{
"NDC": [
{
"NDCCode": "0115-1685-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1685-01) ",
"NDC11Code": "00115-1685-01",
"ProductNDC": "0115-1685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079108",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151221",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. The effectiveness of dexmethylphenidate hydrochloride extended-release in the treatment of ADHD in patients aged 6 years and older was established in 2 placebo-controlled studies in patients meeting DSM-IV criteria for ADHD [see Clinical Studies (14)]. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go”; excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Types requires both inattentive and hyperactive-impulsive criteria to be met. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV characteristics. Need for Comprehensive Treatment Program. Dexmethylphenidate hydrochloride extended-release capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the child’s symptoms. Long-Term Use. The effectiveness of dexmethylphenidate hydrochloride extended-release for long-term use, i.e., for more than 7 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use dexmethylphenidate hydrochloride extended-release for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.3)].",
"Description": "Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a second delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release is available as 5 mg, 10 mg, 15 mg, 20 mg and 30 mg extended-release capsules. Dexmethylphenidate hydrochloride extended-release 5 mg, 10 mg, 15 mg, 20 mg and 30 mg extended-release capsules provide in a single dose the same amount of dexmethylphenidate as dosages of 2.5 mg, 5 mg, 7.5 mg, 10 mg or 15 mg of dexmethylphenidate hydrochloride given twice a day as tablets. Dexmethylphenidate hydrochloride, the d-threo enantiomer of racemic methylphenidate hydrochloride, is a central nervous system (CNS) stimulant. Dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its molecular weight is 269.77 and its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Inactive ingredients: acetyltributyl citrate, ethylcellulose, gelatin, hypromellose, hypromellose acetate succinate, sugar spheres (which contain sucrose and starch [maize]), talc, and titanium dioxide. The 5 mg capsule also contains FD&C Red #3 and FD&C Blue #1. The 10 mg capsule also contains acid red 27 and FD&C Blue #1. The 15 mg capsule also contains D&C Red #28 and FD&C Blue #1. The 20 mg capsule also contains D&C Red #28, D&C Red #33, and FD&C Blue #1. Black printing ink SW-9008/SW-9009 contains black iron oxide, potassium hydroxide, propylene glycol, and shellac."
},
{
"NDCCode": "37662-1685-1",
"PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-1685-1) ",
"NDC11Code": "37662-1685-01",
"ProductNDC": "37662-1685",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hyoscyamus Niger",
"NonProprietaryName": "Hyoscyamus Niger",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221010",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "HYOSCYAMUS NIGER",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221010",
"SamplePackage": "N"
},
{
"NDCCode": "43742-1685-1",
"PackageDescription": "960 mL in 1 BOTTLE, PLASTIC (43742-1685-1) ",
"NDC11Code": "43742-1685-01",
"ProductNDC": "43742-1685",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Anaplasma Phagocytophilum",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20200925",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Deseret Biologicals, Inc",
"SubstanceName": "ANAPLASMA PHAGOCYTOPHILUM",
"StrengthNumber": "120",
"StrengthUnit": "[hp_X]/mL",
"Status": "Unfinished",
"LastUpdate": "2023-12-12",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "25-SEP-20"
},
{
"NDCCode": "50090-1685-1",
"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (50090-1685-1) ",
"NDC11Code": "50090-1685-01",
"ProductNDC": "50090-1685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076794",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150209",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)○ Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)○ Urinary Tract Infections (UTI)○ Acute Uncomplicated Cystitis○ Complicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).",
"Description": "Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.82. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin, USP is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.34. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white to off-white. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate), 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate), and 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). The inactive ingredients are corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch (maize), purified water, silicon dioxide, talc, and titanium dioxide."
},
{
"NDCCode": "51662-1685-1",
"PackageDescription": "4 mL in 1 VIAL (51662-1685-1) ",
"NDC11Code": "51662-1685-01",
"ProductNDC": "51662-1685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211015",
"LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180618",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil Hydrochloride Injection, USP is indicated for the following. Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration. Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White (W-P-W) and Lown-Ganong-Levine (L-G-L) syndromes). In controlled studies in the United States, about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride. Uncontrolled studies reported in the world literature describe a conversion rate of about 80%. About 70% of patients with atrial flutter and/or fibrillation with a faster ventricular rate respond with a decrease in ventricular rate of at least 20%. Conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after verapamil hydrochloride and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. Slowing of the ventricular rate in patients with atrial fibrillation/flutter lasts 30 to 60 minutes after a single injection. Because a small fraction (<1%) of patients treated with verapamil hydrochloride respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation, and an accessory bypass tract, marked hypotension, or extreme bradycardia/asystole - see CONTRAINDICATIONS and WARNINGS), the initial use of verapamil hydrochloride injection should, if possible, be in a treatment setting with monitoring and resuscitation facilities , including D.C.-cardioversion capability (see ADVERSE REACTIONS, Suggested Treatment of Acute Cardiovascular Adverse Reactions). As familiarity with the patient's response is gained, use in an office setting may be acceptable. Cardioversion has been used safely and effectively after verapamil hydrochloride injection.",
"Description": "Verapamil hydrochloride is a calcium antagonist or slow-channel inhibitor. Verapamil Hydrochloride Injection, USP is a sterile, nonpyrogenic solution containing verapamil hydrochloride 2.5 mg/mL and sodium chloride 8.5 mg/mL in water for injection. The solution contains no bacteriostat or antimicrobial agent and is intended for single-dose intravenous administration. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment; pH is 4.0 to 6.5. The chemical name of Verapamil Hydrochloride, USP is benzeneacetonitrile, α-[3-[{2-(3,4-dimethoxyphenyl)ethyl} methylamino] propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil hydrochloride is a white or practically white crystalline powder. It is practically odorless and has a bitter taste. It is soluble in water; freely soluble in chloroform; sparingly soluble in alcohol; practically insoluble in ether. It has the following structural formula. Molecular weight: 491.07. Molecular formula: C27H38N2O4 HCl. Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs."
