{
"NDC": [
{
"NDCCode": "52959-544-25",
"PackageDescription": "25 TABLET in 1 CONTAINER (52959-544-25)",
"NDC11Code": "52959-0544-25",
"ProductNDC": "52959-544",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "H.J. Harkins Company Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225."
},
{
"NDCCode": "35356-544-25",
"PackageDescription": "255 g in 1 BOTTLE (35356-544-25) ",
"NDC11Code": "35356-0544-25",
"ProductNDC": "35356-544",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Polyethylene Glycol 3350",
"NonProprietaryName": "Polyethylene Glycol 3350",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20060906",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077706",
"LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
"SubstanceName": "POLYETHYLENE GLYCOL 3350",
"StrengthNumber": "17",
"StrengthUnit": "g/17g",
"Pharm_Classes": "Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20060906",
"SamplePackage": "N"
},
{
"NDCCode": "43547-544-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (43547-544-25) / 2 mL in 1 VIAL, SINGLE-DOSE (43547-544-01) ",
"NDC11Code": "43547-0544-25",
"ProductNDC": "43547-544",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20190320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210927",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190320",
"SamplePackage": "N",
"IndicationAndUsage": "In Anesthesia. Glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. In Peptic Ulcer. For use in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. : 1 Limitations of Use, 2 Glycopyrrolate injection is not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.",
"Description": "Glycopyrrolate injection, USP is a synthetic anticholinergic agent. Each 1 mL contains. Glycopyrrolate, USP 0.2 mg. Water for Injection, USP q.s. pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. For Intramuscular (IM) or Intravenous (IV) administration. Solution does not contain preservatives. Glycopyrrolate is a quaternary ammonium salt with the following chemical name. 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33. Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24oC)."
},
{
"NDCCode": "43744-544-25",
"PackageDescription": "25 g in 1 DRUM (43744-544-25)",
"NDC11Code": "43744-0544-25",
"ProductNDC": "43744-544",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Levofloxacin Hemihydrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110808",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "69945-544-00",
"PackageDescription": ".25 Ci in 1 VIAL (69945-544-00) ",
"NDC11Code": "69945-0544-00",
"ProductNDC": "69945-544",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Germanium-68",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20201022",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Curium US LLC",
"SubstanceName": "GERMANIUM",
"StrengthNumber": "1",
"StrengthUnit": "Ci/Ci",
"Status": "Unfinished",
"LastUpdate": "2026-03-21",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "23-OCT-20"
},
{
"NDCCode": "52959-544-01",
"PackageDescription": "100 TABLET in 1 CONTAINER (52959-544-01)",
"NDC11Code": "52959-0544-01",
"ProductNDC": "52959-544",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "H.J. Harkins Company Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225."
},
{
"NDCCode": "52959-544-10",
"PackageDescription": "10 TABLET in 1 CONTAINER (52959-544-10)",
"NDC11Code": "52959-0544-10",
"ProductNDC": "52959-544",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "H.J. Harkins Company Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225."
},
{
"NDCCode": "52959-544-12",
"PackageDescription": "12 TABLET in 1 CONTAINER (52959-544-12)",
"NDC11Code": "52959-0544-12",
"ProductNDC": "52959-544",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "H.J. Harkins Company Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225."
},
{
"NDCCode": "52959-544-15",
"PackageDescription": "15 TABLET in 1 CONTAINER (52959-544-15)",
"NDC11Code": "52959-0544-15",
"ProductNDC": "52959-544",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "H.J. Harkins Company Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225."
},
{
"NDCCode": "52959-544-20",
"PackageDescription": "20 TABLET in 1 CONTAINER (52959-544-20)",
"NDC11Code": "52959-0544-20",
"ProductNDC": "52959-544",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "H.J. Harkins Company Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225."
},
{
"NDCCode": "52959-544-21",
"PackageDescription": "21 TABLET in 1 CONTAINER (52959-544-21)",
"NDC11Code": "52959-0544-21",
"ProductNDC": "52959-544",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "H.J. Harkins Company Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225."
},
{
"NDCCode": "52959-544-30",
"PackageDescription": "30 TABLET in 1 CONTAINER (52959-544-30)",
"NDC11Code": "52959-0544-30",
"ProductNDC": "52959-544",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "H.J. Harkins Company Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225."
