RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>80066-663-25</NDCCode>
    <PackageDescription>25 PATCH in 1 BAG (80066-663-25)  &gt; 5 mL in 1 PATCH</PackageDescription>
    <NDC11Code>80066-0663-25</NDC11Code>
    <ProductNDC>80066-663</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer Wipe 75%</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200820</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Pharmaxx, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.75</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200820</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Alcohol Sanitizer Wipe to help reduce bacteria/germs that potentially can cause disease.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-663-09</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (10237-663-09)  &gt; 25 g in 1 TUBE</PackageDescription>
    <NDC11Code>10237-0663-09</NDC11Code>
    <ProductNDC>10237-663</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Truly Radiant</ProprietaryName>
    <ProprietaryNameSuffix>Whitening And Enamel Strengthening</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Fluoride 0.243%</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>.243</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>54864-663-15</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (54864-663-15) </PackageDescription>
    <NDC11Code>54864-0663-15</NDC11Code>
    <ProductNDC>54864-663</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20130327</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>DOTTIKON EXCLUSIVE SYNTHESIS AG</LabelerName>
    <SubstanceName>DIMETHYL FUMARATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2021-02-24</LastUpdate>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>27-MAR-13</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>54864-663-37</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (54864-663-37) </PackageDescription>
    <NDC11Code>54864-0663-37</NDC11Code>
    <ProductNDC>54864-663</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20130327</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>DOTTIKON EXCLUSIVE SYNTHESIS AG</LabelerName>
    <SubstanceName>DIMETHYL FUMARATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2021-02-24</LastUpdate>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>27-MAR-13</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>63736-663-01</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (63736-663-01)  &gt; 25 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>63736-0663-01</NDC11Code>
    <ProductNDC>63736-663</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Privine</ProprietaryName>
    <NonProprietaryName>Naphazoline Hydrochloride</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20090716</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Insight Pharmaceuticals LLC</LabelerName>
    <SubstanceName>NAPHAZOLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.125</StrengthNumber>
    <StrengthUnit>mL/25mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>for the temporary relief of nasal congestion: 1 due to a cold, 2 due to hay fever or other upper respiratory allergies, 3 helps clear nasal passages; shrinks swollen membranes, 4 temporarily restores freer breathing through the nose.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>64896-663-09</NDCCode>
    <PackageDescription>25 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-663-09) </PackageDescription>
    <NDC11Code>64896-0663-09</NDC11Code>
    <ProductNDC>64896-663</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rytary</ProprietaryName>
    <NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150112</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA203312</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>LEVODOPA; CARBIDOPA HYDRATE</SubstanceName>
    <StrengthNumber>195; 48.75</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>RYTARY is indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.</IndicationAndUsage>
    <Description>RYTARY is a combination of carbidopa, an inhibitor of aromatic amino acid decarboxylation, and levodopa, an aromatic amino acid, in extended-release capsules for oral use. Carbidopa is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.2. It is designated chemically as (-)-L-α-hydrazino-3, 4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its molecular formula is C10H14N2O4  H2O and its structural formula is. Capsule content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.2. Levodopa is a white to off-white, crystalline powder, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (−)-3-(3, 4-Dihydroxyphenyl)-L-alanine. Its molecular formula is C9H11NO4 and its structural formula is. Each extended-release capsule contains 23.75 mg carbidopa, USP and 95 mg levodopa USP, 36.25 mg carbidopa, USP and 145 mg levodopa USP, 48.75 mg carbidopa, USP and 195 mg levodopa USP, or 61.25 mg carbidopa, USP and 245 mg levodopa USP. The inactive ingredients are microcrystalline cellulose, mannitol, tartaric acid, ethyl cellulose, hypromellose, sodium starch glycolate, sodium lauryl sulfate, povidone, talc, methacrylic acid copolymers, triethyl citrate, croscarmellose sodium, and magnesium stearate. All capsule shells contain gelatin and titanium dioxide. In addition, all blue capsule shells contain FD&amp;C Blue #2 and yellow iron oxide. All yellow capsule shells contain yellow iron oxide. All capsules imprinted with blue pharmaceutical ink contain FD&amp;C Blue #2, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>71052-663-25</NDCCode>
