RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>29300-250-87</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (29300-250-87)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (29300-250-11) </PackageDescription>
    <NDC11Code>29300-0250-87</NDC11Code>
    <ProductNDC>29300-250</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
    <NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161110</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204831</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Donepezil hydrochloride is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (1).</IndicationAndUsage>
    <Description>Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has a molecular formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 5 and 10 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. The film coating contains talc, polyethylene glycol, polyvinyl alcohol and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide as a coloring agent. Donepezil hydrochloride orally disintegrating tablets USP are available for oral administration. Each Donepezil hydrochloride orally disintegrating tablet USP contains 5 or 10 mg of donepezil hydrochloride. Inactive ingredients are mannitol, silicified microcrystalline cellulose, low substituted hydroxypropyl cellulose, sucralose, orange flavor,sodium stearyl fumarate. Additionally, the 10 mg tablet contains iron oxide yellow as a coloring agent.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-251-87</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (29300-251-87)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (29300-251-11) </PackageDescription>
    <NDC11Code>29300-0251-87</NDC11Code>
    <ProductNDC>29300-251</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
    <NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161110</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204831</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Donepezil hydrochloride is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (1).</IndicationAndUsage>
    <Description>Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has a molecular formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 5 and 10 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. The film coating contains talc, polyethylene glycol, polyvinyl alcohol and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide as a coloring agent. Donepezil hydrochloride orally disintegrating tablets USP are available for oral administration. Each Donepezil hydrochloride orally disintegrating tablet USP contains 5 or 10 mg of donepezil hydrochloride. Inactive ingredients are mannitol, silicified microcrystalline cellulose, low substituted hydroxypropyl cellulose, sucralose, orange flavor,sodium stearyl fumarate. Additionally, the 10 mg tablet contains iron oxide yellow as a coloring agent.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-226-52</NDCCode>
    <PackageDescription>250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-226-52) </PackageDescription>
    <NDC11Code>29300-0226-52</NDC11Code>
    <ProductNDC>29300-226</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metronidazole</ProprietaryName>
    <NonProprietaryName>Metronidazole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203458</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>METRONIDAZOLE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic  T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. Amebiasis Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablet therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablet therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Metronidazole tablets, USP 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets USP contain 250 mg or 500 mg of metronidazole. Inactive ingredients include powdered cellulose, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, hypromellose, polyethylene glycol, stearic acid, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-297-52</NDCCode>
    <PackageDescription>250 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-297-52) </PackageDescription>
    <NDC11Code>29300-0297-52</NDC11Code>
    <ProductNDC>29300-297</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranolazine</ProprietaryName>
    <NonProprietaryName>Ranolazine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230316</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213083</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>RANOLAZINE</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-11-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
    <Description>Ranolazine extended-release tablets are available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as as 1-piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, sodium hydroxide and sodium lauryl sulfate. The film coating contains ferrosoferric oxide (1000 mg only), iron oxide red (1000 mg only), iron oxide yellow (1000 mg only), polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-239-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (29300-239-05) </PackageDescription>
    <NDC11Code>29300-0239-05</NDC11Code>
    <ProductNDC>29300-239</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tolterodine Tartrate</ProprietaryName>
    <NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200805</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205399</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200805</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.</IndicationAndUsage>
    <Description>Tolterodine tartrate tablets contain tolterodine tartrate USP. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). The empirical formula of tolterodine tartrate is C26H37NO7, and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 14.7657 mg/mL. It is sparingly soluble in water, slightly soluble in anhydrous ethanol, practically insoluble in heptane. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate. The inactive ingredients are microcrystalline cellulose, dibasic calcium phosphate dihydrate, sodium starch glycolate type B (pH 3.0 to 5.0), colloidal silicon dioxide, magnesium stearate, hypromellose, stearic acid, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-239-16</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (29300-239-16) </PackageDescription>
