{
"NDC": [
{
"NDCCode": "0591-4050-94",
"PackageDescription": "1 BOTTLE in 1 CARTON (0591-4050-94) / 112 mL in 1 BOTTLE",
"NDC11Code": "00591-4050-94",
"ProductNDC": "0591-4050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20200817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211534",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200817",
"SamplePackage": "N",
"IndicationAndUsage": "Adults. Sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)]. Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) for oral suspension. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Sildenafil for oral suspension, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® (sildenafil tablets USP) for erectile dysfunction. Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water. Sildenafil for oral suspension is supplied as white to off-white powder containing 1.57 g of sildenafil citrate, USP (equivalent to 1.12 g sildenafil) in an amber glass bottle intended for reconstitution. Following reconstitution with 90 mL water, the total volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil. The inactive ingredients include anhydrous citric acid, colloidal silicon dioxide, grape flavor, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, titanium dioxide, and xanthan gum. In addition to the bottle, a press-in bottle adapter and an oral dosing syringe (with 0.5 mL and 2 mL dose markings) are provided."
},
{
"NDCCode": "0591-2533-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-2533-60) ",
"NDC11Code": "00591-2533-60",
"ProductNDC": "0591-2533",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dalfampridine",
"NonProprietaryName": "Dalfampridine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206836",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "DALFAMPRIDINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Potassium Channel Antagonists [MoA], Potassium Channel Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2022-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220531",
"SamplePackage": "N",
"IndicationAndUsage": "Dalfampridine extended-release tablets are indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed [see Clinical Studies (14)].",
"Description": "Dalfampridine, USP is a potassium channel blocker, available in a 10 mg tablet strength. Each tablet contains 10 mg dalfampridine, formulated as an extended-release tablet for twice-daily oral administration. Dalfampridine, USP is also known by its chemical name, 4-aminopyridine, with the following structure. Dalfampridine extended-release tablets are available in a 10 mg strength and are white to off-white, biconvex, oval shaped, film-coated, unscored tablets, debossed with “WPI” on one side and “2533” on the other side, containing 10 mg of dalfampridine. Inactive ingredients consist of colloidal silicon dioxide, dibasic calcium phosphate, hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide. Dalfampridine, USP is a fine white powder with a molecular weight of 94.1, CAS 504-24-5, and a molecular formula of C5H6N2. At ambient conditions, dalfampridine is soluble in water and methanol, sparingly soluble in acetone, 2-butanone, ethyl acetate, dichloromethane, ethanol, isopropanol alcohol and isobutyl alcohol; slightly soluble in toluene and diisopropyl ether; very slightly soluble in hexane and heptane."
},
{
"NDCCode": "0591-3153-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0591-3153-01) ",
"NDC11Code": "00591-3153-01",
"ProductNDC": "0591-3153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20020917",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA063065",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20020917",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms:Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis.Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Klebsiella aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Minocycline hydrochloride, USP is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C23H27N3O7HCl M.W. 493.94. Each minocycline hydrochloride capsule, USP, for oral administration, contains the equivalent of 50 mg, 75 mg, or 100 mg of minocycline. In addition, each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg, and 100 mg capsule shells contain: D&C Red No. 28, D&C Yellow No. 10, gelatin, and titanium dioxide. The 75 mg capsule shell also contains FD&C Yellow No. 6. The 100 mg capsule shell also contains black iron oxide. The black imprinting ink contains the following ingredients that are common to all strengths: black iron oxide, butyl alcohol, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, propylene glycol, and shellac glaze."
},
{
"NDCCode": "0591-5694-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0591-5694-01) ",
"NDC11Code": "00591-5694-01",
"ProductNDC": "0591-5694",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19920201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA063181",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19920201",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms:Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis.Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Klebsiella aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Minocycline hydrochloride, USP is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C23H27N3O7HCl M.W. 493.94. Each minocycline hydrochloride capsule, USP, for oral administration, contains the equivalent of 50 mg, 75 mg, or 100 mg of minocycline. In addition, each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg, and 100 mg capsule shells contain: D&C Red No. 28, D&C Yellow No. 10, gelatin, and titanium dioxide. The 75 mg capsule shell also contains FD&C Yellow No. 6. The 100 mg capsule shell also contains black iron oxide. The black imprinting ink contains the following ingredients that are common to all strengths: black iron oxide, butyl alcohol, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, propylene glycol, and shellac glaze."