},
{
"NDCCode": "52959-544-35",
"PackageDescription": "35 TABLET in 1 CONTAINER (52959-544-35)",
"NDC11Code": "52959-0544-35",
"ProductNDC": "52959-544",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "H.J. Harkins Company Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225."
},
{
"NDCCode": "52959-544-40",
"PackageDescription": "40 TABLET in 1 CONTAINER (52959-544-40)",
"NDC11Code": "52959-0544-40",
"ProductNDC": "52959-544",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "H.J. Harkins Company Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225."
},
{
"NDCCode": "52959-544-45",
"PackageDescription": "45 TABLET in 1 CONTAINER (52959-544-45)",
"NDC11Code": "52959-0544-45",
"ProductNDC": "52959-544",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "H.J. Harkins Company Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225."
},
{
"NDCCode": "52959-544-50",
"PackageDescription": "50 TABLET in 1 CONTAINER (52959-544-50)",
"NDC11Code": "52959-0544-50",
"ProductNDC": "52959-544",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "H.J. Harkins Company Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225."
},
{
"NDCCode": "52959-544-60",
"PackageDescription": "60 TABLET in 1 CONTAINER (52959-544-60)",
"NDC11Code": "52959-0544-60",
"ProductNDC": "52959-544",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "H.J. Harkins Company Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225."
},
{
"NDCCode": "52959-002-25",
"PackageDescription": "25 TABLET in 1 BOTTLE (52959-002-25) ",
"NDC11Code": "52959-0002-25",
"ProductNDC": "52959-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20011008",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20011008",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains. temporarily reduces fever."
},
{
"NDCCode": "52959-003-25",
"PackageDescription": "25 TABLET in 1 BOTTLE, PLASTIC (52959-003-25) ",
"NDC11Code": "52959-0003-25",
"ProductNDC": "52959-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19880930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089805",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "CODEINE PHOSPHATE; ACETAMINOPHEN",
"StrengthNumber": "30; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19880930",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.",
"Description": "Acetaminophen and codeine is supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. Each 300 mg/30 mg Acetaminophen and Codeine Phosphate Tablet contains: Acetaminophen ......................................................................................................300 mg Codeine Phosphate ..................................................................................................30 mg."
},
{
"NDCCode": "52959-026-25",
"PackageDescription": "25 TABLET in 1 BOTTLE, PLASTIC (52959-026-25)",
"NDC11Code": "52959-0026-25",
"ProductNDC": "52959-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carisoprodol",
"NonProprietaryName": "Carisoprodol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040124",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "CARISOPRODOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carisoprodol Tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [see DOSAGE AND ADMINISTRATION (2)].",
"Description": "Carisoprodol Tablets are available as 350 mg round, white tablets. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is. Other Ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, methylcellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid."
},
{
"NDCCode": "52959-033-25",
"PackageDescription": "25 TABLET in 1 BOTTLE (52959-033-25)",
"NDC11Code": "52959-0033-25",
"ProductNDC": "52959-033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meclizine Hydrochloride",
"NonProprietaryName": "Meclizine Hydrocloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040659",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC],Emesis Suppression [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "For the management of nausea and vomiting, and dizziness associated with motion sickness.",
"Description": "Chemically, Meclizine HCl is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. C25H27ClN2. 2HCl. H2O M.W. 481.88Meclizine HCI Tablets, USP are available in two different strengths: 12.5 mg and 25 mg. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose. Also, Meclizine HCI Tablets USP, 12.5 mg contains FD&C Blue #1 Aluminum Lake (11-13%) and Meclizine HCI Tablets USP, 25 mg contains D&C Yellow #10 Aluminum Lake (15-20%)."
},
{
"NDCCode": "52959-047-25",
"PackageDescription": "25 TABLET in 1 BOTTLE (52959-047-25) ",
"NDC11Code": "52959-0047-25",
"ProductNDC": "52959-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diazepam",
"NonProprietaryName": "Diazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071135",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "DIAZEPAM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160125",
"SamplePackage": "N",
"IndicationAndUsage": "Diazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13ClN2O and the molecular weight is 284.75. The structural formula is as follows. Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, magnesium stearate and microcrystalline cellulose. Diazepam Tablets USP 5 mg also contain D&C Yellow No. 10. Diazepam Tablets USP 10 mg also contain FD&C Blue No. 1."
