RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>55513-813-28</NDCCode>
    <PackageDescription>28 AMPULE in 1 CARTON (55513-813-28)  / 5 mL in 1 AMPULE (55513-813-01) </PackageDescription>
    <NDC11Code>55513-0813-28</NDC11Code>
    <ProductNDC>55513-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Corlanor</ProprietaryName>
    <NonProprietaryName>Ivabradine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190419</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209964</ApplicationNumber>
    <LabelerName>Amgen Inc</LabelerName>
    <SubstanceName>IVABRADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190419</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Corlanor (ivabradine) is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: : 1 To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. (1.1), 2 For the treatment of stable symptomatic heart failure due to dilated cardiomyopathy in pediatric patients ages 6 months and older. (1.2).</IndicationAndUsage>
    <Description>Corlanor (ivabradine) tablets and oral solution contains ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility. The chemical name for ivabradine hydrochloride is 3-(3-{[((7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl] methyl amino} propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one, hydrochloride. The molecular formula is C27H36N2O5∙HCl, and the molecular weight (free base + HCl) is 505.1 (468.6 + 36.5). The chemical structure of ivabradine is shown in Figure 1. Figure 1. Chemical Structure of Ivabradine. Tablets. Corlanor tablets are supplied in 5 mg and 7.5 mg tablets for oral administration. The tablets contain 5 mg and 7.5 mg of ivabradine, as the active ingredient, equivalent to 5.39 mg and 8.09 mg of ivabradine hydrochloride, respectively. The tablets contain the following inactive ingredients: colloidal silicon dioxide, glycerol, hypromellose, lactose monohydrate, magnesium stearate, maize starch, maltodextrin, polyethylene glycol 6000, red iron oxide, titanium dioxide, and yellow iron oxide. Oral Solution. Corlanor 5 mg/5 mL (1 mg/mL) oral solution is formulated as a sterile, preservative-free, colorless solution for oral administration. Each 5 mL ampule contains 5 mg of ivabradine, equivalent to 5.39 mg ivabradine hydrochloride, as the active ingredient. The solution contains the following inactive ingredients: maltitol and water.</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-137-28</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (55513-137-28)  &gt; 28 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>55513-0137-28</NDC11Code>
    <ProductNDC>55513-137</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Otezla</ProprietaryName>
    <NonProprietaryName>Apremilast</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200226</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205437</ApplicationNumber>
    <LabelerName>Amgen Inc</LabelerName>
    <SubstanceName>APREMILAST</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-03-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200226</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55513-137-95</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (55513-137-95)  / 28 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>55513-0137-95</NDC11Code>
    <ProductNDC>55513-137</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Otezla</ProprietaryName>
    <NonProprietaryName>Apremilast</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200226</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205437</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>APREMILAST</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200226</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>OTEZLA/OTEZLA XR, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of. Adult patients with: 1 Active psoriatic arthritis (1.1), 2 Plaque psoriasis who are candidates for phototherapy or systemic therapy (1.2), 3 Oral ulcers associated with Behçet's Disease (1.3).</IndicationAndUsage>
    <Description>The active ingredient in OTEZLA/OTEZLA XR tablets is apremilast. Apremilast drug substance is non-hygroscopic. Apremilast drug substance is practically insoluble in water and slightly soluble in alcohol. Apremilast is a phosphodiesterase 4 (PDE4) inhibitor. Apremilast is known chemically as N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide. Its empirical formula is C22H24N2O7S and the molecular weight is 460.5. The chemical structure is. OTEZLA (apremilast) tablets are supplied in 10 mg, 20 mg, and 30 mg strengths for oral administration. Each tablet contains apremilast as the active ingredient and the following inactive ingredients: croscarmellose sodium, iron oxide red, iron oxide yellow (20 and 30 mg only), iron oxide black (30 mg only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. OTEZLA XR (apremilast) extended-release tablets are supplied in a 75 mg strength for oral administration. Each tablet contains apremilast as the active ingredient and the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hydroxypropyl methylcellulose acetate succinate, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, sodium chloride, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>61786-813-06</NDCCode>
    <PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61786-813-06)</PackageDescription>
    <NDC11Code>61786-0813-06</NDC11Code>
