{
"NDC": [
{
"NDCCode": "16590-931-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (16590-931-05) > 5 mL in 1 BOTTLE",
"NDC11Code": "16590-0931-05",
"ProductNDC": "16590-931",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20080317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076616",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ofloxacin Otic Solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below. Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aereus. Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa and Staphylococcus aureus. Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus, and Streptococcus pneumoniae.",
"Description": "Ofloxacin Otic Solution 0.3% is a sterile aqueous anti-infective (anti-bacterial) solution for otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated carboxyquinolone with a benzoxazine ring. The chemical name of ofloxacin is (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4-benzoxazine-6- carboxylic acid. The empirical formula of ofloxacin is C18H20FN3O4 and its molecular weight is 361.38. The structural formula is. Ofloxacin Otic Solution contains. Active: Ofloxacin 0.3% (3 mg/mL). Preservative: Benzalkonium chloride (0.0025%). Inactives: Purified water and sodium chloride. Hydrochloric acid and sodium hydroxide added to adjust pH."
},
{
"NDCCode": "16590-002-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (16590-002-05) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "16590-0002-05",
"ProductNDC": "16590-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acular",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19921201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019700",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "ACULAR® ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. ACULAR® ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.",
"Description": "ACULAR® (ketorolac tromethamine ophthalmic solution) is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure:. ACULAR® ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. ACULAR® ophthalmic solution is a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.40. The osmolality of ACULAR® ophthalmic solution is 290 mOsml/kg. Each mL of ACULAR® ophthalmic solution contains: Active: ketorolac tromethamine 0.5%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium 0.1%; octoxynol 40; purified water; sodium chloride; and hydrochloric acid and/or sodium hydroxide to adjust pH."
},
{
"NDCCode": "16590-007-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (16590-007-05) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "16590-0007-05",
"ProductNDC": "16590-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alrex",
"NonProprietaryName": "Loteprednol Etabonate",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19980309",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020803",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "LOTEPREDNOL ETABONATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "ALREX Ophthalmic Suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.",
"Description": "ALREX® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. C24H31ClO7Mol. Wt. 466.96. Chemical Name. chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 2 mg (0.2%);. INACTIVES: Edetate Disodium, Glycerin, Povidone, Purified Water and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.4-5.5. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%."
},
{
"NDCCode": "16590-043-05",
"PackageDescription": "5 CAPSULE in 1 BOTTLE (16590-043-05)",
"NDC11Code": "16590-0043-05",
"ProductNDC": "16590-043",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefadroxil",
"NonProprietaryName": "Cefadroxil",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20070125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065352",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "CEFADROXIL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Cefadroxil capsules contain the following inactive ingredients: Lactose monohydrate, magnesium stearate, FD&C Blue No.1, D&C Red No.28, FD&C Red No. 40, titanium dioxide, gelatin, sodium lauryl sulphate, and edible black ink (black iron oxide)."
},
{
"NDCCode": "16590-068-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (16590-068-05) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "16590-0068-05",
"ProductNDC": "16590-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone Sodium Phosphate",
"NonProprietaryName": "Dexamethasone Sodium Phosphate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19960726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040069",
"LabelerName": "Stat Rx USA",
"SubstanceName": "DEXAMETHASONE SODIUM PHOSPHATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of the following conditions. Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical or thermal burns, or penetration of foreign bodies. Steroid responsive inflammatory conditions of the external auditory meatus, such as allergic otitis externa, selected purulent and nonpurulent infective otitis externa when the hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.",
"Description": "Dexamethasone Sodium Phosphate Ophthalmic Solution USP, is a sterile, topical steroid solution. The active ingredient is represented by the following structural formula. C22H28FNa2O8P. Mol. wt. 516.41. Chemical Name: 9-fluoro-11β, 17-dihydroxy-16α-methyl-21-[phosphonooxy]pregna-1, 4-diene-3,20-dione disodium salt. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic. Dexamethasone is a synthetic analog of naturally occurring glucocorticoids (hydrocortisone and cortisone). Dexamethasone sodium phosphate is a water soluble, inorganic ester of dexamethasone. It is approximately three thousand times more soluble at 25°C than hydrocortisone. Each mL Contains: ACTIVE: Dexamethasone Sodium Phosphate, [equivalent to 1 mg (0.1%) Dexamethasone Phosphate]. INACTIVES: Sodium Citrate, Sodium Borate, Creatinine, Polysorbate 80, Edetate Disodium Dihydrate, Purified Water. Hydrochloric Acid may be added to adjust pH (6.6 - 7.8). PRESERVATIVES ADDED: Sodium Bisulfite 0.1%, Phenylethyl Alcohol 0.25%, Benzalkonium Chloride 0.02%."
},
{
"NDCCode": "16590-167-05",
"PackageDescription": "5 mL in 1 BOTTLE (16590-167-05)",
"NDC11Code": "16590-0167-05",
"ProductNDC": "16590-167",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone",
"NonProprietaryName": "Neomycin, Polymyxin B And Dexamethasone",
"DosageFormName": "SUSPENSION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19840522",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062341",
"LabelerName": "STAT RX LLC USA",
"SubstanceName": "NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE",
"StrengthNumber": "3.5; 10000; 1",
"StrengthUnit": "mg/mL; U/mL; mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens and streptococci, including Streptococcus pneumoniae.",
"Description": "Neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. The chemical structure for the active ingredient, dexamethasone, is. Established Name. dexamethasone. Chemical Name. pregna-1, 4-diene-3, 20-dione, 9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-. The other active ingredients are neomycin sulfate and polymyxin B sulfate. Each mL contains: Actives: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Preservative: benzalkonium chloride 0.004%. Vehicle: hypromellose 2910 0.5%. Inactives: sodium chloride, polysorbate 20, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water."
},
{
"NDCCode": "16590-175-05",
"PackageDescription": "5 mL in 1 BOTTLE, DROPPER (16590-175-05)",
"NDC11Code": "16590-0175-05",
"ProductNDC": "16590-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20040514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076615",
"LabelerName": "STAT RX LLC USA",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:. *Efficacy for this organism was studied in fewer than 10 infections.",
"Description": "Ofloxacin ophthalmic solution 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use. (±)-9-Fluoro-2, 3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4 benzoxazine-6-carboxylic acid. Contains. Active: ofloxacin 0.3% (3 mg/mL). Preservative: benzalkonium chloride (0.005%). Inactives: sodium chloride and purified water. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. Ofloxacin ophthalmic solution is unbuffered and formulated with a pH of 6.4 (range - 6.0 to 6.8). It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure."
