RESTful Lookup — Test-Drive (2007 – 2026)

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  <NDC>
    <NDCCode>59746-514-06</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (59746-514-06) </PackageDescription>
    <NDC11Code>59746-0514-06</NDC11Code>
    <ProductNDC>59746-514</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levofloxacin</ProprietaryName>
    <NonProprietaryName>Levofloxacin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203613</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>LEVOFLOXACIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59746-514-14</NDCCode>
    <PackageDescription>50 TABLET, FILM COATED in 1 BOTTLE (59746-514-14) </PackageDescription>
    <NDC11Code>59746-0514-14</NDC11Code>
    <ProductNDC>59746-514</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levofloxacin</ProprietaryName>
    <NonProprietaryName>Levofloxacin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203613</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>LEVOFLOXACIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59746-514-32</NDCCode>
    <PackageDescription>10 TABLET, FILM COATED in 1 BLISTER PACK (59746-514-32) </PackageDescription>
    <NDC11Code>59746-0514-32</NDC11Code>
    <ProductNDC>59746-514</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levofloxacin</ProprietaryName>
    <NonProprietaryName>Levofloxacin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203613</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>LEVOFLOXACIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>11673-514-06</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (11673-514-06)  &gt; 160 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
    <NDC11Code>11673-0514-06</NDC11Code>
    <ProductNDC>11673-514</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Up And Up Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181228</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203599</ApplicationNumber>
    <LabelerName>Target Corporation</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-07-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>51511-514-06</NDCCode>
    <PackageDescription>2400 POUCH in 1 BOX (51511-514-06)  &gt; 6 STRIP in 1 POUCH</PackageDescription>
    <NDC11Code>51511-0514-06</NDC11Code>
    <ProductNDC>51511-514</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Salicylic Acid Corn Remover</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>STRIP</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part358B</ApplicationNumber>
    <LabelerName>ASO Pharmaceutical Co. Ltd.</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-11</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>51862-514-06</NDCCode>
    <PackageDescription>6 BLISTER PACK in 1 CARTON (51862-514-06)  &gt; 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>51862-0514-06</NDC11Code>
    <ProductNDC>51862-514</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desogestrel And Ethinyl Estradiol</ProprietaryName>
    <NonProprietaryName>Desogestrel And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20201004</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091234</ApplicationNumber>
    <LabelerName>Mayne Pharma Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2022-12-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201004</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Desogestrel and ethinyl estradiol tablets have not been studied for and is not indicated for use in emergency contraception.</IndicationAndUsage>
    <Description>Desogestrel and ethinyl estradiol tablets, USP provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each "active" orange tablet with "S3" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitamin E, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&amp;C Yellow #10 Aluminum Lake, FD&amp;C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&amp;C Red #40 Aluminum Lake, FD&amp;C Blue #2 Aluminum Lake. Each "inactive" reminder white, biconvex, round tablets with "P" debossed on one side and "N" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>53113-514-06</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (53113-514-06)  / 180 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>53113-0514-06</NDC11Code>
    <ProductNDC>53113-514</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dr. Sana Cough And Chest Congestion Dm</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hydrobromide, Guaifenesin</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250414</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>GADAL Laboratories, Inc</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
    <StrengthNumber>20; 200</StrengthNumber>
    <StrengthUnit>mg/30mL; mg/30mL</StrengthUnit>
    <Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250414</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59279-514-06</NDCCode>
    <PackageDescription>180 mL in 1 BOTTLE, PLASTIC (59279-514-06)</PackageDescription>
    <NDC11Code>59279-0514-06</NDC11Code>
    <ProductNDC>59279-514</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Therapeutic</ProprietaryName>
    <NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
    <DosageFormName>RINSE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20070101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part358H</ApplicationNumber>
    <LabelerName>Mediceutical Laboratories, LTD</LabelerName>
    <SubstanceName>PYRITHIONE ZINC</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>62980-514-06</NDCCode>
    <PackageDescription>35 TABLET, FILM COATED in 1 CARTON (62980-514-06) </PackageDescription>
    <NDC11Code>62980-0514-06</NDC11Code>
    <ProductNDC>62980-514</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranitidine</ProprietaryName>
    <ProprietaryNameSuffix>150 Mg</ProprietaryNameSuffix>
    <NonProprietaryName>Ranitidine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210010</ApplicationNumber>
    <LabelerName>Vivimed Labs Limited</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>65162-514-06</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (65162-514-06) </PackageDescription>
    <NDC11Code>65162-0514-06</NDC11Code>
    <ProductNDC>65162-514</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Spironolactone</ProprietaryName>
