{
"NDC": [
{
"NDCCode": "69489-122-03",
"PackageDescription": "3 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (69489-122-03) ",
"NDC11Code": "69489-0122-03",
"ProductNDC": "69489-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ximino",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201108",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201922",
"LabelerName": "Journey Medical Corporation",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20201108",
"SamplePackage": "Y"
},
{
"NDCCode": "69489-122-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69489-122-30) ",
"NDC11Code": "69489-0122-30",
"ProductNDC": "69489-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ximino",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201108",
"EndMarketingDate": "20240331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201922",
"LabelerName": "Journey Medical Corporation",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201108",
"EndMarketingDatePackage": "20240331",
"SamplePackage": "N",
"IndicationAndUsage": "Ximino is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1). Limitations of Use. Ximino did not demonstrate any effect on non-inflammatory acne lesions. Safety of Ximino has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. (14).",
"Description": "The active ingredient in Ximino Extended-Release Capsules is minocycline hydrochloride, a semi synthetic derivative of tetracycline. Ximino is a tetracycline-class drug. Ximino is known chemically as [4 S‑(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below. Minocycline hydrochloride, USP is a yellow crystalline powder, sparingly soluble in water, soluble in solutions of alkali hydroxides and carbonates, slightly soluble in alcohol, practically insoluble in chloroform and in ether. Ximino (minocycline hydrochloride) Extended-Release Capsules for oral administration contain minocycline hydrochloride, USP equivalent to 45 mg, 90 mg, or 135 mg of minocycline. The Extended-Release Capsules contain the following inactive ingredients: colloidal silicon dioxide, D&C Yellow #10 (in 45 mg strength), FD&C Blue #1, FD&C Yellow #6 (in 45 mg and 135 mg strength), gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, and titanium dioxide. The 45 mg, 90 mg, and 135 mg capsules also contain Opadry Clear which contains hypromellose, polyethylene glycol 400, polyethylene glycol 6000, and talc. Ximino Extended-Release Capsules also contain black ink which contains black iron oxide, potassium hydroxide, propylene glycol, and shellac."
},
{
"NDCCode": "69489-121-03",
"PackageDescription": "3 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (69489-121-03) ",
"NDC11Code": "69489-0121-03",
"ProductNDC": "69489-121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ximino",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201108",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201922",
"LabelerName": "Journey Medical Corporation",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20201108",
"SamplePackage": "Y"
},
{
"NDCCode": "69489-123-03",
"PackageDescription": "3 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (69489-123-03) ",
"NDC11Code": "69489-0123-03",
"ProductNDC": "69489-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ximino",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201108",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201922",
"LabelerName": "Journey Medical Corporation",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "135",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20201108",
"SamplePackage": "Y"
},
{
"NDCCode": "69489-201-03",
"PackageDescription": "1 CAN in 1 CARTON (69489-201-03) / 3 g in 1 CAN",
"NDC11Code": "69489-0201-03",
"ProductNDC": "69489-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amzeeq",
"NonProprietaryName": "Minocycline",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220325",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212379",
"LabelerName": "Journey Medical Corporation",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2024-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230125",
"SamplePackage": "Y",
"IndicationAndUsage": "AMZEEQ is indicated for the topical treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older [ see Clinical Studies ( 14) ]. Limitations of Use. This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated [ see Warnings and Precautions ( 5.14) ].",
"Description": "Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S‑ (4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a‑ tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below. C 23H 27N 3O 7HCl M. W. 493.94. Each gram of AMZEEQ contains micronized minocycline 40 mg equivalent to 43 mg minocycline hydrochloride in a yellow suspension foam. In addition, the 4% AMZEEQ topical foam contains the following inactive ingredients: soybean oil, coconut oil, light mineral oil, cyclomethicone, cetostearyl alcohol, stearic acid, myristyl alcohol, hydrogenated castor oil, white wax (beeswax), stearyl alcohol, docosanol. AMZEEQ topical foam is dispensed from an aluminum container (can) pressurized with propellant (butane + isobutane + propane)."
},
{
"NDCCode": "69489-212-03",
"PackageDescription": "1 CAN in 1 CARTON (69489-212-03) / 3 g in 1 CAN",
"NDC11Code": "69489-0212-03",
"ProductNDC": "69489-212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zilxi",
"NonProprietaryName": "Minocycline",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213690",
"LabelerName": "Journey Medical Corporation",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2024-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231101",
"SamplePackage": "Y",
"IndicationAndUsage": "ZILXI is indicated for the treatment of inflammatory lesions of rosacea in adults [see Clinical Studies (14)]. Limitations of Use. This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ZILXI should be used only as indicated [see Warnings and Precautions (5.14)].",
"Description": "Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S‑(4α,4aα,5aα,12aα)]-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a‑tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. C23H27N3O7HClM. W. 493.94. Each gram of ZILXI contains micronized 15 mg minocycline equivalent to 16 mg minocycline hydrochloride in a yellow suspension foam. In addition, the 1.5% ZILXI topical foam contains the following inactive ingredients: soybean oil, coconut oil, light mineral oil, cyclomethicone, cetostearyl alcohol, stearic acid, myristyl alcohol, hydrogenated castor oil, white wax (beeswax), stearyl alcohol, docosanol. ZILXI topical foam is dispensed from an aluminum container (can) pressurized with propellant (butane + isobutane + propane)."