},
{
"NDCCode": "16590-224-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (16590-224-05) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "16590-0224-05",
"ProductNDC": "16590-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobramycin",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19960131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064096",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "TOBRAMYCIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tobramycin Ophthalmic Solution USP, 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobramycin Ophthalmic Solution USP, 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in pediatric patients.",
"Description": "Tobramycin Ophthalmic Solution USP, 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Tobramycin is a water soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. The molecular formula is C18H37N5O9, the molecular weight is 467.52 and the structural formula is:. Chemical Name. O-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1 → 4)}-O-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1 → 6)}-2- deoxystreptamine. Each mL contains. Active: Tobramycin 3 mg (0.3%). Inactives: Boric Acid, Sodium Chloride, Sodium Sulfate, Tyloxapol, Sodium Hydroxide and/or Sulfuric Acid to adjust pH (7.0 to 8.0), and Purified Water USP. Preservative: Benzalkonium Chloride 0.1 mg (0.01%)."
},
{
"NDCCode": "16590-376-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (16590-376-05) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "16590-0376-05",
"ProductNDC": "16590-376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20091105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078434",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ketorolac Tromethamine Ophthalmic Solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac Tromethamine Ophthalmic Solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.",
"Description": "Ketorolac Tromethamine Ophthalmic Solution is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-benzoyl-2, 3-dihydro-1H pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-l,3-propanediol(1:1) and it has the following structural formula:. The molecular formula of Ketorolac Tromethamine Ophthalmic Solution is C15H13NO3C4H11NO3. Ketorolac Tromethamine Ophthalmic Solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac Tromethamine Ophthalmic Solution is a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of Ketorolac Ophthalmic Solution is 290 mOsml/kg. Each mL of Ketorolac Tromethamine Ophthalmic Solution contains:. Active: ketorolac tromethamine 0.5%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium 0.1%; octoxynol 40; sodium chloride; hydrochloric acid and/or sodium hydroxide may be added to adjust the pH (6.8-7.4) and purified water."
},
{
"NDCCode": "16590-421-05",
"PackageDescription": "5 mL in 1 BOTTLE, PLASTIC (16590-421-05)",
"NDC11Code": "16590-0421-05",
"ProductNDC": "16590-421",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin Hydrochloride",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20040507",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019992",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "3.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ciprofloxacin Hydrochloride Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Corneal Ulcers:. Pseudomonas aeruginosa. Serratia marcescens*. Staphylococcus aureus. Staphylococcus epidermidis. Streptococcus pneumoniae. Streptococcus (Viridans Group)*. Conjunctivitis:. Haemophilus influenzae. Staphylococcus aureus. Staphylococcus epidermidis. Streptococcus pneumoniae. *Efficacy for this organism was studied in fewer than 10 infections.",
"Description": "Ciprofloxacin Hydrochloride Ophthalmic Solution is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid. It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each mL of Ciprofloxacin Hydrochloride Ophthalmic Solution contains: Active: ciprofloxacin HCl 3.5 mg equivalent to 3 mg base. Preservative: benzalkonium chloride 0.006%. Inactive: sodium acetate, acetic acid, mannitol 4.6%, edetate disodium 0.05%, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm."
},
{
"NDCCode": "16590-881-05",
"PackageDescription": "5 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (16590-881-05)",
"NDC11Code": "16590-0881-05",
"ProductNDC": "16590-881",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Avelox Abc Pack",
"NonProprietaryName": "Moxifloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19991210",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021085",
"LabelerName": "Stat Rx USA",
"SubstanceName": "MOXIFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "AVELOX Tablets and I.V. are indicated for the treatment of adults (≥ 18 years of age) with infections caused by susceptible strains of the designated microorganisms in the conditions listed below. (See DOSAGE AND ADMINISTRATION for specific recommendations. In addition, for I.V. use, see PRECAUTIONS, Geriatric Use.). Acute Bacterial Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis. Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus, or Moraxella catarrhalis. Community Acquired Pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant strains*), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydia pneumoniae. * MDRSP, Multi-drug resistant Streptococcus pneumoniae includes isolates previously known as PRSP (Penicillin-resistant S. pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC ≥ 2 µg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. Uncomplicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes. Complicated Intra-Abdominal Infections including polymicrobial infections such as abscess caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus species. Complicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae (See Clinical Studies). Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. Therapy with AVELOX may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVELOX and other antibacterial drugs, AVELOX 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": "AVELOX (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and is available as AVELOX Tablets for oral administration and as AVELOX I.V. for intravenous administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow crystalline substance with a molecular weight of 437.9. Its empirical formula is C21H24FN3O4*HCl and its chemical structure is as follows. AVELOX Tablets are available as film-coated tablets containing moxifloxacin hydrochloride (equivalent to 400 mg moxifloxacin). The inactive ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and ferric oxide. AVELOX I.V. is available in ready-to-use 250 mL latex-free flexibags as a sterile, preservative free, 0.8% sodium chloride aqueous solution of moxifloxacin hydrochloride (containing 400 mg moxifloxacin) with pH ranging from 4.1 to 4.6. The appearance of the intravenous solution is yellow. The color does not affect, nor is it indicative of, product stability. The inactive ingredients are sodium chloride, USP, Water for Injection, USP, and may include hydrochloric acid and/or sodium hydroxide for pH adjustment. AVELOX I.V. contains approximately 34.2 mEq (787 mg) of sodium in 250 mL."
},
{
"NDCCode": "31382-931-05",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (31382-931-05) > 10 CARTRIDGE in 1 BLISTER PACK > 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "31382-0931-05",
"ProductNDC": "31382-931",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbocaine With Neo-cobefrin",
"NonProprietaryName": "Mepivacaine Hydrochloride And Levonordefrin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20110101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088388",
"LabelerName": "Caresteam Health, Inc.",
"SubstanceName": "MEPIVACAINE HYDROCHLORIDE; LEVONORDEFRIN",
"StrengthNumber": "20; .05",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "CARBOCAINE is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients.",
"Description": "CARBOCAINE (mepivacaine hydrochloride), a tertiary amine used as a local anesthetic, is 1-methyl-2', 6' - pipecoloxylidide monohydrochloride with the following structural formula. It is a white, crystalline, odorless powder soluble in water, but very resistant to both acid and alkaline hydrolysis. NEO-COBEFRIN, a sympathomimetic amine used as a vasoconstrictor in local anesthetic solution, is (-)--(1-Aminoethyl)-3, 4-dihydroxybenzyl alcohol with the following structural formula. It is a white or buff-colored crystalline solid, freely soluble in aqueous solutions of mineral acids, but practically insoluble in water. DENTAL CARTRIDGES MAY NOT BE AUTOCLAVED. CARBOCAINE 3% injection and CARBOCAINE 2% with NEO-COBEFRIN 1:20,000 injection are sterile solutions for injection."
