RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>54809-1025-8</NDCCode>
    <PackageDescription>44000 CAPSULE, DELAYED RELEASE PELLETS in 1 DRUM (54809-1025-8) </PackageDescription>
    <NDC11Code>54809-1025-08</NDC11Code>
    <ProductNDC>54809-1025</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Pancrelipase</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
    <StartMarketingDate>20131021</StartMarketingDate>
    <MarketingCategoryName>EXPORT ONLY</MarketingCategoryName>
    <LabelerName>Abbott Laboratories GmbH</LabelerName>
    <SubstanceName>PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE</SubstanceName>
    <StrengthNumber>120000; 24000; 76000</StrengthNumber>
    <StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-04-03</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>07-DEC-21</StartMarketingDatePackage>
    <Description>Pancrelipase, 3000 Delayed-release Capsules (BULK). Pancrelipase, 6000 Delayed-release Capsules (BULK). Pancrelipase, 12000 Delayed-release Capsules (BULK). Pancrelipase, 24000 Delayed-release Capsules (BULK). Pancrelipase, 36000 Delayed-release Capsules (BULK).</Description>
  </NDC>
  <NDC>
    <NDCCode>54809-1025-9</NDCCode>
    <PackageDescription>51000 CAPSULE, DELAYED RELEASE PELLETS in 1 DRUM (54809-1025-9)</PackageDescription>
    <NDC11Code>54809-1025-09</NDC11Code>
    <ProductNDC>54809-1025</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Pancrelipase</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
    <StartMarketingDate>20131021</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Abbott Laboratories GmbH</LabelerName>
    <SubstanceName>PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE</SubstanceName>
    <StrengthNumber>24000; 76000; 120000</StrengthNumber>
    <StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>54809-1024-8</NDCCode>
    <PackageDescription>80000 CAPSULE, DELAYED RELEASE PELLETS in 1 DRUM (54809-1024-8) </PackageDescription>
    <NDC11Code>54809-1024-08</NDC11Code>
    <ProductNDC>54809-1024</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Pancrelipase</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
    <StartMarketingDate>20131021</StartMarketingDate>
    <MarketingCategoryName>EXPORT ONLY</MarketingCategoryName>
    <LabelerName>Abbott Laboratories GmbH</LabelerName>
    <SubstanceName>PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE</SubstanceName>
    <StrengthNumber>60000; 12000; 38000</StrengthNumber>
    <StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-04-03</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>07-DEC-21</StartMarketingDatePackage>
    <Description>Pancrelipase, 3000 Delayed-release Capsules (BULK). Pancrelipase, 6000 Delayed-release Capsules (BULK). Pancrelipase, 12000 Delayed-release Capsules (BULK). Pancrelipase, 24000 Delayed-release Capsules (BULK). Pancrelipase, 36000 Delayed-release Capsules (BULK).</Description>
  </NDC>
  <NDC>
    <NDCCode>54809-1026-8</NDCCode>
    <PackageDescription>120000 CAPSULE, DELAYED RELEASE PELLETS in 1 DRUM (54809-1026-8) </PackageDescription>
    <NDC11Code>54809-1026-08</NDC11Code>
    <ProductNDC>54809-1026</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Pancrelipase</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
    <StartMarketingDate>20131021</StartMarketingDate>
    <MarketingCategoryName>EXPORT ONLY</MarketingCategoryName>
    <LabelerName>Abbott Laboratories GmbH</LabelerName>
    <SubstanceName>PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE</SubstanceName>
    <StrengthNumber>30000; 6000; 19000</StrengthNumber>
    <StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-04-03</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>07-DEC-21</StartMarketingDatePackage>
    <Description>Pancrelipase, 3000 Delayed-release Capsules (BULK). Pancrelipase, 6000 Delayed-release Capsules (BULK). Pancrelipase, 12000 Delayed-release Capsules (BULK). Pancrelipase, 24000 Delayed-release Capsules (BULK). Pancrelipase, 36000 Delayed-release Capsules (BULK).</Description>
  </NDC>
  <NDC>
    <NDCCode>54809-3823-8</NDCCode>
    <PackageDescription>60000 CAPSULE, DELAYED RELEASE PELLETS in 1 DRUM (54809-3823-8) </PackageDescription>
    <NDC11Code>54809-3823-08</NDC11Code>
    <ProductNDC>54809-3823</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Pancrelipase</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
    <StartMarketingDate>20131021</StartMarketingDate>
    <MarketingCategoryName>EXPORT ONLY</MarketingCategoryName>
    <LabelerName>Abbott Laboratories GmbH</LabelerName>
    <SubstanceName>PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE</SubstanceName>
    <StrengthNumber>15000; 3000; 9500</StrengthNumber>
    <StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-04-03</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>04-SEP-17</StartMarketingDatePackage>
    <Description>Pancrelipase, 3000 Delayed-release Capsules (BULK). Pancrelipase, 6000 Delayed-release Capsules (BULK). Pancrelipase, 12000 Delayed-release Capsules (BULK). Pancrelipase, 24000 Delayed-release Capsules (BULK). Pancrelipase, 36000 Delayed-release Capsules (BULK).</Description>
  </NDC>
  <NDC>
    <NDCCode>54809-9048-8</NDCCode>
    <PackageDescription>28000 CAPSULE, DELAYED RELEASE PELLETS in 1 DRUM (54809-9048-8) </PackageDescription>
    <NDC11Code>54809-9048-08</NDC11Code>
    <ProductNDC>54809-9048</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Pancrelipase</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
    <StartMarketingDate>20131021</StartMarketingDate>
    <MarketingCategoryName>EXPORT ONLY</MarketingCategoryName>
    <LabelerName>Abbott Laboratories GmbH</LabelerName>
    <SubstanceName>PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE</SubstanceName>
    <StrengthNumber>180000; 36000; 114000</StrengthNumber>
    <StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-04-03</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>07-DEC-21</StartMarketingDatePackage>
    <Description>Pancrelipase, 3000 Delayed-release Capsules (BULK). Pancrelipase, 6000 Delayed-release Capsules (BULK). Pancrelipase, 12000 Delayed-release Capsules (BULK). Pancrelipase, 24000 Delayed-release Capsules (BULK). Pancrelipase, 36000 Delayed-release Capsules (BULK).</Description>
  </NDC>
