RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>62135-546-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (62135-546-05) </PackageDescription>
    <NDC11Code>62135-0546-05</NDC11Code>
    <ProductNDC>62135-546</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080630</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040804</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC</LabelerName>
    <SubstanceName>HYDROXYZINE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230628</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C 21H 27ClN 2O 2· 2HCl M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg, or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, stearic acid and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>62135-546-12</NDCCode>
    <PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (62135-546-12) </PackageDescription>
    <NDC11Code>62135-0546-12</NDC11Code>
    <ProductNDC>62135-546</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080630</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040804</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC</LabelerName>
    <SubstanceName>HYDROXYZINE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230628</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C 21H 27ClN 2O 2· 2HCl M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg, or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, stearic acid and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>17478-546-05</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (17478-546-05)  &gt; 4 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>17478-0546-05</NDC11Code>
    <ProductNDC>17478-546</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Granisetron Hydrochloride</ProprietaryName>
    <NonProprietaryName>Granisetron Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20091001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079078</ApplicationNumber>
    <LabelerName>Akorn</LabelerName>
    <SubstanceName>GRANISETRON HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT3) receptor antagonist indicated for: : 1 The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. .</IndicationAndUsage>
    <Description>Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT3) receptor antagonist. Chemically it is endo-N-(9-methyl-9-azabicyclo [3.3.1] non-3-yl)-1-methyl-1H-indazole-3-carboxamide hydrochloride. Its chemical structure is:. Granisetron hydrochloride. C18H24N4OHCl         M.W. 348.9 (312.4 free base). Granisetron hydrochloride is a white to off-white solid that is readily soluble in water and normal saline at 20°C. Granisetron hydrochloride injection, USP is a clear, colorless, sterile, nonpyrogenic, aqueous solution for intravenous administration. Granisetron hydrochloride injection, USP 1 mg/mL is available in 1 mL Single-dose and 4 mL Multiple-dose vials. Granisetron hydrochloride injection, USP 0.1 mg/mL is available in a 1 mL single-dose vial. 1 mg/mL: Each 1 mL contains: Active: Granisetron hydrochloride 1.12 mg, equivalent to granisetron, 1 mg; Inactives: Sodium Chloride, 9 mg; Citric Acid, 2 mg; Sodium Citrate, Dihydrate, Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH (approximately 4.0 to 6.0), and Water for Injection q.s. to 1 mL; Preservative: Benzyl Alcohol, 10 mg. 0.1 mg/mL (preservative-free): Each mL contains: Active: Granisetron hydrochloride 0.112 mg, equivalent to granisetron, 0.1 mg; Inactives: Sodium Chloride, 9 mg; Citric Acid, 2 mg: Sodium Citrate, Dihydrate, Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH (approximately 4.0 to 6.0), and Water for Injection q.s. to 1 mL.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-546-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (31722-546-05) </PackageDescription>
    <NDC11Code>31722-0546-05</NDC11Code>
    <ProductNDC>31722-546</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lithium Carbonate</ProprietaryName>
    <NonProprietaryName>Lithium Carbonate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090702</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LITHIUM CARBONATE</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Mood Stabilizer [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-12-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder.  Treatment of acute manic and mixed episodes in patients 7 years and older [see Clinical Studies ( 14)]  Maintenance treatment in patients 7 years and older [see Clinical Studies ( 14)].</IndicationAndUsage>
    <Description>Each capsule for oral administration contains lithium carbonate USP, 150 mg, 300 mg or 600 mg and the following inactive ingredients: gelatin, sodium lauryl sulfate, talc, titanium dioxide and the imprinting ink contains black iron oxide E172 dye, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. Lithium Carbonate USP is a white, light, alkaline powder with molecular formula Li 2CO 3 and  molecular weight 73.89.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-546-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (43598-546-05) </PackageDescription>
    <NDC11Code>43598-0546-05</NDC11Code>
    <ProductNDC>43598-546</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180709</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207510</ApplicationNumber>
