{
"NDC": [
{
"NDCCode": "62135-189-23",
"PackageDescription": "2 TRAY in 1 BOX (62135-189-23) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (62135-189-20) ",
"NDC11Code": "62135-0189-23",
"ProductNDC": "62135-189",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol Sulfate",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20070626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077788",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250326",
"SamplePackage": "N",
"IndicationAndUsage": "Albuterol Sulfate Syrup is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease.",
"Description": "Albuterol Sulfate Syrup contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diolsulfate (2:1) (salt) and the following chemical structure:. (C 13H 21NO 3) 2H 2SO 4 M.W. 576.7. Albuterol sulfate is a white or practically white powder freely soluble in water and slightly soluble in alcohol, in chloroform, and in ether per USP definition. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol Sulfate Syrup for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 mL). Albuterol Sulfate Syrup also contains the inactive ingredients Purified water, hypromellose, citric acid anhydrous, sodium citrate dihydrate, sodium benzoate, sorbitol solution, strawberry flavor, and FD&C Yellow # 6. The pH of the syrup is 3.2 to 4.2."
},
{
"NDCCode": "55301-189-23",
"PackageDescription": "9 BLISTER PACK in 1 CARTON (55301-189-23) / 8 TABLET in 1 BLISTER PACK",
"NDC11Code": "55301-0189-23",
"ProductNDC": "55301-189",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sleep-aid",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19900410",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M010",
"LabelerName": "ARMY AND AIR FORCE EXCHANGE SERVICE",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19900410",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional sleeplessness. reduces time to fall asleep if you have difficulty falling asleep."
},
{
"NDCCode": "68999-189-23",
"PackageDescription": "2 TRAY in 1 BOX (68999-189-23) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (68999-189-20) ",
"NDC11Code": "68999-0189-23",
"ProductNDC": "68999-189",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol Sulfate",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20070626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077788",
"LabelerName": "Chartwell Governmental & Specialty RX, LLC.",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"IndicationAndUsage": "Albuterol Sulfate Syrup is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease.",
"Description": "Albuterol Sulfate Syrup contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diolsulfate (2:1) (salt) and the following chemical structure:. (C 13H 21NO 3) 2H 2SO 4M.W. 576.7. Albuterol sulfate is a white or practically white powder freely soluble in water and slightly soluble in alcohol, in chloroform, and in ether per USP definition. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol Sulfate Syrup for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 mL). Albuterol Sulfate Syrup also contains the inactive ingredients purified water, hypromellose, citric acid anhydrous, sodium citrate dihydrate, sodium benzoate, sorbitol solution, strawberry flavor, and FD&C Yellow # 6. The pH of the syrup is 3.2 to 4.2."
},
{
"NDCCode": "62135-189-24",
"PackageDescription": "2 TRAY in 1 BOX (62135-189-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-189-05) ",
"NDC11Code": "62135-0189-24",
"ProductNDC": "62135-189",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol Sulfate",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20070626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077788",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250326",
"SamplePackage": "N",
"IndicationAndUsage": "Albuterol Sulfate Syrup is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease.",
"Description": "Albuterol Sulfate Syrup contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diolsulfate (2:1) (salt) and the following chemical structure:. (C 13H 21NO 3) 2H 2SO 4 M.W. 576.7. Albuterol sulfate is a white or practically white powder freely soluble in water and slightly soluble in alcohol, in chloroform, and in ether per USP definition. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol Sulfate Syrup for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 mL). Albuterol Sulfate Syrup also contains the inactive ingredients Purified water, hypromellose, citric acid anhydrous, sodium citrate dihydrate, sodium benzoate, sorbitol solution, strawberry flavor, and FD&C Yellow # 6. The pH of the syrup is 3.2 to 4.2."
},
{
"NDCCode": "62135-189-41",
"PackageDescription": "120 mL in 1 CONTAINER (62135-189-41) ",
"NDC11Code": "62135-0189-41",
"ProductNDC": "62135-189",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol Sulfate",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20070626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077788",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220608",
"SamplePackage": "N",
"IndicationAndUsage": "Albuterol Sulfate Syrup is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease.",
"Description": "Albuterol Sulfate Syrup contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diolsulfate (2:1) (salt) and the following chemical structure:. (C 13H 21NO 3) 2H 2SO 4 M.W. 576.7. Albuterol sulfate is a white or practically white powder freely soluble in water and slightly soluble in alcohol, in chloroform, and in ether per USP definition. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol Sulfate Syrup for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 mL). Albuterol Sulfate Syrup also contains the inactive ingredients Purified water, hypromellose, citric acid anhydrous, sodium citrate dihydrate, sodium benzoate, sorbitol solution, strawberry flavor, and FD&C Yellow # 6. The pH of the syrup is 3.2 to 4.2."
},
{
"NDCCode": "62135-189-47",
"PackageDescription": "473 mL in 1 CONTAINER (62135-189-47) ",
"NDC11Code": "62135-0189-47",
"ProductNDC": "62135-189",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol Sulfate",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20070626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077788",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220608",
"SamplePackage": "N",
"IndicationAndUsage": "Albuterol Sulfate Syrup is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease.",
"Description": "Albuterol Sulfate Syrup contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diolsulfate (2:1) (salt) and the following chemical structure:. (C 13H 21NO 3) 2H 2SO 4 M.W. 576.7. Albuterol sulfate is a white or practically white powder freely soluble in water and slightly soluble in alcohol, in chloroform, and in ether per USP definition. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol Sulfate Syrup for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 mL). Albuterol Sulfate Syrup also contains the inactive ingredients Purified water, hypromellose, citric acid anhydrous, sodium citrate dihydrate, sodium benzoate, sorbitol solution, strawberry flavor, and FD&C Yellow # 6. The pH of the syrup is 3.2 to 4.2."