},
{
"NDCCode": "52959-076-25",
"PackageDescription": "25 TABLET in 1 BOTTLE (52959-076-25)",
"NDC11Code": "52959-0076-25",
"ProductNDC": "52959-076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078558",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.",
"Description": "Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (p – isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide."
},
{
"NDCCode": "52959-077-25",
"PackageDescription": "25 TABLET in 1 BOTTLE (52959-077-25)",
"NDC11Code": "52959-0077-25",
"ProductNDC": "52959-077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078558",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.",
"Description": "Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (p – isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide."
},
{
"NDCCode": "52959-126-25",
"PackageDescription": "25 TABLET in 1 BOTTLE, PLASTIC (52959-126-25)",
"NDC11Code": "52959-0126-25",
"ProductNDC": "52959-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040256",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "PredniSONE Tablets are indicated in the following conditions: 1 Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer, 2 Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis, 3 Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis, 4 Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis, 5 Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions, 6 Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis, 7 Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisAspiration pneumonitisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, 8 Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia, 9 Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood, 10 Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus, 11 Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.",
"Description": "PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg."
},
{
"NDCCode": "52959-127-25",
"PackageDescription": "25 TABLET in 1 BOTTLE, PLASTIC (52959-127-25)",
"NDC11Code": "52959-0127-25",
"ProductNDC": "52959-127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040392",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "PredniSONE Tablets are indicated in the following conditions: 1 Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer, 2 Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis, 3 Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis, 4 Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis, 5 Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions, 6 Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis, 7 Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisAspiration pneumonitisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, 8 Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia, 9 Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood, 10 Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus, 11 Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.",
"Description": "PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg."
},
{
"NDCCode": "52959-187-25",
"PackageDescription": "25 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52959-187-25)",
"NDC11Code": "52959-0187-25",
"ProductNDC": "52959-187",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19880524",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:. headache . toothache . backache . menstrual cramps. the common cold . muscular aches . minor pain of arthritis. temporarily reduces fever."
},
{
"NDCCode": "52959-260-25",
"PackageDescription": "25 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52959-260-25)",
"NDC11Code": "52959-0260-25",
"ProductNDC": "52959-260",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sudogest",
"NonProprietaryName": "Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19941001",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. temporarily relieves sinus congestion and pressure ."
},
{
"NDCCode": "52959-370-25",
"PackageDescription": "25 TABLET in 1 BOTTLE, PLASTIC (52959-370-25)",
"NDC11Code": "52959-0370-25",
"ProductNDC": "52959-370",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Aspirin And Caffeine",
"NonProprietaryName": "Butalbital, Aspirin And Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19790605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086162",
"LabelerName": "H.J. Harkins Company",
"SubstanceName": "BUTALBITAL; ASPIRIN; CAFFEINE",
"StrengthNumber": "50; 325; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturates [CS],Barbiturate [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Butalbital, aspirin, and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of butalbital, aspirin, and caffeine in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Each Butalbital, Aspirin, and Caffeine tablet for oral administration contains. Butalbital, USP 50 mg. Aspirin, USP 325 mg. Caffeine, USP 40 mg. Butalbital, 5-allyl-5-isobutyl-barbituric acid, a white odorless crystalline powder; is a short-to intermediate-acting barbiturate. Its structural formula is as follows. Aspirin, salicylic acid acetate, is a non-opiate analgesic, anti-inflammatory and antipyretic agent. It occurs as a white, crystalline tabular or needle-like powder and is odorless or has a faint odor. Its structural formula is as follows. Caffeine, 1,3,7-trimethylxanthine, is a central nervous system stimulant which occurs as a white powder or white glistening needles. It also has a bitter taste. Its structural formula is as follows. Inactive Ingredients: Hydrogenated Vegetable Oil, Microcrystalline Cellulose, Sodium Starch Glycolate, Starch 1500 and Talc."