    <LabelerName>Dr. Reddy�s Laboratories Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 7.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180709</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxycodone and Acetaminophen Tablets, is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets, for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Oxycodone Acetaminophen Tablets, USP is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone hydrochloride USP ......................................................................................... 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone). Acetaminophen USP ........................................................................................................ 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: Colloidal silicon dioxide, pregelatinized starch, crospovidone, croscarmellose sodium, microcrystalline cellulose, stearic acid and magnesium stearate. In addition, the 7.5 mg/325 mg strength contains FD&amp;C Red # 40 Aluminum Lake. Oxycodone and Acetaminophen Tablets, USP contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 · HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets, USP contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-546-05</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (46708-546-05)  / 5 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>46708-0546-05</NDC11Code>
    <ProductNDC>46708-546</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%</ProprietaryName>
    <NonProprietaryName>Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20201122</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212942</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201122</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Timolol maleate ophthalmic gel forming solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
    <Description>Timolol maleate ophthalmic gel forming solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3­ [(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is:       25° [α]                    in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°).       405 nm Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate ophthalmic gel forming solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. The pH of the solution is approximately 7.0, and the osmolarity is 260-330 mOsm. Each mL of Timolol maleate ophthalmic gel forming solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of Timolol maleate ophthalmic gel forming solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: gellan gum, tromethamine, mannitol, and water for injection. Preservative: benzododecinium bromide 0.012%. The gel forming solution contains a purified anionic heteropolysaccharide derived from gellan gum. An aqueous solution of gellan gum, in the presence of a cation, has the ability to gel. Upon contact with the precorneal tear film, Timolol maleate ophthalmic gel forming solution forms a gel that is subsequently removed by the flow of tears.</Description>
  </NDC>
  <NDC>
    <NDCCode>47781-546-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (47781-546-05) </PackageDescription>
    <NDC11Code>47781-0546-05</NDC11Code>
    <ProductNDC>47781-546</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171031</StartMarketingDate>
    <EndMarketingDate>20231101</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA063067</ApplicationNumber>
    <LabelerName>Alvogen, Inc.</LabelerName>
    <SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-11-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20171031</StartMarketingDatePackage>
    <EndMarketingDatePackage>20231101</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49281-545-05</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (49281-545-05)  *  .5 mL in 1 VIAL, SINGLE-DOSE (49281-547-58)  *  .6 mL in 1 VIAL, SINGLE-DOSE (49281-546-05)</PackageDescription>
    <NDC11Code>49281-0545-05</NDC11Code>
    <ProductNDC>49281-545</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Acthib</ProprietaryName>
    <NonProprietaryName>Haemophilus Influenzae Type B Strain 1482 Capsular Polysaccharide Tetanus Toxoid Conjugate Antigen</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19930330</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103935</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>55111-546-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (55111-546-05) </PackageDescription>
    <NDC11Code>55111-0546-05</NDC11Code>
    <ProductNDC>55111-546</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080616</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078301</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>37.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-12-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080616</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine hydrochloride in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride USP is an off-white to white crystalline powder and soluble in methanol. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>59746-546-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (59746-546-05) </PackageDescription>
    <NDC11Code>59746-0546-05</NDC11Code>