    <PackageDescription>25 g in 1 CONTAINER (71052-663-25) </PackageDescription>
    <NDC11Code>71052-0663-25</NDC11Code>
    <ProductNDC>71052-663</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Dorzolamide Hcl</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20200624</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>DARMERICA, LLC</LabelerName>
    <SubstanceName>DORZOLAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>g/1000g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>16-JUL-20</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>16571-663-01</NDCCode>
    <PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE (16571-663-01) </PackageDescription>
    <NDC11Code>16571-0663-01</NDC11Code>
    <ProductNDC>16571-663</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200115</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA010721</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, 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>2025-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200115</StartMarketingDatePackage>
    <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, 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 Inactive ingredients for the tablets are: corn starch; dibasic calcium phosphate; magnesium stearate; polyethylene glycol; sucrose. The 12.5 mg tablets also contain: FD&amp;C Blue # 1. The 25 mg tablets also contain: FD&amp;C Yellow # 6 and D&amp;C Yellow # 10. The 50 mg tablets also contain: FD&amp;C Blue # 1, FD&amp;C Yellow # 6 and D&amp;C Yellow # 10. 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. Each meclizine hydrochloride 50 mg tablet contains 50 mg of meclizine dihydrochloride equivalent to 42.14 mg of meclizine free base.Chewable Tablets Inactive ingredients for the chewable tablets are: corn starch, colloidal silicon dioxide, FD&amp;C Red # 40, lactose monohydrate, magnesium stearate, raspberry flavor, saccharin sodium, and talc. Each meclizine hydrochloride 25 mg chewable tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base.</Description>
  </NDC>
  <NDC>
    <NDCCode>16714-663-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (16714-663-01) </PackageDescription>
    <NDC11Code>16714-0663-01</NDC11Code>
    <ProductNDC>16714-663</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080131</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078787</ApplicationNumber>
    <LabelerName>NorthStar Rx LLC</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080131</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .</IndicationAndUsage>
    <Description>The active ingredient in gabapentin capsules, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each capsule contains the following inactive ingredients: corn starch and talc. The empty hard gelatin capsule shell consists of gelatin, sodium lauryl sulfate, and titanium dioxide. In addition 300 mg also contains yellow iron oxide and 400 mg also contains yellow iron oxide and red iron oxide. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>16714-663-02</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (16714-663-02) </PackageDescription>
    <NDC11Code>16714-0663-02</NDC11Code>
    <ProductNDC>16714-663</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080131</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078787</ApplicationNumber>
    <LabelerName>NorthStar Rx LLC</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080131</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .</IndicationAndUsage>
    <Description>The active ingredient in gabapentin capsules, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each capsule contains the following inactive ingredients: corn starch and talc. The empty hard gelatin capsule shell consists of gelatin, sodium lauryl sulfate, and titanium dioxide. In addition 300 mg also contains yellow iron oxide and 400 mg also contains yellow iron oxide and red iron oxide. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-663-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (21695-663-90)</PackageDescription>
    <NDC11Code>21695-0663-90</NDC11Code>
    <ProductNDC>21695-663</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lyrica</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050610</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021724</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>LYRICA is indicated for.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>23155-663-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (23155-663-01) </PackageDescription>
    <NDC11Code>23155-0663-01</NDC11Code>
    <ProductNDC>23155-663</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Calcitriol</ProprietaryName>
    <NonProprietaryName>Calcitriol</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180529</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091356</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CALCITRIOL</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Predialysis Patients. Calcitriol capsule is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients. Calcitriol capsule is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Hypoparathyroidism Patients. Calcitriol capsule is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypopara-thyroidism.</IndicationAndUsage>