},
{
"NDCCode": "40032-931-05",
"PackageDescription": "500 mL in 1 BOTTLE (40032-931-05)",
"NDC11Code": "40032-0931-05",
"ProductNDC": "40032-931",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20150814",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204602",
"LabelerName": "Novel laboratories, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Attention Deficit Disorders, Narcolepsy. Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate Hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.",
"Description": "Methylphenidate HCl oral solution, is a mild central nervous system (CNS) stimulant, available as 5 mg/5 mL and 10 mg/5 mL oral solutions for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white to off white powder. It is soluble in water, alcohol, and chloroform. Each mL of Methylphenidate Hydrochloride Oral Solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP. Each mL of Methylphenidate Hydrochloride Oral Solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. In addition, Methylphenidate Hydrochloride Oral Solution also contains the following inactive ingredients: PEG 1450, glycerin, phosphoric acid, grape flavor, and purified water."
},
{
"NDCCode": "43386-931-05",
"PackageDescription": "500 mL in 1 BOTTLE (43386-931-05) ",
"NDC11Code": "43386-0931-05",
"ProductNDC": "43386-931",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20151215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204602",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2023-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151215",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride oral solution is indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older, 2 Narcolepsy.",
"Description": "Methylphenidate hydrochloride oral solution contains methylphenidate hydrochloride a CNS stimulant. It is available as an oral solution in 5 mg/5 mL and 10 mg/5 mL strengths for oral administration. Chemically, methylphenidate hydrochloride is (d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride and its structural formula is. Methylphenidate hydrochloride, USP is a white to off white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride, USP. Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. Methylphenidate hydrochloride oral solution also contains the following inactive ingredients: PEG 1450, glycerin, phosphoric acid grape flavor, and purified water."
},
{
"NDCCode": "49884-931-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (49884-931-05)",
"NDC11Code": "49884-0931-05",
"ProductNDC": "49884-931",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078381",
"LabelerName": "Par Pharmaceutical Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "5; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2017-01-05",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Amlodipine besylate and benazepril hydrochloride capsules is a combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting enzyme (ACE) inhibitor. Amlodipine besylate and benazepril hydrochloride capsules is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.( 1).",
"Description": "Amlodipine besylate and benazepril hydrochloride capsules is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)¬propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its molecular formula is C 24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4 dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C 20H25CIN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine besylate and benazepril hydrochloride capsules are formulated in six different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, gelatin, hydrogenated castor oil, lactose monohydrate, magnesium stearate, microcrystalline cellulose, partially pregelatinized maize starch, polysorbate 80, sodium starch glycolate, titanium dioxide, and Opadry ClearYS-1-19025-A containing: hypromellose and polyethylene glycol 400. The 2.5 mg/10 mg capsule also contains FD&C green #3, FD&C red #40, and D&C yellow #10; the 5 mg/10 mg capsule also contains D&C red #28, FD&C red #40, and D&C yellow # 10; the 5 mg/20 mg capsule also contains FD&C blue #1 and FD&C red #40; the 10 mg/20 mg capsule also contains FD&C blue #1 and D&C red #28; the 5 mg/40 mg and the 10 mg/40 mg capsules also contains FD&C blue #1 and D&C red #28. The capsules also have printing in edible black ink which contains the following ingredients:, iron oxide black, propylene glycol, shellac glaze, FD&C blue #1, FD&C blue #2, FD&C red #40, and D&C yellow #10."
},
{
"NDCCode": "54458-931-05",
"PackageDescription": "360 TABLET in 1 CARTON (54458-931-05)",
"NDC11Code": "54458-0931-05",
"ProductNDC": "54458-931",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077877",
"LabelerName": "International Labs, Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-02-06"
},
{
"NDCCode": "58657-931-05",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (58657-931-05) / 10 TABLET in 1 BLISTER PACK (58657-931-10) ",
"NDC11Code": "58657-0931-05",
"ProductNDC": "58657-931",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212378",
"LabelerName": "Method Pharmaceuticals LLC",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250601",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg or 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, zinc stearate."
},
{
"NDCCode": "61919-931-05",
"PackageDescription": "5 mL in 1 BOTTLE (61919-931-05) ",
"NDC11Code": "61919-0931-05",
"ProductNDC": "61919-931",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin",
"DosageFormName": "SOLUTION",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078222",
"LabelerName": "DIRECT RX",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20140101",
"SamplePackage": "N",
"IndicationAndUsage": "Ofloxacin Otic Solution, 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below. Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus. Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa, and Staphylococcus aureus. Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus, and Streptococcus pneumoniae.",
"Description": "Ofloxacin Otic Solution, 0.3% is a sterile aqueous anti-infective (anti-bacterial) solution for otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated carboxyquinolone with a benzoxazine ring. The chemical name of ofloxacin is: (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid. The empirical formula of ofloxacin is C18H20FN3O4 and its molecular weight is 361.38. The structural formula is. [chemical]. Each mL of Ofloxacin Otic Solution contains 0.3% (3 mg/mL) ofloxacin with benzalkonium chloride (0.0025%), sodium chloride (0.9%), and water for injection. Hydrochloric acid and sodium hydroxide are added to adjust the pH to 6.5 ± 0.5."
},
{
"NDCCode": "67877-931-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (67877-931-05) ",
"NDC11Code": "67877-0931-05",
"ProductNDC": "67877-931",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213320",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "850",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2025-08-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250825",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients hypromellose, magnesium stearate, polyethylene glycol/macrogol, povidone, titanium dioxide and artificial blackberry flavor (maltodextrin, triacetin and artificial flavors). Metformin hydrochloride tablets dissolution USP Test-1 is used."
},
{
"NDCCode": "68428-931-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-931-05)",
"NDC11Code": "68428-0931-05",
"ProductNDC": "68428-931",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Derris Pinnata",
"NonProprietaryName": "Dalbergia Pinnata Root",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "DALBERGIA PINNATA ROOT",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "72603-931-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (72603-931-05) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "72603-0931-05",
"ProductNDC": "72603-931",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brimonidine Tartrate And Timolol Maleate",
"NonProprietaryName": "Brimonidine Tartrate And Timolol Maleate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20231123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201949",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "BRIMONIDINE TARTRATE; TIMOLOL MALEATE",
"StrengthNumber": "2; 5",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Antagonists [MoA], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260424",
"SamplePackage": "N",
"IndicationAndUsage": "Brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP.The IOP-lowering of brimonidine tartrate/timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.",
"Description": "Brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5%, sterile, contains brimonidine tartrate, a relatively selective alpha-2 adrenergic receptor agonist, and timolol maleate, a non-selective beta-adrenergic receptor inhibitor (topical intraocular pressure lowering agent) for topical ophthalmic use. The structural formulae are: Brimonidine tartrate. 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24 Timolol maleate. (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)-oxy]-2-propanol maleate (1:1) (salt); MW= 432.50 as the maleate salt In solution, brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5% has a clear, greenish-yellow color. It has an osmolality of 260-330 mOsmol/kg and a pH during its shelf life of 6.5-7.3. Brimonidine tartrate appears as an off-white, or white to pale-yellow powder and is soluble in both water (1.5 mg/mL) and in the product vehicle (3 mg/mL) at pH 7.2. Timolol maleate appears as a white, odorless, crystalline powder and is soluble in water, methanol, and alcohol. Each mL of brimonidine tartrate/timolol maleate ophthalmic solution contains the active ingredients brimonidine tartrate 0.2% and timolol 0.5% (6.8 mg/mL timolol maleate) with the inactive ingredients benzalkonium chloride 0.005%; sodium phosphate, dibasic heptahydrate; sodium phosphate, monobasic monohydrate; water for injection; and hydrochloric acid and/or sodium hydroxide to adjust pH."
