RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>16590-685-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (16590-685-90)</PackageDescription>
    <NDC11Code>16590-0685-90</NDC11Code>
    <ProductNDC>16590-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078858</ApplicationNumber>
    <LabelerName>STAT RX USA LLC</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.</IndicationAndUsage>
    <Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below.                          250 mg tablets: FD&amp;C Blue # 2 Lake of indigo carmine.                          500 mg tablets: Ferric oxide yellow.                          750 mg tablets: Ferric oxide red and FD&amp;C # 6 lake of sunset yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-685-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (16590-685-30)</PackageDescription>
    <NDC11Code>16590-0685-30</NDC11Code>
    <ProductNDC>16590-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078858</ApplicationNumber>
    <LabelerName>STAT RX USA LLC</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.</IndicationAndUsage>
    <Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below.                          250 mg tablets: FD&amp;C Blue # 2 Lake of indigo carmine.                          500 mg tablets: Ferric oxide yellow.                          750 mg tablets: Ferric oxide red and FD&amp;C # 6 lake of sunset yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-685-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (16590-685-60)</PackageDescription>
    <NDC11Code>16590-0685-60</NDC11Code>
    <ProductNDC>16590-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078858</ApplicationNumber>
    <LabelerName>STAT RX USA LLC</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.</IndicationAndUsage>
    <Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below.                          250 mg tablets: FD&amp;C Blue # 2 Lake of indigo carmine.                          500 mg tablets: Ferric oxide yellow.                          750 mg tablets: Ferric oxide red and FD&amp;C # 6 lake of sunset yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-685-09</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (16571-685-09) </PackageDescription>
    <NDC11Code>16571-0685-09</NDC11Code>
    <ProductNDC>16571-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212285</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clomipramine hydrochloride capsules USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are egodystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of Clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/ day (up to 200 mg) for all children and adolescents. The effectiveness of Clomipramine hydrochloride capsules for long term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use Clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
    <Description>Clomipramine hydrochloride capsules USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f] azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride USP is a white or slightly yellow, crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients. D&amp;C Yellow 10, FD&amp;C Red 40, FD&amp;C Blue 1 (50 mg capsules only), gelatin, magnesium stearate, pregelatinized starch, and titanium dioxide. Each capsule is imprinted with black pharmaceutical ink which contains ammonia solution, butyl alcohol, dehydrated alcohol, black iron oxide, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water and shellac. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>16714-685-02</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (16714-685-02) </PackageDescription>
    <NDC11Code>16714-0685-02</NDC11Code>
    <ProductNDC>16714-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077691</ApplicationNumber>
    <LabelerName>NorthStar Rx LLC</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia. .</IndicationAndUsage>
    <Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β (2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 5 mg, 10 mg, 20 mg, 40 mg or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, citric acid monohydrate, isopropyl alcohol, magnesium stearate and butylated hydroxyanisole. Simvastatin 5 mg also contains ferric oxide yellow, simvastatin 10 mg and simvastatin 20 mg also contains ferric oxide red and ferric oxide yellow, simvastatin 40 mg and simvastatin 80 mg also contains ferric oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>21749-685-90</NDCCode>
    <PackageDescription>1250 mL in 1 PACKAGE (21749-685-90) </PackageDescription>
    <NDC11Code>21749-0685-90</NDC11Code>
    <ProductNDC>21749-685</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Purell Professional Healthy Sp 0.5pct Bak Antimicrobial Foam</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20171015</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>GOJO Industries, Inc.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.005</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180402</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> Handwash to help decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42291-685-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (42291-685-90)</PackageDescription>
    <NDC11Code>42291-0685-90</NDC11Code>
    <ProductNDC>42291-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Probenecid And Colchicine</ProprietaryName>
    <NonProprietaryName>Probenecid And Colchicine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120508</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040618</ApplicationNumber>
    <LabelerName>AvKARE, Inc.</LabelerName>
    <SubstanceName>PROBENECID; COLCHICINE</SubstanceName>
    <StrengthNumber>500; .5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-02-05</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>45865-685-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (45865-685-90)</PackageDescription>
    <NDC11Code>45865-0685-90</NDC11Code>
    <ProductNDC>45865-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110829</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078722</ApplicationNumber>
    <LabelerName>Medsource Pharmaceuticals</LabelerName>