},
{
"NDCCode": "62135-626-23",
"PackageDescription": "210 TABLET, FILM COATED in 1 BOTTLE (62135-626-23) ",
"NDC11Code": "62135-0626-23",
"ProductNDC": "62135-626",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19840911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062505",
"LabelerName": "Chartwell RX LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Tablets and Capsules and Doxycycline for Oral Suspension; for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C 22H 24N 2O 8∙H 2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C 22H 24N 2O 8∙HCl) 2∙C 2H 6O∙H 2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inactive ingredients in the capsule formulations are: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and stearic acid. 50 mg gelatin capsule shell contains: FD&C Blue #1, D&C Yellow #10, titanium dioxide and gelatin. 100 mg gelatin capsule shell contains: FD&C Blue #1, titanium dioxide and gelatin. Black ink contains shellac glaze in SD-45, black iron oxide, propylene glycol, FD&C Blue #2, FD&C Red # 40, FD&C Blue # 1, D&C Yellow # 10, butyl alcohol, denatured alcohol. Each capsule, for oral administration, contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline. Inactive ingredients for the oral suspension formulation are: confectioner's sugar, D&C red #27 aluminum lake, methylparaben, microcrystalline cellulose/ sodium carboxymethylcellulose, natural raspberry flavor; propylparaben, simethicone and sucrose. When reconstituted, each teaspoonful (5 mL) doxycycline suspension, for oral administration, contains doxycycline monohydrate equivalent to 25 mg of doxycycline. Inactive ingredients for the tablet formulation are: anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 50 mg or 100 mg doxycycline. Doxycycline Hyclate Tablets, USP meets USP Dissolution test 3."
},
{
"NDCCode": "62135-774-23",
"PackageDescription": "2 TRAY in 1 BOX (62135-774-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-774-10) ",
"NDC11Code": "62135-0774-23",
"ProductNDC": "62135-774",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19980925",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040026",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250210",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine is useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated 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 postoperative 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 5 mL (teaspoonful) of Promethazine Hydrochloride Oral Solution, USP contains: 6.25 mg of Promethazine Hydrochloride, USP. The inactive ingredients present are alcohol 7%, ascorbic acid, citric acid anhydrous, D&C Yellow No. 10, FD&C Red No. 40, FD&C Blue No. 1, FD&C Yellow No. 6, methylparaben, natural cherry flavor, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate, and sucrose. Citric acid anhydrous or sodium citrate dihydrate is used to adjust the pH to 4.6 to 5.0. Promethazine Hydrochloride, USP is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine Hydrochloride, USP, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine,N,N,á-trimethyl-, monohydrochloride,(±)-, with the following structural formula. 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 freely soluble in water and soluble in alcohol."
},
{
"NDCCode": "62135-803-23",
"PackageDescription": "2 TRAY in 1 BOX (62135-803-23) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (62135-803-20) ",
"NDC11Code": "62135-0803-23",
"ProductNDC": "62135-803",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20200423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212718",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250320",
"SamplePackage": "N",
"IndicationAndUsage": "Herpes Zoster Infections:Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes:Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox:Acyclovir is indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpesviruses. Acyclovir Suspension, USP is formulated for oral administration. Each teaspoonful (5 mL) of Acyclovir Oral Suspension, USP contains 200 mg of acyclovir and the following inactive ingredients: banana flavor, carboxymethylcellulose sodium, glycerin, methylparaben, microcrystalline cellulose, propylparaben, purified water and sorbitol. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3and a molecular weight of 225.20. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of Acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula."
},
{
"NDCCode": "62135-885-23",
"PackageDescription": "2 TRAY in 1 BOX (62135-885-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-885-10) ",
"NDC11Code": "62135-0885-23",
"ProductNDC": "62135-885",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide Oral Solution",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20240515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215154",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250210",
"SamplePackage": "N",
"IndicationAndUsage": "Lacosamide Oral Solution is indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2) .",
"Description": "The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3 methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
},
{
"NDCCode": "62135-962-23",
"PackageDescription": "2 TRAY in 1 BOX (62135-962-23) / 10 CUP in 1 TRAY / 7.5 mL in 1 CUP (62135-962-07) ",
"NDC11Code": "62135-0962-23",
"ProductNDC": "62135-962",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250213",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "20",
"StrengthUnit": "mg/5mL",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250213",
"SamplePackage": "N",
"IndicationAndUsage": "A. Sedative B. Anticonvulsant - For the treatment of generalized and partial seizures.",
"Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid and has the empirical formula C 12H 12N 2O 3. Its molecular weight is 232.24. It has the following structural formula:. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. Phenobarbital Oral Solution, USP is red colored liquid with cherry flavor. Each 5 mL (teaspoon) contains 20 mg Phenobarbital and Alcohol 13.5%. The oral solution also contains FD&C Red #40, glycerin, sucrose, wild cherry flavor, and purified water."
},
{
"NDCCode": "62135-985-23",
"PackageDescription": "1500 CAPSULE in 1 BOTTLE (62135-985-23)",
"NDC11Code": "62135-0985-23",
"ProductNDC": "62135-985",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19840911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062500",
"LabelerName": "Chartwell RX LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-10-19",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0143-9292-01",
"PackageDescription": "1 VIAL in 1 BOX, UNIT-DOSE (0143-9292-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "00143-9292-01",
"ProductNDC": "0143-9292",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thiotepa",
"NonProprietaryName": "Thiotepa",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRACAVITARY; INTRAVENOUS; INTRAVESICAL",
"StartMarketingDate": "20230929",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211755",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "THIOTEPA",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230929",
"SamplePackage": "N",
"Description": "Thiotepa for Injection, USP is an alkylating agent. Thiotepa for Injection, USP is supplied as a non-pyrogenic, sterile lyophilized white powder for intravenous, intracavitary, or intravesical use after reconstitution and dilution. Thiotepa for Injection, USP is available in a single-dose vial containing: 100 mg thiotepa. After reconstitution with 10 ml of water for injection, each ml contains 10 mg thiotepa. Thiotepa is a synthetic product with antitumor activity. The chemical name for thiotepa is Tris(1-aziridinyl)phosphine sulfide. Thiotepa has the following structural formula. Thiotepa has the molecular formula C6H12N3PS, and a molecular weight of 189.23, and it appears as fine, white crystalline flakes, with a melting range of 52°C to 57°C. It is soluble in water and organic solvents. When reconstituted with sterile water for injection, the resulting solution has a pH of approximately 5.5 to 7.5. Thiotepa is unstable in acid medium."