},
{
"NDCCode": "62991-1685-1",
"PackageDescription": ".025 kg in 1 JAR (62991-1685-1) ",
"NDC11Code": "62991-1685-01",
"ProductNDC": "62991-1685",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120409",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "LETCO MEDICAL, LLC",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "09-APR-12",
"EndMarketingDatePackage": "31-JAN-26"
},
{
"NDCCode": "64942-1685-1",
"PackageDescription": "107 g in 1 CAN (64942-1685-1) ",
"NDC11Code": "64942-1685-01",
"ProductNDC": "64942-1685",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dove",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Conopco, Inc. d/b/a Unilever",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "20.2",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2024-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200201",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm wetness.",
"Description": "Dove Advanced Care Dry Spray Rose Petals 48h Antiperspirant Deodorant."
},
{
"NDCCode": "70121-1685-1",
"PackageDescription": "1 CARTRIDGE in 1 CARTON (70121-1685-1) / 1.2 mL in 1 CARTRIDGE",
"NDC11Code": "70121-1685-01",
"ProductNDC": "70121-1685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Exenatide",
"NonProprietaryName": "Exenatide",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20241122",
"EndMarketingDate": "20270630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206697",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "EXENATIDE",
"StrengthNumber": "250",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20241122",
"EndMarketingDatePackage": "20270630",
"SamplePackage": "N",
"IndicationAndUsage": "Exenatide injection is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Exenatide is a synthetic peptide, GLP-1 receptor agonist, that was originally identified in the lizard Heloderma suspectum. Exenatide is a 39-amino acid peptide amide. Exenatide has the empirical formula C184H282N50O60S and molecular weight of 4186.6 Daltons. The amino acid sequence for exenatide is shown below. H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2. Exenatide injection, USP is supplied for subcutaneous administration as a sterile, preserved isotonic solution in a glass cartridge that has been assembled in a pen-injector (pen). Each milliliter (mL) contains 250 micrograms (mcg) synthetic exenatide, USP; 2.2 mg metacresol as an antimicrobial preservative; mannitol as a tonicity-adjusting agent; and glacial acetic acid and sodium acetate trihydrate in water for injection as a buffering solution at pH 4.5. Two prefilled pens are available to deliver unit doses of 5 mcg per dose or 10 mcg per dose. Each prefilled pen will deliver 60 doses to provide for 30 days of twice daily administration (BID). Each prefilled device is filled with volume to allow delivery of 1.2 mL or 2.4 mL. Each device contains additional volume to allow for troubleshooting the device 4 times."
},
{
"NDCCode": "70771-1685-1",
"PackageDescription": "1 VIAL in 1 CARTON (70771-1685-1) > 50 mL in 1 VIAL",
"NDC11Code": "70771-1685-01",
"ProductNDC": "70771-1685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nelarabine",
"NonProprietaryName": "Nelarabine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20211117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215037",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "NELARABINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211117",
"SamplePackage": "N"
},
{
"NDCCode": "71335-1685-1",
"PackageDescription": "30 TABLET in 1 BOTTLE (71335-1685-1) ",
"NDC11Code": "71335-1685-01",
"ProductNDC": "71335-1685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040901",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200806",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1 -hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4.HCl HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275oC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, stearic acid and FD&C Yellow # 6."
},
{
"NDCCode": "72162-1685-1",
"PackageDescription": "100 TABLET in 1 BOTTLE (72162-1685-1) ",
"NDC11Code": "72162-1685-01",
"ProductNDC": "72162-1685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071173",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240111",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol tablets, USP are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets, USP are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets, USP are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets, USP are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets, USP should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.",
"Description": "Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4’—fluorobutyrophenone and it has the following structural formula. C21H23ClFNO2 375.87. Haloperidol is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, pregelatinized starch. In addition, the 1 mg, 5 mg and 10 mg tablets contain D&C Yellow No. 10 Aluminum Lake. The 5 mg and 10 mg tablets contain FD&C Blue No. 1 Aluminum Lake, 20 mg tablets contain FD&C Red No. 40 Aluminum Lake."