},
{
"NDCCode": "0591-5694-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (0591-5694-60) ",
"NDC11Code": "00591-5694-60",
"ProductNDC": "0591-5694",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19920201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA063181",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060525",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms:Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis.Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Klebsiella aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Minocycline hydrochloride, USP is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C23H27N3O7HCl M.W. 493.94. Each minocycline hydrochloride capsule, USP, for oral administration, contains the equivalent of 50 mg, 75 mg, or 100 mg of minocycline. In addition, each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg, and 100 mg capsule shells contain: D&C Red No. 28, D&C Yellow No. 10, gelatin, and titanium dioxide. The 75 mg capsule shell also contains FD&C Yellow No. 6. The 100 mg capsule shell also contains black iron oxide. The black imprinting ink contains the following ingredients that are common to all strengths: black iron oxide, butyl alcohol, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, propylene glycol, and shellac glaze."
},
{
"NDCCode": "0591-5695-50",
"PackageDescription": "50 CAPSULE in 1 BOTTLE, PLASTIC (0591-5695-50) ",
"NDC11Code": "00591-5695-50",
"ProductNDC": "0591-5695",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19930501",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA063065",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19930501",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms:Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis.Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Klebsiella aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Minocycline hydrochloride, USP is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C23H27N3O7HCl M.W. 493.94. Each minocycline hydrochloride capsule, USP, for oral administration, contains the equivalent of 50 mg, 75 mg, or 100 mg of minocycline. In addition, each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg, and 100 mg capsule shells contain: D&C Red No. 28, D&C Yellow No. 10, gelatin, and titanium dioxide. The 75 mg capsule shell also contains FD&C Yellow No. 6. The 100 mg capsule shell also contains black iron oxide. The black imprinting ink contains the following ingredients that are common to all strengths: black iron oxide, butyl alcohol, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, propylene glycol, and shellac glaze."
},
{
"NDCCode": "0186-4050-01",
"PackageDescription": "30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4050-01) ",
"NDC11Code": "00186-4050-01",
"ProductNDC": "0186-4050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nexium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "GRANULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021957",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120905",
"SamplePackage": "N",
"IndicationAndUsage": "NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral. suspension are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).",
"Description": "The active ingredient in NEXIUM® (esomeprazole magnesium) delayed-release capsules for oral administration and NEXIUM (esomeprazole magnesium) for delayed-release oral suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each NEXIUM delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: D&C Red #28, D&C Yellow #10, ethyl alcohol, FD&C Blue #1, FD&C Red #40, gelatin, isopropyl alcohol, n-butyl alcohol, polyvinyl pyrrolidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide. Each packet of NEXIUM for delayed-release oral suspension contains esomeprazole, in the form of same enteric-coated granules used in NEXIUM delayed-release capsules, and also inactive granules: 1 2.5 mg esomeprazole (equivalent to 2.8 mg esomeprazole magnesium trihydrate), 2 5 mg esomeprazole (equivalent to 5.6 mg esomeprazole magnesium trihydrate), 3 10 mg esomeprazole (equivalent to 11.1 mg esomeprazole magnesium trihydrate), 4 20 mg esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate), 5 40 mg esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate)."
},
{
"NDCCode": "0220-4050-41",
"PackageDescription": "5 [hp_C] in 1 TUBE (0220-4050-41) ",
"NDC11Code": "00220-4050-41",
"ProductNDC": "0220-4050",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pilocarpus",
"NonProprietaryName": "Pilocarpus Jaborandii Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "PILOCARPUS JABORANDI LEAF",
"StrengthNumber": "5",
"StrengthUnit": "[hp_C]/5[hp_C]",
"Status": "Active",
"LastUpdate": "2023-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830303",
"SamplePackage": "N",
"IndicationAndUsage": "Hypersalivation*."
},
{
"NDCCode": "0264-4050-80",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-4050-80) / 50 mL in 1 CONTAINER",
"NDC11Code": "00264-4050-80",
"ProductNDC": "0264-4050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210218",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204957",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2023-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210218",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen Injection is indicated for: 1 the management of mild to moderate pain in adult and pediatric patients 2 years and older, 2 the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, 3 the reduction of fever in adult and pediatric patients.",
"Description": "Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. Its chemical name is N-acetyl-p-aminophenol. Acetaminophen has a molecular weight of 151.16. Its structural formula is:. Acetaminophen Injection is a sterile, clear, colorless, non pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion. It has a pH of approximately 5.0 and an osmolality of approximately 290 mOsm/kg. Each 100 mL contains 1,000 mg Acetaminophen, USP, 3,800 mg Mannitol, USP, 30 mg Sodium Citrate Dihydrate USP, and Water for Injection, USP qs. Each 50 mL contains 500 mg Acetaminophen, USP, 1,900 mg Mannitol, USP, 15 mg Sodium Citrate Dihydrate USP, and Water for Injection, USP qs. pH is adjusted with glacial acetic acid. Not made with natural rubber latex, PVC or DEHP."
