PH20. It is a glycosylated protein with an approximate molecular weight of 49 kDa under nonreducing, deglycosylated conditions. KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution supplied in single-dose vials for subcutaneous administration. KEYTRUDA QLEX is supplied as two different configurations: : 1 Each KEYTRUDA QLEX 2.4 mL single-dose vial contains 395 mg of pembrolizumab and 4,800 units of berahyaluronidase alfa, and histidine (0.7 mg), histidine hydrochloride monohydrate (4.1 mg), methionine (3.6 mg), polysorbate 80 (0.5 mg), sucrose (168 mg), and Water for Injection, USP. The pH is 5.3-5.9. , 2 Each KEYTRUDA QLEX 4.8 mL single-dose vial contains 790 mg of pembrolizumab and 9,600 units of berahyaluronidase alfa, and histidine (1.4 mg), histidine hydrochloride monohydrate (8.2 mg), methionine (7.2 mg), polysorbate 80 (1 mg), sucrose (336 mg), and Water for Injection, USP. The pH is 5.3-5.9."
},
{
"NDCCode": "0006-5083-01",
"PackageDescription": "1 VIAL in 1 CARTON (0006-5083-01) / 4.8 mL in 1 VIAL (0006-5083-99) ",
"NDC11Code": "00006-5083-01",
"ProductNDC": "0006-5083",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Keytruda Qlex",
"NonProprietaryName": "Pembrolizumab And Berahyaluronidase Alfa-pmph",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250919",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761467",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "PEMBROLIZUMAB; BERAHYALURONIDASE ALFA",
"StrengthNumber": "165; 2000",
"StrengthUnit": "mg/mL; U/mL",
"Pharm_Classes": "Endoglycosidase [EPC], Glycoside Hydrolases [CS], Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250919",
"SamplePackage": "N",
"IndicationAndUsage": "KEYTRUDA QLEX is a combination of pembrolizumab, a programmed death receptor-1 (PD-1)-blocking antibody, and berahyaluronidase alfa, an endoglycosidase, indicated:. Melanoma: 1 for the treatment of adult patients with unresectable or metastatic melanoma. (1.1), 2 for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection. (1.1).",
"Description": "KEYTRUDA QLEX is a fixed-combination drug product containing pembrolizumab and berahyaluronidase alfa. Pembrolizumab is a programmed death receptor-1 (PD 1)-blocking antibody. Pembrolizumab is a humanized monoclonal IgG4 kappa antibody with an approximate molecular weight of 149 kDa. Pembrolizumab is produced in recombinant Chinese hamster ovary (CHO) cells. Berahyaluronidase alfa is an endoglycosidase used to enhance dispersion and permeation, which facilitates delivery of increased volume of pembrolizumab that is co-administered subcutaneously. It is produced by mammalian CHO (Chinese Hamster Ovary) cells containing a DNA plasmid encoding a variant of human hyaluronidase PH20. It is a glycosylated protein with an approximate molecular weight of 49 kDa under nonreducing, deglycosylated conditions. KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution supplied in single-dose vials for subcutaneous administration. KEYTRUDA QLEX is supplied as two different configurations: : 1 Each KEYTRUDA QLEX 2.4 mL single-dose vial contains 395 mg of pembrolizumab and 4,800 units of berahyaluronidase alfa, and histidine (0.7 mg), histidine hydrochloride monohydrate (4.1 mg), methionine (3.6 mg), polysorbate 80 (0.5 mg), sucrose (168 mg), and Water for Injection, USP. The pH is 5.3-5.9. , 2 Each KEYTRUDA QLEX 4.8 mL single-dose vial contains 790 mg of pembrolizumab and 9,600 units of berahyaluronidase alfa, and histidine (1.4 mg), histidine hydrochloride monohydrate (8.2 mg), methionine (7.2 mg), polysorbate 80 (1 mg), sucrose (336 mg), and Water for Injection, USP. The pH is 5.3-5.9."