},
{
"NDCCode": "50090-1685-0",
"PackageDescription": "6 TABLET, FILM COATED in 1 BOTTLE (50090-1685-0) ",
"NDC11Code": "50090-1685-00",
"ProductNDC": "50090-1685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076794",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150209",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)○ Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)○ Urinary Tract Infections (UTI)○ Acute Uncomplicated Cystitis○ Complicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).",
"Description": "Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.82. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin, USP is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.34. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white to off-white. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate), 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate), and 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). The inactive ingredients are corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch (maize), purified water, silicon dioxide, talc, and titanium dioxide."
},
{
"NDCCode": "50090-1685-2",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (50090-1685-2) ",
"NDC11Code": "50090-1685-02",
"ProductNDC": "50090-1685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076794",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150209",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)○ Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)○ Urinary Tract Infections (UTI)○ Acute Uncomplicated Cystitis○ Complicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).",
"Description": "Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.82. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin, USP is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.34. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white to off-white. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate), 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate), and 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). The inactive ingredients are corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch (maize), purified water, silicon dioxide, talc, and titanium dioxide."
},
{
"NDCCode": "50090-1685-3",
"PackageDescription": "3 TABLET, FILM COATED in 1 BOTTLE (50090-1685-3) ",
"NDC11Code": "50090-1685-03",
"ProductNDC": "50090-1685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076794",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210910",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)○ Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)○ Urinary Tract Infections (UTI)○ Acute Uncomplicated Cystitis○ Complicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).",
"Description": "Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.82. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin, USP is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.34. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white to off-white. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate), 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate), and 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). The inactive ingredients are corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch (maize), purified water, silicon dioxide, talc, and titanium dioxide."
},
{
"NDCCode": "0067-0115-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (0067-0115-01) / 237 mL in 1 BOTTLE",
"NDC11Code": "00067-0115-01",
"ProductNDC": "0067-0115",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Theraflu-d Flu Relief Max Strength Plus Nasal Decongestant",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Pseudoephedrine Hcl",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20240619",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "1000; 30; 60",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240619",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to a common cold or flu: headacheminor aches and painsminor sore throat paincough due to minor throat and bronchial irritationnasal and sinus congestion. temporarily reduces fever."
},
{
"NDCCode": "0115-0511-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0115-0511-01) ",
"NDC11Code": "00115-0511-01",
"ProductNDC": "0115-0511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100201",
"EndMarketingDate": "20231207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075868",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "67",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-12-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100201",
"EndMarketingDatePackage": "20231207",
"SamplePackage": "N",
"IndicationAndUsage": "Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia. Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see WARNINGS and PRECAUTIONS). Fredrickson Classification of Hyperlipoproteinemias. The NCEP Treatment Guidelines.",
"Description": "Fenofibrate capsules (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79° to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients: The inactive ingredients in fenofibrate capsules include croscarmellose sodium, hypromellose type 2910/6 cP, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shells contain gelatin and titanium dioxide. The 67 mg capsule shells also contain D&C Yellow No. 10 and FD&C Yellow No. 6. The 200 mg capsule shells also contain D&C Red No. 28, D&C Yellow No. 10, and FD&C Red No. 40. Additionally, the capsule imprint ink contains shellac glaze, ferrosoferric oxide, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, D&C Yellow No. 10 Aluminum Lake, and FD&C Blue No. 1."
},
{
"NDCCode": "0115-0522-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0115-0522-01) ",
"NDC11Code": "00115-0522-01",
"ProductNDC": "0115-0522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075868",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "134",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100201",
"SamplePackage": "N",
"IndicationAndUsage": "Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia. Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see WARNINGS and PRECAUTIONS). Fredrickson Classification of Hyperlipoproteinemias. The NCEP Treatment Guidelines.",
"Description": "Fenofibrate capsules (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79° to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients: The inactive ingredients in fenofibrate capsules include croscarmellose sodium, hypromellose type 2910/6 cP, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shells contain gelatin and titanium dioxide. The 67 mg capsule shells also contain D&C Yellow No. 10 and FD&C Yellow No. 6. The 200 mg capsule shells also contain D&C Red No. 28, D&C Yellow No. 10, and FD&C Red No. 40. Additionally, the capsule imprint ink contains shellac glaze, ferrosoferric oxide, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, D&C Yellow No. 10 Aluminum Lake, and FD&C Blue No. 1."
},
{
"NDCCode": "0115-0533-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0115-0533-01) ",
"NDC11Code": "00115-0533-01",
"ProductNDC": "0115-0533",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075868",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100201",
"SamplePackage": "N",
"IndicationAndUsage": "Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia. Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see WARNINGS and PRECAUTIONS). Fredrickson Classification of Hyperlipoproteinemias. The NCEP Treatment Guidelines.",
"Description": "Fenofibrate capsules (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79° to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients: The inactive ingredients in fenofibrate capsules include croscarmellose sodium, hypromellose type 2910/6 cP, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shells contain gelatin and titanium dioxide. The 67 mg capsule shells also contain D&C Yellow No. 10 and FD&C Yellow No. 6. The 200 mg capsule shells also contain D&C Red No. 28, D&C Yellow No. 10, and FD&C Red No. 40. Additionally, the capsule imprint ink contains shellac glaze, ferrosoferric oxide, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, D&C Yellow No. 10 Aluminum Lake, and FD&C Blue No. 1."