},
{
"NDCCode": "52959-471-25",
"PackageDescription": "25 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52959-471-25)",
"NDC11Code": "52959-0471-25",
"ProductNDC": "52959-471",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etodolac",
"NonProprietaryName": "Etodolac",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19980520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075009",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "ETODOLAC",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac tablets are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following: 1. Osteoarthritis 2. Rheumatoid arthritis.",
"Description": "Etodolac is a member of the pyranocarboxylic acid group of non-steroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±)1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. It has a pKa of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH 7.4. It has the following structural formula. C17H21NO3 M.W. 287.37. The inactive ingredients in etodolac tablets include: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate, titanium dioxide, FD&C Red No. 40, and FD&C Blue No. 2. The 400 mg tablet also contains D&C Yellow No. 10."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>52959-544-25</NDCCode>
<PackageDescription>25 TABLET in 1 CONTAINER (52959-544-25)</PackageDescription>
<NDC11Code>52959-0544-25</NDC11Code>
<ProductNDC>52959-544</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>H.J. Harkins Company Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>35356-544-25</NDCCode>
<PackageDescription>255 g in 1 BOTTLE (35356-544-25) </PackageDescription>
<NDC11Code>35356-0544-25</NDC11Code>
<ProductNDC>35356-544</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060906</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077706</ApplicationNumber>
<LabelerName>Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
<StrengthNumber>17</StrengthNumber>
<StrengthUnit>g/17g</StrengthUnit>
<Pharm_Classes>Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43547-544-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (43547-544-25) / 2 mL in 1 VIAL, SINGLE-DOSE (43547-544-01) </PackageDescription>
<NDC11Code>43547-0544-25</NDC11Code>
<ProductNDC>43547-544</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20190320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210927</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In Anesthesia. Glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. In Peptic Ulcer. For use in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. : 1 Limitations of Use, 2 Glycopyrrolate injection is not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.</IndicationAndUsage>
<Description>Glycopyrrolate injection, USP is a synthetic anticholinergic agent. Each 1 mL contains. Glycopyrrolate, USP 0.2 mg. Water for Injection, USP q.s. pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. For Intramuscular (IM) or Intravenous (IV) administration. Solution does not contain preservatives. Glycopyrrolate is a quaternary ammonium salt with the following chemical name. 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33. Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24oC).</Description>
</NDC>
<NDC>
<NDCCode>43744-544-25</NDCCode>
<PackageDescription>25 g in 1 DRUM (43744-544-25)</PackageDescription>
<NDC11Code>43744-0544-25</NDC11Code>
<ProductNDC>43744-544</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Levofloxacin Hemihydrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110808</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69945-544-00</NDCCode>
<PackageDescription>.25 Ci in 1 VIAL (69945-544-00) </PackageDescription>
<NDC11Code>69945-0544-00</NDC11Code>
<ProductNDC>69945-544</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Germanium-68</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20201022</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Curium US LLC</LabelerName>
<SubstanceName>GERMANIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>Ci/Ci</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-03-21</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>23-OCT-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>52959-544-01</NDCCode>
<PackageDescription>100 TABLET in 1 CONTAINER (52959-544-01)</PackageDescription>
<NDC11Code>52959-0544-01</NDC11Code>
<ProductNDC>52959-544</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>H.J. Harkins Company Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>52959-544-10</NDCCode>
<PackageDescription>10 TABLET in 1 CONTAINER (52959-544-10)</PackageDescription>
<NDC11Code>52959-0544-10</NDC11Code>
<ProductNDC>52959-544</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>H.J. Harkins Company Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>52959-544-12</NDCCode>
<PackageDescription>12 TABLET in 1 CONTAINER (52959-544-12)</PackageDescription>
<NDC11Code>52959-0544-12</NDC11Code>
<ProductNDC>52959-544</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>H.J. Harkins Company Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>52959-544-15</NDCCode>
<PackageDescription>15 TABLET in 1 CONTAINER (52959-544-15)</PackageDescription>
<NDC11Code>52959-0544-15</NDC11Code>
<ProductNDC>52959-544</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>H.J. Harkins Company Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>52959-544-20</NDCCode>
<PackageDescription>20 TABLET in 1 CONTAINER (52959-544-20)</PackageDescription>
<NDC11Code>52959-0544-20</NDC11Code>
<ProductNDC>52959-544</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>H.J. Harkins Company Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>52959-544-21</NDCCode>
<PackageDescription>21 TABLET in 1 CONTAINER (52959-544-21)</PackageDescription>
<NDC11Code>52959-0544-21</NDC11Code>
<ProductNDC>52959-544</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>H.J. Harkins Company Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>52959-544-30</NDCCode>
<PackageDescription>30 TABLET in 1 CONTAINER (52959-544-30)</PackageDescription>
<NDC11Code>52959-0544-30</NDC11Code>