},
{
"NDCCode": "0065-0800-50",
"PackageDescription": "1 KIT in 1 PACKAGE (0065-0800-50) * 480 mL in 1 BOTTLE, GLASS * 20 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00065-0800-50",
"ProductNDC": "0065-0800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bss Plus",
"NonProprietaryName": "Balanced Salt Solution Enriched With Bicarbonate, Dextrose, And Glutathione",
"DosageFormName": "KIT",
"StartMarketingDate": "19820628",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018469",
"LabelerName": "Alcon Laboratories, Inc.",
"Status": "Active",
"LastUpdate": "2024-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19820628",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: BSS PLUS is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye.",
"Description": "DESCRIPTION: BSS PLUS® is a sterile intraocular irrigating solution for use during all intraocular surgical procedures, including those requiring a relatively long intraocular perfusion time (e.g., pars plana vitrectomy, phacoemulsification, extracapsular cataract extraction/lens aspiration, anterior segment reconstruction, etc.). The solution does not contain a preservative and should be prepared just prior to use in surgery. Part I: Part I is a sterile 480 mL solution in a 500 mL single-dose bottle to which the Part II concentrate is added. Each mL of Part I contains: sodium chloride 7.44 mg, potassium chloride 0.395 mg, dibasic sodium phosphate 0.433 mg, sodium bicarbonate 2.19 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection. Part II: Part II is a sterile concentrate in a 20 mL single-dose vial for addition to Part I. Each mL of Part II contains: calcium chloride dihydrate 3.85 mg, magnesium chloride hexahydrate 5 mg, dextrose 23 mg, glutathione disulfide (oxidized glutathione) 4.6 mg, in water for injection. After addition of BSS PLUS Part II to the Part I bottle, each mL of the reconstituted product contains: sodium chloride 7.14 mg, potassium chloride 0.38 mg, calcium chloride dihydrate 0.154 mg, magnesium chloride hexahydrate 0.2 mg, dibasic sodium phosphate 0.42 mg, sodium bicarbonate 2.1 mg, dextrose 0.92 mg, glutathione disulfide (oxidized glutathione) 0.184 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection. The reconstituted product has a pH of approximately 7.4. Osmolality is approximately 305 mOsm."
},
{
"NDCCode": "0065-0800-94",
"PackageDescription": "1 KIT in 1 PACKAGE (0065-0800-94) * 480 mL in 1 BAG * 20 mL in 1 VIAL, GLASS",
"NDC11Code": "00065-0800-94",
"ProductNDC": "0065-0800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bss Plus",
"NonProprietaryName": "Balanced Salt Solution Enriched With Bicarbonate, Dextrose, And Glutathione",
"DosageFormName": "KIT",
"StartMarketingDate": "20130620",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018469",
"LabelerName": "Alcon Laboratories, Inc.",
"Status": "Active",
"LastUpdate": "2024-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130620",
"SamplePackage": "N",
"IndicationAndUsage": "BSS PLUS solution is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye.",
"Description": "BSS PLUS® is a sterile intraocular irrigating solution for use during all intraocular surgical procedures, including those requiring a relatively long intraocular perfusion time (e.g., pars plana vitrectomy, phacoemulsification, extra capsular cataract extraction/lens aspiration, anterior segment reconstruction, etc.). The solution does not contain a preservative and should be prepared just prior to use in surgery.Part I: Part I is a sterile 480 mL solution in a 500 mL single-dose bag to which the Part II concentrate is added. Each mL of Part I contains: sodium chloride 7.44 mg, potassium chloride 0.395 mg, dibasic sodium phosphate 0.433 mg, sodium bicarbonate 2.19 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.Part II: Part II is a sterile concentrate in a 20 mL single-dose vial for addition to Part I. Each mL of Part II contains: calcium chloride dihydrate 3.85 mg, magnesium chloride hexahydrate 5 mg, dextrose 23 mg, glutathione disulfide (oxidized glutathione) 4.6 mg, in water for injection.After addition of BSS PLUS solution Part II to the Part I bag, each mL of the reconstituted product contains: sodium chloride 7.14 mg, potassium chloride 0.38 mg, calcium chloride dihydrate 0.154 mg, magnesium chloride hexahydrate 0.2 mg, dibasic sodium phosphate 0.42 mg, sodium bicarbonate 2.1 mg, dextrose 0.92 mg, glutathione disulfide (oxidized glutathione) 0.184 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.The reconstituted product has a pH of approximately 7.4. Osmolality is approximately 305 mOsm."
},
{
"NDCCode": "0093-3160-06",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (0093-3160-06) ",
"NDC11Code": "00093-3160-06",
"ProductNDC": "0093-3160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefdinir",
"NonProprietaryName": "Cefdinir",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20070509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065368",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "CEFDINIR",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2024-02-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070509",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.",
"Description": "Cefdinir Capsules USP contain the active ingredient cefdinir, USP an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is (6R,7R)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir,USP is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7.0 phosphate buffer. Cefdinir has the structural formula shown below. C14H13N5O5S2 M.W. 395.41. Cefdinir Capsules USP contain 300 mg cefdinir, USP and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide, croscarmellose sodium, D&C red #28, D&C yellow #10, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C green #3, FD&C red #40, FD&C red #40 aluminum lake, gelatin, iron oxide black, magnesium stearate, polyoxyl 40 stearate, propylene glycol, shellac glaze, sodium lauryl sulfate, and titanium dioxide."
