{
"NDC": [
{
"NDCCode": "65162-685-86",
"PackageDescription": "118 mL in 1 BOTTLE (65162-685-86) ",
"NDC11Code": "65162-0685-86",
"ProductNDC": "65162-685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20091027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090992",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091027",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam oral solution is indicated for adjunctive therapy for the treatment of: : 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) .",
"Description": "Levetiracetam oral solution, USP is an antiepileptic drug available as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam oral solution, USP contains 100 mg of levetiracetam, USP per mL. Inactive ingredients: anhydrous citric acid, artificial grape flavor, glycerin, magnasweet, maltitol, methylparaben, potassium acesulfame, propylparaben and sodium citrate."
},
{
"NDCCode": "65162-685-90",
"PackageDescription": "473 mL in 1 BOTTLE (65162-685-90) ",
"NDC11Code": "65162-0685-90",
"ProductNDC": "65162-685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20091027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090992",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091027",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam oral solution is indicated for adjunctive therapy for the treatment of: : 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) .",
"Description": "Levetiracetam oral solution, USP is an antiepileptic drug available as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam oral solution, USP contains 100 mg of levetiracetam, USP per mL. Inactive ingredients: anhydrous citric acid, artificial grape flavor, glycerin, magnasweet, maltitol, methylparaben, potassium acesulfame, propylparaben and sodium citrate."
},
{
"NDCCode": "65162-003-86",
"PackageDescription": "1 BOTTLE in 1 CARTON (65162-003-86) / 118 mL in 1 BOTTLE",
"NDC11Code": "65162-0003-86",
"ProductNDC": "65162-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20091007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090765",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091007",
"SamplePackage": "N",
"IndicationAndUsage": "relieves itching due to hives (urticaria). This product will not prevent hives or a allergic skin reaction from occurring."
},
{
"NDCCode": "65162-005-86",
"PackageDescription": "1 BOTTLE in 1 CARTON (65162-005-86) / 118 mL in 1 BOTTLE",
"NDC11Code": "65162-0005-86",
"ProductNDC": "65162-005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20091007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090765",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091007",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose and throat."
},
{
"NDCCode": "65162-672-86",
"PackageDescription": "1 BOTTLE in 1 CARTON (65162-672-86) > 118 mL in 1 BOTTLE",
"NDC11Code": "65162-0672-86",
"ProductNDC": "65162-672",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"ProprietaryNameSuffix": "Pain Reliever/ Fever Reducer",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20111112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200457",
"LabelerName": "Amneal Pharmaceuticals",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Temporarily: 1 ■ Relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache."
},
{
"NDCCode": "65162-678-86",
"PackageDescription": "118 mL in 1 BOTTLE (65162-678-86) ",
"NDC11Code": "65162-0678-86",
"ProductNDC": "65162-678",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20091230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040882",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091230",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine HCl Oral Solution is useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each teaspoonful (5 mL) of Promethazine HCl Oral Solution, USP contains 6.25 mg of promethazine HCl, USP in a flavored syrup base with a pH between 4.7 and 5.2. Alcohol 7%. The inactive ingredients present are alcohol, ascorbic acid, citric acid, D&C Yellow # 10, edetate disodium, FD&C Blue # 1, glycerin, methylparaben, natural and artificial banana flavor, natural and artificial fruit flavor, saccharin sodium, sodium benzoate, sodium citrate, and sucrose. Promethazine HCl, USP is a racemic compound; the molecular formula is C17H20N2SHCl and its molecular weight is 320.88. Promethazine HCl USP, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine HCl, USP occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol."
},
{
"NDCCode": "65162-679-86",
"PackageDescription": "118 mL in 1 BOTTLE (65162-679-86) ",
"NDC11Code": "65162-0679-86",
"ProductNDC": "65162-679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride And Phenylephrine Hydrochloride",
"NonProprietaryName": "Promethazine And Phenylephrine",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20090825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040902",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "6.25; 5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090825",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride and phenylephrine hydrochloride oral solution, USP is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.",
"Description": "Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride, USP 6.25 mg; phenylephrine hydrochloride, USP 5 mg. Alcohol 7%. Inactive Ingredients: alcohol, ascorbic acid, caramel color, citric acid, edetate disodium, glycerin, methylparaben, natural & artificial citrus flavor, purified water, saccharin sodium, sodium benzoate, sodium citrate, sodium metabisulfite and sucrose. Promethazine hydrochloride, USP, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride, USP occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2SHCl and the following structural formula:. Phenylephrine hydrochloride, USP is a sympathomimetic amine salt which is chemically designated as (-)-m-Hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride. It occurs as white or nearly white crystals, having a bitter taste. It is freely soluble in water and alcohol. Phenylephrine hydrochloride, USP is subject to oxidation and must be protected from light and air. It has a molecular weight of 203.67, a molecular formula of C9H13NO2HCl, and the following structural formula:."