},
{
"NDCCode": "0143-9565-01",
"PackageDescription": "1 VIAL in 1 BOX, UNIT-DOSE (0143-9565-01) > 1.5 mL in 1 VIAL",
"NDC11Code": "00143-9565-01",
"ProductNDC": "0143-9565",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thiotepa",
"NonProprietaryName": "Thiotepa",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRACAVITARY; INTRAVENOUS; INTRAVESICAL",
"StartMarketingDate": "20010601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075547",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "THIOTEPA",
"StrengthNumber": "15",
"StrengthUnit": "mg/1.5mL",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2021-11-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010601",
"SamplePackage": "N",
"IndicationAndUsage": "Thiotepa for Injection, USP has been tried with varying results in the palliation of a wide variety of neoplastic diseases. However, the most consistent results have been seen in the following tumors: 1 1.Adenocarcinoma of the breast., 2 2.Adenocarcinoma of the ovary., 3 3.For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities., 4 4.For the treatment of superficial papillary carcinoma of the urinary bladder.",
"Description": "Thiotepa for Injection, USP is an ethylenimine-type compound. It is supplied as a non-pyrogenic, sterile Iyophilized powder for intravenous, intracavitary or intravesical administration, containing 15 mg of thiotepa. Thiotepa is a synthetic product with antitumor activity. The chemical name for thiotepa is Tris(1-aziridinyl)phosphine sulfide. Thiotepa has the following structural formula. Thiotepa has the molecular formula C6H12N3PS, and a molecular weight of 189.22. When reconstituted with sterile water for injection, the resulting solution has a pH of approximately 5.5 to 7.5. Thiotepa is stable in alkaline medium and unstable in acid medium."
},
{
"NDCCode": "0409-4160-03",
"PackageDescription": "12 POUCH in 1 CASE (0409-4160-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG",
"NDC11Code": "00409-4160-03",
"ProductNDC": "0409-4160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn Ii",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19860403",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019438",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYL-TYROSINE; GLYCINE",
"StrengthNumber": "462; 700; 735; 120; 209; 280; 140; 350; 695; 713; 490; 517; 210; 505; 371; 189; 350",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-05-23"
},
{
"NDCCode": "13630-0227-4",
"PackageDescription": "189 mL in 1 CAN (13630-0227-4) ",
"NDC11Code": "13630-0227-04",
"ProductNDC": "13630-0227",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Florida Salt Scrub",
"ProprietaryNameSuffix": "Broad Spectrum Spf 30",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170818",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Prime Packaging, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "24.75; 61.88; 41.25; 41.25",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-04-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170818",
"SamplePackage": "N"
},
{
"NDCCode": "16714-189-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (16714-189-01) ",
"NDC11Code": "16714-0189-01",
"ProductNDC": "16714-189",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sirolimus",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208691",
"LabelerName": "NORTHSTAR RX LLC",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211018",
"SamplePackage": "N",
"IndicationAndUsage": "Sirolimus tablets are an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: 1 Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 to 4 months after transplantation (1.1)., 2 Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3)., 3 Sirolimus tablets are an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3) .",
"Description": "Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c] [1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is freely soluble in chloroform, acetone, and acetonitrile, insoluble in water. Sirolimus tablets are available as a grey to greenish grey colored film-coated, round shaped beveled edge standard convex tablet containing 0.5 mg sirolimus; as a white to off-white colored film-coated, round shaped beveled edge standard convex tablet containing 1 mg sirolimus; and as a yellow to orange yellow colored film-coated, round shaped beveled edge standard convex tablet containing 2 mg sirolimus. Sirolimus tablets, 2 mg contains FD&C yellow No. 6 as a color additive. The inactive ingredients in sirolimus tablets include: croscarmellose sodium, dl-alpha tocopherol, edetate disodium, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, poloxamer 188, polyethylene glycol, sucrose and titanium dioxide. Additionally, the 0.5 mg dosage strength also contains: iron oxide black, iron oxide yellow and iron oxide red and the 2 mg dosage strength also contains: D&C yellow #10, FD&C yellow #6 and FD&C blue #2."
},
{
"NDCCode": "42254-189-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (42254-189-60)",
"NDC11Code": "42254-0189-60",
"ProductNDC": "42254-189",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zaleplon",
"NonProprietaryName": "Zaleplon",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090505",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078989",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "ZALEPLON",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Zaleplon is indicated for the short-term treatment of insomnia. Zaleplon has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY). It has not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.",
"Description": "Zaleplon is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class. The chemical name of zaleplon is N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide. Its empirical formula is C17H15N5O, and its molecular weight is 305.34. The structural formula is shown below. Zaleplon is a white to off-white powder that is practically insoluble in water and sparingly soluble in alcohol or propylene glycol. Its partition coefficient in octanol/water is constant (log PC = 1.23) over the pH range of 1 to 7. Zaleplon capsules contain zaleplon as the active ingredient. Inactive ingredients consist of microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, sodium lauryl sulfate, magnesium stearate, lactose, gelatin, titanium dioxide, FD&C blue #1, FD&C red #40 and black iron oxide. Zaleplon 5mg capsules also contain FD&C yellow #5."