},
{
"NDCCode": "0115-1010-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0115-1010-01) ",
"NDC11Code": "00115-1010-01",
"ProductNDC": "0115-1010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077971",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20071027",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen, USP is a white to off-white, odorless, or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate."
},
{
"NDCCode": "0115-1011-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0115-1011-01) ",
"NDC11Code": "00115-1011-01",
"ProductNDC": "0115-1011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077971",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210601",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen, USP is a white to off-white, odorless, or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate."
},
{
"NDCCode": "0115-1012-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0115-1012-01) ",
"NDC11Code": "00115-1012-01",
"ProductNDC": "0115-1012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077971",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20071027",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen, USP is a white to off-white, odorless, or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate."
},
{
"NDCCode": "0115-1030-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0115-1030-01)",
"NDC11Code": "00115-1030-01",
"ProductNDC": "0115-1030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Primidone",
"NonProprietaryName": "Primidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040717",
"LabelerName": "Global Pharmaceuticals",
"SubstanceName": "PRIMIDONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0115-1031-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0115-1031-01)",
"NDC11Code": "00115-1031-01",
"ProductNDC": "0115-1031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Primidone",
"NonProprietaryName": "Primidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040717",
"LabelerName": "Global Pharmaceuticals",
"SubstanceName": "PRIMIDONE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0115-1040-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0115-1040-01)",
"NDC11Code": "00115-1040-01",
"ProductNDC": "0115-1040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040724",
"LabelerName": "Global Pharmaceuticals, Division of Impax Laboratories Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-04-13"
},
{
"NDCCode": "0115-1041-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0115-1041-01)",
"NDC11Code": "00115-1041-01",
"ProductNDC": "0115-1041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040724",
"LabelerName": "Global Pharmaceuticals, Division of Impax Laboratories Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-04-13"
},
{
"NDCCode": "0115-1042-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0115-1042-01)",
"NDC11Code": "00115-1042-01",
"ProductNDC": "0115-1042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040791",
"LabelerName": "Global Pharmaceuticals, Division of Impax Laboratories Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-04-13"
},
{
"NDCCode": "0115-1070-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0115-1070-01) ",
"NDC11Code": "00115-1070-01",
"ProductNDC": "0115-1070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dipyridamole",
"NonProprietaryName": "Dipyridamole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040782",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "DIPYRIDAMOLE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210830",
"SamplePackage": "N",
"IndicationAndUsage": "Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.",
"Description": "Dipyridamole is a platelet inhibitor chemically described as 2,2',2\",2'''-[(4,8-Dipiperidinopyrimido[5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. The molecular weight is 504.63 and the molecular formula is C24H40N8O4. The structural formula is represented below. Dipyridamole, USP is intensely yellow crystalline powder or needles. It is practically insoluble in water, sparingly soluble in ethyl alcohol, very slightly soluble in acetone and ethyl acetate. Each tablet, for oral administration, contains 25 mg, 50 mg or 75 mg dipyridamole, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, Type A, talc, and titanium dioxide."
},
{
"NDCCode": "0115-1071-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0115-1071-01) ",
"NDC11Code": "00115-1071-01",
"ProductNDC": "0115-1071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dipyridamole",
"NonProprietaryName": "Dipyridamole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040782",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "DIPYRIDAMOLE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210830",
"SamplePackage": "N",
"IndicationAndUsage": "Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.",
"Description": "Dipyridamole is a platelet inhibitor chemically described as 2,2',2\",2'''-[(4,8-Dipiperidinopyrimido[5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. The molecular weight is 504.63 and the molecular formula is C24H40N8O4. The structural formula is represented below. Dipyridamole, USP is intensely yellow crystalline powder or needles. It is practically insoluble in water, sparingly soluble in ethyl alcohol, very slightly soluble in acetone and ethyl acetate. Each tablet, for oral administration, contains 25 mg, 50 mg or 75 mg dipyridamole, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, Type A, talc, and titanium dioxide."
},
{
"NDCCode": "0115-1072-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0115-1072-01) ",
"NDC11Code": "00115-1072-01",
"ProductNDC": "0115-1072",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dipyridamole",
"NonProprietaryName": "Dipyridamole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040782",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "DIPYRIDAMOLE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210830",
"SamplePackage": "N",
"IndicationAndUsage": "Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.",
"Description": "Dipyridamole is a platelet inhibitor chemically described as 2,2',2\",2'''-[(4,8-Dipiperidinopyrimido[5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. The molecular weight is 504.63 and the molecular formula is C24H40N8O4. The structural formula is represented below. Dipyridamole, USP is intensely yellow crystalline powder or needles. It is practically insoluble in water, sparingly soluble in ethyl alcohol, very slightly soluble in acetone and ethyl acetate. Each tablet, for oral administration, contains 25 mg, 50 mg or 75 mg dipyridamole, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, Type A, talc, and titanium dioxide."