},
{
"NDCCode": "84682-931-05",
"PackageDescription": "100 g in 1 BOX (84682-931-05) ",
"NDC11Code": "84682-0931-05",
"ProductNDC": "84682-931",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Vitamin C Eye Cream",
"NonProprietaryName": "Trstay Vitamin C Eye Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241107",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Zhixin Trade Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241107",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84756-931-05",
"PackageDescription": "100 mL in 1 BOTTLE (84756-931-05) ",
"NDC11Code": "84756-0931-05",
"ProductNDC": "84756-931",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Hair Growth Oil",
"NonProprietaryName": "Trstay Hair Growth Oil",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Xinqian E Commerce Co Ltd",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241213",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "12714-931-40",
"PackageDescription": "7 mg in 1 BLISTER PACK (12714-931-40) ",
"NDC11Code": "12714-0931-40",
"ProductNDC": "12714-931",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Telmisartan",
"DosageFormName": "TABLET",
"StartMarketingDate": "20001201",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Boehringer Ingelheim Pharma GmbH and Co. KG",
"SubstanceName": "TELMISARTAN",
"StrengthNumber": "40",
"StrengthUnit": "mg/40mg",
"Status": "Unfinished",
"LastUpdate": "2025-05-01",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-DEC-00"
},
{
"NDCCode": "12714-931-41",
"PackageDescription": "28 mg in 1 BLISTER PACK (12714-931-41) ",
"NDC11Code": "12714-0931-41",
"ProductNDC": "12714-931",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Telmisartan",
"DosageFormName": "TABLET",
"StartMarketingDate": "20001201",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Boehringer Ingelheim Pharma GmbH and Co. KG",
"SubstanceName": "TELMISARTAN",
"StrengthNumber": "40",
"StrengthUnit": "mg/40mg",
"Status": "Unfinished",
"LastUpdate": "2025-05-01",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-DEC-00"
},
{
"NDCCode": "47682-931-50",
"PackageDescription": "50 PACKET in 1 BOX (47682-931-50) > .8 mL in 1 PACKET",
"NDC11Code": "47682-0931-50",
"ProductNDC": "47682-931",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medi-first Plus Sterile Alcohol Pads",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111223",
"EndMarketingDate": "20210101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Unifirst First Aid Corporation",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20111223",
"EndMarketingDatePackage": "20210101",
"SamplePackage": "N"
},
{
"NDCCode": "51407-931-11",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (51407-931-11) / 26 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "51407-0931-11",
"ProductNDC": "51407-931",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imuldosa",
"NonProprietaryName": "Ustekinumab-srlf",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20241010",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761364",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "USTEKINUMAB-SRLF",
"StrengthNumber": "130",
"StrengthUnit": "mg/26mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250618",
"SamplePackage": "N",
"IndicationAndUsage": "IMULDOSA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. ( 1.1) active psoriatic arthritis (PsA). ( 1.2) moderately to severely active Crohn’s disease (CD). ( 1.3) moderately to severely active ulcerative colitis. ( 1.4) Pediatric patients 6 years and older with: moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy. ( 1.1) active psoriatic arthritis (PsA). ( 1.2).",
"Description": "Ustekinumab-srlf, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-srlf is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-srlf is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. IMULDOSA (ustekinumab-srlf) injection is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellow solution with pH of 5.7- 6.3. IMULDOSA for Subcutaneous Use Available as 45 mg of ustekinumab-srlf in 0.5 mL and 90 mg of ustekinumab-srlf in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29-gauge fixed ½ inch needle. The syringe is fitted with a passive needle guard and a needle cover that does not contains latex. Each 0.5 mL prefilled syringe delivers 45 mg ustekinumab-srlf, histidine (2.23 mg) and L-histidine hydrochloride monohydrate (4.14 mg), polysorbate 80 (0.02 mg), and sucrose (25.9 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-srlf, histidine (4.46 mg) and L-histidine hydrochloride monohydrate (8.28 mg), polysorbate 80 (0.04 mg), and sucrose (51.8 mg). IMULDOSA for Intravenous Infusion Available as 130 mg of ustekinumab-srlf in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-srlf, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), Polysorbate 80 (10.4 mg) and sucrose (2,210 mg)."
},
{
"NDCCode": "55319-931-15",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (55319-931-15) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "55319-0931-15",
"ProductNDC": "55319-931",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Relief",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20191115",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Family Dollar Services Inc",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2023-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20191115",
"SamplePackage": "N"
},
{
"NDCCode": "55700-931-15",
"PackageDescription": "1 BOTTLE in 1 CARTON (55700-931-15) > 150 mL in 1 BOTTLE",
"NDC11Code": "55700-0931-15",
"ProductNDC": "55700-931",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium 1.5%",
"NonProprietaryName": "Diclofenac Sodium Topical",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20211027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204132",
"LabelerName": "Quality Care Products, LLC",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "16.05",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20211027",
"SamplePackage": "N",
"IndicationAndUsage": "Diclofenac sodium is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1).",
"Description": "Diclofenac Sodium Topical Solution USP, 1.5% w/w is a nonsteroidal anti-inflammatory drug, available as a clear, colorless to faintly pink orange solution for topical application. Diclofenac Sodium Topical Solution USP contains 1.5% w/w diclofenac sodium, a benzeneacetic acid derivative that is a nonsteroidal anti-inflammatory drug (NSAID), designated chemically as 2-[(2,6-dichlorophenyl)amino]-benzeneacetic acid, monosodium salt. It is a white to off-white crystalline powder, hygroscopic that is freely soluble in methanol, soluble in ethanol (96 %), sparingly soluble in water, practically insoluble in chloroform and in ether. The molecular weight is 318.14. Its molecular formula is C 14H 10Cl 2NNaO 2 and it has the following structural formula:. Each 1 mL of solution contains 16.05 mg of diclofenac sodium. The inactive ingredients in diclofenac sodium topical solution USP include: alcohol, dimethyl sulfoxide (DMSO, 45.5% w/w), glycerin, propylene glycol and purified water."