    <NDC11Code>29300-0239-16</NDC11Code>
    <ProductNDC>29300-239</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tolterodine Tartrate</ProprietaryName>
    <NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200805</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205399</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200805</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.</IndicationAndUsage>
    <Description>Tolterodine tartrate tablets contain tolterodine tartrate USP. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). The empirical formula of tolterodine tartrate is C26H37NO7, and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 14.7657 mg/mL. It is sparingly soluble in water, slightly soluble in anhydrous ethanol, practically insoluble in heptane. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate. The inactive ingredients are microcrystalline cellulose, dibasic calcium phosphate dihydrate, sodium starch glycolate type B (pH 3.0 to 5.0), colloidal silicon dioxide, magnesium stearate, hypromellose, stearic acid, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-240-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (29300-240-01) </PackageDescription>
    <NDC11Code>29300-0240-01</NDC11Code>
    <ProductNDC>29300-240</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tolterodine Tartrate</ProprietaryName>
    <NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200805</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205399</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200805</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.</IndicationAndUsage>
    <Description>Tolterodine tartrate tablets contain tolterodine tartrate USP. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). The empirical formula of tolterodine tartrate is C26H37NO7, and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 14.7657 mg/mL. It is sparingly soluble in water, slightly soluble in anhydrous ethanol, practically insoluble in heptane. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate. The inactive ingredients are microcrystalline cellulose, dibasic calcium phosphate dihydrate, sodium starch glycolate type B (pH 3.0 to 5.0), colloidal silicon dioxide, magnesium stearate, hypromellose, stearic acid, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-240-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (29300-240-05) </PackageDescription>
    <NDC11Code>29300-0240-05</NDC11Code>
    <ProductNDC>29300-240</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tolterodine Tartrate</ProprietaryName>
    <NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200805</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205399</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200805</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.</IndicationAndUsage>
    <Description>Tolterodine tartrate tablets contain tolterodine tartrate USP. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). The empirical formula of tolterodine tartrate is C26H37NO7, and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 14.7657 mg/mL. It is sparingly soluble in water, slightly soluble in anhydrous ethanol, practically insoluble in heptane. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate. The inactive ingredients are microcrystalline cellulose, dibasic calcium phosphate dihydrate, sodium starch glycolate type B (pH 3.0 to 5.0), colloidal silicon dioxide, magnesium stearate, hypromellose, stearic acid, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-240-13</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (29300-240-13) </PackageDescription>
    <NDC11Code>29300-0240-13</NDC11Code>
    <ProductNDC>29300-240</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tolterodine Tartrate</ProprietaryName>
    <NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200805</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205399</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200805</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.</IndicationAndUsage>
    <Description>Tolterodine tartrate tablets contain tolterodine tartrate USP. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). The empirical formula of tolterodine tartrate is C26H37NO7, and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 14.7657 mg/mL. It is sparingly soluble in water, slightly soluble in anhydrous ethanol, practically insoluble in heptane. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate. The inactive ingredients are microcrystalline cellulose, dibasic calcium phosphate dihydrate, sodium starch glycolate type B (pH 3.0 to 5.0), colloidal silicon dioxide, magnesium stearate, hypromellose, stearic acid, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-240-16</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (29300-240-16) </PackageDescription>
    <NDC11Code>29300-0240-16</NDC11Code>
    <ProductNDC>29300-240</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tolterodine Tartrate</ProprietaryName>
    <NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200805</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205399</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200805</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.</IndicationAndUsage>
    <Description>Tolterodine tartrate tablets contain tolterodine tartrate USP. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). The empirical formula of tolterodine tartrate is C26H37NO7, and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 14.7657 mg/mL. It is sparingly soluble in water, slightly soluble in anhydrous ethanol, practically insoluble in heptane. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate. The inactive ingredients are microcrystalline cellulose, dibasic calcium phosphate dihydrate, sodium starch glycolate type B (pH 3.0 to 5.0), colloidal silicon dioxide, magnesium stearate, hypromellose, stearic acid, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-240-19</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (29300-240-19) </PackageDescription>
    <NDC11Code>29300-0240-19</NDC11Code>
    <ProductNDC>29300-240</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tolterodine Tartrate</ProprietaryName>