    <ProductNDC>59746-546</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citalopram</ProprietaryName>
    <NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151223</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205407</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-10-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>62332-546-05</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (62332-546-05)  / 5 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>62332-0546-05</NDC11Code>
    <ProductNDC>62332-546</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%</ProprietaryName>
    <NonProprietaryName>Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20201122</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212942</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201122</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Timolol maleate ophthalmic gel forming solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
    <Description>Timolol maleate ophthalmic gel forming solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3­ [(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is:       25° [α]                    in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°).       405 nm Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate ophthalmic gel forming solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. The pH of the solution is approximately 7.0, and the osmolarity is 260-330 mOsm. Each mL of Timolol maleate ophthalmic gel forming solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of Timolol maleate ophthalmic gel forming solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: gellan gum, tromethamine, mannitol, and water for injection. Preservative: benzododecinium bromide 0.012%. The gel forming solution contains a purified anionic heteropolysaccharide derived from gellan gum. An aqueous solution of gellan gum, in the presence of a cation, has the ability to gel. Upon contact with the precorneal tear film, Timolol maleate ophthalmic gel forming solution forms a gel that is subsequently removed by the flow of tears.</Description>
  </NDC>
  <NDC>
    <NDCCode>65219-546-05</NDCCode>
    <PackageDescription>10 SYRINGE, PLASTIC in 1 CARTON (65219-546-05)  / 5 mL in 1 SYRINGE, PLASTIC (65219-546-01) </PackageDescription>
    <NDC11Code>65219-0546-05</NDC11Code>
    <ProductNDC>65219-546</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ephedrine Sulfate</ProprietaryName>
    <NonProprietaryName>Ephedrine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250707</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218271</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>EPHEDRINE SULFATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250707</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ephedrine Sulfate Injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.</IndicationAndUsage>
    <Description>Ephedrine is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. Ephedrine Sulfate Injection, USP 5 mg/mL is a clear, colorless, sterile, ready-to-use solution for intravenous injection. The chemical name of ephedrine sulfate is benzenemethanol, α-[1-(methylamino)ethyl]-, [R-(R*,S*)]-, sulfate (2:1) (salt), and the molecular weight is 428.5 g/mol. Its molecular formula is (C10H15NO)2 · H2SO4 and its structural formula is depicted below:. Ephedrine sulfate is freely soluble in water and ethanol, very slightly soluble in chloroform, and practically insoluble in ether. Each mL contains ephedrine sulfate 5 mg (equivalent to 3.8 mg ephedrine base), sodium chloride 8.6 mg, trisodium citrate dihydrate 1.25 mg, citric acid anhydrous 0.25 mg and sodium hydroxide and/or glacial acetic acid for pH adjustment, if necessary. The pH range is 5.0 to 7.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>68428-546-05</NDCCode>
    <PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-546-05) </PackageDescription>
    <NDC11Code>68428-0546-05</NDC11Code>
    <ProductNDC>68428-546</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Origanum Majorana</ProprietaryName>
    <NonProprietaryName>Origanum Majorana</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110214</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>ORIGANUM MAJORANA</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110214</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>71052-546-05</NDCCode>
    <PackageDescription>.5 g in 1 CONTAINER (71052-546-05) </PackageDescription>
    <NDC11Code>71052-0546-05</NDC11Code>
    <ProductNDC>71052-546</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Ptd-dbm Acetate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20190920</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>DARMERICA, LLC</LabelerName>
    <SubstanceName>PEPTIDE B27PD</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20-SEP-19</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>75839-546-05</NDCCode>
    <PackageDescription>.5 g in 1 CONTAINER (75839-546-05)</PackageDescription>
    <NDC11Code>75839-0546-05</NDC11Code>
    <ProductNDC>75839-546</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Ptd-dbm Acetate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20190530</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Attix Pharmaceuticals</LabelerName>