},
{
"NDCCode": "69489-311-60",
"PackageDescription": "1 TUBE in 1 CARTON (69489-311-60) / 60 g in 1 TUBE",
"NDC11Code": "69489-0311-60",
"ProductNDC": "69489-311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eurax",
"NonProprietaryName": "Crotamiton",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260316",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA006927",
"LabelerName": "Journey Medical Corporation",
"SubstanceName": "CROTAMITON",
"StrengthNumber": "100",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20260316",
"SamplePackage": "N",
"IndicationAndUsage": "For eradication of scabies ( Sarcoptes scabiei) and for symptomatic treatment of pruritic skin.",
"Description": "Eurax (crotamiton, USP) is a scabicidal and antipruritic agent available as a cream for topical use only. Eurax provides 10% (w/w) of the synthetic, crotamiton, USP, in a vanishing-cream base containing: carbomer homopolymer type B, cetyl alcohol, diazolidinyl urea, dimethicone, glyceryl monostearate, laureth-23, magnesium aluminum silicate, benzyl alcohol, petrolatum, propylene glycol, sodium hydroxide, steareth-2, and water. Crotamiton is N-ethyl-N-( o-methylphenyl)-2-butenamide and its structural formula is:. Crotamiton, USP is a colorless to slightly yellowish oil, having a faint amine-like odor. It is soluble with alcohol and with methanol. Crotamiton is a mixture of the cisand transisomers. Its molecular weight is 203.28."
},
{
"NDCCode": "10237-144-00",
"PackageDescription": "1 KIT in 1 CARTON (10237-144-00) * 1 BOTTLE, SPRAY in 1 CASE (10237-122-03) / 30 mL in 1 BOTTLE, SPRAY * 1 BOTTLE, SPRAY in 1 CASE (10237-120-03) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "10237-0144-00",
"ProductNDC": "10237-144",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Touchland Disney The Gift Set",
"NonProprietaryName": "Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Church & Dwight Co., Inc.",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "21220-122-03",
"PackageDescription": "13818 L in 1 CYLINDER (21220-122-03) ",
"NDC11Code": "21220-0122-03",
"ProductNDC": "21220-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrous Oxide",
"NonProprietaryName": "Nitrous Oxide",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19761101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205704",
"LabelerName": "General Air Service & Supply Co",
"SubstanceName": "NITROUS OXIDE",
"StrengthNumber": "995",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19761101",
"SamplePackage": "N"
},
{
"NDCCode": "24338-122-03",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (24338-122-03) ",
"NDC11Code": "24338-0122-03",
"ProductNDC": "24338-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ery-tab",
"NonProprietaryName": "Erythromycin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110418",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062298",
"LabelerName": "Arbor Pharmaceuticals, Inc.",
"SubstanceName": "ERYTHROMYCIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2018-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171117",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of ERY-TAB® and other antibacterial drugs, ERY-TAB® 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. ERY-TAB® 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. influenzae are 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 pyogenes or 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 Streptococcus pyogenes or 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. gonorrhoeae in 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 vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.",
"Description": "ERY-TAB® (erythromycin delayed-release tablets) is 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. ERY-TAB® tablets 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. ERY-TAB® tablets 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)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C37H67NO13, and the molecular weight is 733.94. The structural formula is. Inactive Ingredients. Ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, crospovidone, diacetylated monoglycerides, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, sodium citrate, sorbitan monooleate, talc, and titanium dioxide."
},
{
"NDCCode": "25000-122-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (25000-122-03) ",
"NDC11Code": "25000-0122-03",
"ProductNDC": "25000-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090796",
"LabelerName": "MARKSANS PHARMA LIMITED",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110228",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.",
"Description": "Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (< 1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone . The structural formula is represented below:. Ibuprofen tablets, a nonsteroidal anti-inflammatory drug ( NSAID ), are available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycols, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide."
},
{
"NDCCode": "51224-122-03",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (51224-122-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "51224-0122-03",
"ProductNDC": "51224-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin Dihydrate",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190701",
"EndMarketingDate": "20261031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208249",
"LabelerName": "TAGI Pharma, Inc.",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190701",
"EndMarketingDatePackage": "20260531",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].",
"Description": "Azithromycin Tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. Azithromycin is supplied as tablets containing azithromycin dihydrate equivalent to 500 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Blue #1 aluminum lake and lecithin, FD&C Red #40 aluminum Lake, FD&C Yellow #6 aluminum Lake, macrogol/PEG, magnesium stearate, polyvinyl alcohol, pregelatinized starch, talc, and titanium dioxide."
},
{
"NDCCode": "51224-122-09",
"PackageDescription": "3 CARTON in 1 BOX (51224-122-09) / 1 BLISTER PACK in 1 CARTON (51224-122-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "51224-0122-09",
"ProductNDC": "51224-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin Dihydrate",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190701",
"EndMarketingDate": "20261031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208249",
"LabelerName": "TAGI Pharma, Inc.",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2025-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190701",
"EndMarketingDatePackage": "20261031",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].",
"Description": "Azithromycin Tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. Azithromycin is supplied as tablets containing azithromycin dihydrate equivalent to 500 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Blue #1 aluminum lake and lecithin, FD&C Red #40 aluminum Lake, FD&C Yellow #6 aluminum Lake, macrogol/PEG, magnesium stearate, polyvinyl alcohol, pregelatinized starch, talc, and titanium dioxide."