},
{
"NDCCode": "0115-1150-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0115-1150-01)",
"NDC11Code": "00115-1150-01",
"ProductNDC": "0115-1150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acarbose",
"NonProprietaryName": "Acarbose",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078441",
"LabelerName": "Global Pharmaceuticals, Division of Impax Laboratories, Inc.",
"SubstanceName": "ACARBOSE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
}
]
}
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<NDCList>
<NDC>
<NDCCode>0115-1685-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1685-01) </PackageDescription>
<NDC11Code>00115-1685-01</NDC11Code>
<ProductNDC>0115-1685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079108</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. The effectiveness of dexmethylphenidate hydrochloride extended-release in the treatment of ADHD in patients aged 6 years and older was established in 2 placebo-controlled studies in patients meeting DSM-IV criteria for ADHD [see Clinical Studies (14)]. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go”; excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Types requires both inattentive and hyperactive-impulsive criteria to be met. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV characteristics. Need for Comprehensive Treatment Program. Dexmethylphenidate hydrochloride extended-release capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the child’s symptoms. Long-Term Use. The effectiveness of dexmethylphenidate hydrochloride extended-release for long-term use, i.e., for more than 7 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use dexmethylphenidate hydrochloride extended-release for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.3)].</IndicationAndUsage>
<Description>Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a second delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release is available as 5 mg, 10 mg, 15 mg, 20 mg and 30 mg extended-release capsules. Dexmethylphenidate hydrochloride extended-release 5 mg, 10 mg, 15 mg, 20 mg and 30 mg extended-release capsules provide in a single dose the same amount of dexmethylphenidate as dosages of 2.5 mg, 5 mg, 7.5 mg, 10 mg or 15 mg of dexmethylphenidate hydrochloride given twice a day as tablets. Dexmethylphenidate hydrochloride, the d-threo enantiomer of racemic methylphenidate hydrochloride, is a central nervous system (CNS) stimulant. Dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its molecular weight is 269.77 and its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Inactive ingredients: acetyltributyl citrate, ethylcellulose, gelatin, hypromellose, hypromellose acetate succinate, sugar spheres (which contain sucrose and starch [maize]), talc, and titanium dioxide. The 5 mg capsule also contains FD&C Red #3 and FD&C Blue #1. The 10 mg capsule also contains acid red 27 and FD&C Blue #1. The 15 mg capsule also contains D&C Red #28 and FD&C Blue #1. The 20 mg capsule also contains D&C Red #28, D&C Red #33, and FD&C Blue #1. Black printing ink SW-9008/SW-9009 contains black iron oxide, potassium hydroxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>37662-1685-1</NDCCode>
<PackageDescription>200 PELLET in 1 VIAL, GLASS (37662-1685-1) </PackageDescription>
<NDC11Code>37662-1685-01</NDC11Code>
<ProductNDC>37662-1685</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hyoscyamus Niger</ProprietaryName>
<NonProprietaryName>Hyoscyamus Niger</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221010</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>HYOSCYAMUS NIGER</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43742-1685-1</NDCCode>
<PackageDescription>960 mL in 1 BOTTLE, PLASTIC (43742-1685-1) </PackageDescription>
<NDC11Code>43742-1685-01</NDC11Code>
<ProductNDC>43742-1685</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Anaplasma Phagocytophilum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20200925</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc</LabelerName>
<SubstanceName>ANAPLASMA PHAGOCYTOPHILUM</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-12-12</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>25-SEP-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>50090-1685-1</NDCCode>
<PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (50090-1685-1) </PackageDescription>
<NDC11Code>50090-1685-01</NDC11Code>
<ProductNDC>50090-1685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076794</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)○ Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)○ Urinary Tract Infections (UTI)○ Acute Uncomplicated Cystitis○ Complicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).</IndicationAndUsage>
<Description>Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.82. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin, USP is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.34. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white to off-white. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate), 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate), and 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). The inactive ingredients are corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch (maize), purified water, silicon dioxide, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>51662-1685-1</NDCCode>
<PackageDescription>4 mL in 1 VIAL (51662-1685-1) </PackageDescription>
<NDC11Code>51662-1685-01</NDC11Code>
<ProductNDC>51662-1685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180618</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211015</ApplicationNumber>
<LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil Hydrochloride Injection, USP is indicated for the following. Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration. Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White (W-P-W) and Lown-Ganong-Levine (L-G-L) syndromes). In controlled studies in the United States, about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride. Uncontrolled studies reported in the world literature describe a conversion rate of about 80%. About 70% of patients with atrial flutter and/or fibrillation with a faster ventricular rate respond with a decrease in ventricular rate of at least 20%. Conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after verapamil hydrochloride and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. Slowing of the ventricular rate in patients with atrial fibrillation/flutter lasts 30 to 60 minutes after a single injection. Because a small fraction (<1%) of patients treated with verapamil hydrochloride respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation, and an accessory bypass tract, marked hypotension, or extreme bradycardia/asystole - see CONTRAINDICATIONS and WARNINGS), the initial use of verapamil hydrochloride injection should, if possible, be in a treatment setting with monitoring and resuscitation facilities , including D.C.-cardioversion capability (see ADVERSE REACTIONS, Suggested Treatment of Acute Cardiovascular Adverse Reactions). As familiarity with the patient's response is gained, use in an office setting may be acceptable. Cardioversion has been used safely and effectively after verapamil hydrochloride injection.</IndicationAndUsage>