    <Description>Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol is available as capsules containing 0.25 mcg or 0.5 mcg calcitriol All dosage forms contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules contain medium chain triglycerides. Gelatin capsule shells contain glycerin, sorbitol, with the following dye systems: 0.25 mcg FD&amp;C Yellow No. 6, FD&amp;C red No.3 and titanium dioxide; 0.5 mcg- FD&amp;C Yellow No. 6, FD&amp;C red No.3 and titanium dioxide. The imprinting ink contains propylene glycol, shellac, black iron oxide, isopropyl alcohol, N-butyl alcohol and ammonium hydroxide. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol is 9, 10-seco(5Z,7E)-5,7,10(19) cholestatriene-1α, 3β, 25-triol and has the following structural formula. The other names frequently used for calcitriol are lα,25-dihydroxy-cholecalciferol, 1, 25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC.</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-663-01</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 BOX (33261-663-01)  &gt; 9 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>33261-0663-01</NDC11Code>
    <ProductNDC>33261-663</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sumatriptan</ProprietaryName>
    <NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090817</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078327</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Sumatriptan tablets, USP are indicated for the acute treatment of migraine with or without aura in adults.Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, USP, reconsider the diagnosis of migraine before sumatriptan tablets, USP are administered to treat any subsequent attacks. , 2 Sumatriptan tablets, USP are not indicated for the prevention of migraine attacks. , 3 Safety and effectiveness of sumatriptan tablets, USP have not been established for cluster headache. .</IndicationAndUsage>
    <Description>Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole­-5-methanesulfonamide succinate (1:1), and it has the following structure. The molecular formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline.Each sumatriptan tablet, USP for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, polysorbate 80, and sodium bicarbonate.</Description>
  </NDC>
  <NDC>
    <NDCCode>55111-663-01</NDCCode>
    <PackageDescription>100 CAPSULE, LIQUID FILLED in 1 BOTTLE (55111-663-01)</PackageDescription>
    <NDC11Code>55111-0663-01</NDC11Code>
    <ProductNDC>55111-663</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paricalcitol</ProprietaryName>
    <NonProprietaryName>Paricalcitol</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140625</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091412</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>PARICALCITOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2017-11-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140625</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Paricalcitol USP, the active ingredient in paricalcitol capsules, is a synthetically manufactured, metabolically active vitamin D analog of calcitriol with modifications to the side chain (D2) and the A (19-nor) ring. Paricalcitol capsules are available as hard gelatin capsules for oral administration containing 1 microgram, 2 micrograms or 4 micrograms of paricalcitol. Each capsule also contains butylated hydroxytoluene, dehydrated ethanol, medium chain triglycerides and polyoxyl 35 castor oil. The medium chain triglycerides are fractionated from coconut oil or palm kernel oil. The capsule shell is composed of gelatin, sodium lauryl sulfate and titanium dioxide. The gelatin solution is composed of gelatin (210 bloom), red iron oxide (for 1 micrograms and 2 micrograms), yellow iron oxide (for 2 micrograms and 4 micrograms) and polysorbate 80. Paricalcitol is a white to almost white powder with the molecular formula of C27H44O3, which corresponds to a molecular weight of 416.64. Paricalcitol is chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>55111-663-05</NDCCode>
    <PackageDescription>500 CAPSULE, LIQUID FILLED in 1 BOTTLE (55111-663-05)</PackageDescription>
    <NDC11Code>55111-0663-05</NDC11Code>
    <ProductNDC>55111-663</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paricalcitol</ProprietaryName>
    <NonProprietaryName>Paricalcitol</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140625</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091412</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>PARICALCITOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2017-11-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140625</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Paricalcitol USP, the active ingredient in paricalcitol capsules, is a synthetically manufactured, metabolically active vitamin D analog of calcitriol with modifications to the side chain (D2) and the A (19-nor) ring. Paricalcitol capsules are available as hard gelatin capsules for oral administration containing 1 microgram, 2 micrograms or 4 micrograms of paricalcitol. Each capsule also contains butylated hydroxytoluene, dehydrated ethanol, medium chain triglycerides and polyoxyl 35 castor oil. The medium chain triglycerides are fractionated from coconut oil or palm kernel oil. The capsule shell is composed of gelatin, sodium lauryl sulfate and titanium dioxide. The gelatin solution is composed of gelatin (210 bloom), red iron oxide (for 1 micrograms and 2 micrograms), yellow iron oxide (for 2 micrograms and 4 micrograms) and polysorbate 80. Paricalcitol is a white to almost white powder with the molecular formula of C27H44O3, which corresponds to a molecular weight of 416.64. Paricalcitol is chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>55111-663-30</NDCCode>