},
{
"NDCCode": "0409-0365-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0409-0365-01) / 8 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00409-0365-01",
"ProductNDC": "0409-0365",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210628",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022234",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOCETAXEL",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210628",
"SamplePackage": "N",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel (trihydrate) has the following structural formula. Docetaxel (trihydrate) is a white to almost-white powder with an empirical formula of C43H53NO14 ∙ 3H2O, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, pale-yellow to brownish yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous), 520 mg polysorbate 80 NF, 7 mg citric acid monohydrate USP, and 395 mg dehydrated alcohol USP. Docetaxel Injection is available in single-dose vials containing 20 mg (1 mL) or multiple-dose vials containing 80 mg (4 mL) or 160 mg (8 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "0409-0366-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0366-01) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-0366-01",
"ProductNDC": "0409-0366",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022234",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOCETAXEL",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160824",
"SamplePackage": "N",
"IndicationAndUsage": "Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel (trihydrate) has the following structural formula. Docetaxel (trihydrate) is a white to almost-white powder with an empirical formula of C43H53NO14 ∙ 3H2O, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, pale-yellow to brownish yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous), 520 mg polysorbate 80 NF, 7 mg citric acid monohydrate USP, and 395 mg dehydrated alcohol USP. Docetaxel Injection is available in single-dose vials containing 20 mg (1 mL) or multiple-dose vials containing 80 mg (4 mL) or 160 mg (8 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "0409-0367-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0409-0367-01) / 4 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00409-0367-01",
"ProductNDC": "0409-0367",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022234",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOCETAXEL",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160824",
"SamplePackage": "N",
"IndicationAndUsage": "Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel (trihydrate) has the following structural formula. Docetaxel (trihydrate) is a white to almost-white powder with an empirical formula of C43H53NO14 ∙ 3H2O, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, pale-yellow to brownish yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous), 520 mg polysorbate 80 NF, 7 mg citric acid monohydrate USP, and 395 mg dehydrated alcohol USP. Docetaxel Injection is available in single-dose vials containing 20 mg (1 mL) or multiple-dose vials containing 80 mg (4 mL) or 160 mg (8 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "0409-0368-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0409-0368-01) / 8 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00409-0368-01",
"ProductNDC": "0409-0368",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180109",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022234",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOCETAXEL",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180109",
"SamplePackage": "N",
"IndicationAndUsage": "Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel (trihydrate) has the following structural formula. Docetaxel (trihydrate) is a white to almost-white powder with an empirical formula of C43H53NO14 ∙ 3H2O, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, pale-yellow to brownish yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous), 520 mg polysorbate 80 NF, 7 mg citric acid monohydrate USP, and 395 mg dehydrated alcohol USP. Docetaxel Injection is available in single-dose vials containing 20 mg (1 mL) or multiple-dose vials containing 80 mg (4 mL) or 160 mg (8 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "0409-4235-01",
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"NDC11Code": "00409-4235-01",
"ProductNDC": "0409-4235",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210628",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022234",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOCETAXEL",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
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"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel (trihydrate) has the following structural formula. Docetaxel (trihydrate) is a white to almost-white powder with an empirical formula of C43H53NO14 ∙ 3H2O, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, pale-yellow to brownish yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous), 520 mg polysorbate 80 NF, 7 mg citric acid monohydrate USP, and 395 mg dehydrated alcohol USP. Docetaxel Injection is available in single-dose vials containing 20 mg (1 mL) or multiple-dose vials containing 80 mg (4 mL) or 160 mg (8 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution."
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{
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"ProductNDC": "0409-5068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
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"LabelerName": "Hospira, Inc.",
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"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel (trihydrate) has the following structural formula. Docetaxel (trihydrate) is a white to almost-white powder with an empirical formula of C43H53NO14 ∙ 3H2O, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, pale-yellow to brownish yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous), 520 mg polysorbate 80 NF, 7 mg citric acid monohydrate USP, and 395 mg dehydrated alcohol USP. Docetaxel Injection is available in single-dose vials containing 20 mg (1 mL) or multiple-dose vials containing 80 mg (4 mL) or 160 mg (8 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "0456-0400-10",
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"ProductNDC": "0456-0400",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teflaro",
"NonProprietaryName": "Ceftaroline Fosamil",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20101029",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200327",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CEFTAROLINE FOSAMIL",
"StrengthNumber": "400",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2025-11-07",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101029",
"SamplePackage": "N",
"IndicationAndUsage": "Teflaro is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: 1 Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) (1.1), 2 Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older (1.2).",
"Description": "TEFLARO (ceftaroline fosamil) for injection, is a sterile, semi-synthetic, prodrug of the cephalosporin antibacterial class of beta-lactams (β-lactams) for intravenous use. Chemically, the prodrug, ceftaroline fosamil monoacetate monohydrate is (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate monohydrate. Its molecular weight is 762.75. The empirical formula is C22H21N8O8PS4.C2H4O2.H2O. Figure 1: Chemical structure of ceftaroline fosamil. Teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil (equivalent to 668 mg and 446 mg, respectively, of ceftaroline fosamil monoacetate monohydrate). The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowish-white to light yellow sterile powder. Each vial of 400 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 263.3 mg/vial as the solubilizer and alkalizing agent. Each vial of 600 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 395.0 mg/vial as the solubilizer and alkalizing agent. All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see Dosage and Administration (2.3)]. The pH of the constituted solution is pH 4.8 to 6.5."