  <NDC>
    <NDCCode>58118-1025-8</NDCCode>
    <PackageDescription>30 TABLET in 1 BLISTER PACK (58118-1025-8)</PackageDescription>
    <NDC11Code>58118-1025-08</NDC11Code>
    <ProductNDC>58118-1025</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Baclofen</ProprietaryName>
    <NonProprietaryName>Baclofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101020</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074584</ApplicationNumber>
    <LabelerName>Clinical Solutions Wholesale</LabelerName>
    <SubstanceName>BACLOFEN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-07-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>63629-1025-8</NDCCode>
    <PackageDescription>800 TABLET in 1 BOTTLE (63629-1025-8) </PackageDescription>
    <NDC11Code>63629-1025-08</NDC11Code>
    <ProductNDC>63629-1025</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine Besylate</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071102</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077955</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20071102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70710-1025-8</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (70710-1025-8)  / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>70710-1025-08</NDC11Code>
    <ProductNDC>70710-1025</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isotretinoin</ProprietaryName>
    <NonProprietaryName>Isotretinoin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230912</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211568</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>ISOTRETINOIN</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230912</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].</IndicationAndUsage>
    <Description>Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
  </NDC>
  <NDC>
    <NDCCode>71399-1025-8</NDCCode>
    <PackageDescription>100000 TABLET in 1 DRUM (71399-1025-8) </PackageDescription>
    <NDC11Code>71399-1025-08</NDC11Code>
    <ProductNDC>71399-1025</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241206</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>Akron Pharma Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>325</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce fever and for the temporary relief of minor aches and pains due to. headache. muscular aches. backache. minor pain of arthritis. the common cold. toothache. premenstrual and menstrual cramps. Temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0093-1025-06</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (0093-1025-06) </PackageDescription>
    <NDC11Code>00093-1025-06</NDC11Code>
    <ProductNDC>0093-1025</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nefazodone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Nefazodone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20030916</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076037</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>NEFAZODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030916</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nefazodone hydrochloride tablets are indicated for the treatment of depression. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride treatment (see WARNINGS). In many cases, this would lead to the conclusion that other drugs should be tried first. The efficacy of nefazodone in the treatment of depression was established in 6 to 8 week controlled trials of outpatients and in a 6 week controlled trial of depressed inpatients whose diagnoses corresponded most closely to the DSM-III or DSM-IIIR category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks). It must include either depressed mood or loss of interest or pleasure and at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of nefazodone in reducing relapse in patients with major depression who were judged to have had a satisfactory clinical response to 16 weeks of open-label nefazodone treatment for an acute depressive episode has been demonstrated in a randomized placebo-controlled trial (see CLINICAL PHARMACOLOGY). Although remitted patients were followed for as long as 36 weeks in the study cited (i.e., 52 weeks total), the physician who elects to use nefazodone for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Nefazodone hydrochloride tablets, USP are an antidepressant for oral administration with a chemical structure unrelated to selective serotonin reuptake inhibitors, tricyclics, tetracyclics, or monoamine oxidase inhibitors (MAOI). Nefazodone hydrochloride is a synthetically derived phenylpiperazine antidepressant. The chemical name for nefazodone hydrochloride is 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-5-ethyl-2,4-dihydro-4-(2-phenoxyethyl)-3H-1,2,4-triazol-3-one monohydrochloride. The structural formula is. Nefazodone hydrochloride is a nonhygroscopic, white crystalline solid. It is freely soluble in chloroform, soluble in propylene glycol, and slightly soluble in polyethylene glycol and water. Nefazodone hydrochloride tablets, USP are supplied as capsule-shaped tablets containing 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg of nefazodone hydrochloride, USP and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and povidone. Additionally, the 50 mg tablets include ferric oxide red as a colorant, the 150 mg tablets include ferric oxide red and yellow as colorants, and the 200 mg tablets include ferric oxide yellow as a colorant.</Description>
  </NDC>
  <NDC>
    <NDCCode>0121-1025-08</NDCCode>
    <PackageDescription>237 mL in 1 BOTTLE (0121-1025-08) </PackageDescription>
    <NDC11Code>00121-1025-08</NDC11Code>
    <ProductNDC>0121-1025</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cimetidine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cimetidine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250109</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074664</ApplicationNumber>
    <LabelerName>PAI Holdings, LLC dba PAI Pharma</LabelerName>