},
{
"NDCCode": "0264-4050-85",
"PackageDescription": "6 CARTON in 1 CASE (0264-4050-85) > 4 CONTAINER in 1 CARTON (0264-4050-80) > 50 mL in 1 CONTAINER",
"NDC11Code": "00264-4050-85",
"ProductNDC": "0264-4050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210218",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204957",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210218",
"SamplePackage": "N"
},
{
"NDCCode": "0264-4050-90",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-4050-90) / 50 mL in 1 CONTAINER",
"NDC11Code": "00264-4050-90",
"ProductNDC": "0264-4050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231010",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204957",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231010",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen Injection is indicated for: 1 the management of mild to moderate pain in adult and pediatric patients 2 years and older, 2 the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, 3 the reduction of fever in adult and pediatric patients.",
"Description": "Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. Its chemical name is N-acetyl-p-aminophenol. Acetaminophen has a molecular weight of 151.16. Its structural formula is. Acetaminophen Injection is a sterile, clear, colorless, non pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion. It has a pH of approximately 5.0 and an osmolality of approximately 290 mOsm/kg. Each 50 mL contains 500 mg Acetaminophen, USP, 1,900 mg Mannitol, USP, 15 mg Sodium Citrate Dihydrate USP, and Water for Injection, USP qs. pH is adjusted with glacial acetic acid. Not made with natural rubber latex, PVC or DEHP."
},
{
"NDCCode": "0363-4050-04",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (0363-4050-04) / 118 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00363-4050-04",
"ProductNDC": "0363-4050",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cough Cold And Sore Throat",
"ProprietaryNameSuffix": "Childrens",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20141031",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Walgreens",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 200; 5",
"StrengthUnit": "mg/10mL; mg/10mL; mg/10mL; mg/10mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141031",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold and flu symptoms:cough due to minor throat and bronchial irritationthe intensity of coughingthe impulse to cough to help your child get to sleepnasal congestionstuffy nosesore throatminor aches and painsheadache. temporarily reduces fever. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ."
},
{
"NDCCode": "0378-4050-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (0378-4050-05)",
"NDC11Code": "00378-4050-05",
"ProductNDC": "0378-4050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nevirapine",
"NonProprietaryName": "Nevirapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120522",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202523",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "NEVIRAPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-02-26"
},
{
"NDCCode": "0378-4050-80",
"PackageDescription": "180 TABLET in 1 BOTTLE, PLASTIC (0378-4050-80)",
"NDC11Code": "00378-4050-80",
"ProductNDC": "0378-4050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nevirapine",
"NonProprietaryName": "Nevirapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120522",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202523",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "NEVIRAPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-02-26"
},
{
"NDCCode": "0378-4050-91",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (0378-4050-91) ",
"NDC11Code": "00378-4050-91",
"ProductNDC": "0378-4050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nevirapine",
"NonProprietaryName": "Nevirapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120522",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202523",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "NEVIRAPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120522",
"SamplePackage": "N",
"IndicationAndUsage": "Nevirapine is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1, 14.2)]. Limitations of Use. Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine is not recommended to be initiated, unless the benefit outweighs the risk, in: 1 adult females with CD4+ cell counts greater than 250 cells/mm3 or, 2 adult males with CD4+ cell counts greater than 400 cells/mm3 [see Warnings and Precautions (5.1)]. .",
"Description": "Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Nevirapine is structurally a member of the dipyridodiazepinone chemical class of compounds. The chemical name of nevirapine is 11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido [3,2-b:2',3'-e][1,4] diazepin-6-one. Nevirapine, USP is a white to off-white, odorless to nearly odorless, crystalline powder with the molecular weight of 266.30 and the molecular formula C15H14N4O. Nevirapine has the following structural formula:. Nevirapine tablets, USP are for oral administration. Each tablet contains 200 mg of nevirapine and the inactive ingredients colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate (potato)."