},
{
"NDCCode": "51389-122-03",
"PackageDescription": "1 KIT in 1 KIT (51389-122-03) * 1 TUBE in 1 PACKAGE (51389-124-01) > 2.5 g in 1 TUBE * 1 TUBE in 1 PACKAGE (51389-125-01) > 2.5 g in 1 TUBE * 1 TUBE in 1 PACKAGE (51389-123-01) > 2.5 g in 1 TUBE",
"NDC11Code": "51389-0122-03",
"ProductNDC": "51389-122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laura Geller Beauty Sun Kissed Color Lip Balm Trio Broad Spectrum Spf 15 Pink - Coral - Berry",
"NonProprietaryName": "Octisalate, Avobenzone, Octinoxate, Octocrylene",
"DosageFormName": "KIT",
"StartMarketingDate": "20131209",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "LAURA GELLER MAKE UP INC.",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20131209",
"SamplePackage": "N"
},
{
"NDCCode": "52959-122-03",
"PackageDescription": "3 TABLET in 1 BOTTLE (52959-122-03)",
"NDC11Code": "52959-0122-03",
"ProductNDC": "52959-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenazopyridine Hcl",
"NonProprietaryName": "Phenazopyridine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100910",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency frequency, and other discomforts arising from irritation of the mucosa of the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of phenazopyridine for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. The drug should be used for symptomatic relief of pain and not as a substitute for specific surgery or antimicrobial therapy. Phenazopyridine is compatible with antimicrobial therapy and can help relieve pain and discomfort during the interval before antimicrobial therapy controls the infection. Treatment of a urinary tract infection with phenazopyridine should not exceed 2 days. There is no evidence that the combined administration of phenazopyridine and an antimicrobial provides greater benefit than administration of the antimicrobial alone after 2 days. (See Dosage and Administration.).",
"Description": "Phenazopyridine Hydrochloride is a reddish-brown, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. Following is the structural formula. Phenazopyridine HCl tablets contain the following inactive ingredients: Corn Starch, Croscarmellose Sodium, Hypromellose, Light Mineral Oil, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Pregelatinized Starch, and Silicon Dioxide."
},
{
"NDCCode": "53247-122-03",
"PackageDescription": "24 g in 1 TUBE (53247-122-03) ",
"NDC11Code": "53247-0122-03",
"ProductNDC": "53247-122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Maximum Security",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20080101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Bob Barker Company Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "2.2",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20080101",
"SamplePackage": "N",
"IndicationAndUsage": "Helps protect against cavities."
},
{
"NDCCode": "58159-122-03",
"PackageDescription": "20 kg in 1 DRUM (58159-122-03) ",
"NDC11Code": "58159-0122-03",
"ProductNDC": "58159-122",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Voclosporin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250422",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
"SubstanceName": "VOCLOSPORIN",
"StrengthNumber": "35",
"StrengthUnit": "kg/35kg",
"Status": "Unfinished",
"LastUpdate": "2025-05-01",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "22-APR-25"
},
{
"NDCCode": "58354-122-04",
"PackageDescription": "1 PATCH in 1 POUCH (58354-122-04) > 5 g in 1 PATCH (58354-122-03) ",
"NDC11Code": "58354-0122-04",
"ProductNDC": "58354-122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cho-a Derm Beauty Care",
"NonProprietaryName": "Carboxymethylcellulose Sodium",
"DosageFormName": "DRESSING",
"RouteName": "TOPICAL",
"StartMarketingDate": "20211201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Cho-A Pharm.Co.,Ltd.",
"SubstanceName": "CARBOXYMETHYLCELLULOSE SODIUM",
"StrengthNumber": "130",
"StrengthUnit": "g/433g",
"Status": "Deprecated",
"LastUpdate": "2023-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20211201",
"SamplePackage": "N"
},
{
"NDCCode": "58394-022-03",
"PackageDescription": "1 KIT in 1 CARTON (58394-022-03) * 4 mL in 1 SYRINGE (58394-122-03) * 1 mL in 1 PACKET",
"NDC11Code": "58394-0022-03",
"ProductNDC": "58394-022",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Xyntha",
"NonProprietaryName": "Antihemophilic Factor (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20111201",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125264",
"LabelerName": "Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC",
"Status": "Active",
"LastUpdate": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20111201",
"SamplePackage": "N",
"IndicationAndUsage": "XYNTHA, Antihemophilic Factor (Recombinant), is indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "The active ingredient in XYNTHA, Antihemophilic Factor (Recombinant), is a recombinant antihemophilic factor (rAHF), also called coagulation factor VIII, which is produced by recombinant DNA technology. It is secreted by a genetically engineered Chinese hamster ovary (CHO) cell line. The cell line is grown in a chemically defined cell culture medium that contains recombinant insulin, but does not contain any materials derived from human or animal sources. The rAHF in XYNTHA is a purified glycoprotein, with an approximate molecular mass of 170 kDa consisting of 1,438 amino acids, which does not contain the B-domain.13 The amino acid sequence of the rAHF is comparable to the 90 + 80 kDa form of human coagulation factor VIII. The purification process uses a series of chromatography steps, one of which is based on affinity chromatography using a patented synthetic peptide affinity ligand.14 The process also includes a solvent-detergent viral inactivation step and a virus-retaining nanofiltration step. The potency expressed in International Units (IU) is determined using the chromogenic assay of the European Pharmacopoeia. The Wyeth manufacturing reference standard for potency has been calibrated against the World Health Organization (WHO) International Standard for factor VIII activity using the one-stage clotting assay. The specific activity of XYNTHA is 5,500 to 9,900 IU per milligram of protein. XYNTHA is formulated as a sterile, nonpyrogenic, no preservative, lyophilized powder preparation for intravenous injection. Each single-use prefilled dual-chamber syringe (named XYNTHA SOLOFUSE) contains nominally 250, 500, 1000, 2000, or 3000 IU of XYNTHA. Upon reconstitution, the product is a clear to slightly opalescent, colorless solution that contains sodium chloride, sucrose, L-histidine, calcium chloride and polysorbate 80."
