{
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{
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"PackageDescription": "15 CAPSULE in 1 BOTTLE (53002-0622-2) ",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
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"IndicationAndUsage": "Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules USP and other antibacterial drugs, clindamycin hydrochloride capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules USP contain clindamycin hydrochloride USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and talc. Composition of empty hard gelatin capsule shells: For 75 mg strength-size ‘3’: FD&C Blue 1, D&C Yellow 10, gelatin and water. For 150 mg Strength-Size ‘2’: titanium dioxide, FD&C Blue 1, D&C Yellow 10, gelatin and water. For 300 mg Strength-Size ‘0’: FD&C Blue 1, titanium dioxide, gelatin and water. The empty hard gelatin capsules are printed with TekPrint SW-0012 White Ink. Composition of imprinting ink [TekPrint SW-0012 White Ink] utilized for printing on the capsule shell are presented below: Shellac–NF, Dehydrated alcohol–USP, Isopropyl alcohol–USP, Butyl alcohol–NF, Propylene glycol–USP, Strong ammonia solution–NF, Purified water–USP, Potassium hydroxide–NF, Titanium dioxide USP. The structural formula is represented below: The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- α-D- galacto-octopyranoside monohydrochloride."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules USP and other antibacterial drugs, clindamycin hydrochloride capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules USP contain clindamycin hydrochloride USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and talc. Composition of empty hard gelatin capsule shells: For 75 mg strength-size ‘3’: FD&C Blue 1, D&C Yellow 10, gelatin and water. For 150 mg Strength-Size ‘2’: titanium dioxide, FD&C Blue 1, D&C Yellow 10, gelatin and water. For 300 mg Strength-Size ‘0’: FD&C Blue 1, titanium dioxide, gelatin and water. The empty hard gelatin capsules are printed with TekPrint SW-0012 White Ink. Composition of imprinting ink [TekPrint SW-0012 White Ink] utilized for printing on the capsule shell are presented below: Shellac–NF, Dehydrated alcohol–USP, Isopropyl alcohol–USP, Butyl alcohol–NF, Propylene glycol–USP, Strong ammonia solution–NF, Purified water–USP, Potassium hydroxide–NF, Titanium dioxide USP. The structural formula is represented below: The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- α-D- galacto-octopyranoside monohydrochloride."
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{
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"IndicationAndUsage": "Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules USP and other antibacterial drugs, clindamycin hydrochloride capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules USP contain clindamycin hydrochloride USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and talc. Composition of empty hard gelatin capsule shells: For 75 mg strength-size ‘3’: FD&C Blue 1, D&C Yellow 10, gelatin and water. For 150 mg Strength-Size ‘2’: titanium dioxide, FD&C Blue 1, D&C Yellow 10, gelatin and water. For 300 mg Strength-Size ‘0’: FD&C Blue 1, titanium dioxide, gelatin and water. The empty hard gelatin capsules are printed with TekPrint SW-0012 White Ink. Composition of imprinting ink [TekPrint SW-0012 White Ink] utilized for printing on the capsule shell are presented below: Shellac–NF, Dehydrated alcohol–USP, Isopropyl alcohol–USP, Butyl alcohol–NF, Propylene glycol–USP, Strong ammonia solution–NF, Purified water–USP, Potassium hydroxide–NF, Titanium dioxide USP. The structural formula is represented below: The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- α-D- galacto-octopyranoside monohydrochloride."
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"IndicationAndUsage": "Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules USP and other antibacterial drugs, clindamycin hydrochloride capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules USP contain clindamycin hydrochloride USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and talc. Composition of empty hard gelatin capsule shells: For 75 mg strength-size ‘3’: FD&C Blue 1, D&C Yellow 10, gelatin and water. For 150 mg Strength-Size ‘2’: titanium dioxide, FD&C Blue 1, D&C Yellow 10, gelatin and water. For 300 mg Strength-Size ‘0’: FD&C Blue 1, titanium dioxide, gelatin and water. The empty hard gelatin capsules are printed with TekPrint SW-0012 White Ink. Composition of imprinting ink [TekPrint SW-0012 White Ink] utilized for printing on the capsule shell are presented below: Shellac–NF, Dehydrated alcohol–USP, Isopropyl alcohol–USP, Butyl alcohol–NF, Propylene glycol–USP, Strong ammonia solution–NF, Purified water–USP, Potassium hydroxide–NF, Titanium dioxide USP. The structural formula is represented below: The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- α-D- galacto-octopyranoside monohydrochloride."
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"IndicationAndUsage": "Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules USP and other antibacterial drugs, clindamycin hydrochloride capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules USP contain clindamycin hydrochloride USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and talc. Composition of empty hard gelatin capsule shells: For 75 mg strength-size ‘3’: FD&C Blue 1, D&C Yellow 10, gelatin and water. For 150 mg Strength-Size ‘2’: titanium dioxide, FD&C Blue 1, D&C Yellow 10, gelatin and water. For 300 mg Strength-Size ‘0’: FD&C Blue 1, titanium dioxide, gelatin and water. The empty hard gelatin capsules are printed with TekPrint SW-0012 White Ink. Composition of imprinting ink [TekPrint SW-0012 White Ink] utilized for printing on the capsule shell are presented below: Shellac–NF, Dehydrated alcohol–USP, Isopropyl alcohol–USP, Butyl alcohol–NF, Propylene glycol–USP, Strong ammonia solution–NF, Purified water–USP, Potassium hydroxide–NF, Titanium dioxide USP. The structural formula is represented below: The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- α-D- galacto-octopyranoside monohydrochloride."