},
{
"NDCCode": "0409-4050-01",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4050-01) > 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-4050-01",
"ProductNDC": "0409-4050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin",
"NonProprietaryName": "Clindamycin Phosphate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20050609",
"EndMarketingDate": "20170601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062800",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-06-08"
},
{
"NDCCode": "0498-4050-01",
"PackageDescription": "1 KIT in 1 KIT (0498-4050-01) * .9 g in 1 PACKET * .9 g in 1 PACKET (0498-0750-35) * 10 POUCH in 1 CARTON (0498-0121-34) > .3 mL in 1 POUCH (0498-0121-00) ",
"NDC11Code": "00498-4050-01",
"ProductNDC": "0498-4050",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "4050 First Aid Kit",
"NonProprietaryName": "4050 First Aid Kit",
"DosageFormName": "KIT",
"StartMarketingDate": "20181121",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Honeywell Safety Products USA, Inc",
"Status": "Deprecated",
"LastUpdate": "2019-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20181121",
"SamplePackage": "N"
},
{
"NDCCode": "0517-4050-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4050-25) > 50 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00517-4050-25",
"ProductNDC": "0517-4050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mannitol",
"NonProprietaryName": "Mannitol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087409",
"LabelerName": "American Regent, Inc.",
"SubstanceName": "MANNITOL",
"StrengthNumber": "250",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-02-16",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "17359-4050-1",
"PackageDescription": "300 g in 1 CONTAINER (17359-4050-1)",
"NDC11Code": "17359-4050-01",
"ProductNDC": "17359-4050",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Paclitaxel",
"DosageFormName": "POWDER",
"StartMarketingDate": "20070731",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indena SpA",
"SubstanceName": "PACLITAXEL",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "34645-4050-3",
"PackageDescription": "6 mL in 1 POUCH (34645-4050-3) ",
"NDC11Code": "34645-4050-03",
"ProductNDC": "34645-4050",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Povidone Iodine Scrub",
"NonProprietaryName": "Povidone-iodine",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Jianerkang Medical Co., Ltd",
"SubstanceName": "POVIDONE-IODINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100101",
"SamplePackage": "N",
"IndicationAndUsage": "Health-care antiseptic for preparation of the skin prior to surgery First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns Use."
},
{
"NDCCode": "37662-4050-1",
"PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-4050-1) ",
"NDC11Code": "37662-4050-01",
"ProductNDC": "37662-4050",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stannum Phosphoricum",
"NonProprietaryName": "Stannum Phosphoricum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230928",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "STANNIC HYDROGEN PHOSPHATE",
"StrengthNumber": "100",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230928",
"SamplePackage": "N"
},
{
"NDCCode": "37662-4050-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-4050-2) ",
"NDC11Code": "37662-4050-02",
"ProductNDC": "37662-4050",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stannum Phosphoricum",
"NonProprietaryName": "Stannum Phosphoricum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230928",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "STANNIC HYDROGEN PHOSPHATE",
"StrengthNumber": "100",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230928",
"SamplePackage": "N"
},
{
"NDCCode": "37662-4050-3",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (37662-4050-3) ",
"NDC11Code": "37662-4050-03",
"ProductNDC": "37662-4050",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stannum Phosphoricum",
"NonProprietaryName": "Stannum Phosphoricum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230928",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "STANNIC HYDROGEN PHOSPHATE",
"StrengthNumber": "100",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230928",
"SamplePackage": "N"
},
{
"NDCCode": "37662-4050-4",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-4050-4) ",
"NDC11Code": "37662-4050-04",
"ProductNDC": "37662-4050",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stannum Phosphoricum",
"NonProprietaryName": "Stannum Phosphoricum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230928",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "STANNIC HYDROGEN PHOSPHATE",
"StrengthNumber": "100",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230928",
"SamplePackage": "N"
},
{
"NDCCode": "39822-4050-3",
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"NDC11Code": "39822-4050-03",
"ProductNDC": "39822-4050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenytoin Sodium",
"NonProprietaryName": "Phenytoin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20110502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040573",
"LabelerName": "X-GEN Pharmaceuticals, Inc.",
"SubstanceName": "PHENYTOIN SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "39822-4050-6",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (39822-4050-6) > 10 mL in 1 VIAL, SINGLE-DOSE (39822-4050-5)",
"NDC11Code": "39822-4050-06",
"ProductNDC": "39822-4050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenytoin Sodium",
"NonProprietaryName": "Phenytoin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20110502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040573",
"LabelerName": "X-GEN Pharmaceuticals, Inc.",
"SubstanceName": "PHENYTOIN SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "42787-101-50",
"PackageDescription": "1 BOTTLE in 1 CARTON (42787-101-50) > 4050 mg in 1 BOTTLE",
"NDC11Code": "42787-0101-50",
"ProductNDC": "42787-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Value Pharma",
"ProprietaryNameSuffix": "Aspirin Pain Reliever",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121001",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Ajes Pharmaceuticals,LLC",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/81mg",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20121001",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of minor aches and pains or as recommended by your Doctor. Because of this products delayed release action, this product will not provide fast relief of headaches or symptoms needing immediate relief."
},
{
"NDCCode": "42858-075-45",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-075-45) ",
"NDC11Code": "42858-0075-45",
"ProductNDC": "42858-075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA205831",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].",
"Description": "Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&C Blue No. 115 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 4020 mg: D&C Red No. 33, D&C Yellow No. 1030 mg: FD&C Blue No. 1, FD&C Red No. 340 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 4050 mg: D&C Yellow No. 10, FD&C Green No. 360 mg: Black Iron Oxide."