    <PackageDescription>30 CAPSULE, LIQUID FILLED in 1 BOTTLE (55111-663-30)</PackageDescription>
    <NDC11Code>55111-0663-30</NDC11Code>
    <ProductNDC>55111-663</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paricalcitol</ProprietaryName>
    <NonProprietaryName>Paricalcitol</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140625</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091412</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>PARICALCITOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2017-11-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140625</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Paricalcitol USP, the active ingredient in paricalcitol capsules, is a synthetically manufactured, metabolically active vitamin D analog of calcitriol with modifications to the side chain (D2) and the A (19-nor) ring. Paricalcitol capsules are available as hard gelatin capsules for oral administration containing 1 microgram, 2 micrograms or 4 micrograms of paricalcitol. Each capsule also contains butylated hydroxytoluene, dehydrated ethanol, medium chain triglycerides and polyoxyl 35 castor oil. The medium chain triglycerides are fractionated from coconut oil or palm kernel oil. The capsule shell is composed of gelatin, sodium lauryl sulfate and titanium dioxide. The gelatin solution is composed of gelatin (210 bloom), red iron oxide (for 1 micrograms and 2 micrograms), yellow iron oxide (for 2 micrograms and 4 micrograms) and polysorbate 80. Paricalcitol is a white to almost white powder with the molecular formula of C27H44O3, which corresponds to a molecular weight of 416.64. Paricalcitol is chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>55111-663-81</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (55111-663-81)  &gt; 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (55111-663-79)</PackageDescription>
    <NDC11Code>55111-0663-81</NDC11Code>
    <ProductNDC>55111-663</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paricalcitol</ProprietaryName>
    <NonProprietaryName>Paricalcitol</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140625</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091412</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>PARICALCITOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2017-11-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140625</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Paricalcitol USP, the active ingredient in paricalcitol capsules, is a synthetically manufactured, metabolically active vitamin D analog of calcitriol with modifications to the side chain (D2) and the A (19-nor) ring. Paricalcitol capsules are available as hard gelatin capsules for oral administration containing 1 microgram, 2 micrograms or 4 micrograms of paricalcitol. Each capsule also contains butylated hydroxytoluene, dehydrated ethanol, medium chain triglycerides and polyoxyl 35 castor oil. The medium chain triglycerides are fractionated from coconut oil or palm kernel oil. The capsule shell is composed of gelatin, sodium lauryl sulfate and titanium dioxide. The gelatin solution is composed of gelatin (210 bloom), red iron oxide (for 1 micrograms and 2 micrograms), yellow iron oxide (for 2 micrograms and 4 micrograms) and polysorbate 80. Paricalcitol is a white to almost white powder with the molecular formula of C27H44O3, which corresponds to a molecular weight of 416.64. Paricalcitol is chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>55150-262-03</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (55150-262-03)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>55150-0262-03</NDC11Code>
    <ProductNDC>55150-262</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylprednisolone Sodium Succinate</ProprietaryName>
    <NonProprietaryName>Methylprednisolone Sodium Succinate</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20151215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207667</ApplicationNumber>
    <LabelerName>Eugia US LLC</LabelerName>
    <SubstanceName>METHYLPREDNISOLONE SODIUM SUCCINATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of methylprednisolone sodium succinate for injection is indicated as follows:. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
    <Description>Methylprednisolone sodium succinate for injection, USP is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. Methylprednisolone sodium succinate USP is the sodium salt of methylprednisolone hemisuccinate USP, which is formed in situ, with the aid of sodium hydroxide. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below: Methylprednisolone sodium succinate USP is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly.Methylprednisolone sodium succinate for injection, USP is a sterile, white color lyophilized cake, available in preservative and preservative-free formulations: 40 mg (Single-Dose Vial): Each mL (when mixed with 1 mL of Water for Injection USP) contains 53 mg of methylprednisolone sodium succinate USP equivalent to 40 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; 25 mg lactose hydrous. This package does not contain diluent. Each mL (when mixed with 1 mL of Bacteriostatic Water for Injection USP) contains 53 mg of methylprednisolone sodium succinate USP equivalent to 40 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; 25 mg lactose hydrous. This package does not contain diluent. Recommended diluent (Bacteriostatic water) contains benzyl alcohol as a preservative. 