    <NonProprietaryName>Spironolactone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100802</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091426</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>SPIRONOLACTONE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100802</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Spironolactone tablets are an aldosterone antagonist indicated for: 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1)., 2 Use as an add-on therapy 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 (1.2)., 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3)., 4 Treatment of primary hyperaldosternism for: (1.4).</IndicationAndUsage>
    <Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula:. Spironolactone, USP is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, corn starch, croscarmellose sodium, peppermint flavor, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide, and triacetin. The 50 mg tablet also contains D&amp;C yellow # 10 and FD&amp;C yellow # 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-514-06</NDCCode>
    <PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-514-06) </PackageDescription>
    <NDC11Code>68001-0514-06</NDC11Code>
    <ProductNDC>68001-514</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine Fumarate</ProprietaryName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210831</StartMarketingDate>
    <EndMarketingDate>20250831</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090681</ApplicationNumber>
    <LabelerName>Bluepoint Laboratories</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210831</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine Extended-release tablet is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants    (1.3).</IndicationAndUsage>
    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2C 4H 4O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine Extended-release tablets, USP are supplied for oral administration as 150 mg (white), 200 mg (yellow), 300 mg (light yellow), and 400 mg (white). All tablets are round shaped and film coated. Inactive ingredients for quetiapine extended-release tablets, USP are lactose monohydrate, sodium chloride, hydroxypropyl methylcellulose, povidone K30, talc and magnesium stearate. The film coating for all quetiapine extended-release tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, iron oxide yellow (200 and 300 mg tablets) is included in the film coating of specific strengths. Each 150 mg tablet contains 173 mg of quetiapine fumarate, USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230 mg of quetiapine fumarate, USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345 mg of quetiapine fumarate, USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 461 mg of quetiapine fumarate, USP equivalent to 400 mg quetiapine. Quetiapine Extended-release tablets, USP meet USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-514-06</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (68382-514-06) </PackageDescription>
    <NDC11Code>68382-0514-06</NDC11Code>
    <ProductNDC>68382-514</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Telmisartan And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Telmisartan And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171012</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204221</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE; TELMISARTAN</SubstanceName>
    <StrengthNumber>12.5; 80</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171012</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Telmisartan and hydrochlorothiazide tablets are 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with telmisartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy [see Clinical Studies (14)]. Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy for the treatment of hypertension [see Dosage and Administration (2.1)]. Telmisartan and hydrochlorothiazide tablets may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
    <Description>Telmisartan and hydrochlorothiazide tablets, USP are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a thiazide diuretic. Telmisartan, a non-peptide molecule, is chemically described as 4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1H  benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid.  Its molecular formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is. Telmisartan, USP is a white to slightly yellowish, crystalline powder. It is practically insoluble in water, slightly soluble in methanol, sparingly soluble in methylene chloride. It dissolves in 1 M sodium hydroxide. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water and freely soluble in sodium hydroxide solution, in n-butylamine, in dimethylformamide and sparingly soluble in methanol, insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and hydrochlorothiazide tablets, USP are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan USP and hydrochlorothiazide USP, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide red, hypromellose, lactose monohydrate, magnesium stearate, mannitol, meglumine, povidone, sodium hydroxide, sodium stearyl fumarate, sorbitol and talc. Additionally each 80 mg/25 mg contains ferric oxide yellow. USP Dissolution Test is pending. USP organic impurities procedure pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>68428-514-06</NDCCode>
    <PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (68428-514-06) </PackageDescription>
    <NDC11Code>68428-0514-06</NDC11Code>
    <ProductNDC>68428-514</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Moschus</ProprietaryName>
    <NonProprietaryName>Moschus Moschiferus Musk Sac Resin</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110311</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>MOSCHUS MOSCHIFERUS MUSK SAC RESIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-04-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110311</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59746-001-06</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (59746-001-06) </PackageDescription>
    <NDC11Code>59746-0001-06</NDC11Code>
    <ProductNDC>59746-001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylprednisolone</ProprietaryName>
    <NonProprietaryName>Methylprednisolone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19971031</StartMarketingDate>