},
{
"NDCCode": "42858-076-45",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-076-45) ",
"NDC11Code": "42858-0076-45",
"ProductNDC": "42858-076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA205831",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20200401",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].",
"Description": "Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&C Blue No. 115 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 4020 mg: D&C Red No. 33, D&C Yellow No. 1030 mg: FD&C Blue No. 1, FD&C Red No. 340 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 4050 mg: D&C Yellow No. 10, FD&C Green No. 360 mg: Black Iron Oxide."
},
{
"NDCCode": "42858-077-45",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-077-45) ",
"NDC11Code": "42858-0077-45",
"ProductNDC": "42858-077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA205831",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].",
"Description": "Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&C Blue No. 115 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 4020 mg: D&C Red No. 33, D&C Yellow No. 1030 mg: FD&C Blue No. 1, FD&C Red No. 340 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 4050 mg: D&C Yellow No. 10, FD&C Green No. 360 mg: Black Iron Oxide."
}
]
}
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<NDC>
<NDCCode>0591-4050-94</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0591-4050-94) / 112 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00591-4050-94</NDC11Code>
<ProductNDC>0591-4050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211534</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults. Sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)]. Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) for oral suspension. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Sildenafil for oral suspension, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® (sildenafil tablets USP) for erectile dysfunction. Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water. Sildenafil for oral suspension is supplied as white to off-white powder containing 1.57 g of sildenafil citrate, USP (equivalent to 1.12 g sildenafil) in an amber glass bottle intended for reconstitution. Following reconstitution with 90 mL water, the total volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil. The inactive ingredients include anhydrous citric acid, colloidal silicon dioxide, grape flavor, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, titanium dioxide, and xanthan gum. In addition to the bottle, a press-in bottle adapter and an oral dosing syringe (with 0.5 mL and 2 mL dose markings) are provided.</Description>
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<NDC>
<NDCCode>0591-2533-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-2533-60) </PackageDescription>
<NDC11Code>00591-2533-60</NDC11Code>
<ProductNDC>0591-2533</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dalfampridine</ProprietaryName>
<NonProprietaryName>Dalfampridine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206836</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>DALFAMPRIDINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Potassium Channel Antagonists [MoA], Potassium Channel Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dalfampridine extended-release tablets are indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Dalfampridine, USP is a potassium channel blocker, available in a 10 mg tablet strength. Each tablet contains 10 mg dalfampridine, formulated as an extended-release tablet for twice-daily oral administration. Dalfampridine, USP is also known by its chemical name, 4-aminopyridine, with the following structure. Dalfampridine extended-release tablets are available in a 10 mg strength and are white to off-white, biconvex, oval shaped, film-coated, unscored tablets, debossed with “WPI” on one side and “2533” on the other side, containing 10 mg of dalfampridine. Inactive ingredients consist of colloidal silicon dioxide, dibasic calcium phosphate, hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide. Dalfampridine, USP is a fine white powder with a molecular weight of 94.1, CAS 504-24-5, and a molecular formula of C5H6N2. At ambient conditions, dalfampridine is soluble in water and methanol, sparingly soluble in acetone, 2-butanone, ethyl acetate, dichloromethane, ethanol, isopropanol alcohol and isobutyl alcohol; slightly soluble in toluene and diisopropyl ether; very slightly soluble in hexane and heptane.</Description>
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<NDC>
<NDCCode>0591-3153-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0591-3153-01) </PackageDescription>
<NDC11Code>00591-3153-01</NDC11Code>
<ProductNDC>0591-3153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020917</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA063065</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20020917</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Minocycline hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms:Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis.Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Klebsiella aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Minocycline hydrochloride, USP is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C23H27N3O7HCl M.W. 493.94. Each minocycline hydrochloride capsule, USP, for oral administration, contains the equivalent of 50 mg, 75 mg, or 100 mg of minocycline. In addition, each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg, and 100 mg capsule shells contain: D&C Red No. 28, D&C Yellow No. 10, gelatin, and titanium dioxide. The 75 mg capsule shell also contains FD&C Yellow No. 6. The 100 mg capsule shell also contains black iron oxide. The black imprinting ink contains the following ingredients that are common to all strengths: black iron oxide, butyl alcohol, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, propylene glycol, and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>0591-5694-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0591-5694-01) </PackageDescription>
<NDC11Code>00591-5694-01</NDC11Code>