},
{
"NDCCode": "58657-931-01",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (58657-931-01) / 10 TABLET in 1 BLISTER PACK (58657-931-10) ",
"NDC11Code": "58657-0931-01",
"ProductNDC": "58657-931",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212378",
"LabelerName": "Method Pharmaceuticals LLC",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250601",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg or 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, zinc stearate."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>16590-931-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (16590-931-05) > 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>16590-0931-05</NDC11Code>
<ProductNDC>16590-931</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ofloxacin</ProprietaryName>
<NonProprietaryName>Ofloxacin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20080317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076616</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>OFLOXACIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ofloxacin Otic Solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below. Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aereus. Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa and Staphylococcus aureus. Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus, and Streptococcus pneumoniae.</IndicationAndUsage>
<Description>Ofloxacin Otic Solution 0.3% is a sterile aqueous anti-infective (anti-bacterial) solution for otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated carboxyquinolone with a benzoxazine ring. The chemical name of ofloxacin is (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4-benzoxazine-6- carboxylic acid. The empirical formula of ofloxacin is C18H20FN3O4 and its molecular weight is 361.38. The structural formula is. Ofloxacin Otic Solution contains. Active: Ofloxacin 0.3% (3 mg/mL). Preservative: Benzalkonium chloride (0.0025%). Inactives: Purified water and sodium chloride. Hydrochloric acid and sodium hydroxide added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>16590-002-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (16590-002-05) > 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>16590-0002-05</NDC11Code>
<ProductNDC>16590-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acular</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19921201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019700</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>ACULAR® ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. ACULAR® ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.</IndicationAndUsage>
<Description>ACULAR® (ketorolac tromethamine ophthalmic solution) is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure:. ACULAR® ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. ACULAR® ophthalmic solution is a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.40. The osmolality of ACULAR® ophthalmic solution is 290 mOsml/kg. Each mL of ACULAR® ophthalmic solution contains: Active: ketorolac tromethamine 0.5%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium 0.1%; octoxynol 40; purified water; sodium chloride; and hydrochloric acid and/or sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>16590-007-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (16590-007-05) > 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>16590-0007-05</NDC11Code>
<ProductNDC>16590-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alrex</ProprietaryName>
<NonProprietaryName>Loteprednol Etabonate</NonProprietaryName>
<DosageFormName>SUSPENSION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19980309</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020803</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>LOTEPREDNOL ETABONATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>ALREX Ophthalmic Suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.</IndicationAndUsage>
<Description>ALREX® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. C24H31ClO7Mol. Wt. 466.96. Chemical Name. chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 2 mg (0.2%);. INACTIVES: Edetate Disodium, Glycerin, Povidone, Purified Water and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.4-5.5. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.</Description>
</NDC>
<NDC>
<NDCCode>16590-043-05</NDCCode>
<PackageDescription>5 CAPSULE in 1 BOTTLE (16590-043-05)</PackageDescription>
<NDC11Code>16590-0043-05</NDC11Code>
<ProductNDC>16590-043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefadroxil</ProprietaryName>
<NonProprietaryName>Cefadroxil</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065352</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>CEFADROXIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Cefadroxil capsules contain the following inactive ingredients: Lactose monohydrate, magnesium stearate, FD&C Blue No.1, D&C Red No.28, FD&C Red No. 40, titanium dioxide, gelatin, sodium lauryl sulphate, and edible black ink (black iron oxide).</Description>
</NDC>
<NDC>
<NDCCode>16590-068-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (16590-068-05) > 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>16590-0068-05</NDC11Code>
<ProductNDC>16590-068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
<NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19960726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040069</ApplicationNumber>
<LabelerName>Stat Rx USA</LabelerName>
<SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of the following conditions. Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical or thermal burns, or penetration of foreign bodies. Steroid responsive inflammatory conditions of the external auditory meatus, such as allergic otitis externa, selected purulent and nonpurulent infective otitis externa when the hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.</IndicationAndUsage>
<Description>Dexamethasone Sodium Phosphate Ophthalmic Solution USP, is a sterile, topical steroid solution. The active ingredient is represented by the following structural formula. C22H28FNa2O8P. Mol. wt. 516.41. Chemical Name: 9-fluoro-11β, 17-dihydroxy-16α-methyl-21-[phosphonooxy]pregna-1, 4-diene-3,20-dione disodium salt. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic. Dexamethasone is a synthetic analog of naturally occurring glucocorticoids (hydrocortisone and cortisone). Dexamethasone sodium phosphate is a water soluble, inorganic ester of dexamethasone. It is approximately three thousand times more soluble at 25°C than hydrocortisone. Each mL Contains: ACTIVE: Dexamethasone Sodium Phosphate, [equivalent to 1 mg (0.1%) Dexamethasone Phosphate]. INACTIVES: Sodium Citrate, Sodium Borate, Creatinine, Polysorbate 80, Edetate Disodium Dihydrate, Purified Water. Hydrochloric Acid may be added to adjust pH (6.6 - 7.8). PRESERVATIVES ADDED: Sodium Bisulfite 0.1%, Phenylethyl Alcohol 0.25%, Benzalkonium Chloride 0.02%.</Description>
</NDC>
<NDC>
<NDCCode>16590-167-05</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE (16590-167-05)</PackageDescription>
<NDC11Code>16590-0167-05</NDC11Code>
<ProductNDC>16590-167</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone</ProprietaryName>
<NonProprietaryName>Neomycin, Polymyxin B And Dexamethasone</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19840522</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062341</ApplicationNumber>
<LabelerName>STAT RX LLC USA</LabelerName>
<SubstanceName>NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE</SubstanceName>
<StrengthNumber>3.5; 10000; 1</StrengthNumber>
<StrengthUnit>mg/mL; U/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens and streptococci, including Streptococcus pneumoniae.</IndicationAndUsage>
<Description>Neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. The chemical structure for the active ingredient, dexamethasone, is. Established Name. dexamethasone. Chemical Name. pregna-1, 4-diene-3, 20-dione, 9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-. The other active ingredients are neomycin sulfate and polymyxin B sulfate. Each mL contains: Actives: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Preservative: benzalkonium chloride 0.004%. Vehicle: hypromellose 2910 0.5%. Inactives: sodium chloride, polysorbate 20, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water.</Description>
</NDC>
<NDC>
<NDCCode>16590-175-05</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, DROPPER (16590-175-05)</PackageDescription>
<NDC11Code>16590-0175-05</NDC11Code>
<ProductNDC>16590-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ofloxacin</ProprietaryName>
<NonProprietaryName>Ofloxacin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20040514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076615</ApplicationNumber>
<LabelerName>STAT RX LLC USA</LabelerName>
<SubstanceName>OFLOXACIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:. *Efficacy for this organism was studied in fewer than 10 infections.</IndicationAndUsage>