    <SubstanceName>CIMETIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cimetidine Hydrochloride Oral Solution is indicated in. (1) Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine at full dosage for longer than 6 to 8 weeks (see Dosage and Administration-Duodenal Ulcer). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine. (2) Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine 400 mg h.s. for periods of up to 5 years. (3) Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks. (4) Erosive gastroesophageal reflux disease (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of lesions and control of symptoms. The use of cimetidine beyond 12 weeks has not been established (see Dosage and Administration-GERD). (5) The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis,multiple endocrine adenomas).</IndicationAndUsage>
    <Description>Cimetidine is a histamine H2-receptor antagonist. Chemically it is N”-cyano-N-methyl-N’-[2-[[(5- methyl-1 H-imidazol-4-yl) methyl]thio]-ethyl], guanidine. The molecular formula for cimetidine hydrochloride is C10H16N6SHCI and the molecular weight is 288.80. The structural formula of cimetidine hydrochloride is. Cimetidine contains an imidazole ring, and is chemically related to histamine. Cimetidine has a bitter taste and characteristic odor.</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9162-10</NDCCode>
    <PackageDescription>10 VIAL in 1 PACKAGE (0143-9162-10)  / 1025 mg in 1 VIAL (0143-9162-01) </PackageDescription>
    <NDC11Code>00143-9162-10</NDC11Code>
    <ProductNDC>0143-9162</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; ORAL</RouteName>
    <StartMarketingDate>20230202</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210274</ApplicationNumber>
    <LabelerName>HIKMA PHARMACEUTICALS USA INC.</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1025</StrengthNumber>
    <StrengthUnit>mg/mg</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24  HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 g vial contains 1 g vancomycin (equivalent to 1.025 g vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 g vial contains 1.25 g vancomycin (equivalent to 1.28 g vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 g vial contains 1.5 g vancomycin (equivalent to 1.54 g vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)].</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9381-10</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (0143-9381-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9381-01) </PackageDescription>
    <NDC11Code>00143-9381-10</NDC11Code>
    <ProductNDC>0143-9381</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline</ProprietaryName>
    <NonProprietaryName>Doxycycline</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210517</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062992</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals 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>2025-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline for Injection, USP and other antibacterial drugs, Doxycycline for Injection, USP 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. Doxycycline for Injection, USP is indicated in infections caused by the following microorganisms: 1 Rickettsiae (Rocky Mountain spotted fever, typhus fever, and the typhus group, Q fever, rickettsial pox and tick fevers)., 2 Mycoplasma pneumoniae (PPLO, Eaton Agent). , 3 Agents of psittacosis and ornithosis., 4 Agents of lymphogranuloma venereum and granuloma inguinale. , 5 The spirochetal agent of relapsing fever (Borrelia recurrentis).</IndicationAndUsage>
    <Description>Doxycycline for Injection, USP is a sterile, lyophilized powder prepared from a solution of doxycycline hyclate, ascorbic acid and mannitol in water for injection. Doxycycline hyclate is a broad spectrum antibiotic derived from oxytetracycline. It is meant for INTRAVENOUS use only after reconstitution. Doxycycline hyclate is a yellowish crystalline powder which is chemically designated 4-(Dimethylamino)-1,4,4a,5,5a,6,11, 12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. It has the following structural formula.       (C22H24 N2O8  HCl)2  C2H6 O  H2O                                                                                     M.W. 1025.89. Doxycycline hyclate is soluble in water and chars at 201°C without melting. The base doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Each 100 mg vial contains: Doxycycline hyclate equivalent to 100 mg doxycycline; ascorbic acid 480 mg; mannitol 300 mg. pH of the reconstituted solution (10 mg/mL) is between 1.8 and 3.3.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-1025-41</NDCCode>
    <PackageDescription>50 mL in 1 BAG (0338-1025-41) </PackageDescription>
    <NDC11Code>00338-1025-41</NDC11Code>
    <ProductNDC>0338-1025</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Penicillin G Potassium</ProprietaryName>
    <NonProprietaryName>Penicillin G</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19900625</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050638</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>PENICILLIN G POTASSIUM</SubstanceName>
    <StrengthNumber>3000000</StrengthNumber>
    <StrengthUnit>[iU]/50mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19900625</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Penicillin G Potassium Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G. Therapy with Penicillin G Potassium Injection, USP may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below; however, once these results become available, appropriate therapy should be continued. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin G Potassium Injection, USP and other antibacterial drugs, Penicillin G Potassium Injection, USP 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>Penicillin G Potassium, USP is a natural penicillin. It is chemically designated 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid,3,3-dimethyl-7-oxo-6-[(phenylacetyl)amino]-, monopotassium salt, [2S-(2α, 5α, 6β)]. It is crystalline. It is freely soluble in water, in isotonic sodium chloride solution and in dextrose solutions. The structural formula is as shown below. Penicillin G Potassium Injection, USP (equivalent to 2, or 3 million units of penicillin G) is a 50 mL premixed, iso-osmotic, sterile, nonpyrogenic, frozen solution for intravenous administration. Dextrose, USP has been added to the above dosages to adjust osmolality (approximately 1.2 g, and 350 mg as dextrose hydrous, respectively). Sodium Citrate, USP has been added as a buffer (0.20 g and 0.30 g as sodium citrate dihydrate, respectively). The pH has been adjusted with hydrochloric acid and may have been adjusted with sodium hydroxide. The pH is 6.5 (5.5 to 8.0). The solution is contained in a single dose GALAXY container and is intended for intravenous use after thawing to room temperature. This GALAXY container is fabricated from a specially designed multilayer plastic. Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