125 mg (Single-Dose Vial): Each 2 mL (when mixed with 2 mL of Water for Injection USP) contains 165.74 mg of methylprednisolone sodium succinate USP equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.4 mg dibasic sodium phosphate dried. This package does not contain diluent. Each 2 mL (when mixed with 2 mL of Bacteriostatic Water for Injection USP) contains 165.74 mg of methylprednisolone sodium succinate USP equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.4 mg dibasic sodium phosphate dried. This package does not contain diluent. Recommended diluent (Bacteriostatic water) contains benzyl alcohol as a preservative. 500 mg (Multiple-Dose Vial): Each 8 mL (when mixed with 8 mL of Bacteriostatic Water for Injection USP) contains 663 mg of methylprednisolone sodium succinate USP equivalent to 500 mg methylprednisolone; also 6.4 mg monobasic sodium phosphate anhydrous; 69.6 mg dibasic sodium phosphate dried. This package does not contain diluent. Recommended diluent (Bacteriostatic water) contains benzyl alcohol as a preservative. 2 grams (Single-Dose Vial): Each 30.6 mL (when mixed with 30 mL of Bacteriostatic Water for Injection USP) contains 2.65 grams of methylprednisolone sodium succinate USP equivalent to 2 grams methylprednisolone; also 25.6 mg monobasic sodium phosphate anhydrous; 278 mg dibasic sodium phosphate dried. This package does not contain diluent. Recommended diluent (Bacteriostatic water) contains benzyl alcohol as a preservative. IMPORTANT — Use only Water for Injection or Bacteriostatic Water for Injection with Benzyl Alcohol as described above when reconstituting methylprednisolone sodium succinate for injection, USP. Use within 48 hours after mixing. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.</Description>
  </NDC>
  <NDC>
    <NDCCode>55150-263-03</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (55150-263-03)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>55150-0263-03</NDC11Code>
    <ProductNDC>55150-263</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylprednisolone Sodium Succinate</ProprietaryName>
    <NonProprietaryName>Methylprednisolone Sodium Succinate</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20151215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207667</ApplicationNumber>
    <LabelerName>Eugia US LLC</LabelerName>
    <SubstanceName>METHYLPREDNISOLONE SODIUM SUCCINATE</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of methylprednisolone sodium succinate for injection is indicated as follows:. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
    <Description>Methylprednisolone sodium succinate for injection, USP is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. Methylprednisolone sodium succinate USP is the sodium salt of methylprednisolone hemisuccinate USP, which is formed in situ, with the aid of sodium hydroxide. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below: Methylprednisolone sodium succinate USP is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly.Methylprednisolone sodium succinate for injection, USP is a sterile, white color lyophilized cake, available in preservative and preservative-free formulations: 40 mg (Single-Dose Vial): Each mL (when mixed with 1 mL of Water for Injection USP) contains 53 mg of methylprednisolone sodium succinate USP equivalent to 40 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; 25 mg lactose hydrous. This package does not contain diluent. Each mL (when mixed with 1 mL of Bacteriostatic Water for Injection USP) contains 53 mg of methylprednisolone sodium succinate USP equivalent to 40 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; 25 mg lactose hydrous. This package does not contain diluent. Recommended diluent (Bacteriostatic water) contains benzyl alcohol as a preservative. 125 mg (Single-Dose Vial): Each 2 mL (when mixed with 2 mL of Water for Injection USP) contains 165.74 mg of methylprednisolone sodium succinate USP equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.4 mg dibasic sodium phosphate dried. This package does not contain diluent. Each 2 mL (when mixed with 2 mL of Bacteriostatic Water for Injection USP) contains 165.74 mg of methylprednisolone sodium succinate USP equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.4 mg dibasic sodium phosphate dried. This package does not contain diluent. Recommended diluent (Bacteriostatic water) contains benzyl alcohol as a preservative. 500 mg (Multiple-Dose Vial): Each 8 mL (when mixed with 8 mL of Bacteriostatic Water for Injection USP) contains 663 mg of methylprednisolone sodium succinate USP equivalent to 500 mg methylprednisolone; also 6.4 mg monobasic sodium phosphate anhydrous; 69.6 mg dibasic sodium phosphate dried. This package does not contain diluent. Recommended diluent (Bacteriostatic water) contains benzyl alcohol as a preservative. 2 grams (Single-Dose Vial): Each 30.6 mL (when mixed with 30 mL of Bacteriostatic Water for Injection USP) contains 2.65 grams of methylprednisolone sodium succinate USP equivalent to 2 grams methylprednisolone; also 25.6 mg monobasic sodium phosphate anhydrous; 278 mg dibasic sodium phosphate dried. This package does not contain diluent. Recommended diluent (Bacteriostatic water) contains benzyl alcohol as a preservative. IMPORTANT — Use only Water for Injection or Bacteriostatic Water for Injection with Benzyl Alcohol as described above when reconstituting methylprednisolone sodium succinate for injection, USP. Use within 48 hours after mixing. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.</Description>