    <SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <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, USP should be used only for short periods (up to two or three 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, USP has 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 to off-white crystalline powder with the molecular formula C 20H 21NHCl and a molecular weight of 311.9. It has a melting point of 217° C, and a pK a of 8.47 at 25° C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl 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 is supplied as a 5 mg, 7.5 mg and 10 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>47335-685-81</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (47335-685-81) </PackageDescription>
    <NDC11Code>47335-0685-81</NDC11Code>
    <ProductNDC>47335-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208066</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lurasidone hydrochloride tablet is indicated for: 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]., 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]., 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its  chemical  name  is  (3a R,4 S,7 R,7a S)-2-{(1 R,2 R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1­ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2 H-isoindole-1,3-dione hydrochloride. Its molecular formula is C 28H 36N 4O 2S·HCl and its molecular weight is 529.14. The chemical structure is:. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, alginic acid, pregelatinized corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and carnauba wax. The 80 mg tablets also contain yellow iron oxide, FD&amp;C Blue#1 aluminum lake and black iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>60760-685-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (60760-685-90) </PackageDescription>
    <NDC11Code>60760-0685-90</NDC11Code>
    <ProductNDC>60760-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230610</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217411</ApplicationNumber>
    <LabelerName>ST. MARY'S MEDICAL PARK PHARMACY</LabelerName>
    <SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
    <Description>Amitriptyline Hydrochloride, USP a dibenzocycloheptadiene derivative, is a white or practically white, odorless or partially odorless, crystalline powder or small crystals which is Freely soluble in water, in alcohol, in chloroform and in methanol, insoluble in ether. It is designated chemically as 10,11-Dihydro- N,N-dimethyl-5 H-dibenzo[a,d] cycloheptene-Δ 5,γ-propylamine hydrochloride. It has the following structural formula:. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride USP. Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, isopropyl alcohol, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch. The film coating contains Opadry ®Pink (carmine, FD&amp;C Blue #1, FD&amp;C Yellow #6, Hypromellose 2910, polyethylene glycol, titanium dioxide); Opadry ®Green (FD&amp;C Blue #1, FD&amp;C Blue #2, FD&amp;C Red #40, Hypromellose 2910, iron oxide yellow, polyethylene glycol, titanium dioxide); Opadry ®Brown (FD&amp;C Blue #2, FD&amp;C Red #40, Hypromellose 2910, iron oxide red, polyethylene glycol, titanium dioxide); Opadry ®Purple (carmine, FD&amp;C Blue #2, ferrosoferric oxide, Hypromellose 2910, polyethylene glycol, titanium dioxide); Opadry ®Orange (FD&amp;C Yellow #6, Hypromellose 2910, iron oxide red, polyethylene glycol, titanium dioxide); Opadry ®Green (FD&amp;C Blue #1, FD&amp;C Blue #2, FD&amp;C Red #40, Hypromellose 2910, iron oxide yellow, polyethylene glycol, titanium dioxide). FDA approved dissolution specifications differs from the USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>61786-685-19</NDCCode>
    <PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61786-685-19)</PackageDescription>
    <NDC11Code>61786-0685-19</NDC11Code>
    <ProductNDC>61786-685</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Adult Low Dose Aspirin</ProprietaryName>
    <NonProprietaryName>Aspirin</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160509</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>ASPIRIN</SubstanceName>
    <StrengthNumber>81</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-04</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>61919-685-90</NDCCode>
    <PackageDescription>90 BOTTLE in 1 BOTTLE (61919-685-90)  / 60 TABLET, FILM COATED in 1 BOTTLE (61919-685-60) </PackageDescription>
    <NDC11Code>61919-0685-90</NDC11Code>
    <ProductNDC>61919-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078154</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150305</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>1.1 Partial Onset Seizures. Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy. Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. 1.3 Primary Generalized Tonic-Clonic Seizures. Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.</IndicationAndUsage>
    <Description>Levetiracetam USP is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). Levetiracetam tablets USP contain the labeled amount of levetiracetam. For 250 mg, 500 mg and 750 mg strengths. Inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&amp;C Blue No. 2 Aluminum Lake. 500 mg tablets: Yellow Iron Oxide. 750 mg tablets: FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C yellow No.6 Aluminum Lake, iron oxide red. For 1000 mg strength. Inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>65162-685-90</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (65162-685-90) </PackageDescription>
    <NDC11Code>65162-0685-90</NDC11Code>
    <ProductNDC>65162-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091027</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090992</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091027</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam oral solution is indicated for adjunctive therapy for the treatment of: : 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) .</IndicationAndUsage>