  </NDC>
  <NDC>
    <NDCCode>12634-169-98</NDCCode>
    <PackageDescription>8 CAPSULE in 1 BOTTLE (12634-169-98)</PackageDescription>
    <NDC11Code>12634-0169-98</NDC11Code>
    <ProductNDC>12634-169</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840911</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062500</ApplicationNumber>
    <LabelerName>Apotheca Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules 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 is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Capsules and Tablets for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C 22H 24N 2O 8∙H 2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a- pentahydroxy-6-methyl- 1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C 22H 24N 2O 8∙HCl) 2∙C 2H 6O∙H 2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. 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 for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Lactose Anhydrous, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Starch Glycolate, and Stearic Acid. 50 mg gelatin capsule shell contains: FD&amp;C Blue #1, D&amp;C Yellow #10, and other inert ingredients. 100 mg gelatin capsule shell contains: FD&amp;C Blue #1 and other inert ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>16110-601-01</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (16110-601-01) </PackageDescription>
    <NDC11Code>16110-0601-01</NDC11Code>
    <ProductNDC>16110-601</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acticlate</ProprietaryName>
    <ProprietaryNameSuffix>Cap</ProprietaryNameSuffix>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180531</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA208253</ApplicationNumber>
    <LabelerName>Aqua Pharmaceuticals</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2018-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180531</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ACTICLATE® and ACTICLATE® CAP are tetracycline class drugs indicated for: 1 Rickettsial infections (1.1) , 2 Sexually transmitted infections (1.2) , 3 Respiratory tract infections (1.3) , 4 Specific bacterial infections (1.4) , 5 Ophthalmic infections (1.5) , 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy for acute intestinal amebiasis and severe acne (1.8) , 9 Prophylaxis of malaria (1.9) .</IndicationAndUsage>
    <Description>ACTICLATE (doxycycline hyclate) Tablets and ACTICLATE CAP (doxycycline hyclate) Capsules contain doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in an immediate release formulation for oral administration. The molecular formula of doxycycline hyclate is (C22H24N2O8  HCl)2 C2H6O H2O and the molecular weight of doxycycline hyclate is 1025.87. The chemical name for doxycycline hyclate is: 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. The structural formula for doxycycline hyclate is. Figure 1: Structure of Doxycycline Hyclate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. ACTICLATE Tablet: ACTICLATE is available as 75 mg and 150 mg tablets. Each 75 mg tablet contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline. Each 150 mg tablet contains 173.2 mg of doxycycline hyclate equivalent to 150 mg of doxycycline. Inactive ingredients in the tablet formulation are: microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium and magnesium stearate. Film-coating contains: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, FD&amp;C Blue #1 (75 mg Tablet), FD&amp;C Blue #2 (150 mg Tablet) and yellow iron oxide (150 mg Tablet). ACTICLATE Tablets, 75 mg contain 0.34 mg (0.0146 mEq) of sodium. ACTICLATE Tablets, 150 mg contain 0.68 mg (0.0295 mEq) of sodium. ACTICLATE CAP Capsule:ACTICLATE CAP is available as 75 mg capsules. Each 75 mg capsule contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline. Inactive ingredients in the capsule formulation are: microcrystalline cellulose, magnesium stearate, and a hard gelatin capsule which contains titanium dioxide, FD&amp;C Red #40 and FD&amp;C Blue #1. The capsules are printed with edible ink containing ammonium hydroxide, propylene glycol, isopropyl alcohol, N-butyl alcohol, black iron oxide, and shellac glaze in ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>27808-233-01</NDCCode>
    <PackageDescription>50 CAPSULE in 1 BOTTLE (27808-233-01) </PackageDescription>
    <NDC11Code>27808-0233-01</NDC11Code>
    <ProductNDC>27808-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline</ProprietaryName>
    <NonProprietaryName>Doxycycline</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211119</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209402</ApplicationNumber>
    <LabelerName>Cranbury Pharmaceuticals, LLC</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>2025-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline 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. Treatment. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum., 9 Relapsing fever due to Borrelia recurrentis.</IndicationAndUsage>
    <Description>To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline and other antibacterial drugs, doxycycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION. Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as capsules of doxycycline hyclate for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8∙H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a- octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2- naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8∙HCl)2 ∙C2H6O∙H2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. 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. Inert ingredients in the capsule formulations are: FD&amp;C Blue 1, gelatin, magnesium stearate, iron oxide, microcrystalline cellulose, potassium hydroxide, shellac, sodium lauryl sulfate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>27808-233-02</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (27808-233-02) </PackageDescription>