},
{
"NDCCode": "59900-122-03",
"PackageDescription": "3785 mL in 1 JUG (59900-122-03) ",
"NDC11Code": "59900-0122-03",
"ProductNDC": "59900-122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alpet E3 Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190426",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Best Sanitizers, Inc.",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "76",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190426",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 sanitizes hands to help reduce bacteria that potentially can cause disease."
},
{
"NDCCode": "62980-122-03",
"PackageDescription": "60 TABLET in 1 BOTTLE (62980-122-03)",
"NDC11Code": "62980-0122-03",
"ProductNDC": "62980-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090073",
"LabelerName": "Vivimed Labs Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride, USP. The tablets also contain the following inactive ingredients: silicified microcrystalline cellulose, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, triacetin, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, triacetin and iron oxide black (10 mg tablets)."
},
{
"NDCCode": "63545-122-03",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (63545-122-03) ",
"NDC11Code": "63545-0122-03",
"ProductNDC": "63545-122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Argentum Muriaticum",
"NonProprietaryName": "Argentum Muriaticum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, Inc.",
"SubstanceName": "SILVER CHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2021-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210303",
"SamplePackage": "N"
},
{
"NDCCode": "63550-122-03",
"PackageDescription": "50 mL in 1 BOX (63550-122-03) ",
"NDC11Code": "63550-0122-03",
"ProductNDC": "63550-122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Day L",
"NonProprietaryName": "Avobenzone Octisalate Octinoxate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20040301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Kamins Dermatologics Inc.",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE",
"StrengthNumber": "25; 75; 40",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20040301",
"SamplePackage": "N",
"IndicationAndUsage": "A LIGHT, SILKY LOTION THAT DIFFUSES A BLEND OF MOISTURIZERS, ANTI-OXYDANT VOTMINS INTO THE SKIN TO ENHANCE DAY LONG COMFORT AND HYDRATION. THE SKIN'S OUTER LAYERS ARE COVERED WITH A PROTECTIVE SHIELD, PRODUCING A HEALTHY, LUMINESCENT GLOW. Uses ■ Helps prevent sunburn. ■ Higher SPF gives more sunburn protection. ■ Provides moderate protection against sunburn."
},
{
"NDCCode": "64380-122-03",
"PackageDescription": "1000 TABLET in 1 BOTTLE (64380-122-03) ",
"NDC11Code": "64380-0122-03",
"ProductNDC": "64380-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070039",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20251116",
"SamplePackage": "N",
"IndicationAndUsage": "Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with Metronidazole tablets in cases of reinfection. Amebiasis. Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablets therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with Metronidazole tablets therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to Metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole tablets and other antibacterial drugs, metronidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Metronidazole Tablets USP, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets, USP contain 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include anhydrous lactose, colloidal silicon dioxide, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate and stearic acid. The film coating contains hypromelloses, hydroxypropyl cellulose, titanium dioxide, ethyl cellulose, shellac, diacetylated monoglycerides and propylene glycol."
},
{
"NDCCode": "64679-122-03",
"PackageDescription": "60 TABLET in 1 BOTTLE (64679-122-03) ",
"NDC11Code": "64679-0122-03",
"ProductNDC": "64679-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090073",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride, USP. The tablets also contain the following inactive ingredients: silicified microcrystalline cellulose, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, triacetin, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, triacetin and iron oxide black (10 mg tablets)."
},
{
"NDCCode": "66915-122-03",
"PackageDescription": "480 g in 1 JAR (66915-122-03)",
"NDC11Code": "66915-0122-03",
"ProductNDC": "66915-122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Apres Peel Soothing Balm",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110830",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "CoValence, Inc.",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": ".05",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2015-07-17"
},
{
"NDCCode": "67763-122-03",
"PackageDescription": "5 kg in 1 DRUM (67763-122-03)",
"NDC11Code": "67763-0122-03",
"ProductNDC": "67763-122",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Diazepam",
"DosageFormName": "POWDER",
"StartMarketingDate": "20160613",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "R.L.Fine Chem Private Limited",
"SubstanceName": "DIAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "68001-122-03",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-122-03) ",
"NDC11Code": "68001-0122-03",
"ProductNDC": "68001-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090617",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140101",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate extended-release tablets, metoprolol succinate, is a beta 1-selective adrenoceptor blocking agent. Metoprolol succinate extended-release tablets are indicated for the treatment of: : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris ( 1.2) , 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin.( 1.3).",
"Description": "Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. Metoprolol succinate extended-release tablets USP, have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg and 47.5 mg of metoprolol succinate equivalent to 25 mg and 50 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate USP, is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide."