    <ProductNDC>61786-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metronidazole</ProprietaryName>
    <NonProprietaryName>Metronidazole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160812</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203458</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>METRONIDAZOLE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-01-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>70934-813-28</NDCCode>
    <PackageDescription>28 TABLET in 1 BOTTLE, PLASTIC (70934-813-28) </PackageDescription>
    <NDC11Code>70934-0813-28</NDC11Code>
    <ProductNDC>70934-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metronidazole</ProprietaryName>
    <NonProprietaryName>Metronidazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210113</StartMarketingDate>
    <EndMarketingDate>20231031</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203974</ApplicationNumber>
    <LabelerName>Denton Pharma, Inc. DBA Northwind Pharmaceuticals</LabelerName>
    <SubstanceName>METRONIDAZOLE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-11-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20220308</StartMarketingDatePackage>
    <EndMarketingDatePackage>20231031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>76420-813-28</NDCCode>
    <PackageDescription>28 CAPSULE in 1 BOTTLE (76420-813-28) </PackageDescription>
    <NDC11Code>76420-0813-28</NDC11Code>
    <ProductNDC>76420-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220110</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207774</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250531</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate  and other antibacterial drugs, doxycycline hyclate capsules  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>Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules for oral administration. The chemical designation for doxycyclin is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrate. The structural formula of doxycycline hyclate is. Doxycycline hyclate, USP is yellow to light yellow powder. It is freely soluble in water and methanol, sparingly soluble in alcohol; practically insoluble in chloroform and in ether. It dissolves in aqueous solution of alkali hydroxides and carbonates. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule contains doxycycline hyclate equivalent to doxycycline 50 mg or 100 mg and inactive ingredients: anhydrous lactose, croscarmellose sodium, D&amp;C red 28, FD &amp; C blue 1, gelatin, microcrystalline cellulose, magnesium stearate and sodium lauryl sulfate and titanium dioxide. Each capsule cap is printed with white pharmaceutical ink and capsule body is printed with black pharmaceutical ink which contains following ingredient butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, strong ammonia solution, and shellac. Additionally black pharmaceutical ink also contains black iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-813-20</NDCCode>
    <PackageDescription>200 CAPSULE in 1 BOTTLE, PLASTIC (16571-813-20) </PackageDescription>
    <NDC11Code>16571-0813-20</NDC11Code>
    <ProductNDC>16571-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Calcium Acetate</ProprietaryName>
    <NonProprietaryName>Calcium Acetate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211038</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>CALCIUM ACETATE</SubstanceName>
    <StrengthNumber>667</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).</IndicationAndUsage>
    <Description>Calcium acetate, USP acts as a phosphate binder. Its chemical name is Calcium acetate, USP. Its molecular formula is C 4H 6CaO 4, and its molecular weight is 158.17. Its structural formula is:. Each opaque capsule with a blue cap and white body is spin printed in blue and white ink with “SUVEN” printed on the cap and “667” printed on the body. Each capsule contains 667 mg calcium acetate, USP (anhydrous; Ca(CH 3COO) 2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, and water as the inert binder, crospovidone and sodium stearyl fumarate . The gelatin cap and body have the following inactive ingredients: FD&amp;C blue 1, D&amp;C red 28, titanium dioxide and gelatin. Imprinting ink on capsule body contains shellac and FD&amp;C 2 Aluminum Lake and imprinting ink on capsule cap contains shellac, titanium dioxide and potassium hydroxide. Calcium acetate capsules are administered orally for the control of hyperphosphatemia in end-stage renal failure. Meets USP Dissolution Test 4.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-813-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (21695-813-30)</PackageDescription>
    <NDC11Code>21695-0813-30</NDC11Code>
    <ProductNDC>21695-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Terazosin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Terazosin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075317</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>TERAZOSIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Terazosin hydrochloride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin hydrochloride. The long-term effects of terazosin hydrochloride on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin hydrochloride is also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