    <EndMarketingDate>20260501</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040189</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>METHYLPREDNISOLONE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19971031</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260501</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methylprednisolone Tablets are indicated in the following conditions. 1.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. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2.Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Synovitis of osteoarthritis. Acute nonspecific tenosynovitis. Post-traumatic osteoarthritis. Psoriatic arthritis. Epicondylitis. Acute gouty arthritis. 3.Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. 4.Dermatologic Diseases. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Severe seborrheic dermatitis. Exfoliative dermatitis. Mycosis fungoides. Pemphigus. Severe psoriasis. 5.Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitis. Drug hypersensitivity reactions. Serum sickness. Contact dermatitis. Bronchial asthma. Atopic dermatitis. 6.Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis. Sympathetic ophthalmia. Keratitis. Optic neuritis. Allergic conjunctivitis. Chorioretinitis. Iritis and iridocyclitis. 7.Respiratory Diseases. Symptomatic sarcoidosis. Berylliosis. Loeffler’s syndrome not manageable by other means. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. 8.Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 9.Neoplastic Diseases. For palliative management of:. Leukemias and lymphomas in adults. Acute leukemia of childhood. 10.Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11.Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:. Ulcerative colitis. Regional enteritis. 12.Nervous System. Acute exacerbations of multiple sclerosis. 13.Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>Methylprednisolone Tablets, USP contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11, 17, 21-trihydroxy-6- methyl-,(6α,11β)- and the molecular weight is 374.48. The structural formula is represented below. C22H30O5. Methylprednisolone Tablets USP for oral administration, are available as scored tablets in the following strengths: 4 mg, 8 mg, 16 mg, and 32 mg. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous (4 mg and 8 mg), lactose monohydrate (16 mg and 32 mg), magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>59746-002-06</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (59746-002-06) </PackageDescription>
    <NDC11Code>59746-0002-06</NDC11Code>
    <ProductNDC>59746-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylprednisolone</ProprietaryName>
    <NonProprietaryName>Methylprednisolone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19971031</StartMarketingDate>
    <EndMarketingDate>20260501</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040189</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>METHYLPREDNISOLONE</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19971031</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260501</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methylprednisolone Tablets are indicated in the following conditions. 1.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. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2.Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Synovitis of osteoarthritis. Acute nonspecific tenosynovitis. Post-traumatic osteoarthritis. Psoriatic arthritis. Epicondylitis. Acute gouty arthritis. 3.Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. 4.Dermatologic Diseases. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Severe seborrheic dermatitis. Exfoliative dermatitis. Mycosis fungoides. Pemphigus. Severe psoriasis. 5.Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitis. Drug hypersensitivity reactions. Serum sickness. Contact dermatitis. Bronchial asthma. Atopic dermatitis. 6.Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis. Sympathetic ophthalmia. Keratitis. Optic neuritis. Allergic conjunctivitis. Chorioretinitis. Iritis and iridocyclitis. 7.Respiratory Diseases. Symptomatic sarcoidosis. Berylliosis. Loeffler’s syndrome not manageable by other means. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. 8.Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 9.Neoplastic Diseases. For palliative management of:. Leukemias and lymphomas in adults. Acute leukemia of childhood. 10.Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11.Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:. Ulcerative colitis. Regional enteritis. 12.Nervous System. Acute exacerbations of multiple sclerosis. 13.Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>Methylprednisolone Tablets, USP contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11, 17, 21-trihydroxy-6- methyl-,(6α,11β)- and the molecular weight is 374.48. The structural formula is represented below. C22H30O5. Methylprednisolone Tablets USP for oral administration, are available as scored tablets in the following strengths: 4 mg, 8 mg, 16 mg, and 32 mg. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous (4 mg and 8 mg), lactose monohydrate (16 mg and 32 mg), magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>59746-012-06</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (59746-012-06)</PackageDescription>
    <NDC11Code>59746-0012-06</NDC11Code>
    <ProductNDC>59746-012</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Folic Acid</ProprietaryName>
    <NonProprietaryName>Folic Acid</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050614</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040514</ApplicationNumber>
    <LabelerName>JUBILANT CADISTA PHARMACEUTICALS, INC.</LabelerName>
    <SubstanceName>FOLIC ACID</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-01-09</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>59746-113-06</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (59746-113-06) </PackageDescription>
    <NDC11Code>59746-0113-06</NDC11Code>
    <ProductNDC>59746-113</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prochlorperazine Maleate</ProprietaryName>
    <NonProprietaryName>Prochlorperazine Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19980301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040268</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PROCHLORPERAZINE MALEATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For control of severe nausea and vomiting. For the treatment of schizophrenia.Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines).When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS).The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