},
{
"NDCCode": "68984-122-03",
"PackageDescription": "10 BOX, UNIT-DOSE in 1 PACKET (68984-122-03) > 312 mg in 1 BOX, UNIT-DOSE",
"NDC11Code": "68984-0122-03",
"ProductNDC": "68984-122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unpaste",
"NonProprietaryName": "Zero Waste Fluoride Mint Tooth Tabs",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "DENTAL",
"StartMarketingDate": "20221201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Farmina sp. z.o.o.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".62",
"StrengthUnit": "mg/312mg",
"Status": "Deprecated",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20221201",
"SamplePackage": "N"
},
{
"NDCCode": "69097-122-03",
"PackageDescription": "60 TABLET in 1 BOTTLE (69097-122-03) ",
"NDC11Code": "69097-0122-03",
"ProductNDC": "69097-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076343",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140612",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, and 100 mg circular tablets and 200 mg capsule shaped tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-ß-D-fructopyranose sulfamate and has the following structural formula:. Each tablet, for oral administration, contains 25 mg, 50 mg, 100 mg and 200 mg topiramate and has the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate and titanium dioxide. In addition, the 25 mg also contains FD&C Blue#2; the 50 mg and 100 mg also contain red iron oxide and yellow iron oxide; and the 200 mg also contains red iron oxide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>69489-122-03</NDCCode>
<PackageDescription>3 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (69489-122-03) </PackageDescription>
<NDC11Code>69489-0122-03</NDC11Code>
<ProductNDC>69489-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ximino</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201108</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201922</ApplicationNumber>
<LabelerName>Journey Medical Corporation</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201108</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>69489-122-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69489-122-30) </PackageDescription>
<NDC11Code>69489-0122-30</NDC11Code>
<ProductNDC>69489-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ximino</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201108</StartMarketingDate>
<EndMarketingDate>20240331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201922</ApplicationNumber>
<LabelerName>Journey Medical Corporation</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201108</StartMarketingDatePackage>
<EndMarketingDatePackage>20240331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ximino is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1). Limitations of Use. Ximino did not demonstrate any effect on non-inflammatory acne lesions. Safety of Ximino has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. (14).</IndicationAndUsage>
<Description>The active ingredient in Ximino Extended-Release Capsules is minocycline hydrochloride, a semi synthetic derivative of tetracycline. Ximino is a tetracycline-class drug. Ximino is known chemically as [4 S‑(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below. Minocycline hydrochloride, USP is a yellow crystalline powder, sparingly soluble in water, soluble in solutions of alkali hydroxides and carbonates, slightly soluble in alcohol, practically insoluble in chloroform and in ether. Ximino (minocycline hydrochloride) Extended-Release Capsules for oral administration contain minocycline hydrochloride, USP equivalent to 45 mg, 90 mg, or 135 mg of minocycline. The Extended-Release Capsules contain the following inactive ingredients: colloidal silicon dioxide, D&C Yellow #10 (in 45 mg strength), FD&C Blue #1, FD&C Yellow #6 (in 45 mg and 135 mg strength), gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, and titanium dioxide. The 45 mg, 90 mg, and 135 mg capsules also contain Opadry Clear which contains hypromellose, polyethylene glycol 400, polyethylene glycol 6000, and talc. Ximino Extended-Release Capsules also contain black ink which contains black iron oxide, potassium hydroxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69489-121-03</NDCCode>
<PackageDescription>3 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (69489-121-03) </PackageDescription>
<NDC11Code>69489-0121-03</NDC11Code>
<ProductNDC>69489-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ximino</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201108</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201922</ApplicationNumber>
<LabelerName>Journey Medical Corporation</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201108</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>69489-123-03</NDCCode>
<PackageDescription>3 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (69489-123-03) </PackageDescription>
<NDC11Code>69489-0123-03</NDC11Code>
<ProductNDC>69489-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ximino</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201108</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201922</ApplicationNumber>
<LabelerName>Journey Medical Corporation</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>135</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201108</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>69489-201-03</NDCCode>
<PackageDescription>1 CAN in 1 CARTON (69489-201-03) / 3 g in 1 CAN</PackageDescription>
<NDC11Code>69489-0201-03</NDC11Code>
<ProductNDC>69489-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amzeeq</ProprietaryName>
<NonProprietaryName>Minocycline</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220325</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212379</ApplicationNumber>
<LabelerName>Journey Medical Corporation</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230125</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>AMZEEQ is indicated for the topical treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older [ see Clinical Studies ( 14) ]. Limitations of Use. This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated [ see Warnings and Precautions ( 5.14) ].</IndicationAndUsage>
<Description>Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S‑ (4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a‑ tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below. C 23H 27N 3O 7HCl M. W. 493.94. Each gram of AMZEEQ contains micronized minocycline 40 mg equivalent to 43 mg minocycline hydrochloride in a yellow suspension foam. In addition, the 4% AMZEEQ topical foam contains the following inactive ingredients: soybean oil, coconut oil, light mineral oil, cyclomethicone, cetostearyl alcohol, stearic acid, myristyl alcohol, hydrogenated castor oil, white wax (beeswax), stearyl alcohol, docosanol. AMZEEQ topical foam is dispensed from an aluminum container (can) pressurized with propellant (butane + isobutane + propane).</Description>
</NDC>
<NDC>
<NDCCode>69489-212-03</NDCCode>
<PackageDescription>1 CAN in 1 CARTON (69489-212-03) / 3 g in 1 CAN</PackageDescription>
<NDC11Code>69489-0212-03</NDC11Code>
<ProductNDC>69489-212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zilxi</ProprietaryName>
<NonProprietaryName>Minocycline</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213690</ApplicationNumber>