  </NDC>
  <NDC>
    <NDCCode>55150-264-20</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (55150-264-20)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>55150-0264-20</NDC11Code>
    <ProductNDC>55150-264</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylprednisolone Sodium Succinate</ProprietaryName>
    <NonProprietaryName>Methylprednisolone Sodium Succinate</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20151215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207667</ApplicationNumber>
    <LabelerName>Eugia US LLC</LabelerName>
    <SubstanceName>METHYLPREDNISOLONE SODIUM SUCCINATE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of methylprednisolone sodium succinate for injection is indicated as follows:. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
    <Description>Methylprednisolone sodium succinate for injection, USP is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. Methylprednisolone sodium succinate USP is the sodium salt of methylprednisolone hemisuccinate USP, which is formed in situ, with the aid of sodium hydroxide. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below: Methylprednisolone sodium succinate USP is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly.Methylprednisolone sodium succinate for injection, USP is a sterile, white color lyophilized cake, available in preservative and preservative-free formulations: 40 mg (Single-Dose Vial): Each mL (when mixed with 1 mL of Water for Injection USP) contains 53 mg of methylprednisolone sodium succinate USP equivalent to 40 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; 25 mg lactose hydrous. This package does not contain diluent. Each mL (when mixed with 1 mL of Bacteriostatic Water for Injection USP) contains 53 mg of methylprednisolone sodium succinate USP equivalent to 40 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; 25 mg lactose hydrous. This package does not contain diluent. Recommended diluent (Bacteriostatic water) contains benzyl alcohol as a preservative. 125 mg (Single-Dose Vial): Each 2 mL (when mixed with 2 mL of Water for Injection USP) contains 165.74 mg of methylprednisolone sodium succinate USP equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.4 mg dibasic sodium phosphate dried. This package does not contain diluent. Each 2 mL (when mixed with 2 mL of Bacteriostatic Water for Injection USP) contains 165.74 mg of methylprednisolone sodium succinate USP equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.4 mg dibasic sodium phosphate dried. This package does not contain diluent. Recommended diluent (Bacteriostatic water) contains benzyl alcohol as a preservative. 500 mg (Multiple-Dose Vial): Each 8 mL (when mixed with 8 mL of Bacteriostatic Water for Injection USP) contains 663 mg of methylprednisolone sodium succinate USP equivalent to 500 mg methylprednisolone; also 6.4 mg monobasic sodium phosphate anhydrous; 69.6 mg dibasic sodium phosphate dried. This package does not contain diluent. Recommended diluent (Bacteriostatic water) contains benzyl alcohol as a preservative. 2 grams (Single-Dose Vial): Each 30.6 mL (when mixed with 30 mL of Bacteriostatic Water for Injection USP) contains 2.65 grams of methylprednisolone sodium succinate USP equivalent to 2 grams methylprednisolone; also 25.6 mg monobasic sodium phosphate anhydrous; 278 mg dibasic sodium phosphate dried. This package does not contain diluent. Recommended diluent (Bacteriostatic water) contains benzyl alcohol as a preservative. IMPORTANT — Use only Water for Injection or Bacteriostatic Water for Injection with Benzyl Alcohol as described above when reconstituting methylprednisolone sodium succinate for injection, USP. Use within 48 hours after mixing. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.</Description>
  </NDC>
  <NDC>
    <NDCCode>55150-265-50</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (55150-265-50)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>55150-0265-50</NDC11Code>
    <ProductNDC>55150-265</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylprednisolone Sodium Succinate</ProprietaryName>
    <NonProprietaryName>Methylprednisolone Sodium Succinate</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20151215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207667</ApplicationNumber>
    <LabelerName>Eugia US LLC</LabelerName>
    <SubstanceName>METHYLPREDNISOLONE SODIUM SUCCINATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of methylprednisolone sodium succinate for injection is indicated as follows:. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
