{
"NDC": [
{
"NDCCode": "52536-625-10",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (52536-625-10) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "52536-0625-10",
"ProductNDC": "52536-625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone Cypionate",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20190531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206368",
"LabelerName": "Wilshire Pharmaceuticals",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190531",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone Cypionate Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate in men with \"age-related hypogonadism\" (also referred to as \"late-onset hypogonadism\") have not been established.",
"Description": "Testosterone Cypionate Injection, USP, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C 27H 40O 3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP, is available as 200 mg/mL testosterone cypionate. Each mL of the 200 mg/mL solution contains:."
},
{
"NDCCode": "52536-625-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "52536-0625-01",
"ProductNDC": "52536-625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone Cypionate",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20190531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206368",
"LabelerName": "Wilshire Pharmaceuticals",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190531",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone Cypionate Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate in men with \"age-related hypogonadism\" (also referred to as \"late-onset hypogonadism\") have not been established.",
"Description": "Testosterone Cypionate Injection, USP, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C 27H 40O 3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP, is available as 200 mg/mL testosterone cypionate. Each mL of the 200 mg/mL solution contains:."
},
{
"NDCCode": "52536-057-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (52536-057-10) ",
"NDC11Code": "52536-0057-10",
"ProductNDC": "52536-057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amphetamine Sulfate",
"NonProprietaryName": "Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200166",
"LabelerName": "Wilshire Pharmaceuticals",
"SubstanceName": "AMPHETAMINE SULFATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2023-11-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180329",
"SamplePackage": "N"
},
{
"NDCCode": "52536-059-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (52536-059-10) ",
"NDC11Code": "52536-0059-10",
"ProductNDC": "52536-059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amphetamine Sulfate",
"NonProprietaryName": "Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200166",
"LabelerName": "Wilshire Pharmaceuticals",
"SubstanceName": "AMPHETAMINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2023-11-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180329",
"SamplePackage": "N"
},
{
"NDCCode": "52536-063-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (52536-063-10) ",
"NDC11Code": "52536-0063-10",
"ProductNDC": "52536-063",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nateglinide",
"NonProprietaryName": "Nateglinide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205544",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "NATEGLINIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glinide [EPC],Potassium Channel Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190420",
"SamplePackage": "N"
},
{
"NDCCode": "52536-067-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (52536-067-10) ",
"NDC11Code": "52536-0067-10",
"ProductNDC": "52536-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nateglinide",
"NonProprietaryName": "Nateglinide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205544",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "NATEGLINIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glinide [EPC],Potassium Channel Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190420",
"SamplePackage": "N"
},
{
"NDCCode": "52536-107-10",
"PackageDescription": "1 KIT in 1 CARTON (52536-107-10) * 7.5 g in 1 BOTTLE (52536-095-10) * 295 mL in 1 BOTTLE (52536-085-10) ",
"NDC11Code": "52536-0107-10",
"ProductNDC": "52536-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride For Oral Solution",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20230331",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA208910",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230331",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin hydrochloride is indicated for the treatment of Clostridium difficile‑associated diarrhea in adults and pediatric patients less than 18 years of age. Vancomycin hydrochloride is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus(including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age. Important Limitations of Use: 1 Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections., 2 Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.",
"Description": "Vancomycin hydrochloride for oral administration contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis(formerly Nocardia orientalis), which has the chemical formula C 66H 75Cl 2N 9O 24HCl. The molecular weight of vancomycin hydrochloride is 1485.71 g/mol. Vancomycin hydrochloride has the structural formula. Each vancomycin hydrochloride for oral solution kit contains a bottle of vancomycin hydrochloride USP, as white to almost white or tan to brown powder for oral solution, and a bottle of pre‑measured Grape‑Flavored Diluent, in the strengths and volumes listed in Table 3. The Grape‑Flavored Diluent used to reconstitute the oral solution contains: artificial grape flavor, citric acid (anhydrous), D&C Yellow No. 10, FD&C Red No. 40, purified water, sodium benzoate and sucralose."
},
{
"NDCCode": "52536-108-10",
"PackageDescription": "1 KIT in 1 CARTON (52536-108-10) * 15 g in 1 BOTTLE (52536-098-10) * 289 mL in 1 BOTTLE (52536-088-10) ",
"NDC11Code": "52536-0108-10",
"ProductNDC": "52536-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride For Oral Solution",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20230331",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA208910",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230331",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin hydrochloride is indicated for the treatment of Clostridium difficile‑associated diarrhea in adults and pediatric patients less than 18 years of age. Vancomycin hydrochloride is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus(including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age. Important Limitations of Use: 1 Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections., 2 Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.",
"Description": "Vancomycin hydrochloride for oral administration contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis(formerly Nocardia orientalis), which has the chemical formula C 66H 75Cl 2N 9O 24HCl. The molecular weight of vancomycin hydrochloride is 1485.71 g/mol. Vancomycin hydrochloride has the structural formula. Each vancomycin hydrochloride for oral solution kit contains a bottle of vancomycin hydrochloride USP, as white to almost white or tan to brown powder for oral solution, and a bottle of pre‑measured Grape‑Flavored Diluent, in the strengths and volumes listed in Table 3. The Grape‑Flavored Diluent used to reconstitute the oral solution contains: artificial grape flavor, citric acid (anhydrous), D&C Yellow No. 10, FD&C Red No. 40, purified water, sodium benzoate and sucralose."