<ProductNDC>0591-5694</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA063181</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Minocycline hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms:Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis.Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Klebsiella aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Minocycline hydrochloride, USP is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C23H27N3O7HCl M.W. 493.94. Each minocycline hydrochloride capsule, USP, for oral administration, contains the equivalent of 50 mg, 75 mg, or 100 mg of minocycline. In addition, each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg, and 100 mg capsule shells contain: D&C Red No. 28, D&C Yellow No. 10, gelatin, and titanium dioxide. The 75 mg capsule shell also contains FD&C Yellow No. 6. The 100 mg capsule shell also contains black iron oxide. The black imprinting ink contains the following ingredients that are common to all strengths: black iron oxide, butyl alcohol, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, propylene glycol, and shellac glaze.</Description>
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<NDC>
<NDCCode>0591-5694-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (0591-5694-60) </PackageDescription>
<NDC11Code>00591-5694-60</NDC11Code>
<ProductNDC>0591-5694</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA063181</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Minocycline hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms:Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis.Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Klebsiella aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Minocycline hydrochloride, USP is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C23H27N3O7HCl M.W. 493.94. Each minocycline hydrochloride capsule, USP, for oral administration, contains the equivalent of 50 mg, 75 mg, or 100 mg of minocycline. In addition, each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg, and 100 mg capsule shells contain: D&C Red No. 28, D&C Yellow No. 10, gelatin, and titanium dioxide. The 75 mg capsule shell also contains FD&C Yellow No. 6. The 100 mg capsule shell also contains black iron oxide. The black imprinting ink contains the following ingredients that are common to all strengths: black iron oxide, butyl alcohol, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, propylene glycol, and shellac glaze.</Description>
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<NDC>
<NDCCode>0591-5695-50</NDCCode>
<PackageDescription>50 CAPSULE in 1 BOTTLE, PLASTIC (0591-5695-50) </PackageDescription>
<NDC11Code>00591-5695-50</NDC11Code>
<ProductNDC>0591-5695</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930501</StartMarketingDate>
<EndMarketingDate>20270731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA063065</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19930501</StartMarketingDatePackage>
<EndMarketingDatePackage>20270731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Minocycline hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms:Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis.Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Klebsiella aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Minocycline hydrochloride, USP is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C23H27N3O7HCl M.W. 493.94. Each minocycline hydrochloride capsule, USP, for oral administration, contains the equivalent of 50 mg, 75 mg, or 100 mg of minocycline. In addition, each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg, and 100 mg capsule shells contain: D&C Red No. 28, D&C Yellow No. 10, gelatin, and titanium dioxide. The 75 mg capsule shell also contains FD&C Yellow No. 6. The 100 mg capsule shell also contains black iron oxide. The black imprinting ink contains the following ingredients that are common to all strengths: black iron oxide, butyl alcohol, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, propylene glycol, and shellac glaze.</Description>
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<NDC>
<NDCCode>0186-4050-01</NDCCode>
<PackageDescription>30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4050-01) </PackageDescription>
<NDC11Code>00186-4050-01</NDC11Code>
<ProductNDC>0186-4050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nexium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>GRANULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021957</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral. suspension are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
<Description>The active ingredient in NEXIUM® (esomeprazole magnesium) delayed-release capsules for oral administration and NEXIUM (esomeprazole magnesium) for delayed-release oral suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each NEXIUM delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: D&C Red #28, D&C Yellow #10, ethyl alcohol, FD&C Blue #1, FD&C Red #40, gelatin, isopropyl alcohol, n-butyl alcohol, polyvinyl pyrrolidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide. Each packet of NEXIUM for delayed-release oral suspension contains esomeprazole, in the form of same enteric-coated granules used in NEXIUM delayed-release capsules, and also inactive granules: 1 2.5 mg esomeprazole (equivalent to 2.8 mg esomeprazole magnesium trihydrate), 2 5 mg esomeprazole (equivalent to 5.6 mg esomeprazole magnesium trihydrate), 3 10 mg esomeprazole (equivalent to 11.1 mg esomeprazole magnesium trihydrate), 4 20 mg esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate), 5 40 mg esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate).</Description>
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<NDC>
<NDCCode>0220-4050-41</NDCCode>
<PackageDescription>5 [hp_C] in 1 TUBE (0220-4050-41) </PackageDescription>
<NDC11Code>00220-4050-41</NDC11Code>
<ProductNDC>0220-4050</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pilocarpus</ProprietaryName>
<NonProprietaryName>Pilocarpus Jaborandii Leaf</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>PILOCARPUS JABORANDI LEAF</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>[hp_C]/5[hp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypersalivation*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0264-4050-80</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-4050-80) / 50 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-4050-80</NDC11Code>
<ProductNDC>0264-4050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210218</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204957</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen Injection is indicated for: 1 the management of mild to moderate pain in adult and pediatric patients 2 years and older, 2 the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, 3 the reduction of fever in adult and pediatric patients.</IndicationAndUsage>