    <NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200805</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205399</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200805</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.</IndicationAndUsage>
    <Description>Tolterodine tartrate tablets contain tolterodine tartrate USP. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). The empirical formula of tolterodine tartrate is C26H37NO7, and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 14.7657 mg/mL. It is sparingly soluble in water, slightly soluble in anhydrous ethanol, practically insoluble in heptane. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate. The inactive ingredients are microcrystalline cellulose, dibasic calcium phosphate dihydrate, sodium starch glycolate type B (pH 3.0 to 5.0), colloidal silicon dioxide, magnesium stearate, hypromellose, stearic acid, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-252-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (29300-252-01) </PackageDescription>
    <NDC11Code>29300-0252-01</NDC11Code>
    <ProductNDC>29300-252</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212719</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Labetalol hydrochloride tablets USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
    <Description>Labetalol hydrochloride tablets USP are an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride USP has the molecular formula C19H24N2O3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride USP is a white or off-white powder, sparingly soluble in water and ethanol (96%), insoluble in ether and chloroform. Labetalol hydrochloride tablets USP for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate (potato) and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-252-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (29300-252-05) </PackageDescription>
    <NDC11Code>29300-0252-05</NDC11Code>
    <ProductNDC>29300-252</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212719</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Labetalol hydrochloride tablets USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
    <Description>Labetalol hydrochloride tablets USP are an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride USP has the molecular formula C19H24N2O3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride USP is a white or off-white powder, sparingly soluble in water and ethanol (96%), insoluble in ether and chloroform. Labetalol hydrochloride tablets USP for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate (potato) and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-253-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (29300-253-01) </PackageDescription>
    <NDC11Code>29300-0253-01</NDC11Code>
    <ProductNDC>29300-253</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212719</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Labetalol hydrochloride tablets USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
    <Description>Labetalol hydrochloride tablets USP are an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride USP has the molecular formula C19H24N2O3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride USP is a white or off-white powder, sparingly soluble in water and ethanol (96%), insoluble in ether and chloroform. Labetalol hydrochloride tablets USP for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate (potato) and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-253-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (29300-253-05) </PackageDescription>
    <NDC11Code>29300-0253-05</NDC11Code>
    <ProductNDC>29300-253</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212719</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Labetalol hydrochloride tablets USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
    <Description>Labetalol hydrochloride tablets USP are an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride USP has the molecular formula C19H24N2O3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride USP is a white or off-white powder, sparingly soluble in water and ethanol (96%), insoluble in ether and chloroform. Labetalol hydrochloride tablets USP for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate (potato) and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-254-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (29300-254-01) </PackageDescription>
    <NDC11Code>29300-0254-01</NDC11Code>
    <ProductNDC>29300-254</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212719</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Labetalol hydrochloride tablets USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
    <Description>Labetalol hydrochloride tablets USP are an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride USP has the molecular formula C19H24N2O3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride USP is a white or off-white powder, sparingly soluble in water and ethanol (96%), insoluble in ether and chloroform. Labetalol hydrochloride tablets USP for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate (potato) and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-254-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (29300-254-05) </PackageDescription>
    <NDC11Code>29300-0254-05</NDC11Code>
    <ProductNDC>29300-254</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212719</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Labetalol hydrochloride tablets USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
    <Description>Labetalol hydrochloride tablets USP are an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride USP has the molecular formula C19H24N2O3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride USP is a white or off-white powder, sparingly soluble in water and ethanol (96%), insoluble in ether and chloroform. Labetalol hydrochloride tablets USP for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate (potato) and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-306-05</NDCCode>
    <PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-306-05) </PackageDescription>
    <NDC11Code>29300-0306-05</NDC11Code>