},
{
"NDCCode": "65162-680-86",
"PackageDescription": "118 mL in 1 BOTTLE (65162-680-86) ",
"NDC11Code": "65162-0680-86",
"ProductNDC": "65162-680",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride And Dextromethorphan Hydrobromide",
"NonProprietaryName": "Promethazine Hydrochloride And Dextromethorphan Hydrobromide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20110304",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090575",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "6.25; 15",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110304",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.",
"Description": "Each 5 mL (one teaspoonful), for oral administration contains: dextromethorphan hydrobromide USP, 15 mg; promethazine hydrochloride USP, 6.25 mg. Alcohol 7%. Inactive Ingredients: ascorbic acid, citric acid, edetate disodium, FD&C Yellow #6, glycerin, methylparaben, natural & artificial flavors, purified water, saccharin sodium, sodium benzoate, sodium citrate, and sucrose. Dextromethorphan hydrobromide, USP is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α,13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide, USP occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C18H25NOHBrH20, and the following structural formula. Promethazine is a racemic compound. Promethazine hydrochloride USP, a phenothiazine derivative, is chemically designated as \"10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-, monohydrochloride\". Promethazine hydrochloride, USP occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2S HCl, and the following structural formula."
},
{
"NDCCode": "65162-684-86",
"PackageDescription": "118 mL in 1 BOTTLE (65162-684-86) ",
"NDC11Code": "65162-0684-86",
"ProductNDC": "65162-684",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20091007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090766",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091007",
"SamplePackage": "N",
"IndicationAndUsage": "Perennial Allergic Rhinitis: Cetirizine hydrochloride is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria: Cetirizine hydrochloride is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.",
"Description": "Cetirizine hydrochloride is an orally active and selective H1-receptor antagonist. The chemical name is (±) - [2- [4- [(4-chlorophenyl) phenylmethyl]- 1 - piperazinyl] ethoxy] acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with an empirical formula of C21H25ClN2O32HCl. The molecular weight is 461.82 and the chemical structure is shown below. Cetirizine hydrochloride, USP is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution, USP is a clear, colorless to pale yellow solution containing cetirizine hydrochloride, USP at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the oral solution are: glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, sodium acetate, sucrose and water."
},
{
"NDCCode": "65162-694-86",
"PackageDescription": "118 mL in 1 BOTTLE (65162-694-86) ",
"NDC11Code": "65162-0694-86",
"ProductNDC": "65162-694",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine And Phenylephrine Hcl, And Codeine Phosphate",
"NonProprietaryName": "Promethazine, Phenylephrine, Codeine",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20131101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200963",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE",
"StrengthNumber": "6.25; 5; 10",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131101",
"SamplePackage": "N"
},
{
"NDCCode": "65162-695-86",
"PackageDescription": "118 mL in 1 BOTTLE (65162-695-86) ",
"NDC11Code": "65162-0695-86",
"ProductNDC": "65162-695",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride And Codeine Phosphate",
"NonProprietaryName": "Promethazine And Codeine",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20130315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200894",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE",
"StrengthNumber": "6.25; 10",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS],Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2019-02-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130315",
"SamplePackage": "N"
},
{
"NDCCode": "65162-703-86",
"PackageDescription": "1 BOTTLE in 1 CARTON (65162-703-86) / 118.28 mL in 1 BOTTLE",
"NDC11Code": "65162-0703-86",
"ProductNDC": "65162-703",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150922",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201759",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".11",
"StrengthUnit": "mg/118.28mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150922",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone acetonide 0.01% topical oil (scalp oil) is indicated for the treatment of psoriasis of the scalp in adults.",
"Description": "Fluocinolone acetonide 0.01% topical oil contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17 [(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. Chemically, fluocinolone acetonide is C24 H30 F2 O6. It has the following structural formula. Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of fluocinolone acetonide 0.01% topical oil contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, and refined peanut oil NF. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic. Fluocinolone acetonide 0.01% topical oil is formulated with 48% refined peanut oil. The bulk refined peanut oil used in fluocinolone acetonide 0.01% topical oil is heated at 246°C (475°F) for at least 15 minutes. The refined peanut oil used in fluocinolone acetonide 0.01% topical oil is routinely tested for peanut proteins through amino acid analysis; the quantity of amino acids is below 0.5 parts per million (ppm)."
},
{
"NDCCode": "65162-704-86",
"PackageDescription": "1 BOTTLE in 1 CARTON (65162-704-86) / 118.28 mL in 1 BOTTLE",
"NDC11Code": "65162-0704-86",
"ProductNDC": "65162-704",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150922",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201764",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".11",
"StrengthUnit": "mg/118.28mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150922",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone Acetonide 0.01% Topical Oil (Body Oil) is indicated for the topical treatment of: : 1 atopic dermatitis in adults, 2 moderate to severe atopic dermatitis in pediatric patients 3 months of age and older.",
"Description": "Fluocinolone Acetonide 0.01% Topical Oil (Body Oil) contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as Fluocinolone Acetonide 0.01% Topical Oil (Scalp Oil) for use with shower caps for treatment of scalp psoriasis in adults and as fluocinolone acetonide oil, 0.01% for treatment of chronic eczematous external otitis. Chemically, fluocinolone acetonide is C24 H30 F2 O6. It has the following structural formula. Fluocinolone acetonide in Fluocinolone Acetonide 0.01% Topical Oil has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of Fluocinolone Acetonide 0.01% Topical Oil contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, and refined peanut oil NF. Fluocinolone Acetonide 0.01% Topical Oil is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide 0.01% Topical Oil for peanut-sensitive individuals."