<ProductNDC>52959-544</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>H.J. Harkins Company Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>52959-544-35</NDCCode>
<PackageDescription>35 TABLET in 1 CONTAINER (52959-544-35)</PackageDescription>
<NDC11Code>52959-0544-35</NDC11Code>
<ProductNDC>52959-544</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>H.J. Harkins Company Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>52959-544-40</NDCCode>
<PackageDescription>40 TABLET in 1 CONTAINER (52959-544-40)</PackageDescription>
<NDC11Code>52959-0544-40</NDC11Code>
<ProductNDC>52959-544</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>H.J. Harkins Company Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>52959-544-45</NDCCode>
<PackageDescription>45 TABLET in 1 CONTAINER (52959-544-45)</PackageDescription>
<NDC11Code>52959-0544-45</NDC11Code>
<ProductNDC>52959-544</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>H.J. Harkins Company Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>52959-544-50</NDCCode>
<PackageDescription>50 TABLET in 1 CONTAINER (52959-544-50)</PackageDescription>
<NDC11Code>52959-0544-50</NDC11Code>
<ProductNDC>52959-544</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>H.J. Harkins Company Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>52959-544-60</NDCCode>
<PackageDescription>60 TABLET in 1 CONTAINER (52959-544-60)</PackageDescription>
<NDC11Code>52959-0544-60</NDC11Code>
<ProductNDC>52959-544</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>H.J. Harkins Company Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. C8H11N5O3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>52959-002-25</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE (52959-002-25) </PackageDescription>
<NDC11Code>52959-0002-25</NDC11Code>
<ProductNDC>52959-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20011008</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20011008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52959-003-25</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE, PLASTIC (52959-003-25) </PackageDescription>
<NDC11Code>52959-0003-25</NDC11Code>
<ProductNDC>52959-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089805</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>CODEINE PHOSPHATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>30; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.</IndicationAndUsage>
<Description>Acetaminophen and codeine is supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. Each 300 mg/30 mg Acetaminophen and Codeine Phosphate Tablet contains: Acetaminophen ......................................................................................................300 mg Codeine Phosphate ..................................................................................................30 mg.</Description>
</NDC>
<NDC>
<NDCCode>52959-026-25</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE, PLASTIC (52959-026-25)</PackageDescription>
<NDC11Code>52959-0026-25</NDC11Code>
<ProductNDC>52959-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carisoprodol</ProprietaryName>
<NonProprietaryName>Carisoprodol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040124</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>CARISOPRODOL</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carisoprodol Tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [see DOSAGE AND ADMINISTRATION (2)].</IndicationAndUsage>
<Description>Carisoprodol Tablets are available as 350 mg round, white tablets. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is. Other Ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, methylcellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>52959-033-25</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE (52959-033-25)</PackageDescription>
<NDC11Code>52959-0033-25</NDC11Code>
<ProductNDC>52959-033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Meclizine Hydrocloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040659</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC],Emesis Suppression [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the management of nausea and vomiting, and dizziness associated with motion sickness.</IndicationAndUsage>
<Description>Chemically, Meclizine HCl is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. C25H27ClN2. 2HCl. H2O M.W. 481.88Meclizine HCI Tablets, USP are available in two different strengths: 12.5 mg and 25 mg. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose. Also, Meclizine HCI Tablets USP, 12.5 mg contains FD&C Blue #1 Aluminum Lake (11-13%) and Meclizine HCI Tablets USP, 25 mg contains D&C Yellow #10 Aluminum Lake (15-20%).</Description>
</NDC>
<NDC>
<NDCCode>52959-047-25</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE (52959-047-25) </PackageDescription>
<NDC11Code>52959-0047-25</NDC11Code>
<ProductNDC>52959-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diazepam</ProprietaryName>
<NonProprietaryName>Diazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071135</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>DIAZEPAM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13ClN2O and the molecular weight is 284.75. The structural formula is as follows. Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, magnesium stearate and microcrystalline cellulose. Diazepam Tablets USP 5 mg also contain D&C Yellow No. 10. Diazepam Tablets USP 10 mg also contain FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>52959-076-25</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE (52959-076-25)</PackageDescription>
<NDC11Code>52959-0076-25</NDC11Code>
<ProductNDC>52959-076</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078558</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (p – isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>52959-077-25</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE (52959-077-25)</PackageDescription>
<NDC11Code>52959-0077-25</NDC11Code>
<ProductNDC>52959-077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078558</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (p – isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>52959-126-25</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE, PLASTIC (52959-126-25)</PackageDescription>
