RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>52536-515-03</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (52536-515-03) </PackageDescription>
    <NDC11Code>52536-0515-03</NDC11Code>
    <ProductNDC>52536-515</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextroamphetamine Sulfate</ProprietaryName>
    <NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210806</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090533</ApplicationNumber>
    <LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DEXTROAMPHETAMINE SULFATE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210806</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dextroamphetamine sulfate tablets, USP are indicated for: 1 Narcolepsy., 2 Attention Deficit Disorder with Hyperactivity:As an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. .</IndicationAndUsage>
    <Description>Dextroamphetamine sulfate, USP is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate, USP as the neutral sulfate. The structural formula is as follows:. (C 9H 13N) 2∙H 2SO 4M.W.368.49.</Description>
  </NDC>
  <NDC>
    <NDCCode>0944-4625-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0944-4625-01)  / 1 CONTAINER in 1 KIT (0944-4625-02)  / 1 KIT in 1 CONTAINER (0944-4625-03)  *  5 mL in 1 VIAL, GLASS (0944-4257-01)  *  5 mL in 1 VIAL, GLASS (64764-515-50) </PackageDescription>
    <NDC11Code>00944-4625-01</NDC11Code>
    <ProductNDC>0944-4625</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Adynovate</ProprietaryName>
    <NonProprietaryName>Antihemophilic Factor (recombinant) Pegylated</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20151113</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125566</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals Amercia, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
    <Description>ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins.</Description>
  </NDC>
  <NDC>
    <NDCCode>0944-4628-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0944-4628-01)  / 1 CONTAINER in 1 KIT (0944-4628-02)  / 1 KIT in 1 CONTAINER (0944-4628-03)  *  5 mL in 1 VIAL, GLASS (64764-515-50)  *  5 mL in 1 VIAL, GLASS (0944-4263-01) </PackageDescription>
    <NDC11Code>00944-4628-01</NDC11Code>
    <ProductNDC>0944-4628</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Adynovate</ProprietaryName>
    <NonProprietaryName>Antihemophilic Factor (recombinant) Pegylated</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20161025</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125566</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals Amercia, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161025</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ADYNOVATE® is indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
    <Description>ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:. ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700-8000 IU/mg protein. ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Clinical Pharmacology (12.1)]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins.</Description>
  </NDC>
  <NDC>
    <NDCCode>41163-515-03</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (41163-515-03)  / 100 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>41163-0515-03</NDC11Code>
    <ProductNDC>41163-515</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen Pm</ProprietaryName>
    <ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen And Diphenhydramine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>United Natural Foods, Inc. dba UNFI</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54092-515-03</NDCCode>
    <PackageDescription>7 TABLET, EXTENDED RELEASE in 1 BOTTLE (54092-515-03) </PackageDescription>
    <NDC11Code>54092-0515-03</NDC11Code>
    <ProductNDC>54092-515</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Intuniv</ProprietaryName>
    <NonProprietaryName>Guanfacine</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090902</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022037</ApplicationNumber>
    <LabelerName>Shire US Manufacturing Inc.</LabelerName>
    <SubstanceName>GUANFACINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-02-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090902</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>57297-515-03</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (57297-515-03)</PackageDescription>
    <NDC11Code>57297-0515-03</NDC11Code>
    <ProductNDC>57297-515</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisinopril</ProprietaryName>
    <NonProprietaryName>Lisinopril</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077321</ApplicationNumber>
    <LabelerName>LUPIN LIMITED</LabelerName>
    <SubstanceName>LISINOPRIL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Lisinopril tablet USP is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).</IndicationAndUsage>
    <Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch and starch (corn). 5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, red ferric oxide, pre-gelatinized starch and starch (corn). 40 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, yellow ferric oxide, pre-gelatinized starch and starch (corn).</Description>
  </NDC>
  <NDC>
    <NDCCode>59572-515-03</NDCCode>
    <PackageDescription>1 SUSPENSION in 1 BAG (59572-515-03) </PackageDescription>
    <NDC11Code>59572-0515-03</NDC11Code>
    <ProductNDC>59572-515</ProductNDC>
    <ProductTypeName>CELLULAR THERAPY</ProductTypeName>
    <ProprietaryName>Abecma</ProprietaryName>
    <NonProprietaryName>Idecabtagene Vicleucel</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210326</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125736</ApplicationNumber>
    <LabelerName>Celgene Corporation</LabelerName>