<Description>Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. Its chemical name is N-acetyl-p-aminophenol. Acetaminophen has a molecular weight of 151.16. Its structural formula is:. Acetaminophen Injection is a sterile, clear, colorless, non pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion. It has a pH of approximately 5.0 and an osmolality of approximately 290 mOsm/kg. Each 100 mL contains 1,000 mg Acetaminophen, USP, 3,800 mg Mannitol, USP, 30 mg Sodium Citrate Dihydrate USP, and Water for Injection, USP qs. Each 50 mL contains 500 mg Acetaminophen, USP, 1,900 mg Mannitol, USP, 15 mg Sodium Citrate Dihydrate USP, and Water for Injection, USP qs. pH is adjusted with glacial acetic acid. Not made with natural rubber latex, PVC or DEHP.</Description>
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<NDCCode>0264-4050-85</NDCCode>
<PackageDescription>6 CARTON in 1 CASE (0264-4050-85) > 4 CONTAINER in 1 CARTON (0264-4050-80) > 50 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-4050-85</NDC11Code>
<ProductNDC>0264-4050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210218</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204957</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>0264-4050-90</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-4050-90) / 50 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-4050-90</NDC11Code>
<ProductNDC>0264-4050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231010</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204957</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen Injection is indicated for: 1 the management of mild to moderate pain in adult and pediatric patients 2 years and older, 2 the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, 3 the reduction of fever in adult and pediatric patients.</IndicationAndUsage>
<Description>Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. Its chemical name is N-acetyl-p-aminophenol. Acetaminophen has a molecular weight of 151.16. Its structural formula is. Acetaminophen Injection is a sterile, clear, colorless, non pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion. It has a pH of approximately 5.0 and an osmolality of approximately 290 mOsm/kg. Each 50 mL contains 500 mg Acetaminophen, USP, 1,900 mg Mannitol, USP, 15 mg Sodium Citrate Dihydrate USP, and Water for Injection, USP qs. pH is adjusted with glacial acetic acid. Not made with natural rubber latex, PVC or DEHP.</Description>
</NDC>
<NDC>
<NDCCode>0363-4050-04</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (0363-4050-04) / 118 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00363-4050-04</NDC11Code>
<ProductNDC>0363-4050</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cough Cold And Sore Throat</ProprietaryName>
<ProprietaryNameSuffix>Childrens</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141031</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Walgreens</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL; mg/10mL; mg/10mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold and flu symptoms:cough due to minor throat and bronchial irritationthe intensity of coughingthe impulse to cough to help your child get to sleepnasal congestionstuffy nosesore throatminor aches and painsheadache. temporarily reduces fever. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0378-4050-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (0378-4050-05)</PackageDescription>
<NDC11Code>00378-4050-05</NDC11Code>
<ProductNDC>0378-4050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nevirapine</ProprietaryName>
<NonProprietaryName>Nevirapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120522</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202523</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NEVIRAPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-02-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-4050-80</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE, PLASTIC (0378-4050-80)</PackageDescription>
<NDC11Code>00378-4050-80</NDC11Code>
<ProductNDC>0378-4050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nevirapine</ProprietaryName>
<NonProprietaryName>Nevirapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120522</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202523</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NEVIRAPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-02-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-4050-91</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (0378-4050-91) </PackageDescription>
<NDC11Code>00378-4050-91</NDC11Code>
<ProductNDC>0378-4050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nevirapine</ProprietaryName>
<NonProprietaryName>Nevirapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120522</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202523</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NEVIRAPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nevirapine is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1, 14.2)]. Limitations of Use. Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine is not recommended to be initiated, unless the benefit outweighs the risk, in: 1 adult females with CD4+ cell counts greater than 250 cells/mm3 or, 2 adult males with CD4+ cell counts greater than 400 cells/mm3 [see Warnings and Precautions (5.1)]. .</IndicationAndUsage>
<Description>Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Nevirapine is structurally a member of the dipyridodiazepinone chemical class of compounds. The chemical name of nevirapine is 11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido [3,2-b:2',3'-e][1,4] diazepin-6-one. Nevirapine, USP is a white to off-white, odorless to nearly odorless, crystalline powder with the molecular weight of 266.30 and the molecular formula C15H14N4O. Nevirapine has the following structural formula:. Nevirapine tablets, USP are for oral administration. Each tablet contains 200 mg of nevirapine and the inactive ingredients colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate (potato).</Description>
</NDC>
<NDC>
<NDCCode>0409-4050-01</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4050-01) > 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-4050-01</NDC11Code>
<ProductNDC>0409-4050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20050609</StartMarketingDate>
<EndMarketingDate>20170601</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062800</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-06-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>0498-4050-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0498-4050-01) * .9 g in 1 PACKET * .9 g in 1 PACKET (0498-0750-35) * 10 POUCH in 1 CARTON (0498-0121-34) > .3 mL in 1 POUCH (0498-0121-00) </PackageDescription>