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"IndicationAndUsage": "Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules USP and other antibacterial drugs, clindamycin hydrochloride capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules USP contain clindamycin hydrochloride USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and talc. Composition of empty hard gelatin capsule shells: For 75 mg strength-size ‘3’: FD&C Blue 1, D&C Yellow 10, gelatin and water. For 150 mg Strength-Size ‘2’: titanium dioxide, FD&C Blue 1, D&C Yellow 10, gelatin and water. For 300 mg Strength-Size ‘0’: FD&C Blue 1, titanium dioxide, gelatin and water. The empty hard gelatin capsules are printed with TekPrint SW-0012 White Ink. Composition of imprinting ink [TekPrint SW-0012 White Ink] utilized for printing on the capsule shell are presented below: Shellac–NF, Dehydrated alcohol–USP, Isopropyl alcohol–USP, Butyl alcohol–NF, Propylene glycol–USP, Strong ammonia solution–NF, Purified water–USP, Potassium hydroxide–NF, Titanium dioxide USP. The structural formula is represented below: The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- α-D- galacto-octopyranoside monohydrochloride."
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"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules USP and other antibacterial drugs, clindamycin hydrochloride capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules USP contain clindamycin hydrochloride USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and talc. Composition of empty hard gelatin capsule shells: For 75 mg strength-size ‘3’: FD&C Blue 1, D&C Yellow 10, gelatin and water. For 150 mg Strength-Size ‘2’: titanium dioxide, FD&C Blue 1, D&C Yellow 10, gelatin and water. For 300 mg Strength-Size ‘0’: FD&C Blue 1, titanium dioxide, gelatin and water. The empty hard gelatin capsules are printed with TekPrint SW-0012 White Ink. Composition of imprinting ink [TekPrint SW-0012 White Ink] utilized for printing on the capsule shell are presented below: Shellac–NF, Dehydrated alcohol–USP, Isopropyl alcohol–USP, Butyl alcohol–NF, Propylene glycol–USP, Strong ammonia solution–NF, Purified water–USP, Potassium hydroxide–NF, Titanium dioxide USP. The structural formula is represented below: The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- α-D- galacto-octopyranoside monohydrochloride."
},
{
"NDCCode": "0283-0622-29",
"PackageDescription": "4 SYRINGE, PLASTIC in 1 BOX (0283-0622-29) / 1.2 g in 1 SYRINGE, PLASTIC (0283-0622-44) ",
"NDC11Code": "00283-0622-29",
"ProductNDC": "0283-0622",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hurricaine",
"ProprietaryNameSuffix": "Topical Anesthetic",
"NonProprietaryName": "Benzocaine",
"DosageFormName": "GEL",
"RouteName": "DENTAL; ORAL; PERIODONTAL",
"StartMarketingDate": "20221215",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Beutlich Pharmaceuticals, LLC",
"SubstanceName": "BENZOCAINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20221215",
"SamplePackage": "N"
},
{
"NDCCode": "0283-0622-34",
"PackageDescription": "4 SYRINGE, PLASTIC in 1 BOX (0283-0622-34) / 1.2 g in 1 SYRINGE, PLASTIC (0283-0622-43) ",
"NDC11Code": "00283-0622-34",
"ProductNDC": "0283-0622",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hurricaine",
"ProprietaryNameSuffix": "Topical Anesthetic",
"NonProprietaryName": "Benzocaine",
"DosageFormName": "GEL",
"RouteName": "DENTAL; ORAL; PERIODONTAL",
"StartMarketingDate": "20221215",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Beutlich Pharmaceuticals, LLC",
"SubstanceName": "BENZOCAINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221215",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of occasional minor irritation and pain, associated with: 1 canker sores, 2 sore mouth and throat, 3 minor injury of the mouth and gums, 4 minor dental procedures, 5 minor irritation of the mouth and gums caused by dentures or orthodontic appliances."
},
{
"NDCCode": "15631-0622-2",
"PackageDescription": "50 TABLET in 1 CONTAINER (15631-0622-2)",
"NDC11Code": "15631-0622-02",
"ProductNDC": "15631-0622",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lathyrus Sativus",
"NonProprietaryName": "Lathyrus Sativus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151224",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "LATHYRUS SATIVAS SEED",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "37662-0622-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-0622-2) ",
"NDC11Code": "37662-0622-02",
"ProductNDC": "37662-0622",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cuprum Nitricum",
"NonProprietaryName": "Cuprum Nitricum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220617",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "CUPRIC NITRATE HEXAHYDRATE",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-06-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220617",
"SamplePackage": "N"
},
{
"NDCCode": "49288-0622-1",
"PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0622-1)",
"NDC11Code": "49288-0622-01",
"ProductNDC": "49288-0622",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allscale",
"NonProprietaryName": "Allscale",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "ATRIPLEX POLYCARPA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "49288-0622-2",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0622-2)",
"NDC11Code": "49288-0622-02",
"ProductNDC": "49288-0622",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allscale",
"NonProprietaryName": "Allscale",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "ATRIPLEX POLYCARPA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "50090-0622-2",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (50090-0622-2) / 24 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "50090-0622-02",
"ProductNDC": "50090-0622",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aprodine",
"NonProprietaryName": "Pseudoephedrine Hcl And Triprolidine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19930109",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE",
"StrengthNumber": "60; 2.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:runny noseitchy, watery eyesnasal congestionsneezingitching of the nose or throat. temporarily relieves these symptoms due to the common cold:runny nosesneezingnasal congestion."