<Description>Verapamil hydrochloride is a calcium antagonist or slow-channel inhibitor. Verapamil Hydrochloride Injection, USP is a sterile, nonpyrogenic solution containing verapamil hydrochloride 2.5 mg/mL and sodium chloride 8.5 mg/mL in water for injection. The solution contains no bacteriostat or antimicrobial agent and is intended for single-dose intravenous administration. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment; pH is 4.0 to 6.5. The chemical name of Verapamil Hydrochloride, USP is benzeneacetonitrile, α-[3-[{2-(3,4-dimethoxyphenyl)ethyl} methylamino] propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil hydrochloride is a white or practically white crystalline powder. It is practically odorless and has a bitter taste. It is soluble in water; freely soluble in chloroform; sparingly soluble in alcohol; practically insoluble in ether. It has the following structural formula. Molecular weight: 491.07. Molecular formula: C27H38N2O4 HCl. Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs.</Description>
</NDC>
<NDC>
<NDCCode>62991-1685-1</NDCCode>
<PackageDescription>.025 kg in 1 JAR (62991-1685-1) </PackageDescription>
<NDC11Code>62991-1685-01</NDC11Code>
<ProductNDC>62991-1685</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120409</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>LETCO MEDICAL, LLC</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>09-APR-12</StartMarketingDatePackage>
<EndMarketingDatePackage>31-JAN-26</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64942-1685-1</NDCCode>
<PackageDescription>107 g in 1 CAN (64942-1685-1) </PackageDescription>
<NDC11Code>64942-1685-01</NDC11Code>
<ProductNDC>64942-1685</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dove</ProprietaryName>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Conopco, Inc. d/b/a Unilever</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>20.2</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
<Description>Dove Advanced Care Dry Spray Rose Petals 48h Antiperspirant Deodorant.</Description>
</NDC>
<NDC>
<NDCCode>70121-1685-1</NDCCode>
<PackageDescription>1 CARTRIDGE in 1 CARTON (70121-1685-1) / 1.2 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>70121-1685-01</NDC11Code>
<ProductNDC>70121-1685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Exenatide</ProprietaryName>
<NonProprietaryName>Exenatide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20241122</StartMarketingDate>
<EndMarketingDate>20270630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206697</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>EXENATIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241122</StartMarketingDatePackage>
<EndMarketingDatePackage>20270630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Exenatide injection is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Exenatide is a synthetic peptide, GLP-1 receptor agonist, that was originally identified in the lizard Heloderma suspectum. Exenatide is a 39-amino acid peptide amide. Exenatide has the empirical formula C184H282N50O60S and molecular weight of 4186.6 Daltons. The amino acid sequence for exenatide is shown below. H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2. Exenatide injection, USP is supplied for subcutaneous administration as a sterile, preserved isotonic solution in a glass cartridge that has been assembled in a pen-injector (pen). Each milliliter (mL) contains 250 micrograms (mcg) synthetic exenatide, USP; 2.2 mg metacresol as an antimicrobial preservative; mannitol as a tonicity-adjusting agent; and glacial acetic acid and sodium acetate trihydrate in water for injection as a buffering solution at pH 4.5. Two prefilled pens are available to deliver unit doses of 5 mcg per dose or 10 mcg per dose. Each prefilled pen will deliver 60 doses to provide for 30 days of twice daily administration (BID). Each prefilled device is filled with volume to allow delivery of 1.2 mL or 2.4 mL. Each device contains additional volume to allow for troubleshooting the device 4 times.</Description>
</NDC>
<NDC>
<NDCCode>70771-1685-1</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (70771-1685-1) > 50 mL in 1 VIAL</PackageDescription>
<NDC11Code>70771-1685-01</NDC11Code>
<ProductNDC>70771-1685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nelarabine</ProprietaryName>
<NonProprietaryName>Nelarabine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20211117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215037</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>NELARABINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71335-1685-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71335-1685-1) </PackageDescription>
<NDC11Code>71335-1685-01</NDC11Code>
<ProductNDC>71335-1685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040901</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1 -hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4.HCl HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275oC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, stearic acid and FD&C Yellow # 6.</Description>
</NDC>
<NDC>
<NDCCode>72162-1685-1</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (72162-1685-1) </PackageDescription>
<NDC11Code>72162-1685-01</NDC11Code>
<ProductNDC>72162-1685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071173</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol tablets, USP are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets, USP are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets, USP are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets, USP are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets, USP should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
<Description>Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4’—fluorobutyrophenone and it has the following structural formula. C21H23ClFNO2 375.87. Haloperidol is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, pregelatinized starch. In addition, the 1 mg, 5 mg and 10 mg tablets contain D&C Yellow No. 10 Aluminum Lake. The 5 mg and 10 mg tablets contain FD&C Blue No. 1 Aluminum Lake, 20 mg tablets contain FD&C Red No. 40 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>50090-1685-0</NDCCode>
<PackageDescription>6 TABLET, FILM COATED in 1 BOTTLE (50090-1685-0) </PackageDescription>
<NDC11Code>50090-1685-00</NDC11Code>
<ProductNDC>50090-1685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076794</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)○ Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)○ Urinary Tract Infections (UTI)○ Acute Uncomplicated Cystitis○ Complicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).</IndicationAndUsage>
<Description>Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.82. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin, USP is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.34. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white to off-white. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate), 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate), and 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). The inactive ingredients are corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch (maize), purified water, silicon dioxide, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50090-1685-2</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (50090-1685-2) </PackageDescription>