<Description>Ofloxacin ophthalmic solution 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use. (±)-9-Fluoro-2, 3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4 benzoxazine-6-carboxylic acid. Contains. Active: ofloxacin 0.3% (3 mg/mL). Preservative: benzalkonium chloride (0.005%). Inactives: sodium chloride and purified water. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. Ofloxacin ophthalmic solution is unbuffered and formulated with a pH of 6.4 (range - 6.0 to 6.8). It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure.</Description>
</NDC>
<NDC>
<NDCCode>16590-224-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (16590-224-05) > 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>16590-0224-05</NDC11Code>
<ProductNDC>16590-224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobramycin</ProprietaryName>
<NonProprietaryName>Tobramycin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19960131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064096</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>TOBRAMYCIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tobramycin Ophthalmic Solution USP, 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobramycin Ophthalmic Solution USP, 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in pediatric patients.</IndicationAndUsage>
<Description>Tobramycin Ophthalmic Solution USP, 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Tobramycin is a water soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. The molecular formula is C18H37N5O9, the molecular weight is 467.52 and the structural formula is:. Chemical Name. O-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1 → 4)}-O-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1 → 6)}-2- deoxystreptamine. Each mL contains. Active: Tobramycin 3 mg (0.3%). Inactives: Boric Acid, Sodium Chloride, Sodium Sulfate, Tyloxapol, Sodium Hydroxide and/or Sulfuric Acid to adjust pH (7.0 to 8.0), and Purified Water USP. Preservative: Benzalkonium Chloride 0.1 mg (0.01%).</Description>
</NDC>
<NDC>
<NDCCode>16590-376-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (16590-376-05) > 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>16590-0376-05</NDC11Code>
<ProductNDC>16590-376</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20091105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078434</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ketorolac Tromethamine Ophthalmic Solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac Tromethamine Ophthalmic Solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.</IndicationAndUsage>
<Description>Ketorolac Tromethamine Ophthalmic Solution is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-benzoyl-2, 3-dihydro-1H pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-l,3-propanediol(1:1) and it has the following structural formula:. The molecular formula of Ketorolac Tromethamine Ophthalmic Solution is C15H13NO3C4H11NO3. Ketorolac Tromethamine Ophthalmic Solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac Tromethamine Ophthalmic Solution is a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of Ketorolac Ophthalmic Solution is 290 mOsml/kg. Each mL of Ketorolac Tromethamine Ophthalmic Solution contains:. Active: ketorolac tromethamine 0.5%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium 0.1%; octoxynol 40; sodium chloride; hydrochloric acid and/or sodium hydroxide may be added to adjust the pH (6.8-7.4) and purified water.</Description>
</NDC>
<NDC>
<NDCCode>16590-421-05</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, PLASTIC (16590-421-05)</PackageDescription>
<NDC11Code>16590-0421-05</NDC11Code>
<ProductNDC>16590-421</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin Hydrochloride</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20040507</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019992</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ciprofloxacin Hydrochloride Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Corneal Ulcers:. Pseudomonas aeruginosa. Serratia marcescens*. Staphylococcus aureus. Staphylococcus epidermidis. Streptococcus pneumoniae. Streptococcus (Viridans Group)*. Conjunctivitis:. Haemophilus influenzae. Staphylococcus aureus. Staphylococcus epidermidis. Streptococcus pneumoniae. *Efficacy for this organism was studied in fewer than 10 infections.</IndicationAndUsage>
<Description>Ciprofloxacin Hydrochloride Ophthalmic Solution is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid. It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each mL of Ciprofloxacin Hydrochloride Ophthalmic Solution contains: Active: ciprofloxacin HCl 3.5 mg equivalent to 3 mg base. Preservative: benzalkonium chloride 0.006%. Inactive: sodium acetate, acetic acid, mannitol 4.6%, edetate disodium 0.05%, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm.</Description>
</NDC>
<NDC>
<NDCCode>16590-881-05</NDCCode>
<PackageDescription>5 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (16590-881-05)</PackageDescription>
<NDC11Code>16590-0881-05</NDC11Code>
<ProductNDC>16590-881</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Avelox Abc Pack</ProprietaryName>
<NonProprietaryName>Moxifloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19991210</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021085</ApplicationNumber>
<LabelerName>Stat Rx USA</LabelerName>
<SubstanceName>MOXIFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>AVELOX Tablets and I.V. are indicated for the treatment of adults (≥ 18 years of age) with infections caused by susceptible strains of the designated microorganisms in the conditions listed below. (See DOSAGE AND ADMINISTRATION for specific recommendations. In addition, for I.V. use, see PRECAUTIONS, Geriatric Use.). Acute Bacterial Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis. Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus, or Moraxella catarrhalis. Community Acquired Pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant strains*), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydia pneumoniae. * MDRSP, Multi-drug resistant Streptococcus pneumoniae includes isolates previously known as PRSP (Penicillin-resistant S. pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC ≥ 2 µg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. Uncomplicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes. Complicated Intra-Abdominal Infections including polymicrobial infections such as abscess caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus species. Complicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae (See Clinical Studies). Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. Therapy with AVELOX may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVELOX and other antibacterial drugs, AVELOX 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>AVELOX (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and is available as AVELOX Tablets for oral administration and as AVELOX I.V. for intravenous administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow crystalline substance with a molecular weight of 437.9. Its empirical formula is C21H24FN3O4*HCl and its chemical structure is as follows. AVELOX Tablets are available as film-coated tablets containing moxifloxacin hydrochloride (equivalent to 400 mg moxifloxacin). The inactive ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and ferric oxide. AVELOX I.V. is available in ready-to-use 250 mL latex-free flexibags as a sterile, preservative free, 0.8% sodium chloride aqueous solution of moxifloxacin hydrochloride (containing 400 mg moxifloxacin) with pH ranging from 4.1 to 4.6. The appearance of the intravenous solution is yellow. The color does not affect, nor is it indicative of, product stability. The inactive ingredients are sodium chloride, USP, Water for Injection, USP, and may include hydrochloric acid and/or sodium hydroxide for pH adjustment. AVELOX I.V. contains approximately 34.2 mEq (787 mg) of sodium in 250 mL.</Description>
</NDC>
<NDC>
<NDCCode>31382-931-05</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (31382-931-05) > 10 CARTRIDGE in 1 BLISTER PACK > 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>31382-0931-05</NDC11Code>
<ProductNDC>31382-931</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbocaine With Neo-cobefrin</ProprietaryName>
<NonProprietaryName>Mepivacaine Hydrochloride And Levonordefrin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20110101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088388</ApplicationNumber>
<LabelerName>Caresteam Health, Inc.</LabelerName>
<SubstanceName>MEPIVACAINE HYDROCHLORIDE; LEVONORDEFRIN</SubstanceName>
<StrengthNumber>20; .05</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>CARBOCAINE is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients.</IndicationAndUsage>