    <SubstanceName>PEPTIDE B27PD</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>84756-546-05</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (84756-546-05) </PackageDescription>
    <NDC11Code>84756-0546-05</NDC11Code>
    <ProductNDC>84756-546</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ginger King</ProprietaryName>
    <NonProprietaryName>Ginger King</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241202</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Yiwu Luoxin E �Commerce Co Ltd</LabelerName>
    <SubstanceName>NIACINAMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84827-546-05</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (84827-546-05) </PackageDescription>
    <NDC11Code>84827-0546-05</NDC11Code>
    <ProductNDC>84827-546</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Trstay Hyaluronic Acid Serum</ProprietaryName>
    <NonProprietaryName>Trstay Hyaluronic Acid Serum</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241213</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
    <SubstanceName>NIACINAMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>62135-083-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (62135-083-05) </PackageDescription>
    <NDC11Code>62135-0083-05</NDC11Code>
    <ProductNDC>62135-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin</ProprietaryName>
    <NonProprietaryName>Amoxicillin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA061926</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC</LabelerName>
    <SubstanceName>AMOXICILLIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-09-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260716</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adults and Pediatric Patients. : 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. , 2 Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. , 3 Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli. , 4 Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae. .</IndicationAndUsage>
    <Description>Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin, USP molecular formula is C 16H 19N3O 5S3H 2O, and the molecular weight is 419.45. Tablets: Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&amp;C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension: Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.10 mEq (2.29 mg) of sodium. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&amp;C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 125 mg and 250 mg: FD&amp;C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable): Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules: Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&amp;C Yellow No. 10, FD&amp;C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&amp;C Red No. 28 and FD&amp;C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&amp;C Yellow No. 10 Aluminum Lake, FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Blue No. 2 Aluminum Lake, and FD&amp;C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>62135-112-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (62135-112-05) </PackageDescription>
    <NDC11Code>62135-0112-05</NDC11Code>
    <ProductNDC>62135-112</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin</ProprietaryName>
    <NonProprietaryName>Amoxicillin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA061926</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC</LabelerName>
    <SubstanceName>AMOXICILLIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260930</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adults and Pediatric Patients. : 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. , 2 Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. , 3 Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli. , 4 Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae. .</IndicationAndUsage>
    <Description>Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin, USP molecular formula is C 16H 19N3O 5S3H 2O, and the molecular weight is 419.45. Tablets: Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&amp;C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension: Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.10 mEq (2.29 mg) of sodium. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&amp;C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 125 mg and 250 mg: FD&amp;C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable): Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules: Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&amp;C Yellow No. 10, FD&amp;C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&amp;C Red No. 28 and FD&amp;C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&amp;C Yellow No. 10 Aluminum Lake, FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Blue No. 2 Aluminum Lake, and FD&amp;C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>62135-189-24</NDCCode>
    <PackageDescription>2 TRAY in 1 BOX (62135-189-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-189-05) </PackageDescription>
    <NDC11Code>62135-0189-24</NDC11Code>
    <ProductNDC>62135-189</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Albuterol Sulfate</ProprietaryName>