    <Description>Levetiracetam oral solution, USP is an antiepileptic drug available as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam oral solution, USP contains 100 mg of levetiracetam, USP per mL. Inactive ingredients: anhydrous citric acid, artificial grape flavor, glycerin, magnasweet, maltitol, methylparaben, potassium acesulfame, propylparaben and sodium citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>65841-685-16</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (65841-685-16) </PackageDescription>
    <NDC11Code>65841-0685-16</NDC11Code>
    <ProductNDC>65841-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamotrigine</ProprietaryName>
    <NonProprietaryName>Lamotrigine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090127</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077633</ApplicationNumber>
    <LabelerName>Zydus Lifesciences Limited</LabelerName>
    <SubstanceName>LAMOTRIGINE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090127</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69097-685-05</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (69097-685-05) </PackageDescription>
    <NDC11Code>69097-0685-05</NDC11Code>
    <ProductNDC>69097-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
    <NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200110</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212280</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200110</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>. Pregabalin capsules are indicated for.  : 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</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. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg &amp; 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg &amp; 300 mg contains: FD &amp;C Blue 1, FD&amp; C Red 40, FD&amp; C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>70934-685-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (70934-685-90) </PackageDescription>
    <NDC11Code>70934-0685-90</NDC11Code>
    <ProductNDC>70934-685</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief</ProprietaryName>
    <ProprietaryNameSuffix>Non Drowsy</ProprietaryNameSuffix>
    <NonProprietaryName>Loratadine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200429</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075209</ApplicationNumber>
    <LabelerName>Denton Pharma, Inc. dba Northwind Pharmaceuticals</LabelerName>
    <SubstanceName>LORATADINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0143-9168-01</NDCCode>
    <PackageDescription>.5 mL in 1 SYRINGE (0143-9168-01) </PackageDescription>
    <NDC11Code>00143-9168-01</NDC11Code>
    <ProductNDC>0143-9168</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Starjemza</ProprietaryName>
    <NonProprietaryName>Ustekinumab-hmny</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20251027</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761419</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>USTEKINUMAB</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251027</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9169-01</NDCCode>
    <PackageDescription>.5 mL in 1 VIAL (0143-9169-01) </PackageDescription>
    <NDC11Code>00143-9169-01</NDC11Code>
    <ProductNDC>0143-9169</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Starjemza</ProprietaryName>
    <NonProprietaryName>Ustekinumab-hmny</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20251027</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761419</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>USTEKINUMAB</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251027</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9170-01</NDCCode>
    <PackageDescription>1 mL in 1 SYRINGE (0143-9170-01) </PackageDescription>
    <NDC11Code>00143-9170-01</NDC11Code>
    <ProductNDC>0143-9170</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Starjemza</ProprietaryName>
    <NonProprietaryName>Ustekinumab-hmny</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20251027</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761419</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>USTEKINUMAB</SubstanceName>
    <StrengthNumber>90</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251027</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9171-01</NDCCode>
    <PackageDescription>26 mL in 1 VIAL (0143-9171-01) </PackageDescription>
    <NDC11Code>00143-9171-01</NDC11Code>
    <ProductNDC>0143-9171</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Starjemza</ProprietaryName>
    <NonProprietaryName>Ustekinumab-hmny</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20251027</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761419</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>USTEKINUMAB</SubstanceName>
    <StrengthNumber>130</StrengthNumber>
    <StrengthUnit>mg/26mL</StrengthUnit>
    <Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251027</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-685-01</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-685-01) </PackageDescription>
    <NDC11Code>68382-0685-01</NDC11Code>
    <ProductNDC>68382-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nifedipine</ProprietaryName>
    <NonProprietaryName>Nifedipine</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210012</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
    <SubstanceName>NIFEDIPINE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release tablets may also be used where the clinical presentation suggests a possible vasospastic component, but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion, or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers.</IndicationAndUsage>
    <Description>Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4(2-nitrophenyl)-, dimethyl ester, C17 H18 N2O6, and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended release tablet is formulated as a           once-a-day controlled-release tablet for oral administration to provide 30, 60, or 90 mg of nifedipine. Each tablet contains 33 mg nifedipine to provide a 30 mg dose. Each tablet contains 66 mg nifedipine to provide a 60 mg dose. Each tablet contains 99 mg nifedipine to provide a 90 mg dose. Inert ingredients in the formulations are: cellulose acetate; ferrosoferric oxide; hypromellose; magnesium stearate; polyethylene glycol; polyethylene oxide; red iron oxide; shellac; sodium chloride; titanium dioxide; yellow iron oxide and FD&amp;C yellow #6 (90 mg tablet only).</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-685-10</NDCCode>
