{
"NDC": [
{
"NDCCode": "55289-737-88",
"PackageDescription": "112 TABLET in 1 BOTTLE, PLASTIC (55289-737-88)",
"NDC11Code": "55289-0737-88",
"ProductNDC": "55289-737",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040746",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "47335-737-88",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-737-88) ",
"NDC11Code": "47335-0737-88",
"ProductNDC": "47335-737",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078866",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200301",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets, USP (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies(14)]. The efficacy of bupropion hydrochloride extended-release tablets, USP (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].",
"Description": "Bupropion hydrochlorideextended-release tablet, USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (SR) are supplied for oral administration as 100 mg, 150 mg and 200 mg white to off white, film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: hydroxypropyl cellulose, saccharin, anhydrous lactose, colloidal silicon dioxide, talc, stearic acid, polyvinyl alcohol, titanium dioxide and polyethylene glycol 3350. For 100 mg strength - It meets USP dissolution test 7. For 150 mg strength - It meets USP dissolution test 2. For 200 mg strength - FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "55289-997-88",
"PackageDescription": "112 TABLET in 1 BOTTLE, PLASTIC (55289-997-88)",
"NDC11Code": "55289-0997-88",
"ProductNDC": "55289-997",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040736",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55289-737-06",
"PackageDescription": "6 TABLET in 1 BOTTLE, PLASTIC (55289-737-06)",
"NDC11Code": "55289-0737-06",
"ProductNDC": "55289-737",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040746",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55289-737-15",
"PackageDescription": "15 TABLET in 1 BOTTLE, PLASTIC (55289-737-15)",
"NDC11Code": "55289-0737-15",
"ProductNDC": "55289-737",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040746",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55289-737-20",
"PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (55289-737-20)",
"NDC11Code": "55289-0737-20",
"ProductNDC": "55289-737",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040746",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55289-737-21",
"PackageDescription": "21 TABLET in 1 BOTTLE, PLASTIC (55289-737-21)",
"NDC11Code": "55289-0737-21",
"ProductNDC": "55289-737",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040746",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55289-737-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (55289-737-30)",
"NDC11Code": "55289-0737-30",
"ProductNDC": "55289-737",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040746",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55289-737-40",
"PackageDescription": "40 TABLET in 1 BOTTLE, PLASTIC (55289-737-40)",
"NDC11Code": "55289-0737-40",
"ProductNDC": "55289-737",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040746",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55289-737-56",
"PackageDescription": "56 TABLET in 1 BOTTLE, PLASTIC (55289-737-56)",
"NDC11Code": "55289-0737-56",
"ProductNDC": "55289-737",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040746",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55289-737-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (55289-737-60)",
"NDC11Code": "55289-0737-60",
"ProductNDC": "55289-737",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040746",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55289-737-84",
"PackageDescription": "84 TABLET in 1 BOTTLE, PLASTIC (55289-737-84)",
"NDC11Code": "55289-0737-84",
"ProductNDC": "55289-737",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040746",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55289-737-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (55289-737-90)",
"NDC11Code": "55289-0737-90",
"ProductNDC": "55289-737",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040746",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55289-737-93",
"PackageDescription": "180 TABLET in 1 BOTTLE, PLASTIC (55289-737-93)",
"NDC11Code": "55289-0737-93",
"ProductNDC": "55289-737",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040746",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55289-737-98",
"PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (55289-737-98)",
"NDC11Code": "55289-0737-98",
"ProductNDC": "55289-737",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040746",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "71288-737-11",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (71288-737-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-737-10) ",
"NDC11Code": "71288-0737-11",
"ProductNDC": "71288-737",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropivacaine Hydrochloride",
"NonProprietaryName": "Ropivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL",
"StartMarketingDate": "20240730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218713",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240730",
"SamplePackage": "N",
"IndicationAndUsage": "Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.",
"Description": "Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2’,6’-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W. 328.88. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate, USP (equivalent to 2 mg, 5 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8 mg, 7.5 mg or 7.1 mg of sodium chloride, USP; respectively, and sodium hydroxide, NF and hydrochloric acid, NF as pH adjusters, in water for injection, USP. The pH is adjusted between 4.0 to 6.0. The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C."
},
{
"NDCCode": "55289-866-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-01) ",
"NDC11Code": "55289-0866-01",
"ProductNDC": "55289-866",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065095",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140717",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide."