    <Description>Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following structural formula, molecular formula and chemical name. Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, anhydrous. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 459.93. Each terazosin hydrochloride capsule, for oral administration, contains 1 mg, 2 mg, 5 mg or 10 mg of terazosin as terazosin hydrochloride anhydrous. Each capsule contains the following inactive ingredients: crospovidone, lactose (monohydrate), magnesium stearate and microcrystalline cellulose. The capsule shells and imprinting inks contain: D &amp; C Yellow # 10 Aluminum Lake, FD &amp; C Blue # 1 Aluminum Lake, FD &amp; C Blue # 2 Aluminum Lake, FD &amp; C Red # 40 Aluminum Lake, gelatine, pharmaceutical glaze, propylene glycol, silicon dioxide, sodium lauryl sulfate, synthetic black iron oxide, and titanium dioxide. The 5 mg also contains; D &amp; C Red # 28.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-813-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (21695-813-90)</PackageDescription>
    <NDC11Code>21695-0813-90</NDC11Code>
    <ProductNDC>21695-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Terazosin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Terazosin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075317</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>TERAZOSIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Terazosin hydrochloride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin hydrochloride. The long-term effects of terazosin hydrochloride on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin hydrochloride is also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
    <Description>Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following structural formula, molecular formula and chemical name. Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, anhydrous. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 459.93. Each terazosin hydrochloride capsule, for oral administration, contains 1 mg, 2 mg, 5 mg or 10 mg of terazosin as terazosin hydrochloride anhydrous. Each capsule contains the following inactive ingredients: crospovidone, lactose (monohydrate), magnesium stearate and microcrystalline cellulose. The capsule shells and imprinting inks contain: D &amp; C Yellow # 10 Aluminum Lake, FD &amp; C Blue # 1 Aluminum Lake, FD &amp; C Blue # 2 Aluminum Lake, FD &amp; C Red # 40 Aluminum Lake, gelatine, pharmaceutical glaze, propylene glycol, silicon dioxide, sodium lauryl sulfate, synthetic black iron oxide, and titanium dioxide. The 5 mg also contains; D &amp; C Red # 28.</Description>
  </NDC>
  <NDC>
    <NDCCode>50268-813-12</NDCCode>
    <PackageDescription>20 BLISTER PACK in 1 BOX (50268-813-12)  / 1 CAPSULE in 1 BLISTER PACK (50268-813-11) </PackageDescription>
    <NDC11Code>50268-0813-12</NDC11Code>
    <ProductNDC>50268-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ziprasidone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ziprasidone Hcl</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210512</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077561</ApplicationNumber>
    <LabelerName>AvPAK</LabelerName>
    <SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210512</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions ( 5.3) ].  Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions ( 5.3) ]. Schizophrenia. Ziprasidone capsules are indicated for the treatment of schizophrenia in adults [see Clinical Studies ( 14.1)] . Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate): 1 Ziprasidone capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies ( 14.2)]. , 2 Ziprasidone capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults  [see Clinical Studies (  14.2)]. .</IndicationAndUsage>
    <Description>Ziprasidone is an atypical antipsychotic available as ziprasidone capsules, USP for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 g/mol (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro- 2H-indol-2-one. The molecular formula of C 21H 21ClN 4OS (free base of ziprasidone) represents the following structural formula:. Ziprasidone capsules, USP contain a monohydrochloride salt of ziprasidone. Chemically, ziprasidone hydrochloride is 5-[2-[4-(1,2-­benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro- 2H-indol-2-one, monohydrochloride. The molecular formula is C 21H 21ClN 4OS · HCl and its molecular weight is 449.40 g/mol. Ziprasidone hydrochloride is an off white to beige brown powder. Ziprasidone capsules, USP are supplied for oral administration in 20 mg (of ziprasidone free base), 40 mg (of ziprasidone free base), 60 mg (of ziprasidone free base), and 80 mg (of ziprasidone free base) capsules. Ziprasidone capsules contain ziprasidone hydrochloride, colloidal silicon dioxide, crospovidone, magnesium stearate and sodium starch glycolate. Each capsule shell contains the following inactive ingredients: gelatin and titanium dioxide. The 20 mg, 40 mg and 80 mg capsule shells also contain the following inactive ingredients: D&amp;C Red #28, FD&amp;C Blue #1, FD&amp;C Yellow #6. The capsule imprinting ink contains ammonium hydroxide, black iron oxide, potassium hydroxide, propylene glycol and shellac. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>60687-813-94</NDCCode>
    <PackageDescription>20 BLISTER PACK in 1 CARTON (60687-813-94)  / 1 TABLET in 1 BLISTER PACK (60687-813-11) </PackageDescription>
    <NDC11Code>60687-0813-94</NDC11Code>