},
{
"NDCCode": "61680-0622-2",
"PackageDescription": "415 L in 1 CYLINDER (61680-0622-2)",
"NDC11Code": "61680-0622-02",
"ProductNDC": "61680-0622",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19950622",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "South East Alaska Medical Suppliers Inc.",
"SubstanceName": "OXYGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "67296-0622-2",
"PackageDescription": "60 TABLET in 1 BOTTLE (67296-0622-2)",
"NDC11Code": "67296-0622-02",
"ProductNDC": "67296-0622",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077321",
"LabelerName": "RedPharm Drug Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Lisinopril tablets are indicated for the treatment of hypertension. They may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents. Lisinopril tablets are indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis. Lisinopril tablets are indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers. In using lisinopril tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril tablets does not have a similar risk. (See WARNINGS). In considering the use of lisinopril tablets, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in Black patients than in non-Blacks. In addition, ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients (see WARNINGS, Anaphylactoid and Possibly Related Reactions ).",
"Description": "Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, starch. 5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, red iron oxide, starch. 40 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, starch, yellow iron oxide."
},
{
"NDCCode": "70000-0622-2",
"PackageDescription": "36 TABLET in 1 BOTTLE (70000-0622-2) ",
"NDC11Code": "70000-0622-02",
"ProductNDC": "70000-0622",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen And Ibuprofen",
"NonProprietaryName": "Acetaminophen And Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216592",
"LabelerName": "LEADER/ Cardinal Health 110, Inc.",
"SubstanceName": "ACETAMINOPHEN; IBUPROFEN",
"StrengthNumber": "250; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230715",
"SamplePackage": "N",
"IndicationAndUsage": "■ temporarily relieves minor aches and pains due to. ■ headache. ■ toothache. ■ backache. ■ menstrual cramps. ■ muscular aches. ■ minor pain of arthritis."
},
{
"NDCCode": "71335-0622-2",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (71335-0622-2) ",
"NDC11Code": "71335-0622-02",
"ProductNDC": "71335-0622",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin",
"ProprietaryNameSuffix": "Low Dose",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20000701",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180209",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of minor aches and pains. ask your doctor about other uses for aspirin."
},
{
"NDCCode": "53002-0060-1",
"PackageDescription": "2 TABLET, FILM COATED in 1 BOTTLE (53002-0060-1) ",
"NDC11Code": "53002-0060-01",
"ProductNDC": "53002-0060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201506",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/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": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20171001",
"SamplePackage": "N",
"IndicationAndUsage": "Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Cold Sores (Herpes Labialis), 2 Genital HerpesTreatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-infected patientsReduction of transmission, 3 Herpes Zoster.",
"Description": "Valacyclovir hydrochloride, USP is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride, USP equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients crospovidone, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. The chemical name of valacyclovir hydrochloride, USP is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride, USP is a white to off-white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pKas for valacyclovir hydrochloride, USP are 1.90, 7.47, and 9.43. Valacyclovir hydrochloride, USP comply with USP dissolution test 2."
},
{
"NDCCode": "53002-0060-2",
"PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE (53002-0060-2) ",
"NDC11Code": "53002-0060-02",
"ProductNDC": "53002-0060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201506",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/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": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20171001",
"SamplePackage": "N",
"IndicationAndUsage": "Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Cold Sores (Herpes Labialis), 2 Genital HerpesTreatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-infected patientsReduction of transmission, 3 Herpes Zoster.",
"Description": "Valacyclovir hydrochloride, USP is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride, USP equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients crospovidone, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. The chemical name of valacyclovir hydrochloride, USP is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride, USP is a white to off-white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pKas for valacyclovir hydrochloride, USP are 1.90, 7.47, and 9.43. Valacyclovir hydrochloride, USP comply with USP dissolution test 2."
},
{
"NDCCode": "53002-0061-1",
"PackageDescription": "2 TABLET, FILM COATED in 1 BOTTLE (53002-0061-1) ",
"NDC11Code": "53002-0061-01",
"ProductNDC": "53002-0061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090682",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/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": "2025-01-01",
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"IndicationAndUsage": "Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1) : 1 Cold Sores (Herpes Labialis) , 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-1-infected patients Reduction of transmission , 3 Herpes Zoster .",
"Description": "Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir.Valacyclovir tablets, USP are for oral administration. Each tablet contains 556 mg or 1.112 grams of valacyclovir hydrochloride USP (hydrous) equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide.The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride USP (hydrous) is a white or almost white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43."
},
{
"NDCCode": "53002-0061-2",
"PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE (53002-0061-2) ",
"NDC11Code": "53002-0061-02",
"ProductNDC": "53002-0061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090682",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/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": "2025-01-01",
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"IndicationAndUsage": "Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1) : 1 Cold Sores (Herpes Labialis) , 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-1-infected patients Reduction of transmission , 3 Herpes Zoster .",
"Description": "Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir.Valacyclovir tablets, USP are for oral administration. Each tablet contains 556 mg or 1.112 grams of valacyclovir hydrochloride USP (hydrous) equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide.The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride USP (hydrous) is a white or almost white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43."