}
]
}
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<IndicationAndUsage>Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen tablets treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen USP, is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)- butanoic acid, and its structural formula is. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol and in 96% ethanol, practically insoluble in acetone, insoluble in chloroform, dissolves in dilute mineral acids and in dilute solutions of alkali hydroxides. Inactive Ingredients. Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen tablets treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen USP, is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)- butanoic acid, and its structural formula is. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol and in 96% ethanol, practically insoluble in acetone, insoluble in chloroform, dissolves in dilute mineral acids and in dilute solutions of alkali hydroxides. Inactive Ingredients. Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). FDA approved dissolution test specifications differ from USP.</Description>
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<NDCCode>59651-395-99</NDCCode>
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<RouteName>ORAL</RouteName>
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<Description>Baclofen USP, is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)- butanoic acid, and its structural formula is. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol and in 96% ethanol, practically insoluble in acetone, insoluble in chloroform, dissolves in dilute mineral acids and in dilute solutions of alkali hydroxides. Inactive Ingredients. Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). FDA approved dissolution test specifications differ from USP.</Description>
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<NDCCode>59651-034-39</NDCCode>
<PackageDescription>35000 TABLET, EXTENDED RELEASE in 1 BAG (59651-034-39) </PackageDescription>
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<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
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<SubstanceName>ACETAMINOPHEN</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-12-29</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-NOV-22</StartMarketingDatePackage>
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<NDC>
<NDCCode>59651-282-39</NDCCode>
<PackageDescription>3000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-282-39) </PackageDescription>
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<ProductNDC>59651-282</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are 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 delayed-release capsules are selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride USP is a white to brownish-white solid, 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 USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include crospovidone, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, sugar spheres, talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.</Description>
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<NDC>
<NDCCode>59651-324-39</NDCCode>
<PackageDescription>3000 TABLET, FILM COATED in 1 BAG (59651-324-39) </PackageDescription>
<NDC11Code>59651-0324-39</NDC11Code>
<ProductNDC>59651-324</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Fluoxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20200610</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-01-27</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>10-JUN-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-337-39</NDCCode>
<PackageDescription>3000 TABLET, FILM COATED in 1 BAG (59651-337-39) </PackageDescription>
<NDC11Code>59651-0337-39</NDC11Code>
<ProductNDC>59651-337</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2021-11-18</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-MAY-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-440-39</NDCCode>
<PackageDescription>3000 TABLET, DELAYED RELEASE in 1 BAG (59651-440-39) </PackageDescription>
<NDC11Code>59651-0440-39</NDC11Code>
<ProductNDC>59651-440</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<StartMarketingDate>20230712</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM DIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-07-02</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>12-JUL-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-627-39</NDCCode>
<PackageDescription>3000 CAPSULE in 1 BAG (59651-627-39) </PackageDescription>
<NDC11Code>59651-0627-39</NDC11Code>
<ProductNDC>59651-627</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<StartMarketingDate>20190402</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-04-22</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-APR-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-866-39</NDCCode>
<PackageDescription>3000 TABLET, FILM COATED in 1 BAG (59651-866-39) </PackageDescription>
<NDC11Code>59651-0866-39</NDC11Code>
<ProductNDC>59651-866</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20240209</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>09-FEB-24</StartMarketingDatePackage>
</NDC>
<NDC>
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<ProductNDC>59651-890</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<StartMarketingDate>20230914</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-10-10</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>14-SEP-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-976-39</NDCCode>
<PackageDescription>3000 TABLET, FILM COATED in 1 BAG (59651-976-39) </PackageDescription>
<NDC11Code>59651-0976-39</NDC11Code>
<ProductNDC>59651-976</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20250327</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-04-17</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>27-MAR-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59088-210-16</NDCCode>
<PackageDescription>227 g in 1 JAR (59088-210-16) </PackageDescription>
<NDC11Code>59088-0210-16</NDC11Code>