},
{
"NDCCode": "50242-245-86",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (50242-245-86) / 15 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "50242-0245-86",
"ProductNDC": "50242-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phesgo",
"NonProprietaryName": "Pertuzumab, Trastuzumab, And Hyaluronidase-zzxf",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200629",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761170",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "PERTUZUMAB; TRASTUZUMAB; HYALURONIDASE (HUMAN RECOMBINANT)",
"StrengthNumber": "1200; 600; 30000",
"StrengthUnit": "mg/15mL; mg/15mL; U/15mL",
"Pharm_Classes": "Endoglycosidase [EPC], Glycoside Hydrolases [CS], HER2/Neu/cerbB2 Antagonists [MoA], HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC], HER2/neu Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210503",
"SamplePackage": "Y",
"IndicationAndUsage": "PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for: 1 Use in combination with chemotherapy as:neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. (1.1)adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence (1.1), 2 Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. (1.2).",
"Description": "PHESGO is a combination of pertuzumab, trastuzumab, and hyaluronidase. Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). Pertuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Pertuzumab has an approximate molecular weight of 148 kDa. Trastuzumab is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Trastuzumab has a molecular weight of approximately 148 kDa. Hyaluronidase (recombinant human) is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is a glycosylated single-chain protein produced by mammalian (Chinese Hamster Ovary) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase (recombinant human) has a molecular weight of approximately 61 kDa. PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection is a sterile, preservative-free, clear to opalescent, and colorless to slightly brownish solution supplied in single-dose vials for subcutaneous administration. PHESGO injection is supplied as two different configurations: 1 PHESGO is supplied in a 15 mL single-dose vial containing 1,200 mg of pertuzumab, 600 mg of trastuzumab, and 30,000 units of hyaluronidase, and α,α-trehalose (397 mg), L-histidine (6.75 mg), L-histidine hydrochloric monohydrate (53.7 mg), L-methionine (22.4 mg), polysorbate 20 (6 mg), and sucrose (685 mg) with a pH of 5.5., 2 PHESGO is supplied in a 10 mL single-dose vial containing 600 mg of pertuzumab, 600 mg of trastuzumab, and 20,000 units of hyaluronidase, and α,α-trehalose (397 mg), L-histidine (4.4 mg), L-histidine hydrochloric monohydrate (36.1 mg), L-methionine (14.9 mg), polysorbate 20 (4 mg), and sucrose (342 mg) with a pH of 5.5."
},
{
"NDCCode": "50242-260-86",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (50242-260-86) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "50242-0260-86",
"ProductNDC": "50242-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phesgo",
"NonProprietaryName": "Pertuzumab, Trastuzumab, And Hyaluronidase-zzxf",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200629",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761170",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "PERTUZUMAB; TRASTUZUMAB; HYALURONIDASE (HUMAN RECOMBINANT)",
"StrengthNumber": "600; 600; 20000",
"StrengthUnit": "mg/10mL; mg/10mL; U/10mL",
"Pharm_Classes": "Endoglycosidase [EPC], Glycoside Hydrolases [CS], HER2/Neu/cerbB2 Antagonists [MoA], HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC], HER2/neu Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210503",
"SamplePackage": "Y",
"IndicationAndUsage": "PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for: 1 Use in combination with chemotherapy as:neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. (1.1)adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence (1.1), 2 Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. (1.2).",
"Description": "PHESGO is a combination of pertuzumab, trastuzumab, and hyaluronidase. Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). Pertuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Pertuzumab has an approximate molecular weight of 148 kDa. Trastuzumab is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Trastuzumab has a molecular weight of approximately 148 kDa. Hyaluronidase (recombinant human) is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is a glycosylated single-chain protein produced by mammalian (Chinese Hamster Ovary) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase (recombinant human) has a molecular weight of approximately 61 kDa. PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection is a sterile, preservative-free, clear to opalescent, and colorless to slightly brownish solution supplied in single-dose vials for subcutaneous administration. PHESGO injection is supplied as two different configurations: 1 PHESGO is supplied in a 15 mL single-dose vial containing 1,200 mg of pertuzumab, 600 mg of trastuzumab, and 30,000 units of hyaluronidase, and α,α-trehalose (397 mg), L-histidine (6.75 mg), L-histidine hydrochloric monohydrate (53.7 mg), L-methionine (22.4 mg), polysorbate 20 (6 mg), and sucrose (685 mg) with a pH of 5.5., 2 PHESGO is supplied in a 10 mL single-dose vial containing 600 mg of pertuzumab, 600 mg of trastuzumab, and 20,000 units of hyaluronidase, and α,α-trehalose (397 mg), L-histidine (4.4 mg), L-histidine hydrochloric monohydrate (36.1 mg), L-methionine (14.9 mg), polysorbate 20 (4 mg), and sucrose (342 mg) with a pH of 5.5."