},
{
"NDCCode": "53002-0062-1",
"PackageDescription": "2 TABLET, FILM COATED in 1 BOTTLE (53002-0062-1) ",
"NDC11Code": "53002-0062-01",
"ProductNDC": "53002-0062",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir",
"NonProprietaryName": "Valacyclovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203047",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/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": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Valacyclovir tablet, USP is a nucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1) Cold Sores (Herpes Labialis) Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-infected patients Reduction of transmission Herpes Zoster Pediatric Patients (1.2) Cold Sores (Herpes Labialis) Chickenpox Limitations of Use (1.3) The efficacy and safety of valacyclovir tablets, USP have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.",
"Description": "Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride USP equivalent to 500 mg or 1gm valacyclovir and the inactive ingredients crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. In addition to this 500 mg contains FD&C blue #2/ indigo carmine aluminum lake. The chemical name of valacyclovir hydrochloride is L-valine2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester hydrochloride monohydrate. It has the following structural formula:. Valacyclovir hydrochloride USP (monohydrate)is a white or almost white powder with the molecular formula C 13H 23N 6O 5Cl and a molecular weight of 378.81. Valacyclovir hydrochloride USP is freely soluble in water and practically insoluble in 1-octanol. The pka for valacyclovir hydrochloride is 5.95. Valacyclovir Tablets USP, 500 gm and 1 g complies with USP dissolution test 2."
},
{
"NDCCode": "53002-0062-2",
"PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE (53002-0062-2) ",
"NDC11Code": "53002-0062-02",
"ProductNDC": "53002-0062",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir",
"NonProprietaryName": "Valacyclovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203047",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/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": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240101",
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"IndicationAndUsage": "Valacyclovir tablet, USP is a nucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1) Cold Sores (Herpes Labialis) Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-infected patients Reduction of transmission Herpes Zoster Pediatric Patients (1.2) Cold Sores (Herpes Labialis) Chickenpox Limitations of Use (1.3) The efficacy and safety of valacyclovir tablets, USP have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.",
"Description": "Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride USP equivalent to 500 mg or 1gm valacyclovir and the inactive ingredients crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. In addition to this 500 mg contains FD&C blue #2/ indigo carmine aluminum lake. The chemical name of valacyclovir hydrochloride is L-valine2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester hydrochloride monohydrate. It has the following structural formula:. Valacyclovir hydrochloride USP (monohydrate)is a white or almost white powder with the molecular formula C 13H 23N 6O 5Cl and a molecular weight of 378.81. Valacyclovir hydrochloride USP is freely soluble in water and practically insoluble in 1-octanol. The pka for valacyclovir hydrochloride is 5.95. Valacyclovir Tablets USP, 500 gm and 1 g complies with USP dissolution test 2."
},
{
"NDCCode": "53002-0080-2",
"PackageDescription": "20 TABLET in 1 BOTTLE (53002-0080-2) ",
"NDC11Code": "53002-0080-02",
"ProductNDC": "53002-0080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202168",
"LabelerName": "RPK Pharmaceuticals, 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": "2021-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20171001",
"SamplePackage": "N"
},
{
"NDCCode": "53002-0081-2",
"PackageDescription": "20 TABLET in 1 BOTTLE (53002-0081-2) ",
"NDC11Code": "53002-0081-02",
"ProductNDC": "53002-0081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202168",
"LabelerName": "RPK Pharmaceuticals, 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": "2021-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N"
},
{
"NDCCode": "53002-0082-2",
"PackageDescription": "20 TABLET in 1 BOTTLE (53002-0082-2) ",
"NDC11Code": "53002-0082-02",
"ProductNDC": "53002-0082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091022",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075382",
"LabelerName": "RPK Pharmaceuticals, 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": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210101",
"SamplePackage": "N",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations of an antiviral drug for oral administration. Each 800-mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:."
},
{
"NDCCode": "53002-0083-2",
"PackageDescription": "20 TABLET in 1 BOTTLE (53002-0083-2) ",
"NDC11Code": "53002-0083-02",
"ProductNDC": "53002-0083",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180504",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210401",
"LabelerName": "RPK Pharmaceuticals, 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": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20221001",
"SamplePackage": "N",
"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 herpesviruses. Acyclovir Capsules, USP and Acyclovir Tablets, USP are formulations for oral administration. Each capsule contains 200 mg of acyclovir, USP and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C Blue No. 1, FD&C Red No. 3, FD&C Yellow No. 6 and titanium dioxide. Printed with edible black ink. Each 800 mg tablet of acyclovir contains 800 mg of acyclovir, USP and the inactive ingredients magnesium stearate, microcrystalline cellulose PH101, povidone K30, and sodium starch glycolate (Type A) (Starch from Non GMO potatoes). Each 400 mg tablet of acyclovir contains 400 mg of acyclovir, USP and the inactive ingredients magnesium stearate, microcrystalline cellulose PH101, povidone K30, and sodium starch glycolate (Type A) (Starch from Non GMO potatoes). Acyclovir, USP is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37℃ is 2.5mg/mL. The pka’s of acyclovir 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. VIROLOGY. Mechanism of Antiviral Action. Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities. The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC 50 ), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC 50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC 50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC 50 of 1.35 mcg/mL. Drug Resistance. Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy."
},
{
"NDCCode": "53002-0084-2",
"PackageDescription": "20 TABLET in 1 BOTTLE (53002-0084-2) ",
"NDC11Code": "53002-0084-02",
"ProductNDC": "53002-0084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209366",
"LabelerName": "RPK Pharmaceuticals, 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": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir Tablets are formulations for oral administration. Each 800-mg tablet of acyclovir contains 800mg of acyclovir and the inactive ingredients FD&C Blue No. 2, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400mg of acyclovir and the inactive ingredients magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino -1, 9 -dihydro -9 - [(2-hydroxyethoxy) methyl]-6 H-purin-6 -one; it has the following structural formula."