},
{
"NDCCode": "52536-125-10",
"PackageDescription": "10 BOTTLE in 1 CARTON (52536-125-10) / 50 mL in 1 BOTTLE (52536-125-01) ",
"NDC11Code": "52536-0125-10",
"ProductNDC": "52536-125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmedetomidine Hydrochloride",
"NonProprietaryName": "Dexmedetomidine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212791",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250130",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a alpha2-adrenergic receptor agonist indicated for: Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride in 0.9% sodium chloride injection by continuous infusion not to exceed 24 hours. (1.1) Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2).",
"Description": "Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha2-adrenergic agonist. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine. Dexmedetomidine hydrochloride chemical name is (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2 HCl and the structural formula is: Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 8.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine), 1 mg of L-Methionine and 9 mg sodium chloride in water for injection. The solution is preservative-free."
},
{
"NDCCode": "52536-129-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (52536-129-10) ",
"NDC11Code": "52536-0129-10",
"ProductNDC": "52536-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meclizine Hydrochloride",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205136",
"LabelerName": "Wilshire Pharmaceuticals Inc",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190415",
"SamplePackage": "N",
"IndicationAndUsage": "Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.",
"Description": "Meclizine hydrochloride tablets, a histamine (H1) receptor antagonist, are a white or slightly yellowish, crystalline powder. They have the following structural formula. Chemically, meclizine hydrochloride tablets are 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate."
},
{
"NDCCode": "52536-133-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (52536-133-10) ",
"NDC11Code": "52536-0133-10",
"ProductNDC": "52536-133",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meclizine Hydrochloride",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205136",
"LabelerName": "Wilshire Pharmaceuticals Inc",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190415",
"SamplePackage": "N",
"IndicationAndUsage": "Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.",
"Description": "Meclizine hydrochloride tablets, a histamine (H1) receptor antagonist, are a white or slightly yellowish, crystalline powder. They have the following structural formula. Chemically, meclizine hydrochloride tablets are 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate."
},
{
"NDCCode": "52536-137-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (52536-137-10) ",
"NDC11Code": "52536-0137-10",
"ProductNDC": "52536-137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meclizine Hydrochloride",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205136",
"LabelerName": "Wilshire Pharmaceuticals Inc",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190415",
"SamplePackage": "N",
"IndicationAndUsage": "Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.",
"Description": "Meclizine hydrochloride tablets, a histamine (H1) receptor antagonist, are a white or slightly yellowish, crystalline powder. They have the following structural formula. Chemically, meclizine hydrochloride tablets are 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate."
},
{
"NDCCode": "52536-180-10",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (52536-180-10) ",
"NDC11Code": "52536-0180-10",
"ProductNDC": "52536-180",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin",
"NonProprietaryName": "Erythromycin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062298",
"LabelerName": "Wilshire Pharmaceuticals",
"SubstanceName": "ERYTHROMYCIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2024-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190722",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythromycin Delayed-Release Tablets and other antibacterial drugs, Erythromycin Delayed-Release Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin Delayed-Release Tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae(when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzaeare not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenesor Streptococcus pneumoniae. Listeriosis caused by Listeria monocytogenes. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by S treptococcus pyogenesor Staphylococcus aureus(resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica(oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythrocin Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeaein female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitroand limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.",
"Description": "Erythromycin Delayed-Release Tablets, USP are an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. Erythromycin Delayed-Release Tablets, USP for oral administration are available in three dosage strengths, each white oval tablet containing either 250 mg, 333 mg, or 500 mg of erythromycin as the free base. Erythromycin Delayed-Release Tablets, USP comply with USP Dissolution Test 1. Erythromycin is produced by a strain of Saccharopolyspora erythraea(formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α -L- ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl- 6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D- xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C 37H 67NO 13, and the molecular weight is 733.94. The structural formula is:."