},
{
"NDCCode": "0143-9168-01",
"PackageDescription": ".5 mL in 1 SYRINGE (0143-9168-01) ",
"NDC11Code": "00143-9168-01",
"ProductNDC": "0143-9168",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Starjemza",
"NonProprietaryName": "Ustekinumab-hmny",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251027",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761419",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "45",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251027",
"SamplePackage": "N",
"IndicationAndUsage": "STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).",
"Description": "Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg)."
},
{
"NDCCode": "0143-9169-01",
"PackageDescription": ".5 mL in 1 VIAL (0143-9169-01) ",
"NDC11Code": "00143-9169-01",
"ProductNDC": "0143-9169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Starjemza",
"NonProprietaryName": "Ustekinumab-hmny",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251027",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761419",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "45",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251027",
"SamplePackage": "N",
"IndicationAndUsage": "STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).",
"Description": "Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg)."
},
{
"NDCCode": "0143-9170-01",
"PackageDescription": "1 mL in 1 SYRINGE (0143-9170-01) ",
"NDC11Code": "00143-9170-01",
"ProductNDC": "0143-9170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Starjemza",
"NonProprietaryName": "Ustekinumab-hmny",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251027",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761419",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "90",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251027",
"SamplePackage": "N",
"IndicationAndUsage": "STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).",
"Description": "Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg)."
},
{
"NDCCode": "0143-9171-01",
"PackageDescription": "26 mL in 1 VIAL (0143-9171-01) ",
"NDC11Code": "00143-9171-01",
"ProductNDC": "0143-9171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Starjemza",
"NonProprietaryName": "Ustekinumab-hmny",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251027",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761419",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "130",
"StrengthUnit": "mg/26mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251027",
"SamplePackage": "N",
"IndicationAndUsage": "STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).",
"Description": "Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg)."
},
{
"NDCCode": "10135-685-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (10135-685-10) ",
"NDC11Code": "10135-0685-10",
"ProductNDC": "10135-685",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sodium Bicarbonate",
"NonProprietaryName": "Sodium Bicarbonate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200301",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves: 1 acid indigestion heartburn, 2 sour stomach, 3 upset stomach associated with these symptoms."
},
{
"NDCCode": "10967-685-61",
"PackageDescription": "15 g in 1 JAR (10967-685-61) ",
"NDC11Code": "10967-0685-61",
"ProductNDC": "10967-685",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prevage Anti-aging Eye Cream Spf 15",
"NonProprietaryName": "Octinoxate, Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200102",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Revlon",
"SubstanceName": "OXYBENZONE; OCTINOXATE",
"StrengthNumber": "1.4; 4.1",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200102",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg caused by the sun ."
},
{
"NDCCode": "11673-685-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (11673-685-26) / 118 mL in 1 BOTTLE",
"NDC11Code": "11673-0685-26",
"ProductNDC": "11673-685",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20090710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074937",
"LabelerName": "Target Corporation",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090710",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily: : 1 relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache, 2 reduces fever."
},
{
"NDCCode": "11673-685-28",
"PackageDescription": "1 BOTTLE in 1 CARTON (11673-685-28) > 148 mL in 1 BOTTLE",
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"ProductNDC": "11673-685",
"ProductTypeName": "HUMAN OTC DRUG",
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"MarketingCategoryName": "ANDA",
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"LabelerName": "Target Corporation",
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"LastUpdate": "2017-10-26"
},
{
"NDCCode": "11673-685-34",
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"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110312",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily: : 1 relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache, 2 reduces fever."