<NDC11Code>00498-4050-01</NDC11Code>
<ProductNDC>0498-4050</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>4050 First Aid Kit</ProprietaryName>
<NonProprietaryName>4050 First Aid Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20181121</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Honeywell Safety Products USA, Inc</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0517-4050-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4050-25) > 50 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00517-4050-25</NDC11Code>
<ProductNDC>0517-4050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mannitol</ProprietaryName>
<NonProprietaryName>Mannitol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087409</ApplicationNumber>
<LabelerName>American Regent, Inc.</LabelerName>
<SubstanceName>MANNITOL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-02-16</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>17359-4050-1</NDCCode>
<PackageDescription>300 g in 1 CONTAINER (17359-4050-1)</PackageDescription>
<NDC11Code>17359-4050-01</NDC11Code>
<ProductNDC>17359-4050</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Paclitaxel</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20070731</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indena SpA</LabelerName>
<SubstanceName>PACLITAXEL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>34645-4050-3</NDCCode>
<PackageDescription>6 mL in 1 POUCH (34645-4050-3) </PackageDescription>
<NDC11Code>34645-4050-03</NDC11Code>
<ProductNDC>34645-4050</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Povidone Iodine Scrub</ProprietaryName>
<NonProprietaryName>Povidone-iodine</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>Jianerkang Medical Co., Ltd</LabelerName>
<SubstanceName>POVIDONE-IODINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Health-care antiseptic for preparation of the skin prior to surgery First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns Use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37662-4050-1</NDCCode>
<PackageDescription>200 PELLET in 1 VIAL, GLASS (37662-4050-1) </PackageDescription>
<NDC11Code>37662-4050-01</NDC11Code>
<ProductNDC>37662-4050</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stannum Phosphoricum</ProprietaryName>
<NonProprietaryName>Stannum Phosphoricum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230928</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>STANNIC HYDROGEN PHOSPHATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-4050-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-4050-2) </PackageDescription>
<NDC11Code>37662-4050-02</NDC11Code>
<ProductNDC>37662-4050</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stannum Phosphoricum</ProprietaryName>
<NonProprietaryName>Stannum Phosphoricum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230928</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>STANNIC HYDROGEN PHOSPHATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-4050-3</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-4050-3) </PackageDescription>
<NDC11Code>37662-4050-03</NDC11Code>
<ProductNDC>37662-4050</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stannum Phosphoricum</ProprietaryName>
<NonProprietaryName>Stannum Phosphoricum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230928</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>STANNIC HYDROGEN PHOSPHATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-4050-4</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (37662-4050-4) </PackageDescription>
<NDC11Code>37662-4050-04</NDC11Code>
<ProductNDC>37662-4050</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stannum Phosphoricum</ProprietaryName>
<NonProprietaryName>Stannum Phosphoricum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230928</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>STANNIC HYDROGEN PHOSPHATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>39822-4050-3</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (39822-4050-3) > 2 mL in 1 VIAL, SINGLE-DOSE (39822-4050-2)</PackageDescription>
<NDC11Code>39822-4050-03</NDC11Code>
<ProductNDC>39822-4050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenytoin Sodium</ProprietaryName>
<NonProprietaryName>Phenytoin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20110502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040573</ApplicationNumber>
<LabelerName>X-GEN Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PHENYTOIN SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>39822-4050-6</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (39822-4050-6) > 10 mL in 1 VIAL, SINGLE-DOSE (39822-4050-5)</PackageDescription>
<NDC11Code>39822-4050-06</NDC11Code>
<ProductNDC>39822-4050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenytoin Sodium</ProprietaryName>
<NonProprietaryName>Phenytoin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20110502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040573</ApplicationNumber>
<LabelerName>X-GEN Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PHENYTOIN SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42787-101-50</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (42787-101-50) > 4050 mg in 1 BOTTLE</PackageDescription>
<NDC11Code>42787-0101-50</NDC11Code>
<ProductNDC>42787-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Value Pharma</ProprietaryName>
<ProprietaryNameSuffix>Aspirin Pain Reliever</ProprietaryNameSuffix>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Ajes Pharmaceuticals,LLC</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/81mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of minor aches and pains or as recommended by your Doctor. Because of this products delayed release action, this product will not provide fast relief of headaches or symptoms needing immediate relief.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42858-075-45</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-075-45) </PackageDescription>
<NDC11Code>42858-0075-45</NDC11Code>
<ProductNDC>42858-075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
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<Description>Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&C Blue No. 115 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 4020 mg: D&C Red No. 33, D&C Yellow No. 1030 mg: FD&C Blue No. 1, FD&C Red No. 340 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 4050 mg: D&C Yellow No. 10, FD&C Green No. 360 mg: Black Iron Oxide.</Description>
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