},
{
"NDCCode": "43063-189-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (43063-189-30) ",
"NDC11Code": "43063-0189-30",
"ProductNDC": "43063-189",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079153",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-08-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20090930",
"SamplePackage": "N"
},
{
"NDCCode": "43063-189-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (43063-189-60) ",
"NDC11Code": "43063-0189-60",
"ProductNDC": "43063-189",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079153",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-08-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150427",
"SamplePackage": "N"
},
{
"NDCCode": "43598-171-11",
"PackageDescription": "1 VIAL in 1 CARTON (43598-171-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "43598-0171-11",
"ProductNDC": "43598-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thiotepa",
"NonProprietaryName": "Thiotepa",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRACAVITARY; INTRAVENOUS; INTRAVESICAL",
"StartMarketingDate": "20221101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214222",
"LabelerName": "Dr.Reddy's Laboratories Inc.,",
"SubstanceName": "THIOTEPA",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221101",
"SamplePackage": "N",
"Description": "Thiotepa is an alkylating agent. Thiotepa for injection, USP is supplied as a non-pyrogenic, sterile lyophilized white powder for intravenous, intracavitary, or intravesical use after reconstitution and dilution. Thiotepa for injection, USP is available in a single-dose vial containing:. 15 mg thiotepa. After reconstitution with 1.5 ml of water for injection, each ml contains 10 mg thiotepa. 100 mg thiotepa. After reconstitution with 10 ml of water for injection, each ml contains 10 mg thiotepa. Thiotepa is a synthetic product with antitumor activity. The chemical name for thiotepa is Tris(1-aziridinyl)phosphine sulfide. Thiotepa has the following structural formula. Thiotepa, USP has the molecular formula C6H12N3PS, and a molecular weight of 189.23, and it appears as fine, white crystalline flakes, with a melting range of 52°C to 57°C. It is soluble in water and organic solvents. When reconstituted with sterile water for injection, the resulting solution has a pH of approximately 5.5 to 7.5. Thiotepa is unstable in acid medium."
},
{
"NDCCode": "49349-189-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (49349-189-02)",
"NDC11Code": "49349-0189-02",
"ProductNDC": "49349-189",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluphenazine Hydrochloride",
"NonProprietaryName": "Fluphenazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089804",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "FLUPHENAZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-03-23",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50242-122-86",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50242-122-86) / 189 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "50242-0122-86",
"ProductNDC": "50242-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esbriet",
"NonProprietaryName": "Pirfenidone",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170111",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208780",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "PIRFENIDONE",
"StrengthNumber": "267",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Pyridone [EPC], Pyridones [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171023",
"SamplePackage": "Y",
"IndicationAndUsage": "ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).",
"Description": "ESBRIET belongs to the chemical class of pyridone. ESBRIET is available as a white to off-white hard gelatin capsule containing 267 mg of pirfenidone for oral administration, or, as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white to pale yellow, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 109°C. ESBRIET capsule contains pirfenidone and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, povidone, and magnesium stearate. In addition, the capsule shell contains gelatin and titanium dioxide. The capsule brown printing ink includes shellac, iron oxide black, iron oxide red, iron oxide yellow, propylene glycol, ammonium hydroxide. ESBRIET tablets contain pirfenidone and the following inactive ingredients: Microcrystalline cellulose, colloidal anhydrous silica, povidone, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, macrogol (polyethylene glycol), talc, and iron oxide."
},
{
"NDCCode": "53675-189-02",
"PackageDescription": "59 mL in 1 TUBE (53675-189-02) ",
"NDC11Code": "53675-0189-02",
"ProductNDC": "53675-189",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Broad Spectrum Spf 50 Mineral Sunscreen",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200615",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Aruba Aloe Balm NV",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "100; 80",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200615",
"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 aging caused by the sun."
},
{
"NDCCode": "53675-189-06",
"PackageDescription": "177 mL in 1 TUBE (53675-189-06) ",
"NDC11Code": "53675-0189-06",
"ProductNDC": "53675-189",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Broad Spectrum Spf 50 Mineral Sunscreen",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200615",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Aruba Aloe Balm NV",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "100; 80",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200615",
"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 aging caused by the sun."
},
{
"NDCCode": "65219-029-20",
"PackageDescription": "1 VIAL in 1 CARTON (65219-029-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "65219-0029-20",
"ProductNDC": "65219-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thiotepa",
"NonProprietaryName": "Thiotepa",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRACAVITARY; INTRAVENOUS; INTRAVESICAL",
"StartMarketingDate": "20220411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214222",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "THIOTEPA",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220411",
"SamplePackage": "N",
"IndicationAndUsage": "Thiotepa for injection is an alkylating drug indicated: For treatment of adenocarcinoma of the breast or ovary. (1.2) For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. (1.3) For treatment of superficial papillary carcinoma of the urinary bladder. (1.4).",
"Description": "Thiotepa is an alkylating agent. Thiotepa for injection, USP is supplied as a non-pyrogenic, sterile lyophilized white powder for intravenous, intracavitary, or intravesical use after reconstitution and dilution. Thiotepa for Injection, USP is available in a single-dose vial containing. 100 mg thiotepa. After reconstitution with 10 ml of water for injection, each ml contains 10 mg thiotepa. Thiotepa is a synthetic product with antitumor activity. The chemical name for thiotepa is Tris(1-aziridinyl)phosphine sulfide. Thiotepa has the following structural formula. Thiotepa, USP has the molecular formula C6H12N3PS, and a molecular weight of 189.23, and it appears as fine, white crystalline flakes, with a melting range of 52°C to 57°C. It is soluble in water and organic solvents. When reconstituted with sterile water for injection, the resulting solution has a pH of approximately 5.5 to 7.5. Thiotepa is unstable in acid medium."
},
{
"NDCCode": "67751-189-01",
"PackageDescription": "1 TUBE in 1 BLISTER PACK (67751-189-01) > 24.1 g in 1 TUBE",
"NDC11Code": "67751-0189-01",
"ProductNDC": "67751-189",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hello",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20161216",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Navajo Manufacturing Company Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20161216",
"SamplePackage": "N"
},
{
"NDCCode": "68788-8589-1",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8589-1) ",
"NDC11Code": "68788-8589-01",
"ProductNDC": "68788-8589",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211020",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240220",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).",
"Description": "Bupropion hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water, in 0.1 N Hydrochloric acid and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg which are pink round biconvex coated tablets imprinted with '188' in black ink on one side and plain on other side and 300 mg which are pink, round biconvex coated tablets imprinted with '189' in black ink on one side and plain on the other side. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ethylcellulose, glyceryl behenate, hydrochloric acid, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methylene chloride, opacode® (it contains shellac glaze, ferrosoferric oxide, propylene glycol and ammonium hydroxide), opadry® pink (it contains hypromellose, titanium dioxide, triacetin, talc, iron oxide red), polyethylene glycol, povidone, silicon dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The drug Product meets the requirements of USP Dissolution Test 14."