},
{
"NDCCode": "13533-685-20",
"PackageDescription": "1 VIAL in 1 CARTON (13533-685-20) > 50 mL in 1 VIAL (13533-685-21) ",
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"ProductNDC": "13533-685",
"ProductTypeName": "PLASMA DERIVATIVE",
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"EndMarketingDate": "20181108",
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"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
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"StrengthUnit": "g/50mL",
"Pharm_Classes": "Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]",
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"LastUpdate": "2018-11-09",
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"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20181108",
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},
{
"NDCCode": "13533-685-25",
"PackageDescription": "1 VIAL in 1 CARTON (13533-685-25) > 250 mL in 1 VIAL (13533-685-26) ",
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"ProductNDC": "13533-685",
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"EndMarketingDate": "20181108",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101138",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
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"StrengthUnit": "g/50mL",
"Pharm_Classes": "Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19760826",
"EndMarketingDatePackage": "20181108",
"SamplePackage": "N"
},
{
"NDCCode": "13533-685-27",
"PackageDescription": "1 VIAL in 1 CARTON (13533-685-27) > 500 mL in 1 VIAL (13533-685-28) ",
"NDC11Code": "13533-0685-27",
"ProductNDC": "13533-685",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Plasbumin",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19760826",
"EndMarketingDate": "20181108",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101138",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
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"StrengthUnit": "g/50mL",
"Pharm_Classes": "Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19760826",
"EndMarketingDatePackage": "20181108",
"SamplePackage": "N"
},
{
"NDCCode": "13537-685-02",
"PackageDescription": "1 BOTTLE in 1 BOX (13537-685-02) > 30 mL in 1 BOTTLE (13537-685-01)",
"NDC11Code": "13537-0685-02",
"ProductNDC": "13537-685",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Effet Parfait Signs Of Age Appearance Minimizer Foundation Spf 20 Fm",
"ProprietaryNameSuffix": "Medium 5 - Beige",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151123",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": ".07; .0244",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "13811-685-01",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (13811-685-01)",
"NDC11Code": "13811-0685-01",
"ProductNDC": "13811-685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202713",
"LabelerName": "Trigen Laboratories, LLC",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
"StrengthNumber": "5; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-11-22"
},
{
"NDCCode": "13811-685-10",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (13811-685-10)",
"NDC11Code": "13811-0685-10",
"ProductNDC": "13811-685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202713",
"LabelerName": "Trigen Laboratories, LLC",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
"StrengthNumber": "5; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-11-22"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>65162-685-86</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (65162-685-86) </PackageDescription>
<NDC11Code>65162-0685-86</NDC11Code>
<ProductNDC>65162-685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090992</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam oral solution is indicated for adjunctive therapy for the treatment of: : 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) .</IndicationAndUsage>
<Description>Levetiracetam oral solution, USP is an antiepileptic drug available as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam oral solution, USP contains 100 mg of levetiracetam, USP per mL. Inactive ingredients: anhydrous citric acid, artificial grape flavor, glycerin, magnasweet, maltitol, methylparaben, potassium acesulfame, propylparaben and sodium citrate.</Description>
</NDC>
<NDC>
<NDCCode>65162-685-90</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (65162-685-90) </PackageDescription>
<NDC11Code>65162-0685-90</NDC11Code>
<ProductNDC>65162-685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090992</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam oral solution is indicated for adjunctive therapy for the treatment of: : 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) .</IndicationAndUsage>
<Description>Levetiracetam oral solution, USP is an antiepileptic drug available as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam oral solution, USP contains 100 mg of levetiracetam, USP per mL. Inactive ingredients: anhydrous citric acid, artificial grape flavor, glycerin, magnasweet, maltitol, methylparaben, potassium acesulfame, propylparaben and sodium citrate.</Description>
</NDC>
<NDC>
<NDCCode>65162-003-86</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65162-003-86) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>65162-0003-86</NDC11Code>
<ProductNDC>65162-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090765</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves itching due to hives (urticaria). This product will not prevent hives or a allergic skin reaction from occurring.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65162-005-86</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65162-005-86) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>65162-0005-86</NDC11Code>
<ProductNDC>65162-005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090765</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose and throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65162-672-86</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65162-672-86) > 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>65162-0672-86</NDC11Code>
<ProductNDC>65162-672</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<ProprietaryNameSuffix>Pain Reliever/ Fever Reducer</ProprietaryNameSuffix>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111112</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200457</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Temporarily: 1 ■ Relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65162-678-86</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (65162-678-86) </PackageDescription>
<NDC11Code>65162-0678-86</NDC11Code>
<ProductNDC>65162-678</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091230</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040882</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine HCl Oral Solution is useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each teaspoonful (5 mL) of Promethazine HCl Oral Solution, USP contains 6.25 mg of promethazine HCl, USP in a flavored syrup base with a pH between 4.7 and 5.2. Alcohol 7%. The inactive ingredients present are alcohol, ascorbic acid, citric acid, D&C Yellow # 10, edetate disodium, FD&C Blue # 1, glycerin, methylparaben, natural and artificial banana flavor, natural and artificial fruit flavor, saccharin sodium, sodium benzoate, sodium citrate, and sucrose. Promethazine HCl, USP is a racemic compound; the molecular formula is C17H20N2SHCl and its molecular weight is 320.88. Promethazine HCl USP, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine HCl, USP occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>65162-679-86</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (65162-679-86) </PackageDescription>