},
{
"NDCCode": "53002-0085-2",
"PackageDescription": "20 TABLET in 1 BOTTLE (53002-0085-2) ",
"NDC11Code": "53002-0085-02",
"ProductNDC": "53002-0085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203834",
"LabelerName": "RPK Pharmaceuticals, 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": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": "Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets, USP is a formulation for oral administration. Each Acyclovir Tablet contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the inactive ingredients colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. The 400 mg and 800 mg tablet also contains ferric oxide and FD&C blue lake # 2 Indigo carmine AL, respectively. Acyclovir USP is a white to off white crystalline powder, slightly hygroscopic with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225.20. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-. It has the following structural formula:."
}
]
}
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<ProductNDC>53002-0622</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<IndicationAndUsage>Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules USP and other antibacterial drugs, clindamycin hydrochloride capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules USP contain clindamycin hydrochloride USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and talc. Composition of empty hard gelatin capsule shells: For 75 mg strength-size ‘3’: FD&C Blue 1, D&C Yellow 10, gelatin and water. For 150 mg Strength-Size ‘2’: titanium dioxide, FD&C Blue 1, D&C Yellow 10, gelatin and water. For 300 mg Strength-Size ‘0’: FD&C Blue 1, titanium dioxide, gelatin and water. The empty hard gelatin capsules are printed with TekPrint SW-0012 White Ink. Composition of imprinting ink [TekPrint SW-0012 White Ink] utilized for printing on the capsule shell are presented below: Shellac–NF, Dehydrated alcohol–USP, Isopropyl alcohol–USP, Butyl alcohol–NF, Propylene glycol–USP, Strong ammonia solution–NF, Purified water–USP, Potassium hydroxide–NF, Titanium dioxide USP. The structural formula is represented below: The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- α-D- galacto-octopyranoside monohydrochloride.</Description>
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<IndicationAndUsage>Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules USP and other antibacterial drugs, clindamycin hydrochloride capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules USP contain clindamycin hydrochloride USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and talc. Composition of empty hard gelatin capsule shells: For 75 mg strength-size ‘3’: FD&C Blue 1, D&C Yellow 10, gelatin and water. For 150 mg Strength-Size ‘2’: titanium dioxide, FD&C Blue 1, D&C Yellow 10, gelatin and water. For 300 mg Strength-Size ‘0’: FD&C Blue 1, titanium dioxide, gelatin and water. The empty hard gelatin capsules are printed with TekPrint SW-0012 White Ink. Composition of imprinting ink [TekPrint SW-0012 White Ink] utilized for printing on the capsule shell are presented below: Shellac–NF, Dehydrated alcohol–USP, Isopropyl alcohol–USP, Butyl alcohol–NF, Propylene glycol–USP, Strong ammonia solution–NF, Purified water–USP, Potassium hydroxide–NF, Titanium dioxide USP. The structural formula is represented below: The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- α-D- galacto-octopyranoside monohydrochloride.</Description>
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<IndicationAndUsage>Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules USP and other antibacterial drugs, clindamycin hydrochloride capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules USP contain clindamycin hydrochloride USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and talc. Composition of empty hard gelatin capsule shells: For 75 mg strength-size ‘3’: FD&C Blue 1, D&C Yellow 10, gelatin and water. For 150 mg Strength-Size ‘2’: titanium dioxide, FD&C Blue 1, D&C Yellow 10, gelatin and water. For 300 mg Strength-Size ‘0’: FD&C Blue 1, titanium dioxide, gelatin and water. The empty hard gelatin capsules are printed with TekPrint SW-0012 White Ink. Composition of imprinting ink [TekPrint SW-0012 White Ink] utilized for printing on the capsule shell are presented below: Shellac–NF, Dehydrated alcohol–USP, Isopropyl alcohol–USP, Butyl alcohol–NF, Propylene glycol–USP, Strong ammonia solution–NF, Purified water–USP, Potassium hydroxide–NF, Titanium dioxide USP. The structural formula is represented below: The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- α-D- galacto-octopyranoside monohydrochloride.</Description>
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<IndicationAndUsage>Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules USP and other antibacterial drugs, clindamycin hydrochloride capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules USP contain clindamycin hydrochloride USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and talc. Composition of empty hard gelatin capsule shells: For 75 mg strength-size ‘3’: FD&C Blue 1, D&C Yellow 10, gelatin and water. For 150 mg Strength-Size ‘2’: titanium dioxide, FD&C Blue 1, D&C Yellow 10, gelatin and water. For 300 mg Strength-Size ‘0’: FD&C Blue 1, titanium dioxide, gelatin and water. The empty hard gelatin capsules are printed with TekPrint SW-0012 White Ink. Composition of imprinting ink [TekPrint SW-0012 White Ink] utilized for printing on the capsule shell are presented below: Shellac–NF, Dehydrated alcohol–USP, Isopropyl alcohol–USP, Butyl alcohol–NF, Propylene glycol–USP, Strong ammonia solution–NF, Purified water–USP, Potassium hydroxide–NF, Titanium dioxide USP. The structural formula is represented below: The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- α-D- galacto-octopyranoside monohydrochloride.</Description>
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<IndicationAndUsage>Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules USP and other antibacterial drugs, clindamycin hydrochloride capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules USP contain clindamycin hydrochloride USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and talc. Composition of empty hard gelatin capsule shells: For 75 mg strength-size ‘3’: FD&C Blue 1, D&C Yellow 10, gelatin and water. For 150 mg Strength-Size ‘2’: titanium dioxide, FD&C Blue 1, D&C Yellow 10, gelatin and water. For 300 mg Strength-Size ‘0’: FD&C Blue 1, titanium dioxide, gelatin and water. The empty hard gelatin capsules are printed with TekPrint SW-0012 White Ink. Composition of imprinting ink [TekPrint SW-0012 White Ink] utilized for printing on the capsule shell are presented below: Shellac–NF, Dehydrated alcohol–USP, Isopropyl alcohol–USP, Butyl alcohol–NF, Propylene glycol–USP, Strong ammonia solution–NF, Purified water–USP, Potassium hydroxide–NF, Titanium dioxide USP. The structural formula is represented below: The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- α-D- galacto-octopyranoside monohydrochloride.</Description>