},
{
"NDCCode": "68788-8589-3",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8589-3) ",
"NDC11Code": "68788-8589-03",
"ProductNDC": "68788-8589",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211020",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240220",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).",
"Description": "Bupropion hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water, in 0.1 N Hydrochloric acid and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg which are pink round biconvex coated tablets imprinted with '188' in black ink on one side and plain on other side and 300 mg which are pink, round biconvex coated tablets imprinted with '189' in black ink on one side and plain on the other side. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ethylcellulose, glyceryl behenate, hydrochloric acid, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methylene chloride, opacode® (it contains shellac glaze, ferrosoferric oxide, propylene glycol and ammonium hydroxide), opadry® pink (it contains hypromellose, titanium dioxide, triacetin, talc, iron oxide red), polyethylene glycol, povidone, silicon dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The drug Product meets the requirements of USP Dissolution Test 14."
},
{
"NDCCode": "68788-8589-6",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8589-6) ",
"NDC11Code": "68788-8589-06",
"ProductNDC": "68788-8589",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211020",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240220",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).",
"Description": "Bupropion hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water, in 0.1 N Hydrochloric acid and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg which are pink round biconvex coated tablets imprinted with '188' in black ink on one side and plain on other side and 300 mg which are pink, round biconvex coated tablets imprinted with '189' in black ink on one side and plain on the other side. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ethylcellulose, glyceryl behenate, hydrochloric acid, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methylene chloride, opacode® (it contains shellac glaze, ferrosoferric oxide, propylene glycol and ammonium hydroxide), opadry® pink (it contains hypromellose, titanium dioxide, triacetin, talc, iron oxide red), polyethylene glycol, povidone, silicon dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The drug Product meets the requirements of USP Dissolution Test 14."
}
]
}
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<Description>Albuterol Sulfate Syrup contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diolsulfate (2:1) (salt) and the following chemical structure:. (C 13H 21NO 3) 2H 2SO 4 M.W. 576.7. Albuterol sulfate is a white or practically white powder freely soluble in water and slightly soluble in alcohol, in chloroform, and in ether per USP definition. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol Sulfate Syrup for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 mL). Albuterol Sulfate Syrup also contains the inactive ingredients Purified water, hypromellose, citric acid anhydrous, sodium citrate dihydrate, sodium benzoate, sorbitol solution, strawberry flavor, and FD&C Yellow # 6. The pH of the syrup is 3.2 to 4.2.</Description>
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<IndicationAndUsage>Albuterol Sulfate Syrup is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
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<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Albuterol Sulfate Syrup is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
<Description>Albuterol Sulfate Syrup contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diolsulfate (2:1) (salt) and the following chemical structure:. (C 13H 21NO 3) 2H 2SO 4 M.W. 576.7. Albuterol sulfate is a white or practically white powder freely soluble in water and slightly soluble in alcohol, in chloroform, and in ether per USP definition. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol Sulfate Syrup for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 mL). Albuterol Sulfate Syrup also contains the inactive ingredients Purified water, hypromellose, citric acid anhydrous, sodium citrate dihydrate, sodium benzoate, sorbitol solution, strawberry flavor, and FD&C Yellow # 6. The pH of the syrup is 3.2 to 4.2.</Description>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Albuterol Sulfate Syrup is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
<Description>Albuterol Sulfate Syrup contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diolsulfate (2:1) (salt) and the following chemical structure:. (C 13H 21NO 3) 2H 2SO 4 M.W. 576.7. Albuterol sulfate is a white or practically white powder freely soluble in water and slightly soluble in alcohol, in chloroform, and in ether per USP definition. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol Sulfate Syrup for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 mL). Albuterol Sulfate Syrup also contains the inactive ingredients Purified water, hypromellose, citric acid anhydrous, sodium citrate dihydrate, sodium benzoate, sorbitol solution, strawberry flavor, and FD&C Yellow # 6. The pH of the syrup is 3.2 to 4.2.</Description>
</NDC>
<NDC>
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<ProductNDC>62135-626</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
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<StartMarketingDate>19840911</StartMarketingDate>
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<LabelerName>Chartwell RX LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Tablets and Capsules and Doxycycline for Oral Suspension; for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C 22H 24N 2O 8∙H 2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C 22H 24N 2O 8∙HCl) 2∙C 2H 6O∙H 2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inactive ingredients in the capsule formulations are: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and stearic acid. 50 mg gelatin capsule shell contains: FD&C Blue #1, D&C Yellow #10, titanium dioxide and gelatin. 100 mg gelatin capsule shell contains: FD&C Blue #1, titanium dioxide and gelatin. Black ink contains shellac glaze in SD-45, black iron oxide, propylene glycol, FD&C Blue #2, FD&C Red # 40, FD&C Blue # 1, D&C Yellow # 10, butyl alcohol, denatured alcohol. Each capsule, for oral administration, contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline. Inactive ingredients for the oral suspension formulation are: confectioner's sugar, D&C red #27 aluminum lake, methylparaben, microcrystalline cellulose/ sodium carboxymethylcellulose, natural raspberry flavor; propylparaben, simethicone and sucrose. When reconstituted, each teaspoonful (5 mL) doxycycline suspension, for oral administration, contains doxycycline monohydrate equivalent to 25 mg of doxycycline. Inactive ingredients for the tablet formulation are: anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 50 mg or 100 mg doxycycline. Doxycycline Hyclate Tablets, USP meets USP Dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>62135-774-23</NDCCode>
<PackageDescription>2 TRAY in 1 BOX (62135-774-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-774-10) </PackageDescription>
<NDC11Code>62135-0774-23</NDC11Code>