    <NDC11Code>27808-0233-02</NDC11Code>
    <ProductNDC>27808-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline</ProprietaryName>
    <NonProprietaryName>Doxycycline</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211119</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209402</ApplicationNumber>
    <LabelerName>Cranbury Pharmaceuticals, LLC</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>2025-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline 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. Treatment. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum., 9 Relapsing fever due to Borrelia recurrentis.</IndicationAndUsage>
    <Description>To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline and other antibacterial drugs, doxycycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION. Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as capsules of doxycycline hyclate for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8∙H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a- octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2- naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8∙HCl)2 ∙C2H6O∙H2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. 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. Inert ingredients in the capsule formulations are: FD&amp;C Blue 1, gelatin, magnesium stearate, iron oxide, microcrystalline cellulose, potassium hydroxide, shellac, sodium lauryl sulfate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-371-32</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (31722-371-32)  / 10 mL in 1 VIAL (31722-371-31) </PackageDescription>
    <NDC11Code>31722-0371-32</NDC11Code>
    <ProductNDC>31722-371</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline</ProprietaryName>
    <NonProprietaryName>Doxycycline</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250805</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218888</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250805</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of  doxycycline for injection, and other antibacterial drugs, doxycycline for injection 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. Doxycycline for injection is indicated in infections caused by the following microorganisms:   Rickettsiae (Rocky Mountain spotted fever, typhus fever, and the typhus group, Q fever, rickettsial pox and tick fevers).   Mycoplasma pneumoniae(PPLO, Eaton Agent).  Agents of psittacosis and ornithosis.  Agents of lymphogranuloma venereum and granuloma inguinale.  The spirochetal agent of relapsing fever (Borrelia recurrentis). The following gram-negative microorganisms:  Haemophilus ducreyi(chancroid).  Yersinia pestis and Francisella tularensis.  Bartonella bacilliformis.  Bacteroidesspecies.  Vibrio cholerae and Campylobacter fetus.  Brucellaspecies (in conjunction with streptomycin). Because many strains of the following groups of microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended. Doxycycline for injection is indicated for treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:  Escherichia coli.  Enterobacter aerogenes.  Shigellaspecies.  Acinetobacterspecies.  Haemophilus influenzae(respiratory infections).  Klebsiellaspecies (respiratory and urinary infections). Doxycycline for injection is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:  Streptococcusspecies: Up to 44 percent of strains of Streptococcus pyogenesand 74 percent of  Streptococcus faecalis have been found to be resistant to tetracycline drugs. Therefore, tetracyclines should not be used for streptococcal disease unless the organism has been demonstrated to be sensitive. For upper respiratory infections due to group A beta-hemolytic streptococci, penicillin is the usual drug of choice, including prophylaxis of rheumatic fever.  Streptococcus pneumoniae.  Staphylococcus aureus, respiratory, skin and soft tissue infections. Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.  Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of infections due to:  Neisseria gonorrhoeaeand N. meningitidis.  Treponema pallidumand Treponema pertenue(syphilis and yaws).  Listeria monocytogenes.  Clostridiumspecies.  Fusobacterium fusiforme(Vincent’s infection).  Actinomycesspecies. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. Doxycycline for injection is indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence.</IndicationAndUsage>
    <Description>Doxycycline for Injection, USP is a sterile, lyophilized powder prepared from a solution of doxycycline hyclate USP, ascorbic acid and mannitol in water for injection. Doxycycline hyclate is a broad spectrum antibiotic derived from oxytetracycline. It is meant for INTRAVENOUS use only after reconstitution. Doxycycline hyclate is a yellow crystalline powder which is chemically designated 2-Naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro 3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, monohydrochloride, compd. with ethanol (2:1),monohydrate, [4S-(4α,4aα,5α,5aα,6α,12aα)]. It has the following structural formula. (C 22H 24N 2O 8. HCl) 2.C 2H 6O. H 2O                                                                  Molecular Weight: 1025.87 Doxycycline hyclate is soluble in water and chars at 201°C without melting. The base doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Each 100 mg vial contains: Doxycycline hyclate USP equivalent to 100 mg doxycycline; ascorbic acid 480 mg; mannitol 300 mg. pH of the reconstituted solution (10 mg/mL) is between 1.8 and 3.3.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-794-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (40032-794-01) </PackageDescription>
    <NDC11Code>40032-0794-01</NDC11Code>
    <ProductNDC>40032-794</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170906</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207558</ApplicationNumber>