<NDC11Code>65162-0679-86</NDC11Code>
<ProductNDC>65162-679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride And Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine And Phenylephrine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040902</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6.25; 5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride and phenylephrine hydrochloride oral solution, USP is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.</IndicationAndUsage>
<Description>Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride, USP 6.25 mg; phenylephrine hydrochloride, USP 5 mg. Alcohol 7%. Inactive Ingredients: alcohol, ascorbic acid, caramel color, citric acid, edetate disodium, glycerin, methylparaben, natural & artificial citrus flavor, purified water, saccharin sodium, sodium benzoate, sodium citrate, sodium metabisulfite and sucrose. Promethazine hydrochloride, USP, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride, USP occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2SHCl and the following structural formula:. Phenylephrine hydrochloride, USP is a sympathomimetic amine salt which is chemically designated as (-)-m-Hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride. It occurs as white or nearly white crystals, having a bitter taste. It is freely soluble in water and alcohol. Phenylephrine hydrochloride, USP is subject to oxidation and must be protected from light and air. It has a molecular weight of 203.67, a molecular formula of C9H13NO2HCl, and the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>65162-680-86</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (65162-680-86) </PackageDescription>
<NDC11Code>65162-0680-86</NDC11Code>
<ProductNDC>65162-680</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride And Dextromethorphan Hydrobromide</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110304</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090575</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>6.25; 15</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.</IndicationAndUsage>
<Description>Each 5 mL (one teaspoonful), for oral administration contains: dextromethorphan hydrobromide USP, 15 mg; promethazine hydrochloride USP, 6.25 mg. Alcohol 7%. Inactive Ingredients: ascorbic acid, citric acid, edetate disodium, FD&C Yellow #6, glycerin, methylparaben, natural & artificial flavors, purified water, saccharin sodium, sodium benzoate, sodium citrate, and sucrose. Dextromethorphan hydrobromide, USP is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α,13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide, USP occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C18H25NOHBrH20, and the following structural formula. Promethazine is a racemic compound. Promethazine hydrochloride USP, a phenothiazine derivative, is chemically designated as "10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-, monohydrochloride". Promethazine hydrochloride, USP occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2S HCl, and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>65162-684-86</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (65162-684-86) </PackageDescription>
<NDC11Code>65162-0684-86</NDC11Code>
<ProductNDC>65162-684</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090766</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perennial Allergic Rhinitis: Cetirizine hydrochloride is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria: Cetirizine hydrochloride is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.</IndicationAndUsage>
<Description>Cetirizine hydrochloride is an orally active and selective H1-receptor antagonist. The chemical name is (±) - [2- [4- [(4-chlorophenyl) phenylmethyl]- 1 - piperazinyl] ethoxy] acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with an empirical formula of C21H25ClN2O32HCl. The molecular weight is 461.82 and the chemical structure is shown below. Cetirizine hydrochloride, USP is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution, USP is a clear, colorless to pale yellow solution containing cetirizine hydrochloride, USP at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the oral solution are: glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, sodium acetate, sucrose and water.</Description>
</NDC>
<NDC>
<NDCCode>65162-694-86</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (65162-694-86) </PackageDescription>
<NDC11Code>65162-0694-86</NDC11Code>
<ProductNDC>65162-694</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine And Phenylephrine Hcl, And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Promethazine, Phenylephrine, Codeine</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200963</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>6.25; 5; 10</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65162-695-86</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (65162-695-86) </PackageDescription>
<NDC11Code>65162-0695-86</NDC11Code>
<ProductNDC>65162-695</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Promethazine And Codeine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200894</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>6.25; 10</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS],Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-02-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65162-703-86</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65162-703-86) / 118.28 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>65162-0703-86</NDC11Code>
<ProductNDC>65162-703</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150922</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201759</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.11</StrengthNumber>
<StrengthUnit>mg/118.28mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone acetonide 0.01% topical oil (scalp oil) is indicated for the treatment of psoriasis of the scalp in adults.</IndicationAndUsage>
<Description>Fluocinolone acetonide 0.01% topical oil contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17 [(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. Chemically, fluocinolone acetonide is C24 H30 F2 O6. It has the following structural formula. Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of fluocinolone acetonide 0.01% topical oil contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, and refined peanut oil NF. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic. Fluocinolone acetonide 0.01% topical oil is formulated with 48% refined peanut oil. The bulk refined peanut oil used in fluocinolone acetonide 0.01% topical oil is heated at 246°C (475°F) for at least 15 minutes. The refined peanut oil used in fluocinolone acetonide 0.01% topical oil is routinely tested for peanut proteins through amino acid analysis; the quantity of amino acids is below 0.5 parts per million (ppm).</Description>
</NDC>
<NDC>
<NDCCode>65162-704-86</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65162-704-86) / 118.28 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>65162-0704-86</NDC11Code>