<NDC11Code>50090-1685-02</NDC11Code>
<ProductNDC>50090-1685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076794</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)○ Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)○ Urinary Tract Infections (UTI)○ Acute Uncomplicated Cystitis○ Complicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).</IndicationAndUsage>
<Description>Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.82. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin, USP is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.34. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white to off-white. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate), 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate), and 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). The inactive ingredients are corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch (maize), purified water, silicon dioxide, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50090-1685-3</NDCCode>
<PackageDescription>3 TABLET, FILM COATED in 1 BOTTLE (50090-1685-3) </PackageDescription>
<NDC11Code>50090-1685-03</NDC11Code>
<ProductNDC>50090-1685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076794</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)○ Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)○ Urinary Tract Infections (UTI)○ Acute Uncomplicated Cystitis○ Complicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).</IndicationAndUsage>
<Description>Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.82. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin, USP is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.34. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white to off-white. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate), 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate), and 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). The inactive ingredients are corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch (maize), purified water, silicon dioxide, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0067-0115-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0067-0115-01) / 237 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00067-0115-01</NDC11Code>
<ProductNDC>0067-0115</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Theraflu-d Flu Relief Max Strength Plus Nasal Decongestant</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Pseudoephedrine Hcl</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240619</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000; 30; 60</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to a common cold or flu: headacheminor aches and painsminor sore throat paincough due to minor throat and bronchial irritationnasal and sinus congestion. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0115-0511-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0115-0511-01) </PackageDescription>
<NDC11Code>00115-0511-01</NDC11Code>
<ProductNDC>0115-0511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100201</StartMarketingDate>
<EndMarketingDate>20231207</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075868</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>67</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100201</StartMarketingDatePackage>
<EndMarketingDatePackage>20231207</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia. Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see WARNINGS and PRECAUTIONS). Fredrickson Classification of Hyperlipoproteinemias. The NCEP Treatment Guidelines.</IndicationAndUsage>
<Description>Fenofibrate capsules (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79° to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients: The inactive ingredients in fenofibrate capsules include croscarmellose sodium, hypromellose type 2910/6 cP, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shells contain gelatin and titanium dioxide. The 67 mg capsule shells also contain D&C Yellow No. 10 and FD&C Yellow No. 6. The 200 mg capsule shells also contain D&C Red No. 28, D&C Yellow No. 10, and FD&C Red No. 40. Additionally, the capsule imprint ink contains shellac glaze, ferrosoferric oxide, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, D&C Yellow No. 10 Aluminum Lake, and FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>0115-0522-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0115-0522-01) </PackageDescription>
<NDC11Code>00115-0522-01</NDC11Code>
<ProductNDC>0115-0522</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075868</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>134</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia. Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see WARNINGS and PRECAUTIONS). Fredrickson Classification of Hyperlipoproteinemias. The NCEP Treatment Guidelines.</IndicationAndUsage>
<Description>Fenofibrate capsules (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79° to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients: The inactive ingredients in fenofibrate capsules include croscarmellose sodium, hypromellose type 2910/6 cP, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shells contain gelatin and titanium dioxide. The 67 mg capsule shells also contain D&C Yellow No. 10 and FD&C Yellow No. 6. The 200 mg capsule shells also contain D&C Red No. 28, D&C Yellow No. 10, and FD&C Red No. 40. Additionally, the capsule imprint ink contains shellac glaze, ferrosoferric oxide, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, D&C Yellow No. 10 Aluminum Lake, and FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>0115-0533-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0115-0533-01) </PackageDescription>
<NDC11Code>00115-0533-01</NDC11Code>
<ProductNDC>0115-0533</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075868</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia. Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see WARNINGS and PRECAUTIONS). Fredrickson Classification of Hyperlipoproteinemias. The NCEP Treatment Guidelines.</IndicationAndUsage>
<Description>Fenofibrate capsules (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79° to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients: The inactive ingredients in fenofibrate capsules include croscarmellose sodium, hypromellose type 2910/6 cP, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shells contain gelatin and titanium dioxide. The 67 mg capsule shells also contain D&C Yellow No. 10 and FD&C Yellow No. 6. The 200 mg capsule shells also contain D&C Red No. 28, D&C Yellow No. 10, and FD&C Red No. 40. Additionally, the capsule imprint ink contains shellac glaze, ferrosoferric oxide, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, D&C Yellow No. 10 Aluminum Lake, and FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>0115-1010-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0115-1010-01) </PackageDescription>