},
{
"NDCCode": "52536-183-10",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (52536-183-10) ",
"NDC11Code": "52536-0183-10",
"ProductNDC": "52536-183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin",
"NonProprietaryName": "Erythromycin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062298",
"LabelerName": "Wilshire Pharmaceuticals",
"SubstanceName": "ERYTHROMYCIN",
"StrengthNumber": "333",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2024-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190722",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythromycin Delayed-Release Tablets and other antibacterial drugs, Erythromycin Delayed-Release Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin Delayed-Release Tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae(when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzaeare not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenesor Streptococcus pneumoniae. Listeriosis caused by Listeria monocytogenes. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by S treptococcus pyogenesor Staphylococcus aureus(resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica(oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythrocin Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeaein female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitroand limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.",
"Description": "Erythromycin Delayed-Release Tablets, USP are an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. Erythromycin Delayed-Release Tablets, USP for oral administration are available in three dosage strengths, each white oval tablet containing either 250 mg, 333 mg, or 500 mg of erythromycin as the free base. Erythromycin Delayed-Release Tablets, USP comply with USP Dissolution Test 1. Erythromycin is produced by a strain of Saccharopolyspora erythraea(formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α -L- ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl- 6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D- xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C 37H 67NO 13, and the molecular weight is 733.94. The structural formula is:."
},
{
"NDCCode": "52536-186-10",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (52536-186-10) ",
"NDC11Code": "52536-0186-10",
"ProductNDC": "52536-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin",
"NonProprietaryName": "Erythromycin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062298",
"LabelerName": "Wilshire Pharmaceuticals",
"SubstanceName": "ERYTHROMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2024-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190722",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythromycin Delayed-Release Tablets and other antibacterial drugs, Erythromycin Delayed-Release Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin Delayed-Release Tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae(when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzaeare not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenesor Streptococcus pneumoniae. Listeriosis caused by Listeria monocytogenes. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by S treptococcus pyogenesor Staphylococcus aureus(resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica(oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythrocin Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeaein female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitroand limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.",
"Description": "Erythromycin Delayed-Release Tablets, USP are an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. Erythromycin Delayed-Release Tablets, USP for oral administration are available in three dosage strengths, each white oval tablet containing either 250 mg, 333 mg, or 500 mg of erythromycin as the free base. Erythromycin Delayed-Release Tablets, USP comply with USP Dissolution Test 1. Erythromycin is produced by a strain of Saccharopolyspora erythraea(formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α -L- ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl- 6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D- xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C 37H 67NO 13, and the molecular weight is 733.94. The structural formula is:."
},
{
"NDCCode": "52536-682-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (52536-682-10) ",
"NDC11Code": "52536-0682-10",
"ProductNDC": "52536-682",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carisoprodol",
"NonProprietaryName": "Carisoprodol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170215",
"EndMarketingDate": "20270331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205126",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "CARISOPRODOL",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-12-17",
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"SamplePackage": "N",
"IndicationAndUsage": "Carisoprodol Tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.",
"Description": "Carisoprodol Tablets, USP, are available as 250 mg and 350 mg round, white to off-white tablets. Carisoprodol, USP, is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C 12H 24N 2O 4, with a molecular weight of 260.33. The structural formula is:. Other ingredients in the carisoprodol drug product include alginic acid, magnesium stearate, potassium sorbate, starch (corn), and tribasic calcium phosphate."
},
{
"NDCCode": "52536-688-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (52536-688-10) ",
"NDC11Code": "52536-0688-10",
"ProductNDC": "52536-688",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carisoprodol",
"NonProprietaryName": "Carisoprodol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170215",
"EndMarketingDate": "20270331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205126",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "CARISOPRODOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170215",
"EndMarketingDatePackage": "20270331",
"SamplePackage": "N",
"IndicationAndUsage": "Carisoprodol Tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.",
"Description": "Carisoprodol Tablets, USP, are available as 250 mg and 350 mg round, white to off-white tablets. Carisoprodol, USP, is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C 12H 24N 2O 4, with a molecular weight of 260.33. The structural formula is:. Other ingredients in the carisoprodol drug product include alginic acid, magnesium stearate, potassium sorbate, starch (corn), and tribasic calcium phosphate."
},
{
"NDCCode": "13517-625-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (13517-625-10) ",
"NDC11Code": "13517-0625-10",
"ProductNDC": "13517-625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221130",
"EndMarketingDate": "20260930",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "e5 Pharma, LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "16.2",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221130",
"EndMarketingDatePackage": "20260430",
"SamplePackage": "N",
"IndicationAndUsage": "Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.",
"Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg or 97.2 mg of phenobarbital. In addition each tablet contains: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "21749-625-10",
"PackageDescription": "1000 mL in 1 PACKAGE (21749-625-10) ",
"NDC11Code": "21749-0625-10",
"ProductNDC": "21749-625",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Purell Advanced Hand Sanitizer Naturals Gel",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "GOJO Industries, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160101",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "30142-625-10",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (30142-625-10) / 100 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "30142-0625-10",
"ProductNDC": "30142-625",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Headache Relief",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen, Aspirin, Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180430",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "The Kroger Co.",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2024-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180430",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps."