<ProductNDC>59088-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Urea 39.5% With 2% Salicylic Acid</ProprietaryName>
<NonProprietaryName>Urea, Salicylic Acid</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230324</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>UREA; SALICYLIC ACID</SubstanceName>
<StrengthNumber>39.5; 2</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dermatitis, psoriasis, soothes rough and dry skin, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.</IndicationAndUsage>
<Description>Urea 39.5% Cream with 2% Salicylic Acid is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin space. Each gram contains 395 mg of urea, 20 mg of Salicylic Acid in vehicle consisting of: Aqua (Purified Water), Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Dimethicone, Disodium EDTA, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylparaben, Simethicone, Sodium Hydroxide, Squalane, Stearic Acid. Urea is a diamide of carbonic acid with the following chemical structure.</Description>
</NDC>
<NDC>
<NDCCode>59088-698-16</NDCCode>
<PackageDescription>227 g in 1 JAR (59088-698-16) </PackageDescription>
<NDC11Code>59088-0698-16</NDC11Code>
<ProductNDC>59088-698</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Urea 39.5%</ProprietaryName>
<NonProprietaryName>Urea</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230120</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>UREA</SubstanceName>
<StrengthNumber>395</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-01-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.</IndicationAndUsage>
<Description>Urea 39.5% Cream is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram contains 395 mg of urea in a vehicle consisting of: Aqua (Purified Water), Ceteareth-6, Ceteareth-25, Cetyl Alcohol, Methylparaben, Paraffin, Propylene Glycol, Stearyl Alcohol, Xanthan Gum. Urea is a diamide of carbonic acid with the following chemical structure.</Description>
</NDC>
<NDC>
<NDCCode>59651-528-47</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (59651-528-47) / 473 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>59651-0528-47</NDC11Code>
<ProductNDC>59651-528</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251003</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216504</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen oral suspension is indicated for: the relief of the signs and symptoms of: : 1 rheumatoid arthritis , 2 osteoarthritis , 3 ankylosing spondylitis , 4 polyarticular juvenile idiopathic arthritis , 5 tendonitis , 6 bursitis , 7 acute gout .</IndicationAndUsage>
<Description>Naproxen oral suspension, USP is available as a light orange-colored, pineapple-orange flavored homogenous suspension containing 125 mg/5 mL of naproxen USP for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. The molecular weight is 230.26. Its molecular formula is C14H14O3, and it has the following chemical structure. Naproxen USP is a white to off-white crystalline powder. It is soluble in chloroform, in dehydrated alcohol, and in alcohol, sparingly soluble in ether, practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The inactive ingredients in naproxen oral suspension USP include art pineapple flavor, benzyl alcohol, FD&C yellow No. 6, fumaric acid, magnesium aluminum silicate, methylparaben, modified food starch (corn), nat orange flavor, noncrystallizing sorbitol solution, propylene glycol, purified water, sodium chloride (39 mg/5 mL, 0.667 mEq), sucrose, and xanthan gum. The pH of the suspension ranges from 2.2 to 3.7.</Description>
</NDC>
<NDC>
<NDCCode>59651-844-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (59651-844-30) </PackageDescription>
<NDC11Code>59651-0844-30</NDC11Code>
<ProductNDC>59651-844</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin</ProprietaryName>
<NonProprietaryName>Doxepin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216041</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin tablets is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.</IndicationAndUsage>
<Description>Doxepin tablets are available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride, USP is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C19H21NOHCl. Each Doxepin tablet includes the following inactive ingredients: microcrystalline cellulose, magnesium stearate, pregelatinized starch, povidone.</Description>
</NDC>
<NDC>
<NDCCode>59651-845-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (59651-845-30) </PackageDescription>
<NDC11Code>59651-0845-30</NDC11Code>
<ProductNDC>59651-845</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin</ProprietaryName>
<NonProprietaryName>Doxepin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216041</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin tablets is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.</IndicationAndUsage>
<Description>Doxepin tablets are available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride, USP is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C19H21NOHCl. Each Doxepin tablet includes the following inactive ingredients: microcrystalline cellulose, magnesium stearate, pregelatinized starch, povidone.</Description>
</NDC>
<NDC>
<NDCCode>0006-3083-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0006-3083-01) / 2.4 mL in 1 VIAL (0006-3083-99) </PackageDescription>
<NDC11Code>00006-3083-01</NDC11Code>
<ProductNDC>0006-3083</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Keytruda Qlex</ProprietaryName>
<NonProprietaryName>Pembrolizumab And Berahyaluronidase Alfa-pmph</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250919</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761467</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>PEMBROLIZUMAB; BERAHYALURONIDASE ALFA</SubstanceName>
<StrengthNumber>165; 2000</StrengthNumber>
<StrengthUnit>mg/mL; U/mL</StrengthUnit>
<Pharm_Classes>Endoglycosidase [EPC], Glycoside Hydrolases [CS], Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KEYTRUDA QLEX is a combination of pembrolizumab, a programmed death receptor-1 (PD-1)-blocking antibody, and berahyaluronidase alfa, an endoglycosidase, indicated:. Melanoma: 1 for the treatment of adult patients with unresectable or metastatic melanoma. (1.1), 2 for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection. (1.1).</IndicationAndUsage>