    <LabelerName>Novel Laboratories, 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>2018-12-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170906</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets, USP and other antibacterial drugs, Doxycycline Hyclate Tablets, USP 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. Treatment:. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis ., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci ., 5 Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis ., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis ., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum ., 9 Relapsing fever due to Borrelia recurrentis .</IndicationAndUsage>
    <Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Tablets (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. 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. Inert ingredients are: colloidal silicon dioxide, corn starch, croscarmellose sodium, docusate sodium, magnesium stearate, microcrystalline cellulose, ethyl alcohol and a coating containing hypromellose, polyethylene glycol, titanium dioxide, FD&amp;C Blue No. 2 and FD&amp;C Yellow No. 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-794-02</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (40032-794-02) </PackageDescription>
    <NDC11Code>40032-0794-02</NDC11Code>
    <ProductNDC>40032-794</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170906</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207558</ApplicationNumber>
    <LabelerName>Novel Laboratories, 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>2018-12-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170906</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets, USP and other antibacterial drugs, Doxycycline Hyclate Tablets, USP 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. Treatment:. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis ., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci ., 5 Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis ., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis ., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum ., 9 Relapsing fever due to Borrelia recurrentis .</IndicationAndUsage>
    <Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Tablets (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. 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. Inert ingredients are: colloidal silicon dioxide, corn starch, croscarmellose sodium, docusate sodium, magnesium stearate, microcrystalline cellulose, ethyl alcohol and a coating containing hypromellose, polyethylene glycol, titanium dioxide, FD&amp;C Blue No. 2 and FD&amp;C Yellow No. 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-794-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (40032-794-05) </PackageDescription>
    <NDC11Code>40032-0794-05</NDC11Code>
    <ProductNDC>40032-794</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170906</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207558</ApplicationNumber>
    <LabelerName>Novel Laboratories, 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>2018-12-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170906</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets, USP and other antibacterial drugs, Doxycycline Hyclate Tablets, USP 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. Treatment:. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis ., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci ., 5 Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis ., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis ., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum ., 9 Relapsing fever due to Borrelia recurrentis .</IndicationAndUsage>
    <Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Tablets (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. 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. Inert ingredients are: colloidal silicon dioxide, corn starch, croscarmellose sodium, docusate sodium, magnesium stearate, microcrystalline cellulose, ethyl alcohol and a coating containing hypromellose, polyethylene glycol, titanium dioxide, FD&amp;C Blue No. 2 and FD&amp;C Yellow No. 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-794-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (40032-794-10) </PackageDescription>
    <NDC11Code>40032-0794-10</NDC11Code>
    <ProductNDC>40032-794</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170906</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207558</ApplicationNumber>
    <LabelerName>Novel Laboratories, 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>2018-12-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets, USP and other antibacterial drugs, Doxycycline Hyclate Tablets, USP 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. Treatment:. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis ., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci ., 5 Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis ., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis ., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum ., 9 Relapsing fever due to Borrelia recurrentis .</IndicationAndUsage>
    <Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Tablets (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. 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. Inert ingredients are: colloidal silicon dioxide, corn starch, croscarmellose sodium, docusate sodium, magnesium stearate, microcrystalline cellulose, ethyl alcohol and a coating containing hypromellose, polyethylene glycol, titanium dioxide, FD&amp;C Blue No. 2 and FD&amp;C Yellow No. 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-794-50</NDCCode>
    <PackageDescription>50 TABLET in 1 BOTTLE (40032-794-50) </PackageDescription>
    <NDC11Code>40032-0794-50</NDC11Code>
    <ProductNDC>40032-794</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170906</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207558</ApplicationNumber>
    <LabelerName>Novel Laboratories, 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>2018-12-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170906</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets, USP and other antibacterial drugs, Doxycycline Hyclate Tablets, USP 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. Treatment:. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis ., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci ., 5 Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis ., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis ., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum ., 9 Relapsing fever due to Borrelia recurrentis .</IndicationAndUsage>