    <ProductNDC>60687-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylergonovine Maleate</ProprietaryName>
    <NonProprietaryName>Methylergonovine Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210424</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>METHYLERGONOVINE MALEATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Ergolines [CS], Ergot Derivative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Following delivery of the placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.</IndicationAndUsage>
    <Description>Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. TabletsActive ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9,10-didehydro-N-[1-(hydroxy-methyl)propyl]-6-methyl-,[8β(S)]-,(Z)-2-butenedioate(1:1) (salt). Its structural formula is.</Description>
  </NDC>
  <NDC>
    <NDCCode>61649-813-01</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE, SPRAY (61649-813-01) </PackageDescription>
    <NDC11Code>61649-0813-01</NDC11Code>
    <ProductNDC>61649-813</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Attitude Little Leaves Hand Sanitizer - Mango</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20231211</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>9055-7588 Quebec Inc. DBA Attitude</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>78.8</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231211</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>62584-813-01</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (62584-813-01)  / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (62584-813-11) </PackageDescription>
    <NDC11Code>62584-0813-01</NDC11Code>
    <ProductNDC>62584-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxazepam</ProprietaryName>
    <NonProprietaryName>Oxazepam</NonProprietaryName>
    <DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071217</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072253</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>OXAZEPAM</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-11-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20071217</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxazepam capsules are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Anxiety associated with depression is also responsive to oxazepam therapy. This product has been found particularly useful in the management of anxiety, tension, agitation and irritability in older patients. Alcoholics with acute tremulousness, inebriation, or with anxiety associated with alcohol withdrawal are responsive to therapy. The effectiveness of oxazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Oxazepam, USP is the first of a chemical series of compounds known as the 3-hydroxybenzodiazepinones. A therapeutic agent providing versatility and flexibility in control of common emotional disturbances, this product exerts prompt action in a wide variety of disorders associated with anxiety, tension, agitation, and irritability, and anxiety associated with depression. In tolerance and toxicity studies on several animal species, this product reveals significantly greater safety factors than related compounds (chlordiazepoxide and diazepam) and manifests a wide separation of effective doses and doses inducing side effects. Oxazepam capsules, USP contain 10 mg, 15 mg or 30 mg oxazepam, USP and the following inactive ingredients: corn starch, croscarmellose sodium, hypromellose 2910, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate. The capsule shells contain gelatin, methylparaben, propylparaben, and titanium dioxide. In addition, the 10 mg capsule shells contain D&amp;C Red No. 28 and FD&amp;C Red No. 40, the 15 mg capsule shells contain D&amp;C Yellow No. 10 and FD&amp;C Red No. 40, and the 30 mg capsule shells contain D&amp;C Red No. 28, FD&amp;C Blue No. 1, and FD&amp;C Red No. 40. The imprinting ink, for the 10 mg and 15 mg capsules, contains black iron oxide, FD&amp;C Blue No. 1 Brilliant Blue FCF Aluminum Lake, FD&amp;C Blue No. 2 Indigo Carmine Aluminum Lake, FD&amp;C Red No. 40 Allura Red AC Aluminum Lake, D&amp;C Yellow No. 10 Aluminum Lake, shellac, and may also contain propylene glycol. The imprinting ink, for the 30 mg capsules, contains ethyl acetate, FD&amp;C Blue No. 1 Aluminum Lake, and shellac. Oxazepam, USP is 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-2 H-1,4-benzodiazepin-2-one. A white crystalline powder with a molecular weight of 286 .72, its structural formula is as follows:.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-813-00</NDCCode>
    <PackageDescription>1000 CAPSULE in 1 BOTTLE (76420-813-00) </PackageDescription>
    <NDC11Code>76420-0813-00</NDC11Code>