<Description>KEYTRUDA QLEX is a fixed-combination drug product containing pembrolizumab and berahyaluronidase alfa. Pembrolizumab is a programmed death receptor-1 (PD 1)-blocking antibody. Pembrolizumab is a humanized monoclonal IgG4 kappa antibody with an approximate molecular weight of 149 kDa. Pembrolizumab is produced in recombinant Chinese hamster ovary (CHO) cells. Berahyaluronidase alfa is an endoglycosidase used to enhance dispersion and permeation, which facilitates delivery of increased volume of pembrolizumab that is co-administered subcutaneously. It is produced by mammalian CHO (Chinese Hamster Ovary) cells containing a DNA plasmid encoding a variant of human hyaluronidase PH20. It is a glycosylated protein with an approximate molecular weight of 49 kDa under nonreducing, deglycosylated conditions. KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution supplied in single-dose vials for subcutaneous administration. KEYTRUDA QLEX is supplied as two different configurations: : 1 Each KEYTRUDA QLEX 2.4 mL single-dose vial contains 395 mg of pembrolizumab and 4,800 units of berahyaluronidase alfa, and histidine (0.7 mg), histidine hydrochloride monohydrate (4.1 mg), methionine (3.6 mg), polysorbate 80 (0.5 mg), sucrose (168 mg), and Water for Injection, USP. The pH is 5.3-5.9. , 2 Each KEYTRUDA QLEX 4.8 mL single-dose vial contains 790 mg of pembrolizumab and 9,600 units of berahyaluronidase alfa, and histidine (1.4 mg), histidine hydrochloride monohydrate (8.2 mg), methionine (7.2 mg), polysorbate 80 (1 mg), sucrose (336 mg), and Water for Injection, USP. The pH is 5.3-5.9.</Description>
</NDC>
<NDC>
<NDCCode>0006-5083-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0006-5083-01) / 4.8 mL in 1 VIAL (0006-5083-99) </PackageDescription>
<NDC11Code>00006-5083-01</NDC11Code>
<ProductNDC>0006-5083</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Keytruda Qlex</ProprietaryName>
<NonProprietaryName>Pembrolizumab And Berahyaluronidase Alfa-pmph</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250919</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761467</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>PEMBROLIZUMAB; BERAHYALURONIDASE ALFA</SubstanceName>
<StrengthNumber>165; 2000</StrengthNumber>
<StrengthUnit>mg/mL; U/mL</StrengthUnit>
<Pharm_Classes>Endoglycosidase [EPC], Glycoside Hydrolases [CS], Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KEYTRUDA QLEX is a combination of pembrolizumab, a programmed death receptor-1 (PD-1)-blocking antibody, and berahyaluronidase alfa, an endoglycosidase, indicated:. Melanoma: 1 for the treatment of adult patients with unresectable or metastatic melanoma. (1.1), 2 for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection. (1.1).</IndicationAndUsage>
<Description>KEYTRUDA QLEX is a fixed-combination drug product containing pembrolizumab and berahyaluronidase alfa. Pembrolizumab is a programmed death receptor-1 (PD 1)-blocking antibody. Pembrolizumab is a humanized monoclonal IgG4 kappa antibody with an approximate molecular weight of 149 kDa. Pembrolizumab is produced in recombinant Chinese hamster ovary (CHO) cells. Berahyaluronidase alfa is an endoglycosidase used to enhance dispersion and permeation, which facilitates delivery of increased volume of pembrolizumab that is co-administered subcutaneously. It is produced by mammalian CHO (Chinese Hamster Ovary) cells containing a DNA plasmid encoding a variant of human hyaluronidase PH20. It is a glycosylated protein with an approximate molecular weight of 49 kDa under nonreducing, deglycosylated conditions. KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution supplied in single-dose vials for subcutaneous administration. KEYTRUDA QLEX is supplied as two different configurations: : 1 Each KEYTRUDA QLEX 2.4 mL single-dose vial contains 395 mg of pembrolizumab and 4,800 units of berahyaluronidase alfa, and histidine (0.7 mg), histidine hydrochloride monohydrate (4.1 mg), methionine (3.6 mg), polysorbate 80 (0.5 mg), sucrose (168 mg), and Water for Injection, USP. The pH is 5.3-5.9. , 2 Each KEYTRUDA QLEX 4.8 mL single-dose vial contains 790 mg of pembrolizumab and 9,600 units of berahyaluronidase alfa, and histidine (1.4 mg), histidine hydrochloride monohydrate (8.2 mg), methionine (7.2 mg), polysorbate 80 (1 mg), sucrose (336 mg), and Water for Injection, USP. The pH is 5.3-5.9.</Description>
</NDC>
<NDC>
<NDCCode>0065-0800-50</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (0065-0800-50) * 480 mL in 1 BOTTLE, GLASS * 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00065-0800-50</NDC11Code>
<ProductNDC>0065-0800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bss Plus</ProprietaryName>
<NonProprietaryName>Balanced Salt Solution Enriched With Bicarbonate, Dextrose, And Glutathione</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19820628</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018469</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19820628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: BSS PLUS is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye.</IndicationAndUsage>
<Description>DESCRIPTION: BSS PLUS® is a sterile intraocular irrigating solution for use during all intraocular surgical procedures, including those requiring a relatively long intraocular perfusion time (e.g., pars plana vitrectomy, phacoemulsification, extracapsular cataract extraction/lens aspiration, anterior segment reconstruction, etc.). The solution does not contain a preservative and should be prepared just prior to use in surgery. Part I: Part I is a sterile 480 mL solution in a 500 mL single-dose bottle to which the Part II concentrate is added. Each mL of Part I contains: sodium chloride 7.44 mg, potassium chloride 0.395 mg, dibasic sodium phosphate 0.433 mg, sodium bicarbonate 2.19 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection. Part II: Part II is a sterile concentrate in a 20 mL single-dose vial for addition to Part I. Each mL of Part II contains: calcium chloride dihydrate 3.85 mg, magnesium chloride hexahydrate 5 mg, dextrose 23 mg, glutathione disulfide (oxidized glutathione) 4.6 mg, in water for injection. After addition of BSS PLUS Part II to the Part I bottle, each mL of the reconstituted product contains: sodium chloride 7.14 mg, potassium chloride 0.38 mg, calcium chloride dihydrate 0.154 mg, magnesium chloride hexahydrate 0.2 mg, dibasic sodium phosphate 0.42 mg, sodium bicarbonate 2.1 mg, dextrose 0.92 mg, glutathione disulfide (oxidized glutathione) 0.184 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection. The reconstituted product has a pH of approximately 7.4. Osmolality is approximately 305 mOsm.</Description>