<LabelerName>Journey Medical Corporation</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ZILXI is indicated for the treatment of inflammatory lesions of rosacea in adults [see Clinical Studies (14)]. Limitations of Use. This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ZILXI should be used only as indicated [see Warnings and Precautions (5.14)].</IndicationAndUsage>
<Description>Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S‑(4α,4aα,5aα,12aα)]-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a‑tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. C23H27N3O7HClM. W. 493.94. Each gram of ZILXI contains micronized 15 mg minocycline equivalent to 16 mg minocycline hydrochloride in a yellow suspension foam. In addition, the 1.5% ZILXI topical foam contains the following inactive ingredients: soybean oil, coconut oil, light mineral oil, cyclomethicone, cetostearyl alcohol, stearic acid, myristyl alcohol, hydrogenated castor oil, white wax (beeswax), stearyl alcohol, docosanol. ZILXI topical foam is dispensed from an aluminum container (can) pressurized with propellant (butane + isobutane + propane).</Description>
</NDC>
<NDC>
<NDCCode>69489-311-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (69489-311-60) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>69489-0311-60</NDC11Code>
<ProductNDC>69489-311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eurax</ProprietaryName>
<NonProprietaryName>Crotamiton</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260316</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA006927</ApplicationNumber>
<LabelerName>Journey Medical Corporation</LabelerName>
<SubstanceName>CROTAMITON</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For eradication of scabies ( Sarcoptes scabiei) and for symptomatic treatment of pruritic skin.</IndicationAndUsage>
<Description>Eurax (crotamiton, USP) is a scabicidal and antipruritic agent available as a cream for topical use only. Eurax provides 10% (w/w) of the synthetic, crotamiton, USP, in a vanishing-cream base containing: carbomer homopolymer type B, cetyl alcohol, diazolidinyl urea, dimethicone, glyceryl monostearate, laureth-23, magnesium aluminum silicate, benzyl alcohol, petrolatum, propylene glycol, sodium hydroxide, steareth-2, and water. Crotamiton is N-ethyl-N-( o-methylphenyl)-2-butenamide and its structural formula is:. Crotamiton, USP is a colorless to slightly yellowish oil, having a faint amine-like odor. It is soluble with alcohol and with methanol. Crotamiton is a mixture of the cisand transisomers. Its molecular weight is 203.28.</Description>
</NDC>
<NDC>
<NDCCode>10237-144-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (10237-144-00) * 1 BOTTLE, SPRAY in 1 CASE (10237-122-03) / 30 mL in 1 BOTTLE, SPRAY * 1 BOTTLE, SPRAY in 1 CASE (10237-120-03) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>10237-0144-00</NDC11Code>
<ProductNDC>10237-144</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Touchland Disney The Gift Set</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20261001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21220-122-03</NDCCode>
<PackageDescription>13818 L in 1 CYLINDER (21220-122-03) </PackageDescription>
<NDC11Code>21220-0122-03</NDC11Code>
<ProductNDC>21220-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrous Oxide</ProprietaryName>
<NonProprietaryName>Nitrous Oxide</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19761101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205704</ApplicationNumber>
<LabelerName>General Air Service & Supply Co</LabelerName>
<SubstanceName>NITROUS OXIDE</SubstanceName>
<StrengthNumber>995</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19761101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24338-122-03</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (24338-122-03) </PackageDescription>
<NDC11Code>24338-0122-03</NDC11Code>
<ProductNDC>24338-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ery-tab</ProprietaryName>
<NonProprietaryName>Erythromycin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110418</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062298</ApplicationNumber>
<LabelerName>Arbor Pharmaceuticals, Inc.</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>2018-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of ERY-TAB® and other antibacterial drugs, ERY-TAB® 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. ERY-TAB® 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. influenzae are 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 pyogenes or 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 Streptococcus pyogenes or 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. gonorrhoeae in 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 vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.</IndicationAndUsage>
<Description>ERY-TAB® (erythromycin delayed-release tablets) is 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. ERY-TAB® tablets 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. ERY-TAB® tablets 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)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C37H67NO13, and the molecular weight is 733.94. The structural formula is. Inactive Ingredients. Ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, crospovidone, diacetylated monoglycerides, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, sodium citrate, sorbitan monooleate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>25000-122-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (25000-122-03) </PackageDescription>
<NDC11Code>25000-0122-03</NDC11Code>
<ProductNDC>25000-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090796</ApplicationNumber>
<LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (< 1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone . The structural formula is represented below:. Ibuprofen tablets, a nonsteroidal anti-inflammatory drug ( NSAID ), are available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycols, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>51224-122-03</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (51224-122-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51224-0122-03</NDC11Code>
<ProductNDC>51224-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin Dihydrate</ProprietaryName>
<NonProprietaryName>Azithromycin Dihydrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<EndMarketingDate>20261031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208249</ApplicationNumber>
<LabelerName>TAGI Pharma, Inc.</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<EndMarketingDatePackage>20260531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Azithromycin Tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. Azithromycin is supplied as tablets containing azithromycin dihydrate equivalent to 500 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Blue #1 aluminum lake and lecithin, FD&C Red #40 aluminum Lake, FD&C Yellow #6 aluminum Lake, macrogol/PEG, magnesium stearate, polyvinyl alcohol, pregelatinized starch, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>51224-122-09</NDCCode>
<PackageDescription>3 CARTON in 1 BOX (51224-122-09) / 1 BLISTER PACK in 1 CARTON (51224-122-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51224-0122-09</NDC11Code>
<ProductNDC>51224-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin Dihydrate</ProprietaryName>
<NonProprietaryName>Azithromycin Dihydrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<EndMarketingDate>20261031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208249</ApplicationNumber>