    <ProductNDC>29300-306</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tolterodine Tartrate</ProprietaryName>
    <NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216917</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14)].</IndicationAndUsage>
    <Description>Tolterodine tartrate extended-release capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3  phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C26H37NO7,. Its structure is. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pKa value is 9.87 and the solubility in water is 14 mg/mL. It is sparingly soluble in water, slightly soluble in anhydrous ethanol, practically insoluble in heptane. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate extended-release capsules 2 mg capsule for oral administration contains 2 mg of Tolterodine Tartrate USP, and the following inactive ingredients are sugar spheres (which contain sucrose and corn starch), hypromellose, ethylcellulose dispersion type B (which contain ethylcellulose, medium chain triglycerides and oleic acid), talc, gelatin, titanium dioxide, iron oxide yellow, FD &amp; C blue #1 and FD &amp; C red #40. Tolterodine tartrate extended-release capsules 4 mg capsule for oral administration contains 4 mg of Tolterodine Tartrate USP. Inactive ingredients are sugar spheres (which contain sucrose and corn starch), hypromellose, ethylcellulose dispersion type B (which contain ethylcellulose, medium chain triglycerides and oleic acid), talc, gelatin, titanium dioxide, FD &amp; C blue #1 and D &amp; C red #28. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains shellac, propylene glycol, black iron oxide, potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-306-13</NDCCode>
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    <Description>Tolterodine tartrate extended-release capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3  phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C26H37NO7,. Its structure is. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pKa value is 9.87 and the solubility in water is 14 mg/mL. It is sparingly soluble in water, slightly soluble in anhydrous ethanol, practically insoluble in heptane. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate extended-release capsules 2 mg capsule for oral administration contains 2 mg of Tolterodine Tartrate USP, and the following inactive ingredients are sugar spheres (which contain sucrose and corn starch), hypromellose, ethylcellulose dispersion type B (which contain ethylcellulose, medium chain triglycerides and oleic acid), talc, gelatin, titanium dioxide, iron oxide yellow, FD &amp; C blue #1 and FD &amp; C red #40. Tolterodine tartrate extended-release capsules 4 mg capsule for oral administration contains 4 mg of Tolterodine Tartrate USP. Inactive ingredients are sugar spheres (which contain sucrose and corn starch), hypromellose, ethylcellulose dispersion type B (which contain ethylcellulose, medium chain triglycerides and oleic acid), talc, gelatin, titanium dioxide, FD &amp; C blue #1 and D &amp; C red #28. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains shellac, propylene glycol, black iron oxide, potassium hydroxide.</Description>
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    <Description>Tolterodine tartrate extended-release capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3  phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C26H37NO7,. Its structure is. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pKa value is 9.87 and the solubility in water is 14 mg/mL. It is sparingly soluble in water, slightly soluble in anhydrous ethanol, practically insoluble in heptane. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate extended-release capsules 2 mg capsule for oral administration contains 2 mg of Tolterodine Tartrate USP, and the following inactive ingredients are sugar spheres (which contain sucrose and corn starch), hypromellose, ethylcellulose dispersion type B (which contain ethylcellulose, medium chain triglycerides and oleic acid), talc, gelatin, titanium dioxide, iron oxide yellow, FD &amp; C blue #1 and FD &amp; C red #40. Tolterodine tartrate extended-release capsules 4 mg capsule for oral administration contains 4 mg of Tolterodine Tartrate USP. Inactive ingredients are sugar spheres (which contain sucrose and corn starch), hypromellose, ethylcellulose dispersion type B (which contain ethylcellulose, medium chain triglycerides and oleic acid), talc, gelatin, titanium dioxide, FD &amp; C blue #1 and D &amp; C red #28. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains shellac, propylene glycol, black iron oxide, potassium hydroxide.</Description>
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    <Description>Tolterodine tartrate extended-release capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3  phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C26H37NO7,. Its structure is. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pKa value is 9.87 and the solubility in water is 14 mg/mL. It is sparingly soluble in water, slightly soluble in anhydrous ethanol, practically insoluble in heptane. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate extended-release capsules 2 mg capsule for oral administration contains 2 mg of Tolterodine Tartrate USP, and the following inactive ingredients are sugar spheres (which contain sucrose and corn starch), hypromellose, ethylcellulose dispersion type B (which contain ethylcellulose, medium chain triglycerides and oleic acid), talc, gelatin, titanium dioxide, iron oxide yellow, FD &amp; C blue #1 and FD &amp; C red #40. Tolterodine tartrate extended-release capsules 4 mg capsule for oral administration contains 4 mg of Tolterodine Tartrate USP. Inactive ingredients are sugar spheres (which contain sucrose and corn starch), hypromellose, ethylcellulose dispersion type B (which contain ethylcellulose, medium chain triglycerides and oleic acid), talc, gelatin, titanium dioxide, FD &amp; C blue #1 and D &amp; C red #28. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains shellac, propylene glycol, black iron oxide, potassium hydroxide.</Description>