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<IndicationAndUsage>Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules USP and other antibacterial drugs, clindamycin hydrochloride capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules USP contain clindamycin hydrochloride USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and talc. Composition of empty hard gelatin capsule shells: For 75 mg strength-size ‘3’: FD&C Blue 1, D&C Yellow 10, gelatin and water. For 150 mg Strength-Size ‘2’: titanium dioxide, FD&C Blue 1, D&C Yellow 10, gelatin and water. For 300 mg Strength-Size ‘0’: FD&C Blue 1, titanium dioxide, gelatin and water. The empty hard gelatin capsules are printed with TekPrint SW-0012 White Ink. Composition of imprinting ink [TekPrint SW-0012 White Ink] utilized for printing on the capsule shell are presented below: Shellac–NF, Dehydrated alcohol–USP, Isopropyl alcohol–USP, Butyl alcohol–NF, Propylene glycol–USP, Strong ammonia solution–NF, Purified water–USP, Potassium hydroxide–NF, Titanium dioxide USP. The structural formula is represented below: The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- α-D- galacto-octopyranoside monohydrochloride.</Description>
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<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules USP and other antibacterial drugs, clindamycin hydrochloride capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules USP contain clindamycin hydrochloride USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and talc. Composition of empty hard gelatin capsule shells: For 75 mg strength-size ‘3’: FD&C Blue 1, D&C Yellow 10, gelatin and water. For 150 mg Strength-Size ‘2’: titanium dioxide, FD&C Blue 1, D&C Yellow 10, gelatin and water. For 300 mg Strength-Size ‘0’: FD&C Blue 1, titanium dioxide, gelatin and water. The empty hard gelatin capsules are printed with TekPrint SW-0012 White Ink. Composition of imprinting ink [TekPrint SW-0012 White Ink] utilized for printing on the capsule shell are presented below: Shellac–NF, Dehydrated alcohol–USP, Isopropyl alcohol–USP, Butyl alcohol–NF, Propylene glycol–USP, Strong ammonia solution–NF, Purified water–USP, Potassium hydroxide–NF, Titanium dioxide USP. The structural formula is represented below: The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- α-D- galacto-octopyranoside monohydrochloride.</Description>
</NDC>
<NDC>
<NDCCode>0283-0622-29</NDCCode>
<PackageDescription>4 SYRINGE, PLASTIC in 1 BOX (0283-0622-29) / 1.2 g in 1 SYRINGE, PLASTIC (0283-0622-44) </PackageDescription>
<NDC11Code>00283-0622-29</NDC11Code>
<ProductNDC>0283-0622</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hurricaine</ProprietaryName>
<ProprietaryNameSuffix>Topical Anesthetic</ProprietaryNameSuffix>
<NonProprietaryName>Benzocaine</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>DENTAL; ORAL; PERIODONTAL</RouteName>
<StartMarketingDate>20221215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Beutlich Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BENZOCAINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0283-0622-34</NDCCode>
<PackageDescription>4 SYRINGE, PLASTIC in 1 BOX (0283-0622-34) / 1.2 g in 1 SYRINGE, PLASTIC (0283-0622-43) </PackageDescription>
<NDC11Code>00283-0622-34</NDC11Code>
<ProductNDC>0283-0622</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hurricaine</ProprietaryName>
<ProprietaryNameSuffix>Topical Anesthetic</ProprietaryNameSuffix>
<NonProprietaryName>Benzocaine</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>DENTAL; ORAL; PERIODONTAL</RouteName>
<StartMarketingDate>20221215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Beutlich Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BENZOCAINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of occasional minor irritation and pain, associated with: 1 canker sores, 2 sore mouth and throat, 3 minor injury of the mouth and gums, 4 minor dental procedures, 5 minor irritation of the mouth and gums caused by dentures or orthodontic appliances.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-0622-2</NDCCode>
<PackageDescription>50 TABLET in 1 CONTAINER (15631-0622-2)</PackageDescription>
<NDC11Code>15631-0622-02</NDC11Code>
<ProductNDC>15631-0622</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lathyrus Sativus</ProprietaryName>
<NonProprietaryName>Lathyrus Sativus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151224</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>LATHYRUS SATIVAS SEED</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37662-0622-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-0622-2) </PackageDescription>
<NDC11Code>37662-0622-02</NDC11Code>
<ProductNDC>37662-0622</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cuprum Nitricum</ProprietaryName>
<NonProprietaryName>Cuprum Nitricum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220617</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>CUPRIC NITRATE HEXAHYDRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-06-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49288-0622-1</NDCCode>
<PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (49288-0622-1)</PackageDescription>
<NDC11Code>49288-0622-01</NDC11Code>
<ProductNDC>49288-0622</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allscale</ProprietaryName>
<NonProprietaryName>Allscale</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ATRIPLEX POLYCARPA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0622-2</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0622-2)</PackageDescription>
<NDC11Code>49288-0622-02</NDC11Code>
<ProductNDC>49288-0622</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allscale</ProprietaryName>
<NonProprietaryName>Allscale</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ATRIPLEX POLYCARPA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>50090-0622-2</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (50090-0622-2) / 24 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50090-0622-02</NDC11Code>
<ProductNDC>50090-0622</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aprodine</ProprietaryName>
<NonProprietaryName>Pseudoephedrine Hcl And Triprolidine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:runny noseitchy, watery eyesnasal congestionsneezingitching of the nose or throat. temporarily relieves these symptoms due to the common cold:runny nosesneezingnasal congestion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61680-0622-2</NDCCode>
<PackageDescription>415 L in 1 CYLINDER (61680-0622-2)</PackageDescription>
<NDC11Code>61680-0622-02</NDC11Code>
<ProductNDC>61680-0622</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19950622</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>South East Alaska Medical Suppliers Inc.</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67296-0622-2</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (67296-0622-2)</PackageDescription>
<NDC11Code>67296-0622-02</NDC11Code>
<ProductNDC>67296-0622</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077321</ApplicationNumber>
<LabelerName>RedPharm Drug Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lisinopril tablets are indicated for the treatment of hypertension. They may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents. Lisinopril tablets are indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis. Lisinopril tablets are indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers. In using lisinopril tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril tablets does not have a similar risk. (See WARNINGS). In considering the use of lisinopril tablets, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in Black patients than in non-Blacks. In addition, ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients (see WARNINGS, Anaphylactoid and Possibly Related Reactions ).</IndicationAndUsage>