<ProductNDC>62135-774</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980925</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040026</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine is useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated 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 postoperative 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 5 mL (teaspoonful) of Promethazine Hydrochloride Oral Solution, USP contains: 6.25 mg of Promethazine Hydrochloride, USP. The inactive ingredients present are alcohol 7%, ascorbic acid, citric acid anhydrous, D&C Yellow No. 10, FD&C Red No. 40, FD&C Blue No. 1, FD&C Yellow No. 6, methylparaben, natural cherry flavor, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate, and sucrose. Citric acid anhydrous or sodium citrate dihydrate is used to adjust the pH to 4.6 to 5.0. Promethazine Hydrochloride, USP is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine Hydrochloride, USP, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine,N,N,á-trimethyl-, monohydrochloride,(±)-, with the following structural formula. 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 freely soluble in water and soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>62135-803-23</NDCCode>
<PackageDescription>2 TRAY in 1 BOX (62135-803-23) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (62135-803-20) </PackageDescription>
<NDC11Code>62135-0803-23</NDC11Code>
<ProductNDC>62135-803</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212718</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Herpes Zoster Infections:Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes:Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox:Acyclovir is indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpesviruses. Acyclovir Suspension, USP is formulated for oral administration. Each teaspoonful (5 mL) of Acyclovir Oral Suspension, USP contains 200 mg of acyclovir and the following inactive ingredients: banana flavor, carboxymethylcellulose sodium, glycerin, methylparaben, microcrystalline cellulose, propylparaben, purified water and sorbitol. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3and a molecular weight of 225.20. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of Acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>62135-885-23</NDCCode>
<PackageDescription>2 TRAY in 1 BOX (62135-885-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-885-10) </PackageDescription>
<NDC11Code>62135-0885-23</NDC11Code>
<ProductNDC>62135-885</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide Oral Solution</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215154</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lacosamide Oral Solution is indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2) .</IndicationAndUsage>
<Description>The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3 methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
</NDC>
<NDC>
<NDCCode>62135-962-23</NDCCode>
<PackageDescription>2 TRAY in 1 BOX (62135-962-23) / 10 CUP in 1 TRAY / 7.5 mL in 1 CUP (62135-962-07) </PackageDescription>
<NDC11Code>62135-0962-23</NDC11Code>
<ProductNDC>62135-962</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250213</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>A. Sedative B. Anticonvulsant - For the treatment of generalized and partial seizures.</IndicationAndUsage>
<Description>The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid and has the empirical formula C 12H 12N 2O 3. Its molecular weight is 232.24. It has the following structural formula:. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. Phenobarbital Oral Solution, USP is red colored liquid with cherry flavor. Each 5 mL (teaspoon) contains 20 mg Phenobarbital and Alcohol 13.5%. The oral solution also contains FD&C Red #40, glycerin, sucrose, wild cherry flavor, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>62135-985-23</NDCCode>
<PackageDescription>1500 CAPSULE in 1 BOTTLE (62135-985-23)</PackageDescription>
<NDC11Code>62135-0985-23</NDC11Code>
<ProductNDC>62135-985</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062500</ApplicationNumber>
<LabelerName>Chartwell RX LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-10-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0143-9292-01</NDCCode>
<PackageDescription>1 VIAL in 1 BOX, UNIT-DOSE (0143-9292-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>00143-9292-01</NDC11Code>
<ProductNDC>0143-9292</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thiotepa</ProprietaryName>
<NonProprietaryName>Thiotepa</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRACAVITARY; INTRAVENOUS; INTRAVESICAL</RouteName>
<StartMarketingDate>20230929</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211755</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>THIOTEPA</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Thiotepa for Injection, USP is an alkylating agent. Thiotepa for Injection, USP is supplied as a non-pyrogenic, sterile lyophilized white powder for intravenous, intracavitary, or intravesical use after reconstitution and dilution. Thiotepa for Injection, USP is available in a single-dose vial containing: 100 mg thiotepa. After reconstitution with 10 ml of water for injection, each ml contains 10 mg thiotepa. Thiotepa is a synthetic product with antitumor activity. The chemical name for thiotepa is Tris(1-aziridinyl)phosphine sulfide. Thiotepa has the following structural formula. Thiotepa has the molecular formula C6H12N3PS, and a molecular weight of 189.23, and it appears as fine, white crystalline flakes, with a melting range of 52°C to 57°C. It is soluble in water and organic solvents. When reconstituted with sterile water for injection, the resulting solution has a pH of approximately 5.5 to 7.5. Thiotepa is unstable in acid medium.</Description>
</NDC>
<NDC>
<NDCCode>0143-9565-01</NDCCode>
<PackageDescription>1 VIAL in 1 BOX, UNIT-DOSE (0143-9565-01) > 1.5 mL in 1 VIAL</PackageDescription>
<NDC11Code>00143-9565-01</NDC11Code>
<ProductNDC>0143-9565</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thiotepa</ProprietaryName>
<NonProprietaryName>Thiotepa</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRACAVITARY; INTRAVENOUS; INTRAVESICAL</RouteName>
<StartMarketingDate>20010601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075547</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>THIOTEPA</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1.5mL</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-11-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Thiotepa for Injection, USP has been tried with varying results in the palliation of a wide variety of neoplastic diseases. However, the most consistent results have been seen in the following tumors: 1 1.Adenocarcinoma of the breast., 2 2.Adenocarcinoma of the ovary., 3 3.For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities., 4 4.For the treatment of superficial papillary carcinoma of the urinary bladder.</IndicationAndUsage>
<Description>Thiotepa for Injection, USP is an ethylenimine-type compound. It is supplied as a non-pyrogenic, sterile Iyophilized powder for intravenous, intracavitary or intravesical administration, containing 15 mg of thiotepa. Thiotepa is a synthetic product with antitumor activity. The chemical name for thiotepa is Tris(1-aziridinyl)phosphine sulfide. Thiotepa has the following structural formula. Thiotepa has the molecular formula C6H12N3PS, and a molecular weight of 189.22. When reconstituted with sterile water for injection, the resulting solution has a pH of approximately 5.5 to 7.5. Thiotepa is stable in alkaline medium and unstable in acid medium.</Description>
</NDC>
<NDC>
<NDCCode>0409-4160-03</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-4160-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4160-03</NDC11Code>
<ProductNDC>0409-4160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn Ii</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19860403</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019438</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYL-TYROSINE; GLYCINE</SubstanceName>
<StrengthNumber>462; 700; 735; 120; 209; 280; 140; 350; 695; 713; 490; 517; 210; 505; 371; 189; 350</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>13630-0227-4</NDCCode>