    <PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-685-10) </PackageDescription>
    <NDC11Code>68382-0685-10</NDC11Code>
    <ProductNDC>68382-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nifedipine</ProprietaryName>
    <NonProprietaryName>Nifedipine</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210012</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
    <SubstanceName>NIFEDIPINE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release tablets may also be used where the clinical presentation suggests a possible vasospastic component, but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion, or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers.</IndicationAndUsage>
    <Description>Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4(2-nitrophenyl)-, dimethyl ester, C17 H18 N2O6, and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended release tablet is formulated as a           once-a-day controlled-release tablet for oral administration to provide 30, 60, or 90 mg of nifedipine. Each tablet contains 33 mg nifedipine to provide a 30 mg dose. Each tablet contains 66 mg nifedipine to provide a 60 mg dose. Each tablet contains 99 mg nifedipine to provide a 90 mg dose. Inert ingredients in the formulations are: cellulose acetate; ferrosoferric oxide; hypromellose; magnesium stearate; polyethylene glycol; polyethylene oxide; red iron oxide; shellac; sodium chloride; titanium dioxide; yellow iron oxide and FD&amp;C yellow #6 (90 mg tablet only).</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-685-95</NDCCode>
    <PackageDescription>300 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-685-95) </PackageDescription>
    <NDC11Code>68382-0685-95</NDC11Code>
    <ProductNDC>68382-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nifedipine</ProprietaryName>
    <NonProprietaryName>Nifedipine</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210012</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
    <SubstanceName>NIFEDIPINE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release tablets may also be used where the clinical presentation suggests a possible vasospastic component, but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion, or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers.</IndicationAndUsage>
    <Description>Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4(2-nitrophenyl)-, dimethyl ester, C17 H18 N2O6, and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended release tablet is formulated as a           once-a-day controlled-release tablet for oral administration to provide 30, 60, or 90 mg of nifedipine. Each tablet contains 33 mg nifedipine to provide a 30 mg dose. Each tablet contains 66 mg nifedipine to provide a 60 mg dose. Each tablet contains 99 mg nifedipine to provide a 90 mg dose. Inert ingredients in the formulations are: cellulose acetate; ferrosoferric oxide; hypromellose; magnesium stearate; polyethylene glycol; polyethylene oxide; red iron oxide; shellac; sodium chloride; titanium dioxide; yellow iron oxide and FD&amp;C yellow #6 (90 mg tablet only).</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-005-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (16590-005-90)</PackageDescription>
    <NDC11Code>16590-0005-90</NDC11Code>
    <ProductNDC>16590-005</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alprazolam</ProprietaryName>
    <NonProprietaryName>Alprazolam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110325</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074112</ApplicationNumber>
    <LabelerName>STAT Rx USA LLC</LabelerName>
    <SubstanceName>ALPRAZOLAM</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Alprazolam tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of six months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or ‘lump in throat’); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or ‘mind going blank’ because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam.</IndicationAndUsage>
    <Description>Alprazolam is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, for oral administration, contains 0.25, 0.5, or 1 mg of alprazolam. Inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium benzoate. Additionally, the 0.5 mg also contains FD &amp; C Yellow #6 Aluminum Lake, and the 1 mg also contains FD &amp; C Blue #2 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-006-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (16590-006-90)</PackageDescription>
    <NDC11Code>16590-0006-90</NDC11Code>
    <ProductNDC>16590-006</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alprazolam</ProprietaryName>
    <NonProprietaryName>Alprazolam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110325</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074112</ApplicationNumber>
    <LabelerName>STAT Rx USA LLC</LabelerName>
    <SubstanceName>ALPRAZOLAM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Alprazolam tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of six months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or ‘lump in throat’); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or ‘mind going blank’ because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam.</IndicationAndUsage>
    <Description>Alprazolam is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, for oral administration, contains 0.25, 0.5, or 1 mg of alprazolam. Inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium benzoate. Additionally, the 0.5 mg also contains FD &amp; C Yellow #6 Aluminum Lake, and the 1 mg also contains FD &amp; C Blue #2 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-008-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (16590-008-90)</PackageDescription>
    <NDC11Code>16590-0008-90</NDC11Code>