<Description>CARBOCAINE (mepivacaine hydrochloride), a tertiary amine used as a local anesthetic, is 1-methyl-2', 6' - pipecoloxylidide monohydrochloride with the following structural formula. It is a white, crystalline, odorless powder soluble in water, but very resistant to both acid and alkaline hydrolysis. NEO-COBEFRIN, a sympathomimetic amine used as a vasoconstrictor in local anesthetic solution, is (-)--(1-Aminoethyl)-3, 4-dihydroxybenzyl alcohol with the following structural formula. It is a white or buff-colored crystalline solid, freely soluble in aqueous solutions of mineral acids, but practically insoluble in water. DENTAL CARTRIDGES MAY NOT BE AUTOCLAVED. CARBOCAINE 3% injection and CARBOCAINE 2% with NEO-COBEFRIN 1:20,000 injection are sterile solutions for injection.</Description>
</NDC>
<NDC>
<NDCCode>40032-931-05</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (40032-931-05)</PackageDescription>
<NDC11Code>40032-0931-05</NDC11Code>
<ProductNDC>40032-931</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150814</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204602</ApplicationNumber>
<LabelerName>Novel laboratories, Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Attention Deficit Disorders, Narcolepsy. Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate Hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.</IndicationAndUsage>
<Description>Methylphenidate HCl oral solution, is a mild central nervous system (CNS) stimulant, available as 5 mg/5 mL and 10 mg/5 mL oral solutions for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white to off white powder. It is soluble in water, alcohol, and chloroform. Each mL of Methylphenidate Hydrochloride Oral Solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP. Each mL of Methylphenidate Hydrochloride Oral Solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. In addition, Methylphenidate Hydrochloride Oral Solution also contains the following inactive ingredients: PEG 1450, glycerin, phosphoric acid, grape flavor, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>43386-931-05</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (43386-931-05) </PackageDescription>
<NDC11Code>43386-0931-05</NDC11Code>
<ProductNDC>43386-931</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204602</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride oral solution is indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older, 2 Narcolepsy.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride oral solution contains methylphenidate hydrochloride a CNS stimulant. It is available as an oral solution in 5 mg/5 mL and 10 mg/5 mL strengths for oral administration. Chemically, methylphenidate hydrochloride is (d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride and its structural formula is. Methylphenidate hydrochloride, USP is a white to off white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride, USP. Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. Methylphenidate hydrochloride oral solution also contains the following inactive ingredients: PEG 1450, glycerin, phosphoric acid grape flavor, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>49884-931-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (49884-931-05)</PackageDescription>
<NDC11Code>49884-0931-05</NDC11Code>
<ProductNDC>49884-931</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078381</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-05</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amlodipine besylate and benazepril hydrochloride capsules is a combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting enzyme (ACE) inhibitor. Amlodipine besylate and benazepril hydrochloride capsules is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.( 1).</IndicationAndUsage>
<Description>Amlodipine besylate and benazepril hydrochloride capsules is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)¬propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its molecular formula is C 24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4 dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C 20H25CIN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine besylate and benazepril hydrochloride capsules are formulated in six different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, gelatin, hydrogenated castor oil, lactose monohydrate, magnesium stearate, microcrystalline cellulose, partially pregelatinized maize starch, polysorbate 80, sodium starch glycolate, titanium dioxide, and Opadry ClearYS-1-19025-A containing: hypromellose and polyethylene glycol 400. The 2.5 mg/10 mg capsule also contains FD&C green #3, FD&C red #40, and D&C yellow #10; the 5 mg/10 mg capsule also contains D&C red #28, FD&C red #40, and D&C yellow # 10; the 5 mg/20 mg capsule also contains FD&C blue #1 and FD&C red #40; the 10 mg/20 mg capsule also contains FD&C blue #1 and D&C red #28; the 5 mg/40 mg and the 10 mg/40 mg capsules also contains FD&C blue #1 and D&C red #28. The capsules also have printing in edible black ink which contains the following ingredients:, iron oxide black, propylene glycol, shellac glaze, FD&C blue #1, FD&C blue #2, FD&C red #40, and D&C yellow #10.</Description>
</NDC>
<NDC>
<NDCCode>54458-931-05</NDCCode>
<PackageDescription>360 TABLET in 1 CARTON (54458-931-05)</PackageDescription>
<NDC11Code>54458-0931-05</NDC11Code>
<ProductNDC>54458-931</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077877</ApplicationNumber>
<LabelerName>International Labs, Inc.</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-02-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>58657-931-05</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (58657-931-05) / 10 TABLET in 1 BLISTER PACK (58657-931-10) </PackageDescription>
<NDC11Code>58657-0931-05</NDC11Code>
<ProductNDC>58657-931</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212378</ApplicationNumber>
<LabelerName>Method Pharmaceuticals LLC</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg or 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, zinc stearate.</Description>
</NDC>
<NDC>
<NDCCode>61919-931-05</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE (61919-931-05) </PackageDescription>
<NDC11Code>61919-0931-05</NDC11Code>
<ProductNDC>61919-931</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ofloxacin</ProprietaryName>
<NonProprietaryName>Ofloxacin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078222</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>OFLOXACIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ofloxacin Otic Solution, 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below. Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus. Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa, and Staphylococcus aureus. Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus, and Streptococcus pneumoniae.</IndicationAndUsage>
<Description>Ofloxacin Otic Solution, 0.3% is a sterile aqueous anti-infective (anti-bacterial) solution for otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated carboxyquinolone with a benzoxazine ring. The chemical name of ofloxacin is: (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid. The empirical formula of ofloxacin is C18H20FN3O4 and its molecular weight is 361.38. The structural formula is. [chemical]. Each mL of Ofloxacin Otic Solution contains 0.3% (3 mg/mL) ofloxacin with benzalkonium chloride (0.0025%), sodium chloride (0.9%), and water for injection. Hydrochloric acid and sodium hydroxide are added to adjust the pH to 6.5 ± 0.5.</Description>
</NDC>
<NDC>
<NDCCode>67877-931-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (67877-931-05) </PackageDescription>
<NDC11Code>67877-0931-05</NDC11Code>
<ProductNDC>67877-931</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213320</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>850</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients hypromellose, magnesium stearate, polyethylene glycol/macrogol, povidone, titanium dioxide and artificial blackberry flavor (maltodextrin, triacetin and artificial flavors). Metformin hydrochloride tablets dissolution USP Test-1 is used.</Description>
</NDC>
<NDC>
<NDCCode>68428-931-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-931-05)</PackageDescription>
<NDC11Code>68428-0931-05</NDC11Code>
<ProductNDC>68428-931</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Derris Pinnata</ProprietaryName>
<NonProprietaryName>Dalbergia Pinnata Root</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>DALBERGIA PINNATA ROOT</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-29</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>72603-931-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (72603-931-05) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>72603-0931-05</NDC11Code>
<ProductNDC>72603-931</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brimonidine Tartrate And Timolol Maleate</ProprietaryName>
<NonProprietaryName>Brimonidine Tartrate And Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20231123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201949</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>BRIMONIDINE TARTRATE; TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>2; 5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Antagonists [MoA], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP.The IOP-lowering of brimonidine tartrate/timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.</IndicationAndUsage>