<NDC11Code>52959-0126-25</NDC11Code>
<ProductNDC>52959-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040256</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>PredniSONE Tablets are indicated in the following conditions: 1 Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer, 2 Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis, 3 Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis, 4 Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis, 5 Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions, 6 Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis, 7 Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisAspiration pneumonitisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, 8 Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia, 9 Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood, 10 Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus, 11 Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg.</Description>
</NDC>
<NDC>
<NDCCode>52959-127-25</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE, PLASTIC (52959-127-25)</PackageDescription>
<NDC11Code>52959-0127-25</NDC11Code>
<ProductNDC>52959-127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040392</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>PredniSONE Tablets are indicated in the following conditions: 1 Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer, 2 Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis, 3 Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis, 4 Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis, 5 Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions, 6 Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis, 7 Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisAspiration pneumonitisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, 8 Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia, 9 Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood, 10 Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus, 11 Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg.</Description>
</NDC>
<NDC>
<NDCCode>52959-187-25</NDCCode>
<PackageDescription>25 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52959-187-25)</PackageDescription>
<NDC11Code>52959-0187-25</NDC11Code>
<ProductNDC>52959-187</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880524</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:. headache . toothache . backache . menstrual cramps. the common cold . muscular aches . minor pain of arthritis. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52959-260-25</NDCCode>
<PackageDescription>25 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52959-260-25)</PackageDescription>
<NDC11Code>52959-0260-25</NDC11Code>
<ProductNDC>52959-260</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sudogest</ProprietaryName>
<NonProprietaryName>Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19941001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. temporarily relieves sinus congestion and pressure .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52959-370-25</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE, PLASTIC (52959-370-25)</PackageDescription>
<NDC11Code>52959-0370-25</NDC11Code>
<ProductNDC>52959-370</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Aspirin And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Aspirin And Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19790605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086162</ApplicationNumber>
<LabelerName>H.J. Harkins Company</LabelerName>
<SubstanceName>BUTALBITAL; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 325; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturates [CS],Barbiturate [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Butalbital, aspirin, and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of butalbital, aspirin, and caffeine in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Each Butalbital, Aspirin, and Caffeine tablet for oral administration contains. Butalbital, USP 50 mg. Aspirin, USP 325 mg. Caffeine, USP 40 mg. Butalbital, 5-allyl-5-isobutyl-barbituric acid, a white odorless crystalline powder; is a short-to intermediate-acting barbiturate. Its structural formula is as follows. Aspirin, salicylic acid acetate, is a non-opiate analgesic, anti-inflammatory and antipyretic agent. It occurs as a white, crystalline tabular or needle-like powder and is odorless or has a faint odor. Its structural formula is as follows. Caffeine, 1,3,7-trimethylxanthine, is a central nervous system stimulant which occurs as a white powder or white glistening needles. It also has a bitter taste. Its structural formula is as follows. Inactive Ingredients: Hydrogenated Vegetable Oil, Microcrystalline Cellulose, Sodium Starch Glycolate, Starch 1500 and Talc.</Description>
</NDC>
<NDC>
<NDCCode>52959-471-25</NDCCode>
<PackageDescription>25 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52959-471-25)</PackageDescription>
<NDC11Code>52959-0471-25</NDC11Code>
<ProductNDC>52959-471</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etodolac</ProprietaryName>
<NonProprietaryName>Etodolac</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075009</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>ETODOLAC</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac tablets are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following: 1. Osteoarthritis 2. Rheumatoid arthritis.</IndicationAndUsage>
<Description>Etodolac is a member of the pyranocarboxylic acid group of non-steroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±)1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. It has a pKa of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH 7.4. It has the following structural formula. C17H21NO3 M.W. 287.37. The inactive ingredients in etodolac tablets include: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate, titanium dioxide, FD&C Red No. 40, and FD&C Blue No. 2. The 400 mg tablet also contains D&C Yellow No. 10.</Description>
</NDC>
</NDCList>