    <ProductNDC>76420-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220110</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207774</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240507</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate  and other antibacterial drugs, doxycycline hyclate capsules  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>Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules for oral administration. The chemical designation for doxycyclin is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrate. The structural formula of doxycycline hyclate is. Doxycycline hyclate, USP is yellow to light yellow powder. It is freely soluble in water and methanol, sparingly soluble in alcohol; practically insoluble in chloroform and in ether. It dissolves in aqueous solution of alkali hydroxides and carbonates. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule contains doxycycline hyclate equivalent to doxycycline 50 mg or 100 mg and inactive ingredients: anhydrous lactose, croscarmellose sodium, D&amp;C red 28, FD &amp; C blue 1, gelatin, microcrystalline cellulose, magnesium stearate and sodium lauryl sulfate and titanium dioxide. Each capsule cap is printed with white pharmaceutical ink and capsule body is printed with black pharmaceutical ink which contains following ingredient butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, strong ammonia solution, and shellac. Additionally black pharmaceutical ink also contains black iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-813-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (76420-813-01) </PackageDescription>
    <NDC11Code>76420-0813-01</NDC11Code>
    <ProductNDC>76420-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220110</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207774</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240507</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate  and other antibacterial drugs, doxycycline hyclate capsules  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>Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules for oral administration. The chemical designation for doxycyclin is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrate. The structural formula of doxycycline hyclate is. Doxycycline hyclate, USP is yellow to light yellow powder. It is freely soluble in water and methanol, sparingly soluble in alcohol; practically insoluble in chloroform and in ether. It dissolves in aqueous solution of alkali hydroxides and carbonates. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule contains doxycycline hyclate equivalent to doxycycline 50 mg or 100 mg and inactive ingredients: anhydrous lactose, croscarmellose sodium, D&amp;C red 28, FD &amp; C blue 1, gelatin, microcrystalline cellulose, magnesium stearate and sodium lauryl sulfate and titanium dioxide. Each capsule cap is printed with white pharmaceutical ink and capsule body is printed with black pharmaceutical ink which contains following ingredient butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, strong ammonia solution, and shellac. Additionally black pharmaceutical ink also contains black iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-813-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (76420-813-05) </PackageDescription>
    <NDC11Code>76420-0813-05</NDC11Code>
    <ProductNDC>76420-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220110</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207774</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240507</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate  and other antibacterial drugs, doxycycline hyclate capsules  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>Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules for oral administration. The chemical designation for doxycyclin is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrate. The structural formula of doxycycline hyclate is. Doxycycline hyclate, USP is yellow to light yellow powder. It is freely soluble in water and methanol, sparingly soluble in alcohol; practically insoluble in chloroform and in ether. It dissolves in aqueous solution of alkali hydroxides and carbonates. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule contains doxycycline hyclate equivalent to doxycycline 50 mg or 100 mg and inactive ingredients: anhydrous lactose, croscarmellose sodium, D&amp;C red 28, FD &amp; C blue 1, gelatin, microcrystalline cellulose, magnesium stearate and sodium lauryl sulfate and titanium dioxide. Each capsule cap is printed with white pharmaceutical ink and capsule body is printed with black pharmaceutical ink which contains following ingredient butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, strong ammonia solution, and shellac. Additionally black pharmaceutical ink also contains black iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-813-10</NDCCode>
    <PackageDescription>10 CAPSULE in 1 BOTTLE (76420-813-10) </PackageDescription>
    <NDC11Code>76420-0813-10</NDC11Code>
    <ProductNDC>76420-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220110</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207774</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240507</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate  and other antibacterial drugs, doxycycline hyclate capsules  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>Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules for oral administration. The chemical designation for doxycyclin is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrate. The structural formula of doxycycline hyclate is. Doxycycline hyclate, USP is yellow to light yellow powder. It is freely soluble in water and methanol, sparingly soluble in alcohol; practically insoluble in chloroform and in ether. It dissolves in aqueous solution of alkali hydroxides and carbonates. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule contains doxycycline hyclate equivalent to doxycycline 50 mg or 100 mg and inactive ingredients: anhydrous lactose, croscarmellose sodium, D&amp;C red 28, FD &amp; C blue 1, gelatin, microcrystalline cellulose, magnesium stearate and sodium lauryl sulfate and titanium dioxide. Each capsule cap is printed with white pharmaceutical ink and capsule body is printed with black pharmaceutical ink which contains following ingredient butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, strong ammonia solution, and shellac. Additionally black pharmaceutical ink also contains black iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-813-14</NDCCode>