    <Description>Methylprednisolone sodium succinate for injection, USP is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. Methylprednisolone sodium succinate USP is the sodium salt of methylprednisolone hemisuccinate USP, which is formed in situ, with the aid of sodium hydroxide. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below: Methylprednisolone sodium succinate USP is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly.Methylprednisolone sodium succinate for injection, USP is a sterile, white color lyophilized cake, available in preservative and preservative-free formulations: 40 mg (Single-Dose Vial): Each mL (when mixed with 1 mL of Water for Injection USP) contains 53 mg of methylprednisolone sodium succinate USP equivalent to 40 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; 25 mg lactose hydrous. This package does not contain diluent. Each mL (when mixed with 1 mL of Bacteriostatic Water for Injection USP) contains 53 mg of methylprednisolone sodium succinate USP equivalent to 40 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; 25 mg lactose hydrous. This package does not contain diluent. Recommended diluent (Bacteriostatic water) contains benzyl alcohol as a preservative. 125 mg (Single-Dose Vial): Each 2 mL (when mixed with 2 mL of Water for Injection USP) contains 165.74 mg of methylprednisolone sodium succinate USP equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.4 mg dibasic sodium phosphate dried. This package does not contain diluent. Each 2 mL (when mixed with 2 mL of Bacteriostatic Water for Injection USP) contains 165.74 mg of methylprednisolone sodium succinate USP equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.4 mg dibasic sodium phosphate dried. This package does not contain diluent. Recommended diluent (Bacteriostatic water) contains benzyl alcohol as a preservative. 500 mg (Multiple-Dose Vial): Each 8 mL (when mixed with 8 mL of Bacteriostatic Water for Injection USP) contains 663 mg of methylprednisolone sodium succinate USP equivalent to 500 mg methylprednisolone; also 6.4 mg monobasic sodium phosphate anhydrous; 69.6 mg dibasic sodium phosphate dried. This package does not contain diluent. Recommended diluent (Bacteriostatic water) contains benzyl alcohol as a preservative. 2 grams (Single-Dose Vial): Each 30.6 mL (when mixed with 30 mL of Bacteriostatic Water for Injection USP) contains 2.65 grams of methylprednisolone sodium succinate USP equivalent to 2 grams methylprednisolone; also 25.6 mg monobasic sodium phosphate anhydrous; 278 mg dibasic sodium phosphate dried. This package does not contain diluent. Recommended diluent (Bacteriostatic water) contains benzyl alcohol as a preservative. IMPORTANT — Use only Water for Injection or Bacteriostatic Water for Injection with Benzyl Alcohol as described above when reconstituting methylprednisolone sodium succinate for injection, USP. Use within 48 hours after mixing. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.</Description>
  </NDC>
  <NDC>
    <NDCCode>60687-663-21</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 CARTON (60687-663-21)  / 1 TABLET in 1 BLISTER PACK (60687-663-11) </PackageDescription>
    <NDC11Code>60687-0663-21</NDC11Code>
    <ProductNDC>60687-663</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metaxalone</ProprietaryName>
    <NonProprietaryName>Metaxalone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230106</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207466</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>METAXALONE</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230106</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metaxalone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
    <Description>Metaxalone Tablets, USP are available as an 800 mg, capsule shaped, scored pink tablet. Chemically, metaxalone, USP is 5-[(3,5-dimethylphenoxy)methyl]-2-oxazolidinone. The empirical formula is C 12H 15NO 3, which corresponds to a molecular weight of 221.25. The structural formula is:. Metaxalone, USP is a white to almost white, crystalline powder freely soluble in dichloromethane, soluble in methanol, sparingly soluble in ethanol and ethyl acetate, slightly soluble in toluene and isopropanol, insoluble in water and n-hexane. Each tablet contains 800 mg metaxalone, USP and the following inactive ingredients: alginic acid, corn starch, ferric oxide red, copovidone, magnesium stearate, povidone, pregelatinized starch, sodium alginate.</Description>
  </NDC>
  <NDC>
    <NDCCode>60760-663-90</NDCCode>
    <PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-663-90) </PackageDescription>
    <NDC11Code>60760-0663-90</NDC11Code>
    <ProductNDC>60760-663</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metoprolol Succinate</ProprietaryName>
    <NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203894</ApplicationNumber>
    <LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
    <SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metoprolol succinate extended-release tablets, are a beta-adrenergic blocker indicated for the treatment of:  : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure (1.3).</IndicationAndUsage>
    <Description>Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. Metoprolol succinate has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate extended-release tablets in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in alcohol and slightly soluble in isopropyl alcohol. Each metoprolol succinate extended-release tablet intended for oral administration contains metoprolol succinate equivalent to 25 mg, 50 mg, 100 mg or 200 mg of metoprolol tartrate. In addition, each tablet contains the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, glycerin, hypromellose, magnesium stearate, methyl cellulose, microcrystalline cellulose, polyethylene glycol, povidone and talc. Additionally, each metoprolol succinate extended-release tablets contain opadry white 03B580069 which contains hypromellose, polyethylene glycol and titanium dioxide. Meets USP Dissolution Test 4.</Description>