<ProductNDC>65162-704</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150922</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201764</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.11</StrengthNumber>
<StrengthUnit>mg/118.28mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone Acetonide 0.01% Topical Oil (Body Oil) is indicated for the topical treatment of: : 1 atopic dermatitis in adults, 2 moderate to severe atopic dermatitis in pediatric patients 3 months of age and older.</IndicationAndUsage>
<Description>Fluocinolone Acetonide 0.01% Topical Oil (Body Oil) contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as Fluocinolone Acetonide 0.01% Topical Oil (Scalp Oil) for use with shower caps for treatment of scalp psoriasis in adults and as fluocinolone acetonide oil, 0.01% for treatment of chronic eczematous external otitis. Chemically, fluocinolone acetonide is C24 H30 F2 O6. It has the following structural formula. Fluocinolone acetonide in Fluocinolone Acetonide 0.01% Topical Oil has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of Fluocinolone Acetonide 0.01% Topical Oil contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, and refined peanut oil NF. Fluocinolone Acetonide 0.01% Topical Oil is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide 0.01% Topical Oil for peanut-sensitive individuals.</Description>
</NDC>
<NDC>
<NDCCode>50242-245-86</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (50242-245-86) / 15 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>50242-0245-86</NDC11Code>
<ProductNDC>50242-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phesgo</ProprietaryName>
<NonProprietaryName>Pertuzumab, Trastuzumab, And Hyaluronidase-zzxf</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200629</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761170</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>PERTUZUMAB; TRASTUZUMAB; HYALURONIDASE (HUMAN RECOMBINANT)</SubstanceName>
<StrengthNumber>1200; 600; 30000</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; U/15mL</StrengthUnit>
<Pharm_Classes>Endoglycosidase [EPC], Glycoside Hydrolases [CS], HER2/Neu/cerbB2 Antagonists [MoA], HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC], HER2/neu Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210503</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for: 1 Use in combination with chemotherapy as:neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. (1.1)adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence (1.1), 2 Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. (1.2).</IndicationAndUsage>
<Description>PHESGO is a combination of pertuzumab, trastuzumab, and hyaluronidase. Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). Pertuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Pertuzumab has an approximate molecular weight of 148 kDa. Trastuzumab is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Trastuzumab has a molecular weight of approximately 148 kDa. Hyaluronidase (recombinant human) is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is a glycosylated single-chain protein produced by mammalian (Chinese Hamster Ovary) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase (recombinant human) has a molecular weight of approximately 61 kDa. PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection is a sterile, preservative-free, clear to opalescent, and colorless to slightly brownish solution supplied in single-dose vials for subcutaneous administration. PHESGO injection is supplied as two different configurations: 1 PHESGO is supplied in a 15 mL single-dose vial containing 1,200 mg of pertuzumab, 600 mg of trastuzumab, and 30,000 units of hyaluronidase, and α,α-trehalose (397 mg), L-histidine (6.75 mg), L-histidine hydrochloric monohydrate (53.7 mg), L-methionine (22.4 mg), polysorbate 20 (6 mg), and sucrose (685 mg) with a pH of 5.5., 2 PHESGO is supplied in a 10 mL single-dose vial containing 600 mg of pertuzumab, 600 mg of trastuzumab, and 20,000 units of hyaluronidase, and α,α-trehalose (397 mg), L-histidine (4.4 mg), L-histidine hydrochloric monohydrate (36.1 mg), L-methionine (14.9 mg), polysorbate 20 (4 mg), and sucrose (342 mg) with a pH of 5.5.</Description>
</NDC>
<NDC>
<NDCCode>50242-260-86</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (50242-260-86) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>50242-0260-86</NDC11Code>
<ProductNDC>50242-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phesgo</ProprietaryName>
<NonProprietaryName>Pertuzumab, Trastuzumab, And Hyaluronidase-zzxf</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200629</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761170</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>PERTUZUMAB; TRASTUZUMAB; HYALURONIDASE (HUMAN RECOMBINANT)</SubstanceName>
<StrengthNumber>600; 600; 20000</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL; U/10mL</StrengthUnit>
<Pharm_Classes>Endoglycosidase [EPC], Glycoside Hydrolases [CS], HER2/Neu/cerbB2 Antagonists [MoA], HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC], HER2/neu Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210503</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for: 1 Use in combination with chemotherapy as:neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. (1.1)adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence (1.1), 2 Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. (1.2).</IndicationAndUsage>
<Description>PHESGO is a combination of pertuzumab, trastuzumab, and hyaluronidase. Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). Pertuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Pertuzumab has an approximate molecular weight of 148 kDa. Trastuzumab is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Trastuzumab has a molecular weight of approximately 148 kDa. Hyaluronidase (recombinant human) is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is a glycosylated single-chain protein produced by mammalian (Chinese Hamster Ovary) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase (recombinant human) has a molecular weight of approximately 61 kDa. PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection is a sterile, preservative-free, clear to opalescent, and colorless to slightly brownish solution supplied in single-dose vials for subcutaneous administration. PHESGO injection is supplied as two different configurations: 1 PHESGO is supplied in a 15 mL single-dose vial containing 1,200 mg of pertuzumab, 600 mg of trastuzumab, and 30,000 units of hyaluronidase, and α,α-trehalose (397 mg), L-histidine (6.75 mg), L-histidine hydrochloric monohydrate (53.7 mg), L-methionine (22.4 mg), polysorbate 20 (6 mg), and sucrose (685 mg) with a pH of 5.5., 2 PHESGO is supplied in a 10 mL single-dose vial containing 600 mg of pertuzumab, 600 mg of trastuzumab, and 20,000 units of hyaluronidase, and α,α-trehalose (397 mg), L-histidine (4.4 mg), L-histidine hydrochloric monohydrate (36.1 mg), L-methionine (14.9 mg), polysorbate 20 (4 mg), and sucrose (342 mg) with a pH of 5.5.</Description>
</NDC>
<NDC>
<NDCCode>0143-9168-01</NDCCode>
<PackageDescription>.5 mL in 1 SYRINGE (0143-9168-01) </PackageDescription>
<NDC11Code>00143-9168-01</NDC11Code>
<ProductNDC>0143-9168</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Starjemza</ProprietaryName>