    <Description>Prochlorperazine, USP is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Prochlorperazine maleate is designated chemically as 2-chloro-10-[3-(4- methyl-1 -piperazinyl)propyl] phenothiazine maleate [molecular weight 606.10] and has the following structure. Prochlorperazine Maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate is white or pale yellow, practically odorless crystalline powder. It is practically insoluble in water and in alcohol; slightly soluble in warm chloroform.Each tablet, for oral administration contains prochlorperazine maleate equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each tablet contains the following inactive ingredients: D&amp;C yellow no. 10 aluminum lake, FD&amp;C blue no. 2 aluminum lake, FD&amp;C yellow no. 6 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>59746-115-06</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (59746-115-06) </PackageDescription>
    <NDC11Code>59746-0115-06</NDC11Code>
    <ProductNDC>59746-115</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prochlorperazine Maleate</ProprietaryName>
    <NonProprietaryName>Prochlorperazine Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19980301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040268</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PROCHLORPERAZINE MALEATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For control of severe nausea and vomiting. For the treatment of schizophrenia.Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines).When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS).The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
    <Description>Prochlorperazine, USP is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Prochlorperazine maleate is designated chemically as 2-chloro-10-[3-(4- methyl-1 -piperazinyl)propyl] phenothiazine maleate [molecular weight 606.10] and has the following structure. Prochlorperazine Maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate is white or pale yellow, practically odorless crystalline powder. It is practically insoluble in water and in alcohol; slightly soluble in warm chloroform.Each tablet, for oral administration contains prochlorperazine maleate equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each tablet contains the following inactive ingredients: D&amp;C yellow no. 10 aluminum lake, FD&amp;C blue no. 2 aluminum lake, FD&amp;C yellow no. 6 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>59746-121-06</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (59746-121-06) </PackageDescription>
    <NDC11Code>59746-0121-06</NDC11Code>
    <ProductNDC>59746-121</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Meclizine Hydrocloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100604</StartMarketingDate>
    <EndMarketingDate>20261031</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040659</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
    <SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20100604</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Meclizine hydrochloride is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.</IndicationAndUsage>
    <Description>Meclizine hydrochloride, USP a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder. It has the following structural formula. Chemically, meclizine hydrochloride is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Tablets. Meclizine hydrochloride tablets, USP are available in two different strengths: 12.5 mg and 25 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Also, meclizine hydrochloride tablets USP, 12.5 mg contains FD&amp;C blue #1 aluminum lake (11-13%) and meclizine hydrochloride tablets USP, 25 mg contains D&amp;C yellow #10 aluminum lake (15 to 20%). Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base. Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base.</Description>
  </NDC>
  <NDC>
    <NDCCode>59746-122-06</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (59746-122-06) </PackageDescription>
    <NDC11Code>59746-0122-06</NDC11Code>
    <ProductNDC>59746-122</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100604</StartMarketingDate>
    <EndMarketingDate>20261031</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040659</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
    <SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20100604</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Meclizine hydrochloride is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.</IndicationAndUsage>
    <Description>Meclizine hydrochloride, USP a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder. It has the following structural formula. Chemically, meclizine hydrochloride is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Tablets. Meclizine hydrochloride tablets, USP are available in two different strengths: 12.5 mg and 25 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Also, meclizine hydrochloride tablets USP, 12.5 mg contains FD&amp;C blue #1 aluminum lake (11-13%) and meclizine hydrochloride tablets USP, 25 mg contains D&amp;C yellow #10 aluminum lake (15 to 20%). Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base. Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base.</Description>
  </NDC>
  <NDC>
    <NDCCode>59746-171-06</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (59746-171-06) </PackageDescription>
    <NDC11Code>59746-0171-06</NDC11Code>
    <ProductNDC>59746-171</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050606</StartMarketingDate>
    <EndMarketingDate>20260501</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040611</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20050606</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260501</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisone tablets are indicated in the following conditions. 1. 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. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. 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. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. 4. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis. Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler's syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of:. Leukemias and lymphomas in adults. Acute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:. Ulcerative colitis. Regional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or, impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The molecular formula for prednisone is C21H26O5. Chemically, it is 17,21-dihydroxypregna-1,4-diene-3,11,20-trione and has the following structural formula. Molecular weight: 358.44. Prednisone is a white to practically white, odorless, crystalline powder. It melts at about 230°C with some decomposition. Prednisone is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. Each tablet, for oral administration, contains 1 mg of prednisone. Inactive Ingredients: Lactose, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>59746-172-06</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (59746-172-06) </PackageDescription>