</NDC>
<NDC>
<NDCCode>0065-0800-94</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (0065-0800-94) * 480 mL in 1 BAG * 20 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00065-0800-94</NDC11Code>
<ProductNDC>0065-0800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bss Plus</ProprietaryName>
<NonProprietaryName>Balanced Salt Solution Enriched With Bicarbonate, Dextrose, And Glutathione</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130620</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018469</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BSS PLUS solution is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye.</IndicationAndUsage>
<Description>BSS PLUS® is a sterile intraocular irrigating solution for use during all intraocular surgical procedures, including those requiring a relatively long intraocular perfusion time (e.g., pars plana vitrectomy, phacoemulsification, extra capsular cataract extraction/lens aspiration, anterior segment reconstruction, etc.). The solution does not contain a preservative and should be prepared just prior to use in surgery.Part I: Part I is a sterile 480 mL solution in a 500 mL single-dose bag to which the Part II concentrate is added. Each mL of Part I contains: sodium chloride 7.44 mg, potassium chloride 0.395 mg, dibasic sodium phosphate 0.433 mg, sodium bicarbonate 2.19 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.Part II: Part II is a sterile concentrate in a 20 mL single-dose vial for addition to Part I. Each mL of Part II contains: calcium chloride dihydrate 3.85 mg, magnesium chloride hexahydrate 5 mg, dextrose 23 mg, glutathione disulfide (oxidized glutathione) 4.6 mg, in water for injection.After addition of BSS PLUS solution Part II to the Part I bag, each mL of the reconstituted product contains: sodium chloride 7.14 mg, potassium chloride 0.38 mg, calcium chloride dihydrate 0.154 mg, magnesium chloride hexahydrate 0.2 mg, dibasic sodium phosphate 0.42 mg, sodium bicarbonate 2.1 mg, dextrose 0.92 mg, glutathione disulfide (oxidized glutathione) 0.184 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.The reconstituted product has a pH of approximately 7.4. Osmolality is approximately 305 mOsm.</Description>
</NDC>
<NDC>
<NDCCode>0093-3160-06</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (0093-3160-06) </PackageDescription>
<NDC11Code>00093-3160-06</NDC11Code>
<ProductNDC>0093-3160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefdinir</ProprietaryName>
<NonProprietaryName>Cefdinir</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070509</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065368</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>CEFDINIR</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.</IndicationAndUsage>
<Description>Cefdinir Capsules USP contain the active ingredient cefdinir, USP an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is (6R,7R)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir,USP is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7.0 phosphate buffer. Cefdinir has the structural formula shown below. C14H13N5O5S2 M.W. 395.41. Cefdinir Capsules USP contain 300 mg cefdinir, USP and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide, croscarmellose sodium, D&C red #28, D&C yellow #10, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C green #3, FD&C red #40, FD&C red #40 aluminum lake, gelatin, iron oxide black, magnesium stearate, polyoxyl 40 stearate, propylene glycol, shellac glaze, sodium lauryl sulfate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0409-0365-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0409-0365-01) / 8 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00409-0365-01</NDC11Code>
<ProductNDC>0409-0365</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210628</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022234</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DOCETAXEL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel (trihydrate) has the following structural formula. Docetaxel (trihydrate) is a white to almost-white powder with an empirical formula of C43H53NO14 ∙ 3H2O, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, pale-yellow to brownish yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous), 520 mg polysorbate 80 NF, 7 mg citric acid monohydrate USP, and 395 mg dehydrated alcohol USP. Docetaxel Injection is available in single-dose vials containing 20 mg (1 mL) or multiple-dose vials containing 80 mg (4 mL) or 160 mg (8 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
</NDC>
<NDC>
<NDCCode>0409-0366-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0366-01) / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-0366-01</NDC11Code>
<ProductNDC>0409-0366</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022234</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DOCETAXEL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).</IndicationAndUsage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel (trihydrate) has the following structural formula. Docetaxel (trihydrate) is a white to almost-white powder with an empirical formula of C43H53NO14 ∙ 3H2O, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, pale-yellow to brownish yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous), 520 mg polysorbate 80 NF, 7 mg citric acid monohydrate USP, and 395 mg dehydrated alcohol USP. Docetaxel Injection is available in single-dose vials containing 20 mg (1 mL) or multiple-dose vials containing 80 mg (4 mL) or 160 mg (8 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