    <NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
    <DosageFormName>SYRUP</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070626</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077788</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC</LabelerName>
    <SubstanceName>ALBUTEROL SULFATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250326</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Albuterol Sulfate Syrup is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
    <Description>Albuterol Sulfate Syrup contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diolsulfate (2:1) (salt) and the following chemical structure:. (C 13H 21NO 3) 2H 2SO 4 M.W. 576.7. Albuterol sulfate is a white or practically white powder freely soluble in water and slightly soluble in alcohol, in chloroform, and in ether per USP definition. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol Sulfate Syrup for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 mL). Albuterol Sulfate Syrup also contains the inactive ingredients  Purified water, hypromellose, citric acid anhydrous, sodium citrate dihydrate, sodium benzoate, sorbitol solution, strawberry flavor, and FD&amp;C Yellow # 6. The pH of the syrup is 3.2 to 4.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>62135-205-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (62135-205-05) </PackageDescription>
    <NDC11Code>62135-0205-05</NDC11Code>
    <ProductNDC>62135-205</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methimazole</ProprietaryName>
    <NonProprietaryName>Methimazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20010327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040411</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC</LabelerName>
    <SubstanceName>METHIMAZOLE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.</IndicationAndUsage>
    <Description>Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:.</Description>
  </NDC>
  <NDC>
    <NDCCode>62135-210-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (62135-210-05) </PackageDescription>
    <NDC11Code>62135-0210-05</NDC11Code>
    <ProductNDC>62135-210</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Folic Acid</ProprietaryName>
    <NonProprietaryName>Folic Acid</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190530</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090035</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC.</LabelerName>
    <SubstanceName>FOLIC ACID</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220309</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.</IndicationAndUsage>
    <Description>Folic acid, N-[ p-[[(2-amino-4-hydroxy-6-pteridinyl)methyl]-amino] benzoyl]L-glutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para-aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of folic acid are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables. Commercially available folic acid is prepared synthetically. Folic acid occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic acid is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of folic acid (sodium folate). Aqueous solutions of folic acid are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light. The structural formula of folic acid is as follows. Each tablet, for oral administration, contains 1 mg folic acid. Folic acid tablets, USP 1 mg contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, lactose monohydrate, sodium starch glycolate and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>62135-225-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (62135-225-05) </PackageDescription>
    <NDC11Code>62135-0225-05</NDC11Code>
    <ProductNDC>62135-225</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19880812</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062752</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC.</LabelerName>
    <SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by  Streptococcus pyogenes, Streptococcus pneumoniae and  Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by  Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and  Klebsiellasp .) , 3 Skin and soft tissue infections caused by  Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.) , 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox. , 5 Psittacosis caused by  Chlamydophila psittaci., 6 Infections caused by  Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum. , 7 Granuloma inquinale caused by  Klebsiella granulomatis. , 8 Relapsing fever caused by  Borreliasp. , 9 Bartonellosis caused by  Bartonella bacilliformis. , 10 Chancroid caused by  Hemophilus ducreyi. , 11 Tularemia caused by  Francisella tularensis. , 12 Plaque caused by  Yersinia pestis. , 13 Cholera caused by  Vibrio cholerae. , 14 Brucellosis caused by  Brucella species (tetracycline may be used in conjunction with an aminoglycoside). , 15 Infections due to  Campylobacter fetus. , 16 As adjunctive therapy in intestinal amebiasis caused by  Entamoeba histolytica. , 17 Urinary tract infections caused by susceptible strains of  Escherichia coli, Klebsiella,etc. , 18 Other infections caused by susceptible gram-negative organisms such as  E. coli, Enterobacter aerogenes, Shigellasp ., Acinetobactersp ., Klebsiellasp. ,and  Bacteroidessp. , 19 In severe acne, adjunctive therapy with tetracycline may be useful.</IndicationAndUsage>