    <Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Tablets (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. 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. Inert ingredients are: colloidal silicon dioxide, corn starch, croscarmellose sodium, docusate sodium, magnesium stearate, microcrystalline cellulose, ethyl alcohol and a coating containing hypromellose, polyethylene glycol, titanium dioxide, FD&amp;C Blue No. 2 and FD&amp;C Yellow No. 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-645-01</NDCCode>
    <PackageDescription>100 TABLET, COATED in 1 BOTTLE (42806-645-01) </PackageDescription>
    <NDC11Code>42806-0645-01</NDC11Code>
    <ProductNDC>42806-645</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxyclycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214207</ApplicationNumber>
    <LabelerName>EPIC PHARMA, LLC</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Doxycycline hyclate tablets are tetracycline class drugs indicated for: 1 Rickettsial infections (1.1), 2 Sexually transmitted infections (1.2), 3 Respiratory tract infections (1.3), 4 Specific bacterial infections (1.4), 5 Ophthalmic infections (1.5), 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy for acute intestinal amebiasis and severe acne (1.8), 9 Prophylaxis of malaria (1.9).</IndicationAndUsage>
    <Description>Doxycycline Hyclate Tablets, USP contain doxycycline hyclate, USP a tetracycline class drug synthetically derived from oxytetracycline, in an immediate release formulation for oral administration. The molecular formula of doxycycline hyclate is (C22H24N2O8 · HCl)2 ·C2H6O·H2O and the molecular weight of doxycycline hyclate is 1025.87. The chemical name for doxycycline hyclate is: 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2 naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. The structural formula for doxycycline hyclate is. Figure 1: Structure of Doxycycline Hyclate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline hyclate tablets, USP are available as 75 mg and 150 mg tablets. Each 75 mg tablet contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline. Each 150 mg tablet contains 173.2 mg of doxycycline hyclate equivalent to 150 mg of doxycycline. Inactive ingredients in the tablet formulation are: carnauba wax, croscarmellose sodium, FD&amp;C Blue #1 Aluminum Lake (75 mg Tablet), FD&amp;C Blue #2 Aluminum Lake (150 mg Tablet), FD&amp;C Yellow #6 Aluminum Lake (75 mg Tablet), iron oxide yellow (150 mg Tablet), macrogol/PEG, magnesium stearate, NF (vegetable grade), microcrystalline cellulose, polyvinyl alcohol-part hydrolyzed, purified water, sodium lauryl sulfate, talc, titanium dioxide. Doxycycline hyclate tablets USP, 75 mg contain 0.128 mg (0.0056 mEq) of sodium. Doxycycline hyclate tablets USP, 150 mg contain 0.256 mg (0.0111 mEq) of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-645-05</NDCCode>
    <PackageDescription>500 TABLET, COATED in 1 BOTTLE (42806-645-05) </PackageDescription>
    <NDC11Code>42806-0645-05</NDC11Code>
    <ProductNDC>42806-645</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxyclycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214207</ApplicationNumber>
    <LabelerName>EPIC PHARMA, LLC</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Doxycycline hyclate tablets are tetracycline class drugs indicated for: 1 Rickettsial infections (1.1), 2 Sexually transmitted infections (1.2), 3 Respiratory tract infections (1.3), 4 Specific bacterial infections (1.4), 5 Ophthalmic infections (1.5), 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy for acute intestinal amebiasis and severe acne (1.8), 9 Prophylaxis of malaria (1.9).</IndicationAndUsage>
    <Description>Doxycycline Hyclate Tablets, USP contain doxycycline hyclate, USP a tetracycline class drug synthetically derived from oxytetracycline, in an immediate release formulation for oral administration. The molecular formula of doxycycline hyclate is (C22H24N2O8 · HCl)2 ·C2H6O·H2O and the molecular weight of doxycycline hyclate is 1025.87. The chemical name for doxycycline hyclate is: 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2 naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. The structural formula for doxycycline hyclate is. Figure 1: Structure of Doxycycline Hyclate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline hyclate tablets, USP are available as 75 mg and 150 mg tablets. Each 75 mg tablet contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline. Each 150 mg tablet contains 173.2 mg of doxycycline hyclate equivalent to 150 mg of doxycycline. Inactive ingredients in the tablet formulation are: carnauba wax, croscarmellose sodium, FD&amp;C Blue #1 Aluminum Lake (75 mg Tablet), FD&amp;C Blue #2 Aluminum Lake (150 mg Tablet), FD&amp;C Yellow #6 Aluminum Lake (75 mg Tablet), iron oxide yellow (150 mg Tablet), macrogol/PEG, magnesium stearate, NF (vegetable grade), microcrystalline cellulose, polyvinyl alcohol-part hydrolyzed, purified water, sodium lauryl sulfate, talc, titanium dioxide. Doxycycline hyclate tablets USP, 75 mg contain 0.128 mg (0.0056 mEq) of sodium. Doxycycline hyclate tablets USP, 150 mg contain 0.256 mg (0.0111 mEq) of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-645-60</NDCCode>
    <PackageDescription>60 TABLET, COATED in 1 BOTTLE (42806-645-60) </PackageDescription>
    <NDC11Code>42806-0645-60</NDC11Code>
    <ProductNDC>42806-645</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxyclycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214207</ApplicationNumber>
    <LabelerName>EPIC PHARMA, LLC</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Doxycycline hyclate tablets are tetracycline class drugs indicated for: 1 Rickettsial infections (1.1), 2 Sexually transmitted infections (1.2), 3 Respiratory tract infections (1.3), 4 Specific bacterial infections (1.4), 5 Ophthalmic infections (1.5), 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy for acute intestinal amebiasis and severe acne (1.8), 9 Prophylaxis of malaria (1.9).</IndicationAndUsage>