<Description>Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, starch. 5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, red iron oxide, starch. 40 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, starch, yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>70000-0622-2</NDCCode>
<PackageDescription>36 TABLET in 1 BOTTLE (70000-0622-2) </PackageDescription>
<NDC11Code>70000-0622-02</NDC11Code>
<ProductNDC>70000-0622</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Ibuprofen</ProprietaryName>
<NonProprietaryName>Acetaminophen And Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216592</ApplicationNumber>
<LabelerName>LEADER/ Cardinal Health 110, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; IBUPROFEN</SubstanceName>
<StrengthNumber>250; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ temporarily relieves minor aches and pains due to. ■ headache. ■ toothache. ■ backache. ■ menstrual cramps. ■ muscular aches. ■ minor pain of arthritis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71335-0622-2</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BOTTLE (71335-0622-2) </PackageDescription>
<NDC11Code>71335-0622-02</NDC11Code>
<ProductNDC>71335-0622</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin</ProprietaryName>
<ProprietaryNameSuffix>Low Dose</ProprietaryNameSuffix>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of minor aches and pains. ask your doctor about other uses for aspirin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53002-0060-1</NDCCode>
<PackageDescription>2 TABLET, FILM COATED in 1 BOTTLE (53002-0060-1) </PackageDescription>
<NDC11Code>53002-0060-01</NDC11Code>
<ProductNDC>53002-0060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201506</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/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>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Cold Sores (Herpes Labialis), 2 Genital HerpesTreatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-infected patientsReduction of transmission, 3 Herpes Zoster.</IndicationAndUsage>
<Description>Valacyclovir hydrochloride, USP is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride, USP equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients crospovidone, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. The chemical name of valacyclovir hydrochloride, USP is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride, USP is a white to off-white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pKas for valacyclovir hydrochloride, USP are 1.90, 7.47, and 9.43. Valacyclovir hydrochloride, USP comply with USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>53002-0060-2</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE (53002-0060-2) </PackageDescription>
<NDC11Code>53002-0060-02</NDC11Code>
<ProductNDC>53002-0060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201506</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/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>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Cold Sores (Herpes Labialis), 2 Genital HerpesTreatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-infected patientsReduction of transmission, 3 Herpes Zoster.</IndicationAndUsage>
<Description>Valacyclovir hydrochloride, USP is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride, USP equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients crospovidone, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. The chemical name of valacyclovir hydrochloride, USP is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride, USP is a white to off-white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pKas for valacyclovir hydrochloride, USP are 1.90, 7.47, and 9.43. Valacyclovir hydrochloride, USP comply with USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>53002-0061-1</NDCCode>
<PackageDescription>2 TABLET, FILM COATED in 1 BOTTLE (53002-0061-1) </PackageDescription>
<NDC11Code>53002-0061-01</NDC11Code>
<ProductNDC>53002-0061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090682</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/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>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1) : 1 Cold Sores (Herpes Labialis) , 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-1-infected patients Reduction of transmission , 3 Herpes Zoster .</IndicationAndUsage>
<Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir.Valacyclovir tablets, USP are for oral administration. Each tablet contains 556 mg or 1.112 grams of valacyclovir hydrochloride USP (hydrous) equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide.The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride USP (hydrous) is a white or almost white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
</NDC>
<NDC>
<NDCCode>53002-0061-2</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE (53002-0061-2) </PackageDescription>
<NDC11Code>53002-0061-02</NDC11Code>
<ProductNDC>53002-0061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090682</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/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>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1) : 1 Cold Sores (Herpes Labialis) , 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-1-infected patients Reduction of transmission , 3 Herpes Zoster .</IndicationAndUsage>
<Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir.Valacyclovir tablets, USP are for oral administration. Each tablet contains 556 mg or 1.112 grams of valacyclovir hydrochloride USP (hydrous) equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide.The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride USP (hydrous) is a white or almost white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
</NDC>
<NDC>
<NDCCode>53002-0062-1</NDCCode>
<PackageDescription>2 TABLET, FILM COATED in 1 BOTTLE (53002-0062-1) </PackageDescription>
<NDC11Code>53002-0062-01</NDC11Code>
<ProductNDC>53002-0062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir</ProprietaryName>
<NonProprietaryName>Valacyclovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150525</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203047</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/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>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir tablet, USP is a nucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1) Cold Sores (Herpes Labialis) Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-infected patients Reduction of transmission Herpes Zoster Pediatric Patients (1.2) Cold Sores (Herpes Labialis) Chickenpox Limitations of Use (1.3) The efficacy and safety of valacyclovir tablets, USP have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.</IndicationAndUsage>
<Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride USP equivalent to 500 mg or 1gm valacyclovir and the inactive ingredients crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. In addition to this 500 mg contains FD&C blue #2/ indigo carmine aluminum lake. The chemical name of valacyclovir hydrochloride is L-valine2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester hydrochloride monohydrate. It has the following structural formula:. Valacyclovir hydrochloride USP (monohydrate)is a white or almost white powder with the molecular formula C 13H 23N 6O 5Cl and a molecular weight of 378.81. Valacyclovir hydrochloride USP is freely soluble in water and practically insoluble in 1-octanol. The pka for valacyclovir hydrochloride is 5.95. Valacyclovir Tablets USP, 500 gm and 1 g complies with USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>53002-0062-2</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE (53002-0062-2) </PackageDescription>
<NDC11Code>53002-0062-02</NDC11Code>
<ProductNDC>53002-0062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir</ProprietaryName>
<NonProprietaryName>Valacyclovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150525</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203047</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/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>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir tablet, USP is a nucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1) Cold Sores (Herpes Labialis) Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-infected patients Reduction of transmission Herpes Zoster Pediatric Patients (1.2) Cold Sores (Herpes Labialis) Chickenpox Limitations of Use (1.3) The efficacy and safety of valacyclovir tablets, USP have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.</IndicationAndUsage>
<Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride USP equivalent to 500 mg or 1gm valacyclovir and the inactive ingredients crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. In addition to this 500 mg contains FD&C blue #2/ indigo carmine aluminum lake. The chemical name of valacyclovir hydrochloride is L-valine2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester hydrochloride monohydrate. It has the following structural formula:. Valacyclovir hydrochloride USP (monohydrate)is a white or almost white powder with the molecular formula C 13H 23N 6O 5Cl and a molecular weight of 378.81. Valacyclovir hydrochloride USP is freely soluble in water and practically insoluble in 1-octanol. The pka for valacyclovir hydrochloride is 5.95. Valacyclovir Tablets USP, 500 gm and 1 g complies with USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>53002-0080-2</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (53002-0080-2) </PackageDescription>
<NDC11Code>53002-0080-02</NDC11Code>
<ProductNDC>53002-0080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202168</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, 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>2021-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53002-0081-2</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (53002-0081-2) </PackageDescription>
<NDC11Code>53002-0081-02</NDC11Code>
<ProductNDC>53002-0081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202168</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, 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>2021-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53002-0082-2</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (53002-0082-2) </PackageDescription>
<NDC11Code>53002-0082-02</NDC11Code>
<ProductNDC>53002-0082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091022</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075382</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, 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>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations of an antiviral drug for oral administration. Each 800-mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>53002-0083-2</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (53002-0083-2) </PackageDescription>
<NDC11Code>53002-0083-02</NDC11Code>
<ProductNDC>53002-0083</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180504</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210401</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, 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>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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 herpesviruses. Acyclovir Capsules, USP and Acyclovir Tablets, USP are formulations for oral administration. Each capsule contains 200 mg of acyclovir, USP and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C Blue No. 1, FD&C Red No. 3, FD&C Yellow No. 6 and titanium dioxide. Printed with edible black ink. Each 800 mg tablet of acyclovir contains 800 mg of acyclovir, USP and the inactive ingredients magnesium stearate, microcrystalline cellulose PH101, povidone K30, and sodium starch glycolate (Type A) (Starch from Non GMO potatoes). Each 400 mg tablet of acyclovir contains 400 mg of acyclovir, USP and the inactive ingredients magnesium stearate, microcrystalline cellulose PH101, povidone K30, and sodium starch glycolate (Type A) (Starch from Non GMO potatoes). Acyclovir, USP is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37℃ is 2.5mg/mL. The pka’s of acyclovir 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. VIROLOGY. Mechanism of Antiviral Action. Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities. The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC 50 ), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC 50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC 50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC 50 of 1.35 mcg/mL. Drug Resistance. Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy.</Description>
</NDC>
<NDC>
<NDCCode>53002-0084-2</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (53002-0084-2) </PackageDescription>
<NDC11Code>53002-0084-02</NDC11Code>
<ProductNDC>53002-0084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209366</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, 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>2025-01-01</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir Tablets are formulations for oral administration. Each 800-mg tablet of acyclovir contains 800mg of acyclovir and the inactive ingredients FD&C Blue No. 2, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400mg of acyclovir and the inactive ingredients magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino -1, 9 -dihydro -9 - [(2-hydroxyethoxy) methyl]-6 H-purin-6 -one; it has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>53002-0085-2</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (53002-0085-2) </PackageDescription>
<NDC11Code>53002-0085-02</NDC11Code>
<ProductNDC>53002-0085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203834</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, 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>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets, USP is a formulation for oral administration. Each Acyclovir Tablet contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the inactive ingredients colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. The 400 mg and 800 mg tablet also contains ferric oxide and FD&C blue lake # 2 Indigo carmine AL, respectively. Acyclovir USP is a white to off white crystalline powder, slightly hygroscopic with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225.20. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-. It has the following structural formula:.</Description>
</NDC>
</NDCList>