},
{
"NDCCode": "33261-625-10",
"PackageDescription": "10 TABLET in 1 BOTTLE, PLASTIC (33261-625-10)",
"NDC11Code": "33261-0625-10",
"ProductNDC": "33261-625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088238",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis and serum sickness.",
"Description": "Dexamethasone Tablets 0.5 mg, 0.75 mg, 1.5 mg, 4 mg and 6 mg are for oral administration. Each tablet contains 0.5 mg, 0.75 mg, 1.5 mg, 4 mg or 6 mg of dexamethasone. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. It is designated chemically as 9-fluoro-11β, 17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The structural formula is represented below. Each tablet contains anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and stearic acid. In addition, the 0.5 mg tablet contains D&C Yellow #10 and FD&C Yellow #5. The 0.75 mg tablet contains D&C Yellow #10 and FD&C Blue #1. The 1.5 mg tablet contains FD&C Red #40. The 6 mg tablet contains D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6."
},
{
"NDCCode": "42806-625-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (42806-625-10)",
"NDC11Code": "42806-0625-10",
"ProductNDC": "42806-625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulindac",
"NonProprietaryName": "Sulindac",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073262",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "SULINDAC",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "43744-625-10",
"PackageDescription": "1 g in 1 DRUM (43744-625-10)",
"NDC11Code": "43744-0625-10",
"ProductNDC": "43744-625",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mitomycin C",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130110",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "MITOMYCIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "43744-625-15",
"PackageDescription": "10 g in 1 DRUM (43744-625-15)",
"NDC11Code": "43744-0625-15",
"ProductNDC": "43744-625",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mitomycin C",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130110",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "MITOMYCIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "51293-625-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (51293-625-10) ",
"NDC11Code": "51293-0625-10",
"ProductNDC": "51293-625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141124",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "ECI Pharmaceuticals, LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "16.2",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20141124",
"SamplePackage": "N",
"IndicationAndUsage": "Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.",
"Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. Each phenobarbital tablet contains 16.2 mg (1/4 grain), 32.4 mg (1/2 grain), 64.8 mg (1 grain) or 97.2 mg (11/2 grain) of phenobarbital. In addition each tablet contains: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "52125-625-08",
"PackageDescription": "10 TABLET, FILM COATED in 1 VIAL (52125-625-08)",
"NDC11Code": "52125-0625-08",
"ProductNDC": "52125-625",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sudogest",
"NonProprietaryName": "Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141002",
"EndMarketingDate": "20171116",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "54348-625-10",
"PackageDescription": "1 BOTTLE in 1 BOX (54348-625-10) > 10 TABLET in 1 BOTTLE",
"NDC11Code": "54348-0625-10",
"ProductNDC": "54348-625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethox-tmp Ds",
"NonProprietaryName": "Sulfamethoxazole, Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076899",
"LabelerName": "PharmPak, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2022-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190711",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim tablets in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim tablets are not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent. Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia. Traveler’s Diarrhea in Adults: For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole, USP and 160 mg trimethoprim, USP; in tablets, each containing 400 mg sulfamethoxazole, USP and 80 mg trimethoprim, USP for oral administration. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3. It has the following structural formula:. Inactive Ingredients: Magnesium stearate, povidone, pregelatinized starch and sodium starch glycolate."
},
{
"NDCCode": "55111-625-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-625-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-625-79) ",
"NDC11Code": "55111-0625-78",
"ProductNDC": "55111-625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zafirlukast",
"NonProprietaryName": "Zafirlukast",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090372",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "ZAFIRLUKAST",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C9 Inhibitors [MoA], Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2019-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101118",
"SamplePackage": "N",
"IndicationAndUsage": "Zafirlukast tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.",
"Description": "Zafirlukast is a synthetic, selective peptide leukotriene receptor antagonist (LTRA), with the chemical name 4-(5-cyclopentyloxy-carbonylamino-1-methyl-indol-3-ylmethyl)-3-methoxy-N-o-tolylsulfonylbenzamide. The molecular weight of zafirlukast is 575.7 and the structural formula is. The molecular formula is: C31H33N3O6S. Zafirlukast, white to pale yellow coloured powder, freely soluble in tetrahydrofuran, and dimethylsulfoxide and practically insoluble in water. Zafirlukast is supplied as 10 and 20 mg tablets for oral administration. Inactive ingredients: Film coated tablets containing hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate (Type-A) and titanium dioxide. ."
},
{
"NDCCode": "55319-625-10",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (55319-625-10) / 100 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "55319-0625-10",
"ProductNDC": "55319-625",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Headache Relief",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen, Aspirin, Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160831",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Family Dollar (FAMILY WELLNESS)",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160831",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headache a coldarthritis muscular aches toothache premenstrual and menstrual cramps."
},
{
"NDCCode": "55910-625-10",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (55910-625-10) > 100 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "55910-0625-10",
"ProductNDC": "55910-625",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Headache Relief",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen, Aspirin, Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171231",
"EndMarketingDate": "20240112",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171231",
"EndMarketingDatePackage": "20240112",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>52536-625-10</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (52536-625-10) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>52536-0625-10</NDC11Code>
<ProductNDC>52536-625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone Cypionate</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20190531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206368</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone Cypionate Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.</IndicationAndUsage>
<Description>Testosterone Cypionate Injection, USP, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C 27H 40O 3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP, is available as 200 mg/mL testosterone cypionate. Each mL of the 200 mg/mL solution contains:.</Description>
</NDC>
<NDC>
<NDCCode>52536-625-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>52536-0625-01</NDC11Code>
<ProductNDC>52536-625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone Cypionate</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20190531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206368</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone Cypionate Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.</IndicationAndUsage>
<Description>Testosterone Cypionate Injection, USP, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C 27H 40O 3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP, is available as 200 mg/mL testosterone cypionate. Each mL of the 200 mg/mL solution contains:.</Description>
</NDC>
<NDC>
<NDCCode>52536-057-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (52536-057-10) </PackageDescription>
<NDC11Code>52536-0057-10</NDC11Code>
<ProductNDC>52536-057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200166</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals</LabelerName>
<SubstanceName>AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-11-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52536-059-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (52536-059-10) </PackageDescription>
<NDC11Code>52536-0059-10</NDC11Code>
<ProductNDC>52536-059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200166</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals</LabelerName>
<SubstanceName>AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-11-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52536-063-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (52536-063-10) </PackageDescription>
<NDC11Code>52536-0063-10</NDC11Code>
<ProductNDC>52536-063</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nateglinide</ProprietaryName>
<NonProprietaryName>Nateglinide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205544</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NATEGLINIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glinide [EPC],Potassium Channel Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52536-067-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (52536-067-10) </PackageDescription>
<NDC11Code>52536-0067-10</NDC11Code>
<ProductNDC>52536-067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nateglinide</ProprietaryName>
<NonProprietaryName>Nateglinide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205544</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NATEGLINIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glinide [EPC],Potassium Channel Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52536-107-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (52536-107-10) * 7.5 g in 1 BOTTLE (52536-095-10) * 295 mL in 1 BOTTLE (52536-085-10) </PackageDescription>
<NDC11Code>52536-0107-10</NDC11Code>
<ProductNDC>52536-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride For Oral Solution</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230331</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA208910</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin hydrochloride is indicated for the treatment of Clostridium difficile‑associated diarrhea in adults and pediatric patients less than 18 years of age. Vancomycin hydrochloride is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus(including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age. Important Limitations of Use: 1 Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections., 2 Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.</IndicationAndUsage>
<Description>Vancomycin hydrochloride for oral administration contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis(formerly Nocardia orientalis), which has the chemical formula C 66H 75Cl 2N 9O 24HCl. The molecular weight of vancomycin hydrochloride is 1485.71 g/mol. Vancomycin hydrochloride has the structural formula. Each vancomycin hydrochloride for oral solution kit contains a bottle of vancomycin hydrochloride USP, as white to almost white or tan to brown powder for oral solution, and a bottle of pre‑measured Grape‑Flavored Diluent, in the strengths and volumes listed in Table 3. The Grape‑Flavored Diluent used to reconstitute the oral solution contains: artificial grape flavor, citric acid (anhydrous), D&C Yellow No. 10, FD&C Red No. 40, purified water, sodium benzoate and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>52536-108-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (52536-108-10) * 15 g in 1 BOTTLE (52536-098-10) * 289 mL in 1 BOTTLE (52536-088-10) </PackageDescription>
<NDC11Code>52536-0108-10</NDC11Code>
<ProductNDC>52536-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride For Oral Solution</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230331</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA208910</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin hydrochloride is indicated for the treatment of Clostridium difficile‑associated diarrhea in adults and pediatric patients less than 18 years of age. Vancomycin hydrochloride is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus(including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age. Important Limitations of Use: 1 Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections., 2 Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.</IndicationAndUsage>
<Description>Vancomycin hydrochloride for oral administration contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis(formerly Nocardia orientalis), which has the chemical formula C 66H 75Cl 2N 9O 24HCl. The molecular weight of vancomycin hydrochloride is 1485.71 g/mol. Vancomycin hydrochloride has the structural formula. Each vancomycin hydrochloride for oral solution kit contains a bottle of vancomycin hydrochloride USP, as white to almost white or tan to brown powder for oral solution, and a bottle of pre‑measured Grape‑Flavored Diluent, in the strengths and volumes listed in Table 3. The Grape‑Flavored Diluent used to reconstitute the oral solution contains: artificial grape flavor, citric acid (anhydrous), D&C Yellow No. 10, FD&C Red No. 40, purified water, sodium benzoate and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>52536-125-10</NDCCode>
<PackageDescription>10 BOTTLE in 1 CARTON (52536-125-10) / 50 mL in 1 BOTTLE (52536-125-01) </PackageDescription>
<NDC11Code>52536-0125-10</NDC11Code>
<ProductNDC>52536-125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmedetomidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmedetomidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212791</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a alpha2-adrenergic receptor agonist indicated for: Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride in 0.9% sodium chloride injection by continuous infusion not to exceed 24 hours. (1.1) Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2).</IndicationAndUsage>
<Description>Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha2-adrenergic agonist. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine. Dexmedetomidine hydrochloride chemical name is (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2 HCl and the structural formula is: Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 8.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine), 1 mg of L-Methionine and 9 mg sodium chloride in water for injection. The solution is preservative-free.</Description>
</NDC>
<NDC>
<NDCCode>52536-129-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (52536-129-10) </PackageDescription>
<NDC11Code>52536-0129-10</NDC11Code>
<ProductNDC>52536-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205136</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals Inc</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.</IndicationAndUsage>
<Description>Meclizine hydrochloride tablets, a histamine (H1) receptor antagonist, are a white or slightly yellowish, crystalline powder. They have the following structural formula. Chemically, meclizine hydrochloride tablets are 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.</Description>
</NDC>
<NDC>
<NDCCode>52536-133-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (52536-133-10) </PackageDescription>
<NDC11Code>52536-0133-10</NDC11Code>
<ProductNDC>52536-133</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205136</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals Inc</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.</IndicationAndUsage>
<Description>Meclizine hydrochloride tablets, a histamine (H1) receptor antagonist, are a white or slightly yellowish, crystalline powder. They have the following structural formula. Chemically, meclizine hydrochloride tablets are 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.</Description>
</NDC>
<NDC>
<NDCCode>52536-137-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (52536-137-10) </PackageDescription>
<NDC11Code>52536-0137-10</NDC11Code>
<ProductNDC>52536-137</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205136</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals Inc</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.</IndicationAndUsage>
<Description>Meclizine hydrochloride tablets, a histamine (H1) receptor antagonist, are a white or slightly yellowish, crystalline powder. They have the following structural formula. Chemically, meclizine hydrochloride tablets are 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.</Description>
</NDC>
<NDC>
<NDCCode>52536-180-10</NDCCode>
<PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE (52536-180-10) </PackageDescription>
<NDC11Code>52536-0180-10</NDC11Code>
<ProductNDC>52536-180</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin</ProprietaryName>
<NonProprietaryName>Erythromycin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062298</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals</LabelerName>
<SubstanceName>ERYTHROMYCIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythromycin Delayed-Release Tablets and other antibacterial drugs, Erythromycin Delayed-Release Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin Delayed-Release Tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae(when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzaeare not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenesor Streptococcus pneumoniae. Listeriosis caused by Listeria monocytogenes. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by S treptococcus pyogenesor Staphylococcus aureus(resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica(oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythrocin Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeaein female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitroand limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.</IndicationAndUsage>
<Description>Erythromycin Delayed-Release Tablets, USP are an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. Erythromycin Delayed-Release Tablets, USP for oral administration are available in three dosage strengths, each white oval tablet containing either 250 mg, 333 mg, or 500 mg of erythromycin as the free base. Erythromycin Delayed-Release Tablets, USP comply with USP Dissolution Test 1. Erythromycin is produced by a strain of Saccharopolyspora erythraea(formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α -L- ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl- 6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D- xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C 37H 67NO 13, and the molecular weight is 733.94. The structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>52536-183-10</NDCCode>
<PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE (52536-183-10) </PackageDescription>
<NDC11Code>52536-0183-10</NDC11Code>
<ProductNDC>52536-183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin</ProprietaryName>
<NonProprietaryName>Erythromycin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062298</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals</LabelerName>
<SubstanceName>ERYTHROMYCIN</SubstanceName>
<StrengthNumber>333</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythromycin Delayed-Release Tablets and other antibacterial drugs, Erythromycin Delayed-Release Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin Delayed-Release Tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae(when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzaeare not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenesor Streptococcus pneumoniae. Listeriosis caused by Listeria monocytogenes. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by S treptococcus pyogenesor Staphylococcus aureus(resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica(oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythrocin Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeaein female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitroand limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.</IndicationAndUsage>
<Description>Erythromycin Delayed-Release Tablets, USP are an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. Erythromycin Delayed-Release Tablets, USP for oral administration are available in three dosage strengths, each white oval tablet containing either 250 mg, 333 mg, or 500 mg of erythromycin as the free base. Erythromycin Delayed-Release Tablets, USP comply with USP Dissolution Test 1. Erythromycin is produced by a strain of Saccharopolyspora erythraea(formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α -L- ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl- 6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D- xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C 37H 67NO 13, and the molecular weight is 733.94. The structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>52536-186-10</NDCCode>
<PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE (52536-186-10) </PackageDescription>
<NDC11Code>52536-0186-10</NDC11Code>
<ProductNDC>52536-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin</ProprietaryName>
<NonProprietaryName>Erythromycin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062298</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals</LabelerName>
<SubstanceName>ERYTHROMYCIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythromycin Delayed-Release Tablets and other antibacterial drugs, Erythromycin Delayed-Release Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin Delayed-Release Tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae(when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzaeare not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenesor Streptococcus pneumoniae. Listeriosis caused by Listeria monocytogenes. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by S treptococcus pyogenesor Staphylococcus aureus(resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica(oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythrocin Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeaein female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitroand limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.</IndicationAndUsage>
<Description>Erythromycin Delayed-Release Tablets, USP are an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. Erythromycin Delayed-Release Tablets, USP for oral administration are available in three dosage strengths, each white oval tablet containing either 250 mg, 333 mg, or 500 mg of erythromycin as the free base. Erythromycin Delayed-Release Tablets, USP comply with USP Dissolution Test 1. Erythromycin is produced by a strain of Saccharopolyspora erythraea(formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α -L- ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl- 6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D- xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C 37H 67NO 13, and the molecular weight is 733.94. The structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>52536-682-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (52536-682-10) </PackageDescription>
<NDC11Code>52536-0682-10</NDC11Code>
<ProductNDC>52536-682</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carisoprodol</ProprietaryName>
<NonProprietaryName>Carisoprodol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170215</StartMarketingDate>
<EndMarketingDate>20270331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205126</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CARISOPRODOL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170215</StartMarketingDatePackage>
<EndMarketingDatePackage>20270331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carisoprodol Tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.</IndicationAndUsage>
<Description>Carisoprodol Tablets, USP, are available as 250 mg and 350 mg round, white to off-white tablets. Carisoprodol, USP, is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C 12H 24N 2O 4, with a molecular weight of 260.33. The structural formula is:. Other ingredients in the carisoprodol drug product include alginic acid, magnesium stearate, potassium sorbate, starch (corn), and tribasic calcium phosphate.</Description>
</NDC>
<NDC>
<NDCCode>52536-688-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (52536-688-10) </PackageDescription>
<NDC11Code>52536-0688-10</NDC11Code>
<ProductNDC>52536-688</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carisoprodol</ProprietaryName>
<NonProprietaryName>Carisoprodol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170215</StartMarketingDate>
<EndMarketingDate>20270331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205126</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CARISOPRODOL</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170215</StartMarketingDatePackage>
<EndMarketingDatePackage>20270331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carisoprodol Tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.</IndicationAndUsage>
<Description>Carisoprodol Tablets, USP, are available as 250 mg and 350 mg round, white to off-white tablets. Carisoprodol, USP, is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C 12H 24N 2O 4, with a molecular weight of 260.33. The structural formula is:. Other ingredients in the carisoprodol drug product include alginic acid, magnesium stearate, potassium sorbate, starch (corn), and tribasic calcium phosphate.</Description>
</NDC>
<NDC>
<NDCCode>13517-625-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (13517-625-10) </PackageDescription>
<NDC11Code>13517-0625-10</NDC11Code>
<ProductNDC>13517-625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221130</StartMarketingDate>
<EndMarketingDate>20260930</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>e5 Pharma, LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>16.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221130</StartMarketingDatePackage>
<EndMarketingDatePackage>20260430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.</IndicationAndUsage>
<Description>The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg or 97.2 mg of phenobarbital. In addition each tablet contains: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>21749-625-10</NDCCode>
<PackageDescription>1000 mL in 1 PACKAGE (21749-625-10) </PackageDescription>
<NDC11Code>21749-0625-10</NDC11Code>
<ProductNDC>21749-625</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Purell Advanced Hand Sanitizer Naturals Gel</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>GOJO Industries, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-625-10</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (30142-625-10) / 100 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>30142-0625-10</NDC11Code>
<ProductNDC>30142-625</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Headache Relief</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin, Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180430</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>The Kroger Co.</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>33261-625-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE, PLASTIC (33261-625-10)</PackageDescription>
<NDC11Code>33261-0625-10</NDC11Code>
<ProductNDC>33261-625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexamethasone</ProprietaryName>
<NonProprietaryName>Dexamethasone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830428</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088238</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>DEXAMETHASONE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis and serum sickness.</IndicationAndUsage>
<Description>Dexamethasone Tablets 0.5 mg, 0.75 mg, 1.5 mg, 4 mg and 6 mg are for oral administration. Each tablet contains 0.5 mg, 0.75 mg, 1.5 mg, 4 mg or 6 mg of dexamethasone. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. It is designated chemically as 9-fluoro-11β, 17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The structural formula is represented below. Each tablet contains anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and stearic acid. In addition, the 0.5 mg tablet contains D&C Yellow #10 and FD&C Yellow #5. The 0.75 mg tablet contains D&C Yellow #10 and FD&C Blue #1. The 1.5 mg tablet contains FD&C Red #40. The 6 mg tablet contains D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>42806-625-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (42806-625-10)</PackageDescription>
<NDC11Code>42806-0625-10</NDC11Code>
<ProductNDC>42806-625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulindac</ProprietaryName>
<NonProprietaryName>Sulindac</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073262</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>SULINDAC</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43744-625-10</NDCCode>
<PackageDescription>1 g in 1 DRUM (43744-625-10)</PackageDescription>
<NDC11Code>43744-0625-10</NDC11Code>
<ProductNDC>43744-625</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mitomycin C</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130110</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>MITOMYCIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43744-625-15</NDCCode>
<PackageDescription>10 g in 1 DRUM (43744-625-15)</PackageDescription>
<NDC11Code>43744-0625-15</NDC11Code>
<ProductNDC>43744-625</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mitomycin C</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130110</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>MITOMYCIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51293-625-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (51293-625-10) </PackageDescription>
<NDC11Code>51293-0625-10</NDC11Code>
<ProductNDC>51293-625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141124</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ECI Pharmaceuticals, LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>16.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.</IndicationAndUsage>
<Description>The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. Each phenobarbital tablet contains 16.2 mg (1/4 grain), 32.4 mg (1/2 grain), 64.8 mg (1 grain) or 97.2 mg (11/2 grain) of phenobarbital. In addition each tablet contains: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>52125-625-08</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 VIAL (52125-625-08)</PackageDescription>
<NDC11Code>52125-0625-08</NDC11Code>
<ProductNDC>52125-625</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sudogest</ProprietaryName>
<NonProprietaryName>Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141002</StartMarketingDate>
<EndMarketingDate>20171116</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>54348-625-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (54348-625-10) > 10 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>54348-0625-10</NDC11Code>
<ProductNDC>54348-625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethox-tmp Ds</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole, Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076899</ApplicationNumber>
<LabelerName>PharmPak, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim tablets in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim tablets are not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent. Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia. Traveler’s Diarrhea in Adults: For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole, USP and 160 mg trimethoprim, USP; in tablets, each containing 400 mg sulfamethoxazole, USP and 80 mg trimethoprim, USP for oral administration. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3. It has the following structural formula:. Inactive Ingredients: Magnesium stearate, povidone, pregelatinized starch and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>55111-625-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-625-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-625-79) </PackageDescription>
<NDC11Code>55111-0625-78</NDC11Code>
<ProductNDC>55111-625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zafirlukast</ProprietaryName>
<NonProprietaryName>Zafirlukast</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090372</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Limited</LabelerName>
<SubstanceName>ZAFIRLUKAST</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C9 Inhibitors [MoA], Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zafirlukast tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.</IndicationAndUsage>
<Description>Zafirlukast is a synthetic, selective peptide leukotriene receptor antagonist (LTRA), with the chemical name 4-(5-cyclopentyloxy-carbonylamino-1-methyl-indol-3-ylmethyl)-3-methoxy-N-o-tolylsulfonylbenzamide. The molecular weight of zafirlukast is 575.7 and the structural formula is. The molecular formula is: C31H33N3O6S. Zafirlukast, white to pale yellow coloured powder, freely soluble in tetrahydrofuran, and dimethylsulfoxide and practically insoluble in water. Zafirlukast is supplied as 10 and 20 mg tablets for oral administration. Inactive ingredients: Film coated tablets containing hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate (Type-A) and titanium dioxide. .</Description>
</NDC>
<NDC>
<NDCCode>55319-625-10</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (55319-625-10) / 100 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>55319-0625-10</NDC11Code>
<ProductNDC>55319-625</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Headache Relief</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin, Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160831</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Family Dollar (FAMILY WELLNESS)</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160831</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headache a coldarthritis muscular aches toothache premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55910-625-10</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (55910-625-10) > 100 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>55910-0625-10</NDC11Code>
<ProductNDC>55910-625</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Headache Relief</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin, Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171231</StartMarketingDate>
<EndMarketingDate>20240112</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171231</StartMarketingDatePackage>
<EndMarketingDatePackage>20240112</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
</NDCList>