    <PackageDescription>14 CAPSULE in 1 BOTTLE (76420-813-14) </PackageDescription>
    <NDC11Code>76420-0813-14</NDC11Code>
    <ProductNDC>76420-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220110</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207774</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250210</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate  and other antibacterial drugs, doxycycline hyclate capsules  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>Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules for oral administration. The chemical designation for doxycyclin is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrate. The structural formula of doxycycline hyclate is. Doxycycline hyclate, USP is yellow to light yellow powder. It is freely soluble in water and methanol, sparingly soluble in alcohol; practically insoluble in chloroform and in ether. It dissolves in aqueous solution of alkali hydroxides and carbonates. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule contains doxycycline hyclate equivalent to doxycycline 50 mg or 100 mg and inactive ingredients: anhydrous lactose, croscarmellose sodium, D&amp;C red 28, FD &amp; C blue 1, gelatin, microcrystalline cellulose, magnesium stearate and sodium lauryl sulfate and titanium dioxide. Each capsule cap is printed with white pharmaceutical ink and capsule body is printed with black pharmaceutical ink which contains following ingredient butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, strong ammonia solution, and shellac. Additionally black pharmaceutical ink also contains black iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-813-20</NDCCode>
    <PackageDescription>20 CAPSULE in 1 BOTTLE (76420-813-20) </PackageDescription>
    <NDC11Code>76420-0813-20</NDC11Code>
    <ProductNDC>76420-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220110</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207774</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250318</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate  and other antibacterial drugs, doxycycline hyclate capsules  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>Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules for oral administration. The chemical designation for doxycyclin is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrate. The structural formula of doxycycline hyclate is. Doxycycline hyclate, USP is yellow to light yellow powder. It is freely soluble in water and methanol, sparingly soluble in alcohol; practically insoluble in chloroform and in ether. It dissolves in aqueous solution of alkali hydroxides and carbonates. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule contains doxycycline hyclate equivalent to doxycycline 50 mg or 100 mg and inactive ingredients: anhydrous lactose, croscarmellose sodium, D&amp;C red 28, FD &amp; C blue 1, gelatin, microcrystalline cellulose, magnesium stearate and sodium lauryl sulfate and titanium dioxide. Each capsule cap is printed with white pharmaceutical ink and capsule body is printed with black pharmaceutical ink which contains following ingredient butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, strong ammonia solution, and shellac. Additionally black pharmaceutical ink also contains black iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-813-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (76420-813-30) </PackageDescription>
    <NDC11Code>76420-0813-30</NDC11Code>
    <ProductNDC>76420-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220110</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207774</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240507</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate  and other antibacterial drugs, doxycycline hyclate capsules  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>Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules for oral administration. The chemical designation for doxycyclin is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrate. The structural formula of doxycycline hyclate is. Doxycycline hyclate, USP is yellow to light yellow powder. It is freely soluble in water and methanol, sparingly soluble in alcohol; practically insoluble in chloroform and in ether. It dissolves in aqueous solution of alkali hydroxides and carbonates. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule contains doxycycline hyclate equivalent to doxycycline 50 mg or 100 mg and inactive ingredients: anhydrous lactose, croscarmellose sodium, D&amp;C red 28, FD &amp; C blue 1, gelatin, microcrystalline cellulose, magnesium stearate and sodium lauryl sulfate and titanium dioxide. Each capsule cap is printed with white pharmaceutical ink and capsule body is printed with black pharmaceutical ink which contains following ingredient butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, strong ammonia solution, and shellac. Additionally black pharmaceutical ink also contains black iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-813-50</NDCCode>