    <SubstanceName>IDECABTAGENE VICLEUCEL</SubstanceName>
    <StrengthNumber>300000000</StrengthNumber>
    <StrengthUnit>1/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210326</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ABECMA is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.</IndicationAndUsage>
    <Description>ABECMA is a BCMA-directed genetically modified autologous T cell immunotherapy product consisting of a patient's own T cells that are harvested and genetically modified ex vivo through transduction with an anti-BCMA02 chimeric antigen receptor (CAR) lentiviral vector (LVV). Autologous T cells transduced with the anti-BCMA02 CAR LVV express the anti-BCMA CAR on the T cell surface. The CAR is comprised of a murine extracellular single-chain variable fragment (scFv) specific for recognizing B cell maturation antigen (BCMA) followed by a human CD8α hinge and transmembrane domain fused to the T cell cytoplasmic signaling domains of CD137 (4-1BB) and CD3ζ chain, in tandem. Binding of ABECMA to BCMA-expressing target cells leads to signaling initiated by CD3ζ and 4-1BB domains, and subsequent CAR-positive T cell activation. Antigen-specific activation of ABECMA results in CAR-positive T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells. ABECMA is prepared from the patient's peripheral blood mononuclear cells (PBMCs), which are obtained via a standard leukapheresis procedure. The mononuclear cells are enriched for T cells, through activation with anti-CD3 and anti-CD28 antibodies in the presence of IL-2, which are then transduced with the replication-incompetent lentiviral vector containing the anti-BCMA CAR transgene. The transduced T cells are expanded in cell culture, washed, formulated into a suspension, and cryopreserved. The product must pass a sterility test before release for shipping as a frozen suspension in one or more patient-specific infusion bag(s). The product is thawed prior to infusion back into the patient [see Dosage and Administration (2.3) and How Supplied/Storage and Handling (16)]. The ABECMA formulation contains 50% Plasma-Lyte A and 50% CryoStor® CS10, resulting in a final DMSO concentration of 5%.</Description>
  </NDC>
  <NDC>
    <NDCCode>59651-515-03</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (59651-515-03)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>59651-0515-03</NDC11Code>
    <ProductNDC>59651-515</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aripiprazole</ProprietaryName>
    <NonProprietaryName>Aripiprazole</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260218</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216208</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>ARIPIPRAZOLE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aripiprazole orally disintegrating tablets are indicated for the treatment of: : 1 Schizophrenia [see Clinical Studies (14.1)] , 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see Clinical Studies (14.2)], 3 Irritability Associated with Autistic Disorder [see Clinical Studies (14.4)], 4 Treatment of Tourette’s Disorder [see Clinical Studies (14.5)].</IndicationAndUsage>
    <Description>Aripiprazole is an atypical antipsychotic drug that is available as aripiprazole orally disintegrating tablets, USP. Aripiprazole USP is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The molecular formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole orally disintegrating tablets, USP are available in 10 mg and 15 mg strengths. Inactive ingredients include aspartame, calcium stearate, crospovidone, mannitol, silicified microcrystalline cellulose and vanilla flavor (maltodextrin, modified corn starch and natural &amp; artificial flavors).</Description>
  </NDC>
  <NDC>
    <NDCCode>62980-515-03</NDCCode>
    <PackageDescription>250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62980-515-03) </PackageDescription>
    <NDC11Code>62980-0515-03</NDC11Code>
    <ProductNDC>62980-515</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranitidine</ProprietaryName>
    <ProprietaryNameSuffix>300 Mg</ProprietaryNameSuffix>
    <NonProprietaryName>Ranitidine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210010</ApplicationNumber>
    <LabelerName>Vivimed Labs Limited</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63545-515-03</NDCCode>
    <PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (63545-515-03) </PackageDescription>
    <NDC11Code>63545-0515-03</NDC11Code>
    <ProductNDC>63545-515</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Boron</ProprietaryName>
    <NonProprietaryName>Boron</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220503</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>BORON</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-05-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220503</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>65162-515-03</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (65162-515-03) </PackageDescription>
    <NDC11Code>65162-0515-03</NDC11Code>
    <ProductNDC>65162-515</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Spironolactone</ProprietaryName>
    <NonProprietaryName>Spironolactone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100802</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091426</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>SPIRONOLACTONE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100802</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Spironolactone tablets are an aldosterone antagonist indicated for: 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1)., 2 Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.2)., 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3)., 4 Treatment of primary hyperaldosternism for: (1.4).</IndicationAndUsage>