},
{
"NDCCode": "55289-866-02",
"PackageDescription": "2 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-02) ",
"NDC11Code": "55289-0866-02",
"ProductNDC": "55289-866",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065095",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150702",
"SamplePackage": "N",
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"Description": "Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide."
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"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide."
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"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide."
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"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide."
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"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide."
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"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline Hyclate Tablets, USP are an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide."
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"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide."
},
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"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide."
},
{
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"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide."
},
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"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide."
},
{
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"ProductNDC": "55289-866",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
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"StrengthUnit": "mg/1",
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"Description": "Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide."
},
{
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"PackageDescription": "210 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-71) ",
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"Description": "Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide."
},
{
"NDCCode": "55289-866-74",
"PackageDescription": "400 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-74) ",
"NDC11Code": "55289-0866-74",
"ProductNDC": "55289-866",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "ORAL",
"StartMarketingDate": "20030702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065095",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide."
}
]
}
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<Description>Bupropion hydrochlorideextended-release tablet, USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (SR) are supplied for oral administration as 100 mg, 150 mg and 200 mg white to off white, film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: hydroxypropyl cellulose, saccharin, anhydrous lactose, colloidal silicon dioxide, talc, stearic acid, polyvinyl alcohol, titanium dioxide and polyethylene glycol 3350. For 100 mg strength - It meets USP dissolution test 7. For 150 mg strength - It meets USP dissolution test 2. For 200 mg strength - FDA approved dissolution test specifications differ from USP.</Description>
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<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<StrengthNumber>10; 325</StrengthNumber>
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<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
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<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (55289-737-60)</PackageDescription>
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<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040746</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
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<PackageDescription>84 TABLET in 1 BOTTLE, PLASTIC (55289-737-84)</PackageDescription>
<NDC11Code>55289-0737-84</NDC11Code>
<ProductNDC>55289-737</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040746</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55289-737-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (55289-737-90)</PackageDescription>
<NDC11Code>55289-0737-90</NDC11Code>
<ProductNDC>55289-737</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040746</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55289-737-93</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE, PLASTIC (55289-737-93)</PackageDescription>
<NDC11Code>55289-0737-93</NDC11Code>
<ProductNDC>55289-737</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040746</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55289-737-98</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE, PLASTIC (55289-737-98)</PackageDescription>
<NDC11Code>55289-0737-98</NDC11Code>
<ProductNDC>55289-737</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040746</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71288-737-11</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (71288-737-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-737-10) </PackageDescription>
<NDC11Code>71288-0737-11</NDC11Code>
<ProductNDC>71288-737</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL</RouteName>
<StartMarketingDate>20240730</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218713</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240730</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.</IndicationAndUsage>
<Description>Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2’,6’-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W. 328.88. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate, USP (equivalent to 2 mg, 5 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8 mg, 7.5 mg or 7.1 mg of sodium chloride, USP; respectively, and sodium hydroxide, NF and hydrochloric acid, NF as pH adjusters, in water for injection, USP. The pH is adjusted between 4.0 to 6.0. The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>55289-866-01</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-01) </PackageDescription>
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<ProductNDC>55289-866</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065095</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, 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>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55289-866-02</NDCCode>
<PackageDescription>2 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-02) </PackageDescription>
<NDC11Code>55289-0866-02</NDC11Code>
<ProductNDC>55289-866</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065095</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, 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>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150702</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55289-866-04</NDCCode>
<PackageDescription>4 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-04) </PackageDescription>
<NDC11Code>55289-0866-04</NDC11Code>
<ProductNDC>55289-866</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065095</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, 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>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55289-866-06</NDCCode>
<PackageDescription>6 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-06) </PackageDescription>
<NDC11Code>55289-0866-06</NDC11Code>
<ProductNDC>55289-866</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065095</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, 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>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55289-866-07</NDCCode>
<PackageDescription>7 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-07) </PackageDescription>
<NDC11Code>55289-0866-07</NDC11Code>
<ProductNDC>55289-866</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065095</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, 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>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160907</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55289-866-10</NDCCode>
<PackageDescription>10 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-10) </PackageDescription>
<NDC11Code>55289-0866-10</NDC11Code>
<ProductNDC>55289-866</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline Hyclate Tablets, USP are an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline Hyclate Tablets, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 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, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a 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. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide.</Description>
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