    <Description>Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino) -1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is as follows. C 22H 24N 20 8·HCI    M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. Inactive Ingredients: Lactose, and magnesium stearate. The 250 mg and 500 mg capsule shells contain D&amp;C Yellow No. 10, FD&amp;C Yellow No. 6, gelatin, sodium lauryl sulfate, and titanium dioxide. The imprinting ink for the 250 mg and 500 mg capsules contains D&amp;C Yellow No. 10, FD&amp;C Blue No. 1, FD&amp;C Blue No. 2, FD&amp;C Red No. 40, iron oxide black, pharmaceutical shellac glaze, propylene glycol, n-butyl alcohol, and ferrosoferric oxide. This product complies with USP dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>62135-266-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (62135-266-05) </PackageDescription>
    <NDC11Code>62135-0266-05</NDC11Code>
    <ProductNDC>62135-266</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19880812</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062752</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC.</LabelerName>
    <SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by  Streptococcus pyogenes, Streptococcus pneumoniae and  Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by  Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and  Klebsiellasp .) , 3 Skin and soft tissue infections caused by  Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.) , 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox. , 5 Psittacosis caused by  Chlamydophila psittaci., 6 Infections caused by  Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum. , 7 Granuloma inquinale caused by  Klebsiella granulomatis. , 8 Relapsing fever caused by  Borreliasp. , 9 Bartonellosis caused by  Bartonella bacilliformis. , 10 Chancroid caused by  Hemophilus ducreyi. , 11 Tularemia caused by  Francisella tularensis. , 12 Plaque caused by  Yersinia pestis. , 13 Cholera caused by  Vibrio cholerae. , 14 Brucellosis caused by  Brucella species (tetracycline may be used in conjunction with an aminoglycoside). , 15 Infections due to  Campylobacter fetus. , 16 As adjunctive therapy in intestinal amebiasis caused by  Entamoeba histolytica. , 17 Urinary tract infections caused by susceptible strains of  Escherichia coli, Klebsiella,etc. , 18 Other infections caused by susceptible gram-negative organisms such as  E. coli, Enterobacter aerogenes, Shigellasp ., Acinetobactersp ., Klebsiellasp. ,and  Bacteroidessp. , 19 In severe acne, adjunctive therapy with tetracycline may be useful.</IndicationAndUsage>
    <Description>Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino) -1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is as follows. C 22H 24N 20 8·HCI    M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. Inactive Ingredients: Lactose, and magnesium stearate. The 250 mg and 500 mg capsule shells contain D&amp;C Yellow No. 10, FD&amp;C Yellow No. 6, gelatin, sodium lauryl sulfate, and titanium dioxide. The imprinting ink for the 250 mg and 500 mg capsules contains D&amp;C Yellow No. 10, FD&amp;C Blue No. 1, FD&amp;C Blue No. 2, FD&amp;C Red No. 40, iron oxide black, pharmaceutical shellac glaze, propylene glycol, n-butyl alcohol, and ferrosoferric oxide. This product complies with USP dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>62135-272-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (62135-272-05) </PackageDescription>
    <NDC11Code>62135-0272-05</NDC11Code>
    <ProductNDC>62135-272</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ramipril</ProprietaryName>
    <NonProprietaryName>Ramipril</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200826</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078745</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC.</LabelerName>
    <SubstanceName>RAMIPRIL</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200826</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics ( 1.1). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ( 1.3).</IndicationAndUsage>
    <Description>Ramipril, USP is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2 S, 3a S, 6a S)-1 [( S)- N-[( S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [ b]pyrrole-2-carboxylic acid, 1-ethyl ester. The inactive ingredients present are pregelatinized starch NF, gelatin, and titanium dioxide. The 1.25 mg capsule shell contains D&amp;C Yellow # 10 and FD&amp;C Yellow # 6 the 2.5 mg capsule shell contains D&amp;C Red # 28, D&amp;C Yellow # 10 and FD&amp;C Red #40, the 5 mg capsule shell contains D&amp;C Red # 28, D&amp;C Red # 33, D&amp;C Yellow # 10 and FD&amp;C Blue #1, and the 10 mg capsule shell contains D&amp;C Red # 28, and FD&amp;C Blue #1. Capsule shells are imprinted with black ink containing shellac, black iron oxide, n-butyl alcohol, propylene glycol, FD&amp;C Blue #2, FD&amp;C Red #40, D&amp;C Yellow #10 and FD&amp;C Blue #1. The structural formula for ramipril is. Its molecular formula is C 23H 32N 2O 5and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.</Description>
  </NDC>
  <NDC>