<PackageDescription>189 mL in 1 CAN (13630-0227-4) </PackageDescription>
<NDC11Code>13630-0227-04</NDC11Code>
<ProductNDC>13630-0227</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Florida Salt Scrub</ProprietaryName>
<ProprietaryNameSuffix>Broad Spectrum Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170818</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Prime Packaging, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>24.75; 61.88; 41.25; 41.25</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-04-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16714-189-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (16714-189-01) </PackageDescription>
<NDC11Code>16714-0189-01</NDC11Code>
<ProductNDC>16714-189</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sirolimus</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208691</ApplicationNumber>
<LabelerName>NORTHSTAR RX LLC</LabelerName>
<SubstanceName>SIROLIMUS</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sirolimus tablets are an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: 1 Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 to 4 months after transplantation (1.1)., 2 Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3)., 3 Sirolimus tablets are an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3) .</IndicationAndUsage>
<Description>Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c] [1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is freely soluble in chloroform, acetone, and acetonitrile, insoluble in water. Sirolimus tablets are available as a grey to greenish grey colored film-coated, round shaped beveled edge standard convex tablet containing 0.5 mg sirolimus; as a white to off-white colored film-coated, round shaped beveled edge standard convex tablet containing 1 mg sirolimus; and as a yellow to orange yellow colored film-coated, round shaped beveled edge standard convex tablet containing 2 mg sirolimus. Sirolimus tablets, 2 mg contains FD&C yellow No. 6 as a color additive. The inactive ingredients in sirolimus tablets include: croscarmellose sodium, dl-alpha tocopherol, edetate disodium, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, poloxamer 188, polyethylene glycol, sucrose and titanium dioxide. Additionally, the 0.5 mg dosage strength also contains: iron oxide black, iron oxide yellow and iron oxide red and the 2 mg dosage strength also contains: D&C yellow #10, FD&C yellow #6 and FD&C blue #2.</Description>
</NDC>
<NDC>
<NDCCode>42254-189-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (42254-189-60)</PackageDescription>
<NDC11Code>42254-0189-60</NDC11Code>
<ProductNDC>42254-189</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zaleplon</ProprietaryName>
<NonProprietaryName>Zaleplon</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090505</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078989</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>ZALEPLON</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Zaleplon is indicated for the short-term treatment of insomnia. Zaleplon has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY). It has not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.</IndicationAndUsage>
<Description>Zaleplon is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class. The chemical name of zaleplon is N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide. Its empirical formula is C17H15N5O, and its molecular weight is 305.34. The structural formula is shown below. Zaleplon is a white to off-white powder that is practically insoluble in water and sparingly soluble in alcohol or propylene glycol. Its partition coefficient in octanol/water is constant (log PC = 1.23) over the pH range of 1 to 7. Zaleplon capsules contain zaleplon as the active ingredient. Inactive ingredients consist of microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, sodium lauryl sulfate, magnesium stearate, lactose, gelatin, titanium dioxide, FD&C blue #1, FD&C red #40 and black iron oxide. Zaleplon 5mg capsules also contain FD&C yellow #5.</Description>
</NDC>
<NDC>
<NDCCode>43063-189-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (43063-189-30) </PackageDescription>
<NDC11Code>43063-0189-30</NDC11Code>
<ProductNDC>43063-189</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079153</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-08-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43063-189-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (43063-189-60) </PackageDescription>
<NDC11Code>43063-0189-60</NDC11Code>
<ProductNDC>43063-189</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079153</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-08-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43598-171-11</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (43598-171-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>43598-0171-11</NDC11Code>
<ProductNDC>43598-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thiotepa</ProprietaryName>
<NonProprietaryName>Thiotepa</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRACAVITARY; INTRAVENOUS; INTRAVESICAL</RouteName>
<StartMarketingDate>20221101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214222</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Inc.,</LabelerName>
<SubstanceName>THIOTEPA</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Thiotepa is an alkylating agent. Thiotepa for injection, USP is supplied as a non-pyrogenic, sterile lyophilized white powder for intravenous, intracavitary, or intravesical use after reconstitution and dilution. Thiotepa for injection, USP is available in a single-dose vial containing:. 15 mg thiotepa. After reconstitution with 1.5 ml of water for injection, each ml contains 10 mg thiotepa. 100 mg thiotepa. After reconstitution with 10 ml of water for injection, each ml contains 10 mg thiotepa. Thiotepa is a synthetic product with antitumor activity. The chemical name for thiotepa is Tris(1-aziridinyl)phosphine sulfide. Thiotepa has the following structural formula. Thiotepa, USP has the molecular formula C6H12N3PS, and a molecular weight of 189.23, and it appears as fine, white crystalline flakes, with a melting range of 52°C to 57°C. It is soluble in water and organic solvents. When reconstituted with sterile water for injection, the resulting solution has a pH of approximately 5.5 to 7.5. Thiotepa is unstable in acid medium.</Description>
</NDC>
<NDC>
<NDCCode>49349-189-02</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (49349-189-02)</PackageDescription>
<NDC11Code>49349-0189-02</NDC11Code>
<ProductNDC>49349-189</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluphenazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fluphenazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089804</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>FLUPHENAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-23</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50242-122-86</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50242-122-86) / 189 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50242-0122-86</NDC11Code>
<ProductNDC>50242-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esbriet</ProprietaryName>
<NonProprietaryName>Pirfenidone</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170111</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208780</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>PIRFENIDONE</SubstanceName>
<StrengthNumber>267</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171023</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