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    <Description>Tolterodine tartrate extended-release capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3  phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C26H37NO7,. Its structure is. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pKa value is 9.87 and the solubility in water is 14 mg/mL. It is sparingly soluble in water, slightly soluble in anhydrous ethanol, practically insoluble in heptane. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate extended-release capsules 2 mg capsule for oral administration contains 2 mg of Tolterodine Tartrate USP, and the following inactive ingredients are sugar spheres (which contain sucrose and corn starch), hypromellose, ethylcellulose dispersion type B (which contain ethylcellulose, medium chain triglycerides and oleic acid), talc, gelatin, titanium dioxide, iron oxide yellow, FD &amp; C blue #1 and FD &amp; C red #40. Tolterodine tartrate extended-release capsules 4 mg capsule for oral administration contains 4 mg of Tolterodine Tartrate USP. Inactive ingredients are sugar spheres (which contain sucrose and corn starch), hypromellose, ethylcellulose dispersion type B (which contain ethylcellulose, medium chain triglycerides and oleic acid), talc, gelatin, titanium dioxide, FD &amp; C blue #1 and D &amp; C red #28. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains shellac, propylene glycol, black iron oxide, potassium hydroxide.</Description>
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    <Description>Tolterodine tartrate extended-release capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3  phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C26H37NO7,. Its structure is. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pKa value is 9.87 and the solubility in water is 14 mg/mL. It is sparingly soluble in water, slightly soluble in anhydrous ethanol, practically insoluble in heptane. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate extended-release capsules 2 mg capsule for oral administration contains 2 mg of Tolterodine Tartrate USP, and the following inactive ingredients are sugar spheres (which contain sucrose and corn starch), hypromellose, ethylcellulose dispersion type B (which contain ethylcellulose, medium chain triglycerides and oleic acid), talc, gelatin, titanium dioxide, iron oxide yellow, FD &amp; C blue #1 and FD &amp; C red #40. Tolterodine tartrate extended-release capsules 4 mg capsule for oral administration contains 4 mg of Tolterodine Tartrate USP. Inactive ingredients are sugar spheres (which contain sucrose and corn starch), hypromellose, ethylcellulose dispersion type B (which contain ethylcellulose, medium chain triglycerides and oleic acid), talc, gelatin, titanium dioxide, FD &amp; C blue #1 and D &amp; C red #28. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains shellac, propylene glycol, black iron oxide, potassium hydroxide.</Description>
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    <Description>Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration.  Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP:  Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD &amp; C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate &amp; yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D &amp; C Red No. 30, FD &amp; C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD &amp; C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.</Description>
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    <Description>Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration.  Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP:  Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD &amp; C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate &amp; yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D &amp; C Red No. 30, FD &amp; C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD &amp; C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.</Description>
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    <Description>Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration.  Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP:  Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD &amp; C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate &amp; yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D &amp; C Red No. 30, FD &amp; C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD &amp; C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.</Description>
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    <IndicationAndUsage>Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
    <Description>Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration.  Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP:  Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD &amp; C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate &amp; yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D &amp; C Red No. 30, FD &amp; C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD &amp; C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.</Description>
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    <IndicationAndUsage>Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
    <Description>Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration.  Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP:  Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD &amp; C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate &amp; yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D &amp; C Red No. 30, FD &amp; C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD &amp; C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.</Description>
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    <IndicationAndUsage>Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
    <Description>Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration.  Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP:  Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD &amp; C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate &amp; yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D &amp; C Red No. 30, FD &amp; C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD &amp; C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.</Description>
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