    <PackageDescription>50 CAPSULE in 1 BOTTLE (76420-813-50) </PackageDescription>
    <NDC11Code>76420-0813-50</NDC11Code>
    <ProductNDC>76420-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220110</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207774</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240507</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate  and other antibacterial drugs, doxycycline hyclate capsules  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>Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules for oral administration. The chemical designation for doxycyclin is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrate. The structural formula of doxycycline hyclate is. Doxycycline hyclate, USP is yellow to light yellow powder. It is freely soluble in water and methanol, sparingly soluble in alcohol; practically insoluble in chloroform and in ether. It dissolves in aqueous solution of alkali hydroxides and carbonates. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule contains doxycycline hyclate equivalent to doxycycline 50 mg or 100 mg and inactive ingredients: anhydrous lactose, croscarmellose sodium, D&amp;C red 28, FD &amp; C blue 1, gelatin, microcrystalline cellulose, magnesium stearate and sodium lauryl sulfate and titanium dioxide. Each capsule cap is printed with white pharmaceutical ink and capsule body is printed with black pharmaceutical ink which contains following ingredient butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, strong ammonia solution, and shellac. Additionally black pharmaceutical ink also contains black iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-813-60</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (76420-813-60) </PackageDescription>
    <NDC11Code>76420-0813-60</NDC11Code>
    <ProductNDC>76420-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220110</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207774</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240507</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate  and other antibacterial drugs, doxycycline hyclate capsules  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>Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules for oral administration. The chemical designation for doxycyclin is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrate. The structural formula of doxycycline hyclate is. Doxycycline hyclate, USP is yellow to light yellow powder. It is freely soluble in water and methanol, sparingly soluble in alcohol; practically insoluble in chloroform and in ether. It dissolves in aqueous solution of alkali hydroxides and carbonates. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule contains doxycycline hyclate equivalent to doxycycline 50 mg or 100 mg and inactive ingredients: anhydrous lactose, croscarmellose sodium, D&amp;C red 28, FD &amp; C blue 1, gelatin, microcrystalline cellulose, magnesium stearate and sodium lauryl sulfate and titanium dioxide. Each capsule cap is printed with white pharmaceutical ink and capsule body is printed with black pharmaceutical ink which contains following ingredient butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, strong ammonia solution, and shellac. Additionally black pharmaceutical ink also contains black iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-813-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (76420-813-90) </PackageDescription>
    <NDC11Code>76420-0813-90</NDC11Code>
    <ProductNDC>76420-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220110</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207774</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240507</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate  and other antibacterial drugs, doxycycline hyclate capsules  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>Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules for oral administration. The chemical designation for doxycyclin is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrate. The structural formula of doxycycline hyclate is. Doxycycline hyclate, USP is yellow to light yellow powder. It is freely soluble in water and methanol, sparingly soluble in alcohol; practically insoluble in chloroform and in ether. It dissolves in aqueous solution of alkali hydroxides and carbonates. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule contains doxycycline hyclate equivalent to doxycycline 50 mg or 100 mg and inactive ingredients: anhydrous lactose, croscarmellose sodium, D&amp;C red 28, FD &amp; C blue 1, gelatin, microcrystalline cellulose, magnesium stearate and sodium lauryl sulfate and titanium dioxide. Each capsule cap is printed with white pharmaceutical ink and capsule body is printed with black pharmaceutical ink which contains following ingredient butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, strong ammonia solution, and shellac. Additionally black pharmaceutical ink also contains black iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-002-04</NDCCode>
    <PackageDescription>4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-002-04)  / 1 mL in 1 VIAL, SINGLE-DOSE (55513-002-01) </PackageDescription>
    <NDC11Code>55513-0002-04</NDC11Code>