</NDC>
<NDC>
<NDCCode>0409-0367-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0409-0367-01) / 4 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00409-0367-01</NDC11Code>
<ProductNDC>0409-0367</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022234</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DOCETAXEL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).</IndicationAndUsage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel (trihydrate) has the following structural formula. Docetaxel (trihydrate) is a white to almost-white powder with an empirical formula of C43H53NO14 ∙ 3H2O, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, pale-yellow to brownish yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous), 520 mg polysorbate 80 NF, 7 mg citric acid monohydrate USP, and 395 mg dehydrated alcohol USP. Docetaxel Injection is available in single-dose vials containing 20 mg (1 mL) or multiple-dose vials containing 80 mg (4 mL) or 160 mg (8 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
</NDC>
<NDC>
<NDCCode>0409-0368-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0409-0368-01) / 8 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00409-0368-01</NDC11Code>
<ProductNDC>0409-0368</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180109</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022234</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DOCETAXEL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).</IndicationAndUsage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel (trihydrate) has the following structural formula. Docetaxel (trihydrate) is a white to almost-white powder with an empirical formula of C43H53NO14 ∙ 3H2O, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, pale-yellow to brownish yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous), 520 mg polysorbate 80 NF, 7 mg citric acid monohydrate USP, and 395 mg dehydrated alcohol USP. Docetaxel Injection is available in single-dose vials containing 20 mg (1 mL) or multiple-dose vials containing 80 mg (4 mL) or 160 mg (8 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
</NDC>
<NDC>
<NDCCode>0409-4235-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-4235-01) / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-4235-01</NDC11Code>
<ProductNDC>0409-4235</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210628</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022234</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DOCETAXEL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel (trihydrate) has the following structural formula. Docetaxel (trihydrate) is a white to almost-white powder with an empirical formula of C43H53NO14 ∙ 3H2O, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, pale-yellow to brownish yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous), 520 mg polysorbate 80 NF, 7 mg citric acid monohydrate USP, and 395 mg dehydrated alcohol USP. Docetaxel Injection is available in single-dose vials containing 20 mg (1 mL) or multiple-dose vials containing 80 mg (4 mL) or 160 mg (8 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
</NDC>
<NDC>
<NDCCode>0409-5068-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0409-5068-01) / 4 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00409-5068-01</NDC11Code>
<ProductNDC>0409-5068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210628</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022234</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DOCETAXEL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel (trihydrate) has the following structural formula. Docetaxel (trihydrate) is a white to almost-white powder with an empirical formula of C43H53NO14 ∙ 3H2O, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, pale-yellow to brownish yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous), 520 mg polysorbate 80 NF, 7 mg citric acid monohydrate USP, and 395 mg dehydrated alcohol USP. Docetaxel Injection is available in single-dose vials containing 20 mg (1 mL) or multiple-dose vials containing 80 mg (4 mL) or 160 mg (8 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
</NDC>
<NDC>
<NDCCode>0456-0400-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01) </PackageDescription>
<NDC11Code>00456-0400-10</NDC11Code>
<ProductNDC>0456-0400</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teflaro</ProprietaryName>
<NonProprietaryName>Ceftaroline Fosamil</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20101029</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200327</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>CEFTAROLINE FOSAMIL</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Teflaro is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: 1 Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) (1.1), 2 Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older (1.2).</IndicationAndUsage>
<Description>TEFLARO (ceftaroline fosamil) for injection, is a sterile, semi-synthetic, prodrug of the cephalosporin antibacterial class of beta-lactams (β-lactams) for intravenous use. Chemically, the prodrug, ceftaroline fosamil monoacetate monohydrate is (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate monohydrate. Its molecular weight is 762.75. The empirical formula is C22H21N8O8PS4.C2H4O2.H2O. Figure 1: Chemical structure of ceftaroline fosamil. Teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil (equivalent to 668 mg and 446 mg, respectively, of ceftaroline fosamil monoacetate monohydrate). The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowish-white to light yellow sterile powder. Each vial of 400 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 263.3 mg/vial as the solubilizer and alkalizing agent. Each vial of 600 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 395.0 mg/vial as the solubilizer and alkalizing agent. All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see Dosage and Administration (2.3)]. The pH of the constituted solution is pH 4.8 to 6.5.</Description>
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