<LabelerName>TAGI Pharma, Inc.</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<EndMarketingDatePackage>20261031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Azithromycin Tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. Azithromycin is supplied as tablets containing azithromycin dihydrate equivalent to 500 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Blue #1 aluminum lake and lecithin, FD&C Red #40 aluminum Lake, FD&C Yellow #6 aluminum Lake, macrogol/PEG, magnesium stearate, polyvinyl alcohol, pregelatinized starch, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>51389-122-03</NDCCode>
<PackageDescription>1 KIT in 1 KIT (51389-122-03) * 1 TUBE in 1 PACKAGE (51389-124-01) > 2.5 g in 1 TUBE * 1 TUBE in 1 PACKAGE (51389-125-01) > 2.5 g in 1 TUBE * 1 TUBE in 1 PACKAGE (51389-123-01) > 2.5 g in 1 TUBE</PackageDescription>
<NDC11Code>51389-0122-03</NDC11Code>
<ProductNDC>51389-122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laura Geller Beauty Sun Kissed Color Lip Balm Trio Broad Spectrum Spf 15 Pink - Coral - Berry</ProprietaryName>
<NonProprietaryName>Octisalate, Avobenzone, Octinoxate, Octocrylene</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20131209</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>LAURA GELLER MAKE UP INC.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52959-122-03</NDCCode>
<PackageDescription>3 TABLET in 1 BOTTLE (52959-122-03)</PackageDescription>
<NDC11Code>52959-0122-03</NDC11Code>
<ProductNDC>52959-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenazopyridine Hcl</ProprietaryName>
<NonProprietaryName>Phenazopyridine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100910</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency frequency, and other discomforts arising from irritation of the mucosa of the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of phenazopyridine for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. The drug should be used for symptomatic relief of pain and not as a substitute for specific surgery or antimicrobial therapy. Phenazopyridine is compatible with antimicrobial therapy and can help relieve pain and discomfort during the interval before antimicrobial therapy controls the infection. Treatment of a urinary tract infection with phenazopyridine should not exceed 2 days. There is no evidence that the combined administration of phenazopyridine and an antimicrobial provides greater benefit than administration of the antimicrobial alone after 2 days. (See Dosage and Administration.).</IndicationAndUsage>
<Description>Phenazopyridine Hydrochloride is a reddish-brown, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. Following is the structural formula. Phenazopyridine HCl tablets contain the following inactive ingredients: Corn Starch, Croscarmellose Sodium, Hypromellose, Light Mineral Oil, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Pregelatinized Starch, and Silicon Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>53247-122-03</NDCCode>
<PackageDescription>24 g in 1 TUBE (53247-122-03) </PackageDescription>
<NDC11Code>53247-0122-03</NDC11Code>
<ProductNDC>53247-122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Maximum Security</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20080101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Bob Barker Company Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2.2</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps protect against cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58159-122-03</NDCCode>
<PackageDescription>20 kg in 1 DRUM (58159-122-03) </PackageDescription>
<NDC11Code>58159-0122-03</NDC11Code>
<ProductNDC>58159-122</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Voclosporin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20250422</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>NURAY CHEMICALS PRIVATE LIMITED</LabelerName>
<SubstanceName>VOCLOSPORIN</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>kg/35kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-05-01</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>22-APR-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>58354-122-04</NDCCode>
<PackageDescription>1 PATCH in 1 POUCH (58354-122-04) > 5 g in 1 PATCH (58354-122-03) </PackageDescription>
<NDC11Code>58354-0122-04</NDC11Code>
<ProductNDC>58354-122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cho-a Derm Beauty Care</ProprietaryName>
<NonProprietaryName>Carboxymethylcellulose Sodium</NonProprietaryName>
<DosageFormName>DRESSING</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20211201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Cho-A Pharm.Co.,Ltd.</LabelerName>
<SubstanceName>CARBOXYMETHYLCELLULOSE SODIUM</SubstanceName>
<StrengthNumber>130</StrengthNumber>
<StrengthUnit>g/433g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58394-022-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (58394-022-03) * 4 mL in 1 SYRINGE (58394-122-03) * 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>58394-0022-03</NDC11Code>
<ProductNDC>58394-022</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Xyntha</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20111201</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125264</ApplicationNumber>
<LabelerName>Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XYNTHA, Antihemophilic Factor (Recombinant), is indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>The active ingredient in XYNTHA, Antihemophilic Factor (Recombinant), is a recombinant antihemophilic factor (rAHF), also called coagulation factor VIII, which is produced by recombinant DNA technology. It is secreted by a genetically engineered Chinese hamster ovary (CHO) cell line. The cell line is grown in a chemically defined cell culture medium that contains recombinant insulin, but does not contain any materials derived from human or animal sources. The rAHF in XYNTHA is a purified glycoprotein, with an approximate molecular mass of 170 kDa consisting of 1,438 amino acids, which does not contain the B-domain.13 The amino acid sequence of the rAHF is comparable to the 90 + 80 kDa form of human coagulation factor VIII. The purification process uses a series of chromatography steps, one of which is based on affinity chromatography using a patented synthetic peptide affinity ligand.14 The process also includes a solvent-detergent viral inactivation step and a virus-retaining nanofiltration step. The potency expressed in International Units (IU) is determined using the chromogenic assay of the European Pharmacopoeia. The Wyeth manufacturing reference standard for potency has been calibrated against the World Health Organization (WHO) International Standard for factor VIII activity using the one-stage clotting assay. The specific activity of XYNTHA is 5,500 to 9,900 IU per milligram of protein. XYNTHA is formulated as a sterile, nonpyrogenic, no preservative, lyophilized powder preparation for intravenous injection. Each single-use prefilled dual-chamber syringe (named XYNTHA SOLOFUSE) contains nominally 250, 500, 1000, 2000, or 3000 IU of XYNTHA. Upon reconstitution, the product is a clear to slightly opalescent, colorless solution that contains sodium chloride, sucrose, L-histidine, calcium chloride and polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>59900-122-03</NDCCode>
<PackageDescription>3785 mL in 1 JUG (59900-122-03) </PackageDescription>
<NDC11Code>59900-0122-03</NDC11Code>