  </NDC>
  <NDC>
    <NDCCode>60846-663-01</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60846-663-01) </PackageDescription>
    <NDC11Code>60846-0663-01</NDC11Code>
    <ProductNDC>60846-663</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rytary</ProprietaryName>
    <NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250625</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA203312</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
    <StrengthNumber>48.75; 195</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250625</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>RYTARY is indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.</IndicationAndUsage>
    <Description>RYTARY is a combination of carbidopa, an inhibitor of aromatic amino acid decarboxylation, and levodopa, an aromatic amino acid, in extended-release capsules for oral use. Carbidopa is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.2. It is designated chemically as (-)-L-α-hydrazino-3, 4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its molecular formula is C10H14N2O4  H2O and its structural formula is. Capsule content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.2. Levodopa is a white to off-white, crystalline powder, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (−)-3-(3, 4-Dihydroxyphenyl)-L-alanine. Its molecular formula is C9H11NO4 and its structural formula is. Each extended-release capsule contains 23.75 mg carbidopa, USP and 95 mg levodopa USP, 36.25 mg carbidopa, USP and 145 mg levodopa USP, 48.75 mg carbidopa, USP and 195 mg levodopa USP, or 61.25 mg carbidopa, USP and 245 mg levodopa USP. The inactive ingredients are microcrystalline cellulose, mannitol, tartaric acid, ethyl cellulose, hypromellose, sodium starch glycolate, sodium lauryl sulfate, povidone, talc, methacrylic acid copolymers, triethyl citrate, croscarmellose sodium, and magnesium stearate. All capsule shells contain gelatin and titanium dioxide. In addition, all blue capsule shells contain FD&amp;C Blue #2 and yellow iron oxide. All yellow capsule shells contain yellow iron oxide. All capsules imprinted with blue pharmaceutical ink contain FD&amp;C Blue #2, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>61786-663-02</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE (61786-663-02)</PackageDescription>
    <NDC11Code>61786-0663-02</NDC11Code>
    <ProductNDC>61786-663</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azithromycin</ProprietaryName>
    <NonProprietaryName>Azithromycin</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160413</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065246</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-07-25</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>62207-663-21</NDCCode>
    <PackageDescription>1 POUCH in 1 BOX (62207-663-21)  &gt; 5000 CAPSULE in 1 POUCH</PackageDescription>
    <NDC11Code>62207-0663-21</NDC11Code>
    <ProductNDC>62207-663</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Acetaminophen And Diphenhydramine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <StartMarketingDate>20091211</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Granules India Limited</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>62207-663-22</NDCCode>
    <PackageDescription>1 POUCH in 1 BOX (62207-663-22)  &gt; 25000 CAPSULE in 1 POUCH</PackageDescription>
    <NDC11Code>62207-0663-22</NDC11Code>
    <ProductNDC>62207-663</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Acetaminophen And Diphenhydramine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <StartMarketingDate>20091211</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Granules India Limited</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>62207-663-23</NDCCode>
    <PackageDescription>1 POUCH in 1 BOX (62207-663-23)  &gt; 30000 CAPSULE in 1 POUCH</PackageDescription>
    <NDC11Code>62207-0663-23</NDC11Code>
    <ProductNDC>62207-663</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Acetaminophen And Diphenhydramine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <StartMarketingDate>20091211</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Granules India Limited</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>62207-663-31</NDCCode>
    <PackageDescription>5000 CAPSULE in 1 POUCH (62207-663-31)</PackageDescription>
    <NDC11Code>62207-0663-31</NDC11Code>
    <ProductNDC>62207-663</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Acetaminophen And Diphenhydramine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <StartMarketingDate>20091211</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Granules India Limited</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>62207-663-32</NDCCode>
    <PackageDescription>10000 CAPSULE in 1 POUCH (62207-663-32)</PackageDescription>
    <NDC11Code>62207-0663-32</NDC11Code>
    <ProductNDC>62207-663</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Acetaminophen And Diphenhydramine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <StartMarketingDate>20091211</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Granules India Limited</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
</NDCList>