<Description>Brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5%, sterile, contains brimonidine tartrate, a relatively selective alpha-2 adrenergic receptor agonist, and timolol maleate, a non-selective beta-adrenergic receptor inhibitor (topical intraocular pressure lowering agent) for topical ophthalmic use. The structural formulae are: Brimonidine tartrate. 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24 Timolol maleate. (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)-oxy]-2-propanol maleate (1:1) (salt); MW= 432.50 as the maleate salt In solution, brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5% has a clear, greenish-yellow color. It has an osmolality of 260-330 mOsmol/kg and a pH during its shelf life of 6.5-7.3. Brimonidine tartrate appears as an off-white, or white to pale-yellow powder and is soluble in both water (1.5 mg/mL) and in the product vehicle (3 mg/mL) at pH 7.2. Timolol maleate appears as a white, odorless, crystalline powder and is soluble in water, methanol, and alcohol. Each mL of brimonidine tartrate/timolol maleate ophthalmic solution contains the active ingredients brimonidine tartrate 0.2% and timolol 0.5% (6.8 mg/mL timolol maleate) with the inactive ingredients benzalkonium chloride 0.005%; sodium phosphate, dibasic heptahydrate; sodium phosphate, monobasic monohydrate; water for injection; and hydrochloric acid and/or sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>84682-931-05</NDCCode>
<PackageDescription>100 g in 1 BOX (84682-931-05) </PackageDescription>
<NDC11Code>84682-0931-05</NDC11Code>
<ProductNDC>84682-931</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Vitamin C Eye Cream</ProprietaryName>
<NonProprietaryName>Trstay Vitamin C Eye Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241107</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Zhixin Trade Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84756-931-05</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (84756-931-05) </PackageDescription>
<NDC11Code>84756-0931-05</NDC11Code>
<ProductNDC>84756-931</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Hair Growth Oil</ProprietaryName>
<NonProprietaryName>Trstay Hair Growth Oil</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>12714-931-40</NDCCode>
<PackageDescription>7 mg in 1 BLISTER PACK (12714-931-40) </PackageDescription>
<NDC11Code>12714-0931-40</NDC11Code>
<ProductNDC>12714-931</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Telmisartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20001201</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Boehringer Ingelheim Pharma GmbH and Co. KG</LabelerName>
<SubstanceName>TELMISARTAN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/40mg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-05-01</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-DEC-00</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>12714-931-41</NDCCode>
<PackageDescription>28 mg in 1 BLISTER PACK (12714-931-41) </PackageDescription>
<NDC11Code>12714-0931-41</NDC11Code>
<ProductNDC>12714-931</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Telmisartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20001201</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Boehringer Ingelheim Pharma GmbH and Co. KG</LabelerName>
<SubstanceName>TELMISARTAN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/40mg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-05-01</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-DEC-00</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>47682-931-50</NDCCode>
<PackageDescription>50 PACKET in 1 BOX (47682-931-50) > .8 mL in 1 PACKET</PackageDescription>
<NDC11Code>47682-0931-50</NDC11Code>
<ProductNDC>47682-931</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medi-first Plus Sterile Alcohol Pads</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111223</StartMarketingDate>
<EndMarketingDate>20210101</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Unifirst First Aid Corporation</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20111223</StartMarketingDatePackage>
<EndMarketingDatePackage>20210101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51407-931-11</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (51407-931-11) / 26 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>51407-0931-11</NDC11Code>
<ProductNDC>51407-931</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imuldosa</ProprietaryName>
<NonProprietaryName>Ustekinumab-srlf</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20241010</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761364</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>USTEKINUMAB-SRLF</SubstanceName>
<StrengthNumber>130</StrengthNumber>
<StrengthUnit>mg/26mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IMULDOSA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. ( 1.1) active psoriatic arthritis (PsA). ( 1.2) moderately to severely active Crohn’s disease (CD). ( 1.3) moderately to severely active ulcerative colitis. ( 1.4) Pediatric patients 6 years and older with: moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy. ( 1.1) active psoriatic arthritis (PsA). ( 1.2).</IndicationAndUsage>
<Description>Ustekinumab-srlf, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-srlf is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-srlf is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. IMULDOSA (ustekinumab-srlf) injection is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellow solution with pH of 5.7- 6.3. IMULDOSA for Subcutaneous Use Available as 45 mg of ustekinumab-srlf in 0.5 mL and 90 mg of ustekinumab-srlf in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29-gauge fixed ½ inch needle. The syringe is fitted with a passive needle guard and a needle cover that does not contains latex. Each 0.5 mL prefilled syringe delivers 45 mg ustekinumab-srlf, histidine (2.23 mg) and L-histidine hydrochloride monohydrate (4.14 mg), polysorbate 80 (0.02 mg), and sucrose (25.9 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-srlf, histidine (4.46 mg) and L-histidine hydrochloride monohydrate (8.28 mg), polysorbate 80 (0.04 mg), and sucrose (51.8 mg). IMULDOSA for Intravenous Infusion Available as 130 mg of ustekinumab-srlf in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-srlf, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), Polysorbate 80 (10.4 mg) and sucrose (2,210 mg).</Description>
</NDC>
<NDC>
<NDCCode>55319-931-15</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (55319-931-15) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>55319-0931-15</NDC11Code>
<ProductNDC>55319-931</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Relief</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Family Dollar Services Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55700-931-15</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55700-931-15) > 150 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>55700-0931-15</NDC11Code>
<ProductNDC>55700-931</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium 1.5%</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium Topical</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20211027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204132</ApplicationNumber>
<LabelerName>Quality Care Products, LLC</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>16.05</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac sodium is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1).</IndicationAndUsage>
<Description>Diclofenac Sodium Topical Solution USP, 1.5% w/w is a nonsteroidal anti-inflammatory drug, available as a clear, colorless to faintly pink orange solution for topical application. Diclofenac Sodium Topical Solution USP contains 1.5% w/w diclofenac sodium, a benzeneacetic acid derivative that is a nonsteroidal anti-inflammatory drug (NSAID), designated chemically as 2-[(2,6-dichlorophenyl)amino]-benzeneacetic acid, monosodium salt. It is a white to off-white crystalline powder, hygroscopic that is freely soluble in methanol, soluble in ethanol (96 %), sparingly soluble in water, practically insoluble in chloroform and in ether. The molecular weight is 318.14. Its molecular formula is C 14H 10Cl 2NNaO 2 and it has the following structural formula:. Each 1 mL of solution contains 16.05 mg of diclofenac sodium. The inactive ingredients in diclofenac sodium topical solution USP include: alcohol, dimethyl sulfoxide (DMSO, 45.5% w/w), glycerin, propylene glycol and purified water.</Description>
</NDC>
<NDC>
<NDCCode>58657-931-01</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (58657-931-01) / 10 TABLET in 1 BLISTER PACK (58657-931-10) </PackageDescription>
<NDC11Code>58657-0931-01</NDC11Code>
<ProductNDC>58657-931</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212378</ApplicationNumber>
<LabelerName>Method Pharmaceuticals LLC</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg or 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, zinc stearate.</Description>
</NDC>
</NDCList>