    <NDCCode>62135-273-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (62135-273-05) </PackageDescription>
    <NDC11Code>62135-0273-05</NDC11Code>
    <ProductNDC>62135-273</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ramipril</ProprietaryName>
    <NonProprietaryName>Ramipril</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200826</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078745</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC.</LabelerName>
    <SubstanceName>RAMIPRIL</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200826</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics ( 1.1). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ( 1.3).</IndicationAndUsage>
    <Description>Ramipril, USP is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2 S, 3a S, 6a S)-1 [( S)- N-[( S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [ b]pyrrole-2-carboxylic acid, 1-ethyl ester. The inactive ingredients present are pregelatinized starch NF, gelatin, and titanium dioxide. The 1.25 mg capsule shell contains D&amp;C Yellow # 10 and FD&amp;C Yellow # 6 the 2.5 mg capsule shell contains D&amp;C Red # 28, D&amp;C Yellow # 10 and FD&amp;C Red #40, the 5 mg capsule shell contains D&amp;C Red # 28, D&amp;C Red # 33, D&amp;C Yellow # 10 and FD&amp;C Blue #1, and the 10 mg capsule shell contains D&amp;C Red # 28, and FD&amp;C Blue #1. Capsule shells are imprinted with black ink containing shellac, black iron oxide, n-butyl alcohol, propylene glycol, FD&amp;C Blue #2, FD&amp;C Red #40, D&amp;C Yellow #10 and FD&amp;C Blue #1. The structural formula for ramipril is. Its molecular formula is C 23H 32N 2O 5and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.</Description>
  </NDC>
  <NDC>
    <NDCCode>62135-274-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (62135-274-05) </PackageDescription>
    <NDC11Code>62135-0274-05</NDC11Code>
    <ProductNDC>62135-274</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ramipril</ProprietaryName>
    <NonProprietaryName>Ramipril</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200826</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078745</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC.</LabelerName>
    <SubstanceName>RAMIPRIL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200826</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics ( 1.1). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ( 1.3).</IndicationAndUsage>
    <Description>Ramipril, USP is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2 S, 3a S, 6a S)-1 [( S)- N-[( S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [ b]pyrrole-2-carboxylic acid, 1-ethyl ester. The inactive ingredients present are pregelatinized starch NF, gelatin, and titanium dioxide. The 1.25 mg capsule shell contains D&amp;C Yellow # 10 and FD&amp;C Yellow # 6 the 2.5 mg capsule shell contains D&amp;C Red # 28, D&amp;C Yellow # 10 and FD&amp;C Red #40, the 5 mg capsule shell contains D&amp;C Red # 28, D&amp;C Red # 33, D&amp;C Yellow # 10 and FD&amp;C Blue #1, and the 10 mg capsule shell contains D&amp;C Red # 28, and FD&amp;C Blue #1. Capsule shells are imprinted with black ink containing shellac, black iron oxide, n-butyl alcohol, propylene glycol, FD&amp;C Blue #2, FD&amp;C Red #40, D&amp;C Yellow #10 and FD&amp;C Blue #1. The structural formula for ramipril is. Its molecular formula is C 23H 32N 2O 5and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.</Description>
  </NDC>
  <NDC>
    <NDCCode>62135-302-24</NDCCode>
    <PackageDescription>2 TRAY in 1 BOX (62135-302-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-302-05) </PackageDescription>
    <NDC11Code>62135-0302-24</NDC11Code>
    <ProductNDC>62135-302</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide</ProprietaryName>
    <NonProprietaryName>Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide</NonProprietaryName>
    <DosageFormName>SYRUP</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200417</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213125</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC</LabelerName>
    <SubstanceName>BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
    <StrengthNumber>2; 30; 10</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL; mg/5mL</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>2024-10-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241016</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.</IndicationAndUsage>
    <Description>Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a light pink colored, clear syrup with a grape flavor. Each 5 mL (1 teaspoonful) contains. Brompheniramine Maleate, USP     . . . . . . . .  2 mg. Pseudoephedrine Hydrochloride, USP . . . . . 30 mg. Dextromethorphan Hydrobromide, USP  . . . 10 mg. Alcohol 0.95% v/v. In a palatable, aromatic vehicle. Inactive Ingredients: sucrose, glycerin, ethyl alcohol, propylene glycol, methylparaben, citric acid, sodium citrate dihydrate, sodium benzoate, FD&amp;C Red No. 40, and artificial grape flavor.  It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 3.0 and 6.0. C 16H 19BrN 2C 4H 4O 4         M.W. 435.31. Brompheniramine Maleate, USP(±)-2- p-Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1). C 10H 15NOHCl                    M.W. 201.69. Pseudoephedrine Hydrochloride, USP (+)-Pseudoephedrine hydrochloride. C 18H 25NOHBrH 2O          M.W. 370.32. Dextromethorphan Hydrobromide, USP 3-Methoxy-17-methyl-9α, 13α, 14α -morphinan hydrobromide monohydrate. Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration.</Description>