<NDC11Code>00115-1010-01</NDC11Code>
<ProductNDC>0115-1010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077971</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen, USP is a white to off-white, odorless, or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>0115-1011-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0115-1011-01) </PackageDescription>
<NDC11Code>00115-1011-01</NDC11Code>
<ProductNDC>0115-1011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077971</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen, USP is a white to off-white, odorless, or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>0115-1012-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0115-1012-01) </PackageDescription>
<NDC11Code>00115-1012-01</NDC11Code>
<ProductNDC>0115-1012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077971</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen, USP is a white to off-white, odorless, or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>0115-1030-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0115-1030-01)</PackageDescription>
<NDC11Code>00115-1030-01</NDC11Code>
<ProductNDC>0115-1030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Primidone</ProprietaryName>
<NonProprietaryName>Primidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040717</ApplicationNumber>
<LabelerName>Global Pharmaceuticals</LabelerName>
<SubstanceName>PRIMIDONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0115-1031-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0115-1031-01)</PackageDescription>
<NDC11Code>00115-1031-01</NDC11Code>
<ProductNDC>0115-1031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Primidone</ProprietaryName>
<NonProprietaryName>Primidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040717</ApplicationNumber>
<LabelerName>Global Pharmaceuticals</LabelerName>
<SubstanceName>PRIMIDONE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0115-1040-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0115-1040-01)</PackageDescription>
<NDC11Code>00115-1040-01</NDC11Code>
<ProductNDC>0115-1040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040724</ApplicationNumber>
<LabelerName>Global Pharmaceuticals, Division of Impax Laboratories Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-04-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>0115-1041-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0115-1041-01)</PackageDescription>
<NDC11Code>00115-1041-01</NDC11Code>
<ProductNDC>0115-1041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040724</ApplicationNumber>
<LabelerName>Global Pharmaceuticals, Division of Impax Laboratories Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-04-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>0115-1042-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0115-1042-01)</PackageDescription>
<NDC11Code>00115-1042-01</NDC11Code>
<ProductNDC>0115-1042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040791</ApplicationNumber>
<LabelerName>Global Pharmaceuticals, Division of Impax Laboratories Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-04-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>0115-1070-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0115-1070-01) </PackageDescription>
<NDC11Code>00115-1070-01</NDC11Code>
<ProductNDC>0115-1070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dipyridamole</ProprietaryName>
<NonProprietaryName>Dipyridamole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040782</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>DIPYRIDAMOLE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.</IndicationAndUsage>
<Description>Dipyridamole is a platelet inhibitor chemically described as 2,2',2",2'''-[(4,8-Dipiperidinopyrimido[5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. The molecular weight is 504.63 and the molecular formula is C24H40N8O4. The structural formula is represented below. Dipyridamole, USP is intensely yellow crystalline powder or needles. It is practically insoluble in water, sparingly soluble in ethyl alcohol, very slightly soluble in acetone and ethyl acetate. Each tablet, for oral administration, contains 25 mg, 50 mg or 75 mg dipyridamole, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, Type A, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0115-1071-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0115-1071-01) </PackageDescription>
<NDC11Code>00115-1071-01</NDC11Code>
<ProductNDC>0115-1071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dipyridamole</ProprietaryName>
<NonProprietaryName>Dipyridamole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040782</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>DIPYRIDAMOLE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.</IndicationAndUsage>
<Description>Dipyridamole is a platelet inhibitor chemically described as 2,2',2",2'''-[(4,8-Dipiperidinopyrimido[5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. The molecular weight is 504.63 and the molecular formula is C24H40N8O4. The structural formula is represented below. Dipyridamole, USP is intensely yellow crystalline powder or needles. It is practically insoluble in water, sparingly soluble in ethyl alcohol, very slightly soluble in acetone and ethyl acetate. Each tablet, for oral administration, contains 25 mg, 50 mg or 75 mg dipyridamole, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, Type A, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0115-1072-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0115-1072-01) </PackageDescription>
<NDC11Code>00115-1072-01</NDC11Code>
<ProductNDC>0115-1072</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dipyridamole</ProprietaryName>
<NonProprietaryName>Dipyridamole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040782</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>DIPYRIDAMOLE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.</IndicationAndUsage>
<Description>Dipyridamole is a platelet inhibitor chemically described as 2,2',2",2'''-[(4,8-Dipiperidinopyrimido[5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. The molecular weight is 504.63 and the molecular formula is C24H40N8O4. The structural formula is represented below. Dipyridamole, USP is intensely yellow crystalline powder or needles. It is practically insoluble in water, sparingly soluble in ethyl alcohol, very slightly soluble in acetone and ethyl acetate. Each tablet, for oral administration, contains 25 mg, 50 mg or 75 mg dipyridamole, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, Type A, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0115-1150-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0115-1150-01)</PackageDescription>
<NDC11Code>00115-1150-01</NDC11Code>
<ProductNDC>0115-1150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acarbose</ProprietaryName>
<NonProprietaryName>Acarbose</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078441</ApplicationNumber>
<LabelerName>Global Pharmaceuticals, Division of Impax Laboratories, Inc.</LabelerName>
<SubstanceName>ACARBOSE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
</NDCList>