<ProductNDC>59900-122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alpet E3 Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190426</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Best Sanitizers, Inc.</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>76</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 sanitizes hands to help reduce bacteria that potentially can cause disease.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62980-122-03</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (62980-122-03)</PackageDescription>
<NDC11Code>62980-0122-03</NDC11Code>
<ProductNDC>62980-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090073</ApplicationNumber>
<LabelerName>Vivimed Labs Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride, USP. The tablets also contain the following inactive ingredients: silicified microcrystalline cellulose, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, triacetin, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, triacetin and iron oxide black (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>63545-122-03</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (63545-122-03) </PackageDescription>
<NDC11Code>63545-0122-03</NDC11Code>
<ProductNDC>63545-122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Argentum Muriaticum</ProprietaryName>
<NonProprietaryName>Argentum Muriaticum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
<SubstanceName>SILVER CHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63550-122-03</NDCCode>
<PackageDescription>50 mL in 1 BOX (63550-122-03) </PackageDescription>
<NDC11Code>63550-0122-03</NDC11Code>
<ProductNDC>63550-122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Day L</ProprietaryName>
<NonProprietaryName>Avobenzone Octisalate Octinoxate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20040301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Kamins Dermatologics Inc.</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>25; 75; 40</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-06-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>A LIGHT, SILKY LOTION THAT DIFFUSES A BLEND OF MOISTURIZERS, ANTI-OXYDANT VOTMINS INTO THE SKIN TO ENHANCE DAY LONG COMFORT AND HYDRATION. THE SKIN'S OUTER LAYERS ARE COVERED WITH A PROTECTIVE SHIELD, PRODUCING A HEALTHY, LUMINESCENT GLOW. Uses ■ Helps prevent sunburn. ■ Higher SPF gives more sunburn protection. ■ Provides moderate protection against sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64380-122-03</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (64380-122-03) </PackageDescription>
<NDC11Code>64380-0122-03</NDC11Code>
<ProductNDC>64380-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070039</ApplicationNumber>
<LabelerName>Strides Pharma Science Limited</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with Metronidazole tablets in cases of reinfection. Amebiasis. Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablets therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with Metronidazole tablets therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to Metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole tablets and other antibacterial drugs, metronidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Metronidazole Tablets USP, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets, USP contain 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include anhydrous lactose, colloidal silicon dioxide, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate and stearic acid. The film coating contains hypromelloses, hydroxypropyl cellulose, titanium dioxide, ethyl cellulose, shellac, diacetylated monoglycerides and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>64679-122-03</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (64679-122-03) </PackageDescription>
<NDC11Code>64679-0122-03</NDC11Code>
<ProductNDC>64679-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090073</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride, USP. The tablets also contain the following inactive ingredients: silicified microcrystalline cellulose, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, triacetin, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, triacetin and iron oxide black (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>66915-122-03</NDCCode>
<PackageDescription>480 g in 1 JAR (66915-122-03)</PackageDescription>
<NDC11Code>66915-0122-03</NDC11Code>
<ProductNDC>66915-122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Apres Peel Soothing Balm</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110830</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>CoValence, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-07-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>67763-122-03</NDCCode>
<PackageDescription>5 kg in 1 DRUM (67763-122-03)</PackageDescription>
<NDC11Code>67763-0122-03</NDC11Code>
<ProductNDC>67763-122</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Diazepam</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20160613</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>R.L.Fine Chem Private Limited</LabelerName>
<SubstanceName>DIAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68001-122-03</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-122-03) </PackageDescription>
<NDC11Code>68001-0122-03</NDC11Code>
<ProductNDC>68001-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090617</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate extended-release tablets, metoprolol succinate, is a beta 1-selective adrenoceptor blocking agent. Metoprolol succinate extended-release tablets are indicated for the treatment of: : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris ( 1.2) , 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin.( 1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. Metoprolol succinate extended-release tablets USP, have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg and 47.5 mg of metoprolol succinate equivalent to 25 mg and 50 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate USP, is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68984-122-03</NDCCode>
<PackageDescription>10 BOX, UNIT-DOSE in 1 PACKET (68984-122-03) > 312 mg in 1 BOX, UNIT-DOSE</PackageDescription>
<NDC11Code>68984-0122-03</NDC11Code>
<ProductNDC>68984-122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unpaste</ProprietaryName>
<NonProprietaryName>Zero Waste Fluoride Mint Tooth Tabs</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20221201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Farmina sp. z.o.o.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.62</StrengthNumber>
<StrengthUnit>mg/312mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69097-122-03</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (69097-122-03) </PackageDescription>
<NDC11Code>69097-0122-03</NDC11Code>
<ProductNDC>69097-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076343</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, and 100 mg circular tablets and 200 mg capsule shaped tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-ß-D-fructopyranose sulfamate and has the following structural formula:. Each tablet, for oral administration, contains 25 mg, 50 mg, 100 mg and 200 mg topiramate and has the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate and titanium dioxide. In addition, the 25 mg also contains FD&C Blue#2; the 50 mg and 100 mg also contain red iron oxide and yellow iron oxide; and the 200 mg also contains red iron oxide.</Description>
</NDC>
</NDCList>