<NonProprietaryName>Ustekinumab-hmny</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20251027</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761419</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>USTEKINUMAB</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
<Description>Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>Ustekinumab-hmny</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
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<StartMarketingDate>20251027</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761419</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>USTEKINUMAB</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
<Description>Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
</NDC>
<NDC>
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<ProprietaryName>Starjemza</ProprietaryName>
<NonProprietaryName>Ustekinumab-hmny</NonProprietaryName>
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<ApplicationNumber>BLA761419</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
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<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
<Description>Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
</NDC>
<NDC>
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<NDC11Code>00143-9171-01</NDC11Code>
<ProductNDC>0143-9171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Starjemza</ProprietaryName>
<NonProprietaryName>Ustekinumab-hmny</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251027</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761419</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>USTEKINUMAB</SubstanceName>
<StrengthNumber>130</StrengthNumber>
<StrengthUnit>mg/26mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
<Description>Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
</NDC>
<NDC>
<NDCCode>10135-685-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (10135-685-10) </PackageDescription>
<NDC11Code>10135-0685-10</NDC11Code>
<ProductNDC>10135-685</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sodium Bicarbonate</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves: 1 acid indigestion heartburn, 2 sour stomach, 3 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10967-685-61</NDCCode>
<PackageDescription>15 g in 1 JAR (10967-685-61) </PackageDescription>
<NDC11Code>10967-0685-61</NDC11Code>
<ProductNDC>10967-685</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Prevage Anti-aging Eye Cream Spf 15</ProprietaryName>
<NonProprietaryName>Octinoxate, Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Revlon</LabelerName>
<SubstanceName>OXYBENZONE; OCTINOXATE</SubstanceName>
<StrengthNumber>1.4; 4.1</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11673-685-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11673-685-26) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>11673-0685-26</NDC11Code>
<ProductNDC>11673-685</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074937</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>100</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>2025-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily: : 1 relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache, 2 reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11673-685-28</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11673-685-28) > 148 mL in 1 BOTTLE</PackageDescription>
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<ProductNDC>11673-685</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Ibuprofen</ProprietaryName>
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<DosageFormName>SUSPENSION</DosageFormName>
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<StartMarketingDate>20090710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074937</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>11673-685-34</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11673-685-34) / 237 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>11673-0685-34</NDC11Code>
<ProductNDC>11673-685</ProductNDC>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20090710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074937</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>100</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>2025-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily: : 1 relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache, 2 reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13533-685-20</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (13533-685-20) > 50 mL in 1 VIAL (13533-685-21) </PackageDescription>
<NDC11Code>13533-0685-20</NDC11Code>
<ProductNDC>13533-685</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Plasbumin</ProprietaryName>
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<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19760826</StartMarketingDate>
<EndMarketingDate>20181108</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101138</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19760826</StartMarketingDatePackage>
<EndMarketingDatePackage>20181108</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13533-685-25</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (13533-685-25) > 250 mL in 1 VIAL (13533-685-26) </PackageDescription>
<NDC11Code>13533-0685-25</NDC11Code>
<ProductNDC>13533-685</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Plasbumin</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19760826</StartMarketingDate>
<EndMarketingDate>20181108</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101138</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19760826</StartMarketingDatePackage>
<EndMarketingDatePackage>20181108</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
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<ProductNDC>13533-685</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Plasbumin</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19760826</StartMarketingDate>
<EndMarketingDate>20181108</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101138</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19760826</StartMarketingDatePackage>
<EndMarketingDatePackage>20181108</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13537-685-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (13537-685-02) > 30 mL in 1 BOTTLE (13537-685-01)</PackageDescription>
<NDC11Code>13537-0685-02</NDC11Code>
<ProductNDC>13537-685</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Effet Parfait Signs Of Age Appearance Minimizer Foundation Spf 20 Fm</ProprietaryName>
<ProprietaryNameSuffix>Medium 5 - Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151123</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.07; .0244</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13811-685-01</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (13811-685-01)</PackageDescription>
<NDC11Code>13811-0685-01</NDC11Code>
<ProductNDC>13811-685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202713</ApplicationNumber>
<LabelerName>Trigen Laboratories, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>5; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>13811-685-10</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (13811-685-10)</PackageDescription>
<NDC11Code>13811-0685-10</NDC11Code>
<ProductNDC>13811-685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202713</ApplicationNumber>
<LabelerName>Trigen Laboratories, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>5; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
</NDCList>