    <Description>Doxycycline Hyclate Tablets, USP contain doxycycline hyclate, USP a tetracycline class drug synthetically derived from oxytetracycline, in an immediate release formulation for oral administration. The molecular formula of doxycycline hyclate is (C22H24N2O8 · HCl)2 ·C2H6O·H2O and the molecular weight of doxycycline hyclate is 1025.87. The chemical name for doxycycline hyclate is: 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2 naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. The structural formula for doxycycline hyclate is. Figure 1: Structure of Doxycycline Hyclate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline hyclate tablets, USP are available as 75 mg and 150 mg tablets. Each 75 mg tablet contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline. Each 150 mg tablet contains 173.2 mg of doxycycline hyclate equivalent to 150 mg of doxycycline. Inactive ingredients in the tablet formulation are: carnauba wax, croscarmellose sodium, FD&amp;C Blue #1 Aluminum Lake (75 mg Tablet), FD&amp;C Blue #2 Aluminum Lake (150 mg Tablet), FD&amp;C Yellow #6 Aluminum Lake (75 mg Tablet), iron oxide yellow (150 mg Tablet), macrogol/PEG, magnesium stearate, NF (vegetable grade), microcrystalline cellulose, polyvinyl alcohol-part hydrolyzed, purified water, sodium lauryl sulfate, talc, titanium dioxide. Doxycycline hyclate tablets USP, 75 mg contain 0.128 mg (0.0056 mEq) of sodium. Doxycycline hyclate tablets USP, 150 mg contain 0.256 mg (0.0111 mEq) of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-646-01</NDCCode>
    <PackageDescription>100 TABLET, COATED in 1 BOTTLE (42806-646-01) </PackageDescription>
    <NDC11Code>42806-0646-01</NDC11Code>
    <ProductNDC>42806-646</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxyclycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214207</ApplicationNumber>
    <LabelerName>EPIC PHARMA, LLC</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Doxycycline hyclate tablets are tetracycline class drugs indicated for: 1 Rickettsial infections (1.1), 2 Sexually transmitted infections (1.2), 3 Respiratory tract infections (1.3), 4 Specific bacterial infections (1.4), 5 Ophthalmic infections (1.5), 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy for acute intestinal amebiasis and severe acne (1.8), 9 Prophylaxis of malaria (1.9).</IndicationAndUsage>
    <Description>Doxycycline Hyclate Tablets, USP contain doxycycline hyclate, USP a tetracycline class drug synthetically derived from oxytetracycline, in an immediate release formulation for oral administration. The molecular formula of doxycycline hyclate is (C22H24N2O8 · HCl)2 ·C2H6O·H2O and the molecular weight of doxycycline hyclate is 1025.87. The chemical name for doxycycline hyclate is: 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2 naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. The structural formula for doxycycline hyclate is. Figure 1: Structure of Doxycycline Hyclate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline hyclate tablets, USP are available as 75 mg and 150 mg tablets. Each 75 mg tablet contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline. Each 150 mg tablet contains 173.2 mg of doxycycline hyclate equivalent to 150 mg of doxycycline. Inactive ingredients in the tablet formulation are: carnauba wax, croscarmellose sodium, FD&amp;C Blue #1 Aluminum Lake (75 mg Tablet), FD&amp;C Blue #2 Aluminum Lake (150 mg Tablet), FD&amp;C Yellow #6 Aluminum Lake (75 mg Tablet), iron oxide yellow (150 mg Tablet), macrogol/PEG, magnesium stearate, NF (vegetable grade), microcrystalline cellulose, polyvinyl alcohol-part hydrolyzed, purified water, sodium lauryl sulfate, talc, titanium dioxide. Doxycycline hyclate tablets USP, 75 mg contain 0.128 mg (0.0056 mEq) of sodium. Doxycycline hyclate tablets USP, 150 mg contain 0.256 mg (0.0111 mEq) of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-646-05</NDCCode>
    <PackageDescription>500 TABLET, COATED in 1 BOTTLE (42806-646-05) </PackageDescription>
    <NDC11Code>42806-0646-05</NDC11Code>
    <ProductNDC>42806-646</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxyclycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214207</ApplicationNumber>
    <LabelerName>EPIC PHARMA, LLC</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Doxycycline hyclate tablets are tetracycline class drugs indicated for: 1 Rickettsial infections (1.1), 2 Sexually transmitted infections (1.2), 3 Respiratory tract infections (1.3), 4 Specific bacterial infections (1.4), 5 Ophthalmic infections (1.5), 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy for acute intestinal amebiasis and severe acne (1.8), 9 Prophylaxis of malaria (1.9).</IndicationAndUsage>
    <Description>Doxycycline Hyclate Tablets, USP contain doxycycline hyclate, USP a tetracycline class drug synthetically derived from oxytetracycline, in an immediate release formulation for oral administration. The molecular formula of doxycycline hyclate is (C22H24N2O8 · HCl)2 ·C2H6O·H2O and the molecular weight of doxycycline hyclate is 1025.87. The chemical name for doxycycline hyclate is: 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2 naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. The structural formula for doxycycline hyclate is. Figure 1: Structure of Doxycycline Hyclate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline hyclate tablets, USP are available as 75 mg and 150 mg tablets. Each 75 mg tablet contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline. Each 150 mg tablet contains 173.2 mg of doxycycline hyclate equivalent to 150 mg of doxycycline. Inactive ingredients in the tablet formulation are: carnauba wax, croscarmellose sodium, FD&amp;C Blue #1 Aluminum Lake (75 mg Tablet), FD&amp;C Blue #2 Aluminum Lake (150 mg Tablet), FD&amp;C Yellow #6 Aluminum Lake (75 mg Tablet), iron oxide yellow (150 mg Tablet), macrogol/PEG, magnesium stearate, NF (vegetable grade), microcrystalline cellulose, polyvinyl alcohol-part hydrolyzed, purified water, sodium lauryl sulfate, talc, titanium dioxide. Doxycycline hyclate tablets USP, 75 mg contain 0.128 mg (0.0056 mEq) of sodium. Doxycycline hyclate tablets USP, 150 mg contain 0.256 mg (0.0111 mEq) of sodium.</Description>
  </NDC>
</NDCList>