    <NDC11Code>59746-0172-06</NDC11Code>
    <ProductNDC>59746-172</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20010829</StartMarketingDate>
    <EndMarketingDate>20260501</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040362</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20010829</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260501</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisone Tablets, USP are indicated in the following conditions. 1. 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 hyperplasiaHypercalcemia associated with cancer Nonsuppurative thyroiditis. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitis             Serum sickness            Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosisLoeffler’s syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitisRegional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or, impending block when used concurrently  with appropriate antituberculous chemotherapy            Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>Prednisone, USP is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone, USP is a white to practically white, odorless, crystalline powder.  It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy- and its molecular weight is 358.43 The structural formula is represented below. Prednisone Tablets, USP are available in 5 strengths: 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mg. In addition, each tablet contains the following inactive Ingredients: Lactose Monohydrate, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate. Also Prednisone Tablets USP, 20 mg contains FD &amp; C yellow # 6, aluminum lake, HT 15-18%.</Description>
  </NDC>
  <NDC>
    <NDCCode>59746-173-06</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (59746-173-06) </PackageDescription>
    <NDC11Code>59746-0173-06</NDC11Code>
    <ProductNDC>59746-173</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20010829</StartMarketingDate>
    <EndMarketingDate>20260501</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040362</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20010829</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260501</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisone Tablets, USP are indicated in the following conditions. 1. 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 hyperplasiaHypercalcemia associated with cancer Nonsuppurative thyroiditis. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitis             Serum sickness            Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosisLoeffler’s syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitisRegional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or, impending block when used concurrently  with appropriate antituberculous chemotherapy            Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>Prednisone, USP is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone, USP is a white to practically white, odorless, crystalline powder.  It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy- and its molecular weight is 358.43 The structural formula is represented below. Prednisone Tablets, USP are available in 5 strengths: 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mg. In addition, each tablet contains the following inactive Ingredients: Lactose Monohydrate, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate. Also Prednisone Tablets USP, 20 mg contains FD &amp; C yellow # 6, aluminum lake, HT 15-18%.</Description>
  </NDC>
  <NDC>
    <NDCCode>59746-175-06</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (59746-175-06) </PackageDescription>
    <NDC11Code>59746-0175-06</NDC11Code>
    <ProductNDC>59746-175</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20010829</StartMarketingDate>
    <EndMarketingDate>20260501</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040362</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20010829</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260501</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisone Tablets, USP are indicated in the following conditions. 1. 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 hyperplasiaHypercalcemia associated with cancer Nonsuppurative thyroiditis. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitis             Serum sickness            Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosisLoeffler’s syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitisRegional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or, impending block when used concurrently  with appropriate antituberculous chemotherapy            Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>Prednisone, USP is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone, USP is a white to practically white, odorless, crystalline powder.  It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy- and its molecular weight is 358.43 The structural formula is represented below. Prednisone Tablets, USP are available in 5 strengths: 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mg. In addition, each tablet contains the following inactive Ingredients: Lactose Monohydrate, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate. Also Prednisone Tablets USP, 20 mg contains FD &amp; C yellow # 6, aluminum lake, HT 15-18%.</Description>
  </NDC>
  <NDC>
    <NDCCode>59746-177-06</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (59746-177-06) </PackageDescription>
    <NDC11Code>59746-0177-06</NDC11Code>
    <ProductNDC>59746-177</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060404</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077563</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060404</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
    <Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217º C, and a pKa of 8.47 at 25º C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:                                            Cyclobenzaprine hydrochloride tablets USP, for oral administration, are available in the following strengths: 5 mg, 7.5 mg and 10 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. In addition, the 5 mg tablet contain FD&amp;C yellow # 6, and both the 5 mg and 10 mg tablets contain iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>59746-211-06</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (59746-211-06) </PackageDescription>