  </NDC>
  <NDC>
    <NDCCode>62135-309-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-05) </PackageDescription>
    <NDC11Code>62135-0309-05</NDC11Code>
    <ProductNDC>62135-309</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciprofloxacin</ProprietaryName>
    <NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210413</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076896</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC.</LabelerName>
    <SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210413</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ciprofloxacin is 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)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C 17H 18FN 3O 3·HC·H 2O and its chemical structure is as follows:. Ciprofloxacin Tablets, USP film-coated are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide. FDA approved dissolution specifications differs from the USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>62135-330-24</NDCCode>
    <PackageDescription>2 TRAY in 1 BOX (62135-330-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-330-05) </PackageDescription>
    <NDC11Code>62135-0330-24</NDC11Code>
    <ProductNDC>62135-330</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisolone Sodium Phosphate</ProprietaryName>
    <NonProprietaryName>Prednisolone Sodium Phosphate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040525</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075988</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC.</LabelerName>
    <SubstanceName>PREDNISOLONE SODIUM PHOSPHATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241014</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisolone sodium phosphate oral solution is indicated in the following conditions. 1. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. 2. Dermatologic Diseases. Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. 3. Edematous States. To induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations, with idiopathic nephrotic syndrome, without uremia. 4. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. 5. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in: ulcerative colitis; regional enteritis. 6. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults; selected cases of secondary thrombocytopenia; acquired (autoimmune) hemolytic anemia; pure red cell aplasia; Diamond-Blackfan anemia. 7. Neoplastic Diseases. For the treatment of acute leukemia and aggressive lymphomas in adults and children. 8. Nervous System. Acute exacerbations of multiple sclerosis. 9. Ophthalmic Diseases. Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; temporal arteritis; sympathetic ophthalmia. 10. Respiratory Diseases. Symptomatic sarcoidosis; idiopathic eosinophilic pneumonias; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; asthma (as distinct from allergic asthma listed above under “Allergic States”), hypersensitivity pneumonitis, idiopathic pulmonary fibrosis, acute exacerbations of chronic obstructive pulmonary disease (COPD), and Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti-PCP antibiotics. Studies support the efficacy of systemic corticosteroids for the treatment of these conditions: allergic bronchopulmonary aspergillosis, idiopathic bronchiolitis obliterans with organizing pneumonia. 11. Rheumatic Disorders. As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; epicondylitis. For the treatment of systemic lupus erythematosus, dermatomyositis (polymyositis), polymyalgia rheumatica, Sjogren’s syndrome, relapsing polychondritis, and certain cases of vasculitis. 12. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block, tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty, and tuberculosis with pleural or pericardial effusion (appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications); Trichinosis with neurologic or myocardial involvement; acute or chronic solid organ rejection (with or without other agents).</IndicationAndUsage>
    <Description>Prednisolone sodium phosphate oral solution is a dye free, clear, colorless to slightly yellow colored, raspberry flavored solution. Each 5 mL (teaspoonful) of prednisolone sodium phosphate oral solution contains 6.7 mg prednisolone sodium phosphate (5 mg prednisolone base) in a palatable, aqueous vehicle. Prednisolone sodium phosphate oral solution also contains edetate disodium, methylparaben, purified water, sodium phosphate dibasic, sodium phosphate monobasic, sorbitol solution, and artificial raspberry flavor. Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane. The chemical name of prednisolone sodium phosphate is: pregna-1,4-diene-3,20-dione, 11,17-dihydroxy-21-(phosphonooxy)- disodium salt, (11β)-. The empirical formula is C 21H 27Na 2O 8P; the molecular weight is 484.39. Its chemical structure is. Pharmacological Category: Glucocorticoid.</Description>
  </NDC>
</NDCList>