<Description>ESBRIET belongs to the chemical class of pyridone. ESBRIET is available as a white to off-white hard gelatin capsule containing 267 mg of pirfenidone for oral administration, or, as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white to pale yellow, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 109°C. ESBRIET capsule contains pirfenidone and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, povidone, and magnesium stearate. In addition, the capsule shell contains gelatin and titanium dioxide. The capsule brown printing ink includes shellac, iron oxide black, iron oxide red, iron oxide yellow, propylene glycol, ammonium hydroxide. ESBRIET tablets contain pirfenidone and the following inactive ingredients: Microcrystalline cellulose, colloidal anhydrous silica, povidone, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, macrogol (polyethylene glycol), talc, and iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>53675-189-02</NDCCode>
<PackageDescription>59 mL in 1 TUBE (53675-189-02) </PackageDescription>
<NDC11Code>53675-0189-02</NDC11Code>
<ProductNDC>53675-189</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Broad Spectrum Spf 50 Mineral Sunscreen</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Aruba Aloe Balm NV</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>100; 80</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200615</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 aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53675-189-06</NDCCode>
<PackageDescription>177 mL in 1 TUBE (53675-189-06) </PackageDescription>
<NDC11Code>53675-0189-06</NDC11Code>
<ProductNDC>53675-189</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Broad Spectrum Spf 50 Mineral Sunscreen</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Aruba Aloe Balm NV</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>100; 80</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200615</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 aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65219-029-20</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (65219-029-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>65219-0029-20</NDC11Code>
<ProductNDC>65219-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thiotepa</ProprietaryName>
<NonProprietaryName>Thiotepa</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRACAVITARY; INTRAVENOUS; INTRAVESICAL</RouteName>
<StartMarketingDate>20220411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214222</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>THIOTEPA</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Thiotepa for injection is an alkylating drug indicated: For treatment of adenocarcinoma of the breast or ovary. (1.2) For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. (1.3) For treatment of superficial papillary carcinoma of the urinary bladder. (1.4).</IndicationAndUsage>
<Description>Thiotepa is an alkylating agent. Thiotepa for injection, USP is supplied as a non-pyrogenic, sterile lyophilized white powder for intravenous, intracavitary, or intravesical use after reconstitution and dilution. Thiotepa for Injection, USP is available in a single-dose vial containing. 100 mg thiotepa. After reconstitution with 10 ml of water for injection, each ml contains 10 mg thiotepa. Thiotepa is a synthetic product with antitumor activity. The chemical name for thiotepa is Tris(1-aziridinyl)phosphine sulfide. Thiotepa has the following structural formula. Thiotepa, USP has the molecular formula C6H12N3PS, and a molecular weight of 189.23, and it appears as fine, white crystalline flakes, with a melting range of 52°C to 57°C. It is soluble in water and organic solvents. When reconstituted with sterile water for injection, the resulting solution has a pH of approximately 5.5 to 7.5. Thiotepa is unstable in acid medium.</Description>
</NDC>
<NDC>
<NDCCode>67751-189-01</NDCCode>
<PackageDescription>1 TUBE in 1 BLISTER PACK (67751-189-01) > 24.1 g in 1 TUBE</PackageDescription>
<NDC11Code>67751-0189-01</NDC11Code>
<ProductNDC>67751-189</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hello</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20161216</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Navajo Manufacturing Company Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-8589-1</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8589-1) </PackageDescription>
<NDC11Code>68788-8589-01</NDC11Code>
<ProductNDC>68788-8589</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211020</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Bupropion hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water, in 0.1 N Hydrochloric acid and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg which are pink round biconvex coated tablets imprinted with '188' in black ink on one side and plain on other side and 300 mg which are pink, round biconvex coated tablets imprinted with '189' in black ink on one side and plain on the other side. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ethylcellulose, glyceryl behenate, hydrochloric acid, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methylene chloride, opacode® (it contains shellac glaze, ferrosoferric oxide, propylene glycol and ammonium hydroxide), opadry® pink (it contains hypromellose, titanium dioxide, triacetin, talc, iron oxide red), polyethylene glycol, povidone, silicon dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The drug Product meets the requirements of USP Dissolution Test 14.</Description>
</NDC>
<NDC>
<NDCCode>68788-8589-3</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8589-3) </PackageDescription>
<NDC11Code>68788-8589-03</NDC11Code>
<ProductNDC>68788-8589</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211020</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Bupropion hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water, in 0.1 N Hydrochloric acid and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg which are pink round biconvex coated tablets imprinted with '188' in black ink on one side and plain on other side and 300 mg which are pink, round biconvex coated tablets imprinted with '189' in black ink on one side and plain on the other side. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ethylcellulose, glyceryl behenate, hydrochloric acid, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methylene chloride, opacode® (it contains shellac glaze, ferrosoferric oxide, propylene glycol and ammonium hydroxide), opadry® pink (it contains hypromellose, titanium dioxide, triacetin, talc, iron oxide red), polyethylene glycol, povidone, silicon dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The drug Product meets the requirements of USP Dissolution Test 14.</Description>
</NDC>
<NDC>
<NDCCode>68788-8589-6</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8589-6) </PackageDescription>
<NDC11Code>68788-8589-06</NDC11Code>
<ProductNDC>68788-8589</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211020</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-23</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Bupropion hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water, in 0.1 N Hydrochloric acid and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg which are pink round biconvex coated tablets imprinted with '188' in black ink on one side and plain on other side and 300 mg which are pink, round biconvex coated tablets imprinted with '189' in black ink on one side and plain on the other side. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ethylcellulose, glyceryl behenate, hydrochloric acid, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methylene chloride, opacode® (it contains shellac glaze, ferrosoferric oxide, propylene glycol and ammonium hydroxide), opadry® pink (it contains hypromellose, titanium dioxide, triacetin, talc, iron oxide red), polyethylene glycol, povidone, silicon dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The drug Product meets the requirements of USP Dissolution Test 14.</Description>
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