    <NDC11Code>59746-0211-06</NDC11Code>
    <ProductNDC>59746-211</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060404</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077563</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060404</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
    <Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217º C, and a pKa of 8.47 at 25º C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:                                            Cyclobenzaprine hydrochloride tablets USP, for oral administration, are available in the following strengths: 5 mg, 7.5 mg and 10 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. In addition, the 5 mg tablet contain FD&amp;C yellow # 6, and both the 5 mg and 10 mg tablets contain iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>59746-216-06</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (59746-216-06) </PackageDescription>
    <NDC11Code>59746-0216-06</NDC11Code>
    <ProductNDC>59746-216</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Spironolactone</ProprietaryName>
    <NonProprietaryName>Spironolactone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203253</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
    <SubstanceName>SPIRONOLACTONE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170404</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Spironolactone tablets are aldosterone antagonist indicated for: : 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1), 2 Use as an add-on therapy 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 (1.2), 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3)., 4 Treatment of primary hyperaldosternism for: (1.4)Short-term preoperative treatmentLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia .</IndicationAndUsage>
    <Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone, USP is freely soluble in benzene and chloroform; soluble in ethyl acetate and in alcohol, slightly soluble in ether, in methanol and in fixed oils and practically insoluble in water.   Inactive ingredients include calcium sulfate dihydrate, corn starch, ferric oxide black, ferric oxide red, ferric oxide yellow, peppermint, hypromellose, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>59746-217-06</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (59746-217-06) </PackageDescription>
    <NDC11Code>59746-0217-06</NDC11Code>
    <ProductNDC>59746-217</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Spironolactone</ProprietaryName>
    <NonProprietaryName>Spironolactone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203253</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
    <SubstanceName>SPIRONOLACTONE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170404</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Spironolactone tablets are aldosterone antagonist indicated for: : 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1), 2 Use as an add-on therapy 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 (1.2), 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3)., 4 Treatment of primary hyperaldosternism for: (1.4)Short-term preoperative treatmentLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia .</IndicationAndUsage>
    <Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone, USP is freely soluble in benzene and chloroform; soluble in ethyl acetate and in alcohol, slightly soluble in ether, in methanol and in fixed oils and practically insoluble in water.   Inactive ingredients include calcium sulfate dihydrate, corn starch, ferric oxide black, ferric oxide red, ferric oxide yellow, peppermint, hypromellose, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>59746-218-06</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (59746-218-06) </PackageDescription>
    <NDC11Code>59746-0218-06</NDC11Code>
    <ProductNDC>59746-218</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Spironolactone</ProprietaryName>
    <NonProprietaryName>Spironolactone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203253</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
    <SubstanceName>SPIRONOLACTONE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170404</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Spironolactone tablets are aldosterone antagonist indicated for: : 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1), 2 Use as an add-on therapy 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 (1.2), 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3)., 4 Treatment of primary hyperaldosternism for: (1.4)Short-term preoperative treatmentLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia .</IndicationAndUsage>
    <Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone, USP is freely soluble in benzene and chloroform; soluble in ethyl acetate and in alcohol, slightly soluble in ether, in methanol and in fixed oils and practically insoluble in water.   Inactive ingredients include calcium sulfate dihydrate, corn starch, ferric oxide black, ferric oxide red, ferric oxide yellow, peppermint, hypromellose, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>59746-382-06</NDCCode>
    <PackageDescription>100 CAPSULE, GELATIN COATED in 1 BOTTLE (59746-382-06) </PackageDescription>
    <NDC11Code>59746-0382-06</NDC11Code>
    <ProductNDC>59746-382</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080211</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078391</ApplicationNumber>
    <LabelerName>JUBILANT CADISTA PHARMACEUTICALS INC.</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080211</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrochlorothiazide capsules are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazide capsules may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors.</IndicationAndUsage>
    <Description>Hydrochlorothiazide capsules, USP 12.5 mg is the 3,4-dihydro derivative of chloro­thiazide. Its chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2; its molecular weight is 297.74; and its structural formula is. It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Hydrochlorothiazide is supplied as 12.5 mg capsules for oral use. Each capsule contains the following inactive ingredients: colloidal silicon dioxide, D&amp;C Yellow No. 10, FD&amp;C Blue No. 1, FD&amp;C Blue No. 2, FD&amp;C Red No. 40, gelatin, iron oxide black, lactose monohydrate, magnesium stearate, pregelatinized starch, propylene glycol, shellac, and titanium dioxide.</Description>
  </NDC>
</NDCList>