    <ProductNDC>55513-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aranesp</ProprietaryName>
    <NonProprietaryName>Darbepoetin Alfa</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20060911</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103951</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>DARBEPOETIN ALFA</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060911</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).</IndicationAndUsage>
    <Description>Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-003-04</NDCCode>
    <PackageDescription>4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-003-04)  / 1 mL in 1 VIAL, SINGLE-DOSE (55513-003-01) </PackageDescription>
    <NDC11Code>55513-0003-04</NDC11Code>
    <ProductNDC>55513-003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aranesp</ProprietaryName>
    <NonProprietaryName>Darbepoetin Alfa</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20060911</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103951</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>DARBEPOETIN ALFA</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060911</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).</IndicationAndUsage>
    <Description>Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).</Description>
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  <NDC>
    <NDCCode>55513-004-04</NDCCode>
    <PackageDescription>4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-004-04)  / 1 mL in 1 VIAL, SINGLE-DOSE (55513-004-01) </PackageDescription>
    <NDC11Code>55513-0004-04</NDC11Code>
    <ProductNDC>55513-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aranesp</ProprietaryName>
    <NonProprietaryName>Darbepoetin Alfa</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20060911</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103951</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>DARBEPOETIN ALFA</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060911</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).</IndicationAndUsage>
    <Description>Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-005-04</NDCCode>
    <PackageDescription>4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-005-04)  / 1 mL in 1 VIAL, SINGLE-DOSE (55513-005-01) </PackageDescription>
    <NDC11Code>55513-0005-04</NDC11Code>
    <ProductNDC>55513-005</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aranesp</ProprietaryName>
    <NonProprietaryName>Darbepoetin Alfa</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20060911</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103951</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>DARBEPOETIN ALFA</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060911</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).</IndicationAndUsage>
    <Description>Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).</Description>
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  <NDC>
    <NDCCode>55513-006-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-006-01)  / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>55513-0006-01</NDC11Code>
    <ProductNDC>55513-006</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aranesp</ProprietaryName>
    <NonProprietaryName>Darbepoetin Alfa</NonProprietaryName>
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    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20060911</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103951</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>DARBEPOETIN ALFA</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060911</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).</IndicationAndUsage>
    <Description>Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-006-21</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-006-21)  / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
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    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aranesp</ProprietaryName>
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    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20060911</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103951</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>DARBEPOETIN ALFA</SubstanceName>
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    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).</IndicationAndUsage>
    <Description>Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-021-04</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 PACKAGE (55513-021-04)  / 4 SYRINGE in 1 BLISTER PACK / .4 mL in 1 SYRINGE (55513-021-01) </PackageDescription>
    <NDC11Code>55513-0021-04</NDC11Code>
    <ProductNDC>55513-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aranesp</ProprietaryName>
    <NonProprietaryName>Darbepoetin Alfa</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20060814</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103951</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>DARBEPOETIN ALFA</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>ug/.4mL</StrengthUnit>
    <Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060814</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).</IndicationAndUsage>
    <Description>Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).</Description>
  </NDC>
</NDCList>