    <Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula:. Spironolactone, USP is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, corn starch, croscarmellose sodium, peppermint flavor, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide, and triacetin. The 50 mg tablet also contains D&amp;C yellow # 10 and FD&amp;C yellow # 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>67254-515-03</NDCCode>
    <PackageDescription>2 kg in 1 DRUM (67254-515-03) </PackageDescription>
    <NDC11Code>67254-0515-03</NDC11Code>
    <ProductNDC>67254-515</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Daptomycin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20140325</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory</LabelerName>
    <SubstanceName>DAPTOMYCIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-01-08</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>25-MAR-14</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>68180-515-03</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (68180-515-03) </PackageDescription>
    <NDC11Code>68180-0515-03</NDC11Code>
    <ProductNDC>68180-515</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisinopril</ProprietaryName>
    <NonProprietaryName>Lisinopril</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060113</StartMarketingDate>
    <EndMarketingDate>20191031</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077321</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LISINOPRIL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20060113</StartMarketingDatePackage>
    <EndMarketingDatePackage>20191031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68428-515-03</NDCCode>
    <PackageDescription>75 PELLET in 1 VIAL, GLASS (68428-515-03) </PackageDescription>
    <NDC11Code>68428-0515-03</NDC11Code>
    <ProductNDC>68428-515</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Murex Purpurea</ProprietaryName>
    <NonProprietaryName>Hexaplex Trunculus Hypobranchial Gland Juice</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110131</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-04-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110131</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>75109-515-03</NDCCode>
    <PackageDescription>25 NOT APPLICABLE in 1 PACKAGE (75109-515-03)  &gt; 101.25 mL in 1 NOT APPLICABLE</PackageDescription>
    <NDC11Code>75109-0515-03</NDC11Code>
    <ProductNDC>75109-515</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Herclean Alcohol Wipes</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200921</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Kangna (Zhejiang) Medical Supplies Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200921</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses■for hand sanitizing to decrease bacteria on the skin■apply topically to the skin to help prevent cross contamination■not recommended for repeated use■dries in seconds.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>76348-515-01</NDCCode>
    <PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 BOX (76348-515-01)  &gt; 84 g in 1 BOTTLE, WITH APPLICATOR (76348-515-03) </PackageDescription>
    <NDC11Code>76348-0515-01</NDC11Code>
    <ProductNDC>76348-515</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mag 5 Pt Warming Formula Roll On</ProprietaryName>
    <NonProprietaryName>Menthol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190319</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>RENU LABORATORIES, INC.</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>4.2</StrengthNumber>
    <StrengthUnit>g/84g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-02-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190319</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>84522-515-03</NDCCode>
    <PackageDescription>30 g in 1 BOX (84522-515-03) </PackageDescription>
    <NDC11Code>84522-0515-03</NDC11Code>
    <ProductNDC>84522-515</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Crepe Repair Face Neck Cream</ProprietaryName>
    <NonProprietaryName>Crepe Repair Face Neck Cream</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241214</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
    <SubstanceName>NIACINAMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241214</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84756-515-03</NDCCode>
    <PackageDescription>30 g in 1 BOX (84756-515-03) </PackageDescription>
    <NDC11Code>84756-0515-03</NDC11Code>
    <ProductNDC>84756-515</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Trstay Dark Spot Corrector Cream</ProprietaryName>
    <NonProprietaryName>Trstay Dark Spot Corrector Cream</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241129</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Yiwu Yucheng E Commerce Co Ltd</LabelerName>
    <SubstanceName>NIACINAMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>52536-004-03</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (52536-004-03) </PackageDescription>
    <NDC11Code>52536-0004-03</NDC11Code>
    <ProductNDC>52536-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azilsartan Medoxomil</ProprietaryName>
    <NonProprietaryName>Azilsartan Kamedoxomil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260427</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA200796</ApplicationNumber>
    <LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AZILSARTAN KAMEDOXOMIL</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Blocker [EPC], Angiotensin 2 Type 1 Receptor Antagonists [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260427</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Azilsartan medoxomil is indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with azilsartan medoxomil. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Azilsartan medoxomil may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
    <Description>Azilsartan medoxomil, a prodrug, is hydrolyzed to azilsartan in the gastrointestinal tract during absorption. Azilsartan is an angiotensin II receptor blocker. The drug substance used in the drug product formulation is the potassium salt of azilsartan medoxomil, also known by the US accepted name of azilsartan kamedoxomil and is chemically described as (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-{[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylate monopotassium salt. Its empirical formula is C30H23KN4O8 and its structural formula is. Azilsartan kamedoxomil is a white to nearly white powder with a molecular weight of 606.62. It is practically insoluble in water and freely soluble in methanol.  Azilsartan Medoxomil Tablets, USP are available for oral use as tablets. The tablets have a characteristic odor. Each azilsartan medoxomil tablet contains 42.68 or 85.36 mg of azilsartan kamedoxomil, which is equivalent to containing 40 mg or 80 mg respectively, of azilsartan medoxomil and the following inactive ingredients: mannitol, fumaric acid, sodium hydroxide, hydroxypropyl cellulose, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>52536-008-03</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (52536-008-03) </PackageDescription>
    <NDC11Code>52536-0008-03</NDC11Code>
    <ProductNDC>52536-008</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azilsartan Medoxomil</ProprietaryName>
    <NonProprietaryName>Azilsartan Kamedoxomil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260427</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA200796</ApplicationNumber>
    <LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AZILSARTAN KAMEDOXOMIL</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Blocker [EPC], Angiotensin 2 Type 1 Receptor Antagonists [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260427</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Azilsartan medoxomil is indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with azilsartan medoxomil. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Azilsartan medoxomil may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
    <Description>Azilsartan medoxomil, a prodrug, is hydrolyzed to azilsartan in the gastrointestinal tract during absorption. Azilsartan is an angiotensin II receptor blocker. The drug substance used in the drug product formulation is the potassium salt of azilsartan medoxomil, also known by the US accepted name of azilsartan kamedoxomil and is chemically described as (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-{[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylate monopotassium salt. Its empirical formula is C30H23KN4O8 and its structural formula is. Azilsartan kamedoxomil is a white to nearly white powder with a molecular weight of 606.62. It is practically insoluble in water and freely soluble in methanol.  Azilsartan Medoxomil Tablets, USP are available for oral use as tablets. The tablets have a characteristic odor. Each azilsartan medoxomil tablet contains 42.68 or 85.36 mg of azilsartan kamedoxomil, which is equivalent to containing 40 mg or 80 mg respectively, of azilsartan medoxomil and the following inactive ingredients: mannitol, fumaric acid, sodium hydroxide, hydroxypropyl cellulose, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>52536-057-03</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (52536-057-03) </PackageDescription>
    <NDC11Code>52536-0057-03</NDC11Code>
    <ProductNDC>52536-057</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amphetamine Sulfate</ProprietaryName>
    <NonProprietaryName>Amphetamine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180329</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200166</ApplicationNumber>
    <LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AMPHETAMINE SULFATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-01-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210107</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amphetamine Sulfate Tablets, USP, are indicated for: 1 Narcolepsy, 2 Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. , 3 Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patient's refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug, such as those described below. .</IndicationAndUsage>
    <Description>Amphetamine Sulfate is a sympathomimetic amino of the amphetamine group. It is a white, odorless crystalline powder. It has a slightly bitter taste. Its solutions are acid to litmus, having a pH of 5.0 to 6.0. It is freely soluble in water and slightly soluble in alcohol. Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate. Each tablet also contains the following inactive ingredients: crospovidone, silicified microcrystalline cellulose and stearic acid. The 10 mg tablet also contains FD&amp;C Blue #1. Structural Formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>52536-059-03</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (52536-059-03) </PackageDescription>
    <NDC11Code>52536-0059-03</NDC11Code>
    <ProductNDC>52536-059</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amphetamine Sulfate</ProprietaryName>
    <NonProprietaryName>Amphetamine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180329</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200166</ApplicationNumber>
    <LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AMPHETAMINE SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-01-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210107</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amphetamine Sulfate Tablets, USP, are indicated for: 1 Narcolepsy, 2 Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. , 3 Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patient's refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug, such as those described below. .</IndicationAndUsage>
    <Description>Amphetamine Sulfate is a sympathomimetic amino of the amphetamine group. It is a white, odorless crystalline powder. It has a slightly bitter taste. Its solutions are acid to litmus, having a pH of 5.0 to 6.0. It is freely soluble in water and slightly soluble in alcohol. Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate. Each tablet also contains the following inactive ingredients: crospovidone, silicified microcrystalline cellulose and stearic acid. The 10 mg tablet also contains FD&amp;C Blue #1. Structural Formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>52536-103-03</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (52536-103-03) </PackageDescription>
    <NDC11Code>52536-0103-03</NDC11Code>
    <ProductNDC>52536-103</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Erythromycin</ProprietaryName>
    <NonProprietaryName>Erythromycin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180315</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA061621</ApplicationNumber>
    <LabelerName>Wilshire Pharmaceuticals</LabelerName>
    <SubstanceName>ERYTHROMYCIN</SubstanceName>
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    <Description>Erythromycin Tablets, USP are an antibacterial product containing erythromycin, USP, in a unique, nonenteric film coating for oral administration. Erythromycin Tablets are available in two strengths containing either 250 mg or 500 mg of erythromycin base. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C37H67NO13, and the molecular weight is 733.94. The structural formula is.</Description>
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    <Description>Erythromycin Tablets, USP are an antibacterial product containing erythromycin, USP, in a unique, nonenteric film coating for oral administration. Erythromycin Tablets are available in two strengths containing either 250 mg or 500 mg of erythromycin base. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C37H67NO13, and the molecular weight is 733.94. The structural formula is.</Description>
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    <Description>Erythromycin Delayed-Release Tablets, USP are an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. Erythromycin Delayed-Release Tablets, USP for oral administration are available in three dosage strengths, each white oval tablet containing either 250 mg, 333 mg, or 500 mg of erythromycin as the free base. Erythromycin Delayed-Release Tablets, USP comply with USP Dissolution Test 1. Erythromycin is produced by a strain of Saccharopolyspora erythraea(formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α -L- ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl- 6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D- xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C 37H 67NO 13, and the molecular weight is 733.94. The structural formula is:.</Description>
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    <Description>Erythromycin Delayed-Release Tablets, USP are an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. Erythromycin Delayed-Release Tablets, USP for oral administration are available in three dosage strengths, each white oval tablet containing either 250 mg, 333 mg, or 500 mg of erythromycin as the free base. Erythromycin Delayed-Release Tablets, USP comply with USP Dissolution Test 1. Erythromycin is produced by a strain of Saccharopolyspora erythraea(formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α -L- ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl- 6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D- xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C 37H 67NO 13, and the molecular weight is 733.94. The structural formula is:.</Description>
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    <Description>Erythromycin Delayed-Release Tablets, USP are an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. Erythromycin Delayed-Release Tablets, USP for oral administration are available in three dosage strengths, each white oval tablet containing either 250 mg, 333 mg, or 500 mg of erythromycin as the free base. Erythromycin Delayed-Release Tablets, USP comply with USP Dissolution Test 1. Erythromycin is produced by a strain of Saccharopolyspora erythraea(formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α -L- ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl- 6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D- xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C 37H 67NO 13, and the molecular weight is 733.94. The structural formula is:.</Description>
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    <EndMarketingDate>20180430</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
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    <StrengthUnit>mg/1</StrengthUnit>
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    <Status>Deprecated</Status>
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    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <NDC11Code>52536-0252-03</NDC11Code>
    <ProductNDC>52536-252</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamotrigine</ProprietaryName>
    <NonProprietaryName>Lamotrigine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140317</StartMarketingDate>
    <EndMarketingDate>20180531</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202887</ApplicationNumber>
    <LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LAMOTRIGINE</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
  </NDC>
</NDCList>