    <ProductNDC>16590-008</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amantadine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Amantadine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19870218</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071293</ApplicationNumber>
    <LabelerName>STAT RX USA LLC</LabelerName>
    <SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.</IndicationAndUsage>
    <Description>Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H18NCl. It has the following structural formula. Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine hydrochloride is available as 100 mg capsules for oral administration. Inactive ingredients: corn starch, croscarmellose sodium, ethylcellulose, FD&amp;C Blue #1, FD&amp;C Red #40, gelatin, magnesium stearate, methylparaben, microcrystalline cellulose, pregelatinized starch, propylparaben, sodium lauryl sulfate and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-009-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (16590-009-90)</PackageDescription>
    <NDC11Code>16590-0009-90</NDC11Code>
    <ProductNDC>16590-009</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ambien</ProprietaryName>
    <NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19930401</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019908</ApplicationNumber>
    <LabelerName>STAT Rx USA LLC</LabelerName>
    <SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.</IndicationAndUsage>
    <Description>Ambien (zolpidem tartrate) is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each Ambien tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, micro-crystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The 5 mg tablet also contains FD&amp;C Red No. 40, iron oxide colorant, and polysorbate 80.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-011-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16590-011-90)</PackageDescription>
    <NDC11Code>16590-0011-90</NDC11Code>
    <ProductNDC>16590-011</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19970911</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040218</ApplicationNumber>
    <LabelerName>STAT Rx USA LLC</LabelerName>
    <SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
    <Description>Amitriptyline HCl is 3-(10,11-dihydro-5H-dibenzo [a,d] cycloheptene-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride. Its empirical formula is C20H23NHCl, and its structural formula is. Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a molecular weight of 313.87. It is a white, odorless, crystalline compound which is freely soluble in water. Amitriptyline HCl is supplied as 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg tablets. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, sodium starch glycolate and titanium dioxide. The 10 mg tablets also contain FD&amp;C blue #1 lake. The 25 mg tablets also contain D&amp;C yellow #10 lake and FD&amp;C blue #2 lake. The 50 mg tablets also contain synthetic black iron oxide, synthetic red iron oxide and synthetic yellow iron oxide. The 75 mg tablets also contain FD&amp;C yellow #6 lake. The 100 mg tablets also contain D&amp;C red #33 lake and FD&amp;C red #40 lake. The 150 mg tablets also contain FD&amp;C blue #2 lake and FD&amp;C yellow #6 lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-012-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16590-012-90)</PackageDescription>
    <NDC11Code>16590-0012-90</NDC11Code>
    <ProductNDC>16590-012</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19970911</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040218</ApplicationNumber>
    <LabelerName>STAT Rx USA LLC</LabelerName>
    <SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
    <Description>Amitriptyline HCl is 3-(10,11-dihydro-5H-dibenzo [a,d] cycloheptene-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride. Its empirical formula is C20H23NHCl, and its structural formula is. Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a molecular weight of 313.87. It is a white, odorless, crystalline compound which is freely soluble in water. Amitriptyline HCl is supplied as 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg tablets. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, sodium starch glycolate and titanium dioxide. The 10 mg tablets also contain FD&amp;C blue #1 lake. The 25 mg tablets also contain D&amp;C yellow #10 lake and FD&amp;C blue #2 lake. The 50 mg tablets also contain synthetic black iron oxide, synthetic red iron oxide and synthetic yellow iron oxide. The 75 mg tablets also contain FD&amp;C yellow #6 lake. The 100 mg tablets also contain D&amp;C red #33 lake and FD&amp;C red #40 lake. The 150 mg tablets also contain FD&amp;C blue #2 lake and FD&amp;C yellow #6 lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-013-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16590-013-90)</PackageDescription>
    <NDC11Code>16590-0013-90</NDC11Code>
    <ProductNDC>16590-013</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19970911</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040218</ApplicationNumber>
    <LabelerName>STAT Rx USA LLC</LabelerName>
    <SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
    <Description>Amitriptyline HCl is 3-(10,11-dihydro-5H-dibenzo [a,d] cycloheptene-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride. Its empirical formula is C20H23NHCl, and its structural formula is. Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a molecular weight of 313.87. It is a white, odorless, crystalline compound which is freely soluble in water. Amitriptyline HCl is supplied as 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg tablets. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, sodium starch glycolate and titanium dioxide. The 10 mg tablets also contain FD&amp;C blue #1 lake. The 25 mg tablets also contain D&amp;C yellow #10 lake and FD&amp;C blue #2 lake. The 50 mg tablets also contain synthetic black iron oxide, synthetic red iron oxide and synthetic yellow iron oxide. The 75 mg tablets also contain FD&amp;C yellow #6 lake. The 100 mg tablets also contain D&amp;C red #33 lake and FD&amp;C red #40 lake. The 150 mg tablets also contain FD&amp;C blue #2 lake and FD&amp;C yellow #6 lake